2025 Speakers

Ashwin Agarwal has served as Chief Financial Officer at Azura Ophthalmics since April 2021. Ashwin has over 25 years of financial, operations, investor relations, business strategy and leadership experience at both private and publicly traded companies spanning from early-stage to global, multi-billion organizations. Before joining, Azura Ophthalmics, Ashwin served as Vice President, Finance, Investor Relations, and Treasury at Evolus, Inc. During his tenure at Evolus, Ashwin strengthened the balance sheet by co-leading over $150M in public financing and driving organizational and operational efficiencies to accelerate revenue growth and improving cash flow. Prior to Evolus, Ashwin served as Vice President, Corporate Strategy for Alder Biopharmaceuticals, Inc. where he was responsible for investor relations, strategic financial planning, commercial market assessment and $250 million in public financing. Before Alder, Ashwin spent fifteen years at Allergan, Inc. in various finance and investor relations roles of increasing responsibility with his last role as Senior Director of Finance and Investor Relations. Ashwin began his career at KPMG where he spent three years in the auditing practice. He holds an MBA with an emphasis in Corporate Finance from the University of Southern California Marshall School of Business and a B.A. in Accounting from California State University, Fullerton.

Dr Åhnblad is a Medical Doctor trained at Karolinska University & University Hospital. He is inventor and patent holder of several medical devices for nasal applications.

Dr Åhnblad is also the founder and Chief Physician of Danvik ÖNH (ENT) Stockholm, and the inventor of Trigenas™ – the NosePlug platform for Nasal Drug Delivery.

Dr. Ali is Sr. Director of Scientific Affairs and Technical Marketing at Ascendia Pharma. He worked in the Pharma industry for over 30 years. His expertise includes synthesis and formulation of small molecules such as lipids and oncology drugs, liposomes and gene delivery, hot melt extrusion, spray drying among, self emulsifying drug delivery systems (SEDDS; SMEDDS).

Dr. Ali obtained his PhD in Chemistry from the City University of New York, NY, and continued his postdoctoral work in Physical Biochemistry and Biophysics at the University of Minnesota and Cornell University.  Dr. Ali served as a member of the editorial advisory board of several pharmaceutical journals. He is also the Editor-In-Chief of Journal of Analytical and Pharmaceutical Research. Dr. Ali is served as vice chair of the USP Council of Expert for Excipient Test Methods committee (2020-2025) and will continue as USP Council of Expert for Excipient Chapters in 2025-2030 cycle. Dr. Ali is the recipient of IPEC Foundation’s 2020 Henk de Jong industrial research award for his contributions to formulations and excipient technologies. He has published over 70 articles in scientific journals and is an inventor of several US and European patents. Dr. Ali is also an AAPS Fellow.

Dr. Christine Allen is CEO and co-founder of Intrepid Labs Inc., a company leveraging AI, automation, and deep pharmaceutical expertise to accelerate drug formulation and develop proprietary delivery technologies. Intrepid’s approach helps bring transformative medicines to patients faster, improving therapeutic outcomes and enhancing patient care.

Christine is also a full professor at the University of Toronto (U of T), internationally recognized for her contributions to drug formulation and development, with over 180 peer-reviewed publications. She is a distinguished fellow of both the American Institute for Medical and Biological Engineering and the Canadian Academy of Health Sciences. Christine has held significant leadership roles, including President of both the Controlled Release Society and the Canadian Society for Pharmaceutical Sciences, and Editor-in- Chief of the Journal of Controlled Release.

Her academic leadership includes serving as the inaugural Associate Vice-President and Vice Provost Strategic Initiatives and Interim Dean of the Leslie Dan Faculty of Pharmacy at U of T.

Jonathan has over 20 years of multidisciplinary experience in regulated medical products (drugs, biologics, medical devices, and combination products) at multiple global companies, with practical experience in drug delivery-focused Development/Engineering, Quality Assurance, and Regulatory Affairs for various combination product types. His specialties include digital health (including smart packaging/connected devices and software as a medical device, or SaMD) and in vitro diagnostics, along with clinical development (bridging) and lifecycle management for combination products. Jonathan earned his BS in Chemical Engineering from Northwestern University and is ASQ certified as a Manager of Quality/Organizational Excellence and a Quality Engineer. In his "free time,", Jonathan engages with the global combination product community by speaking at conferences, lecturing in courses, serving key roles within prominent industry organizations, and interfacing with regulators on a variety of topics.

Dr Mansoor M. Amiji serves as a University Distinguished Professor, Professor of Pharmaceutical Sciences, and Professor of Chemical Engineering at Northeastern University in Boston, Massachusetts. He earned his BS in Pharmacy from Northeastern University in 1988 and his PhD in Pharmaceutical Sciences from Purdue University in 1992.

At Northeastern, Dr Amiji educates both undergraduate and graduate students while leading cutting-edge research. His work focuses on developing biocompatible materials from natural and synthetic polymers, designing targeted drug and gene delivery systems for cancer and infectious diseases, and advancing nanotechnology applications for medical diagnosis, imaging, and therapeutics.

Dr Amiji has edited 14 books, contributed over 70 book chapters, and authored more than 400 peer- reviewed articles. Recognized as a Highly Cited Researcher (top 1%) in Pharmacology and Toxicology, he holds a Google H-index of 112. His accolades include the Nano Science and Technology Institute’s Award for Outstanding Contributions to Nanotechnology, Microtechnology, and Biotechnology, the American Association of Pharmaceutical Scientists (AAPS) Meritorious Manuscript Award, and the Controlled Release Society’s (CRS) Nagai Award. Dr Amiji is an elected Fellow of the American Association for the Advancement of Science (AAAS), the American Institute of Medical and Biological Engineering (AIMBE), AAPS, and CRS.

Dr. Patrick Anquetil is Portal Instrument’s CEO. He is a distinguished leader in the bioengineering field, renowned for developing world-class teams and successfully transitioning bioengineering enterprises from the conceptual stage to commercial success. Before establishing Portal, he co-founded two medical diagnostics companies: SynapDx and Aretais. His professional journey began as an equity research analyst at the boutique investment firm Susquehanna International Group, authoring and promoting equity research reports to portfolio managers and hedge funds. Dr. Anquetil is an accomplished academic, holding a Ph.D. in bio-instrumentation from the Massachusetts Institute of Technology (MIT), an MBA from Harvard Business School, and master's degrees from ETH Zurich and the University of Tokyo. He holds several patents and his scientific work has appeared in peer-reviewed publications as well as mainstream media, including MIT Technology Review, Wired Magazine, PBS, and CNBC.

Drew Applefield is a seasoned biotechnology professional with nearly two decades of diverse experience spanning research, consulting, investing, and business development. Currently serving as Director of Search & Evaluation at Sanofi, Drew leverages his extensive background to scout for innovative platform technologies that could drive future therapeutic advancements, with a specific focus on cell and gene therapies.

Drew holds a PhD in Biochemistry from Johns Hopkins University, and has previously held business development roles at Precision BioSciences, Eisai, and Legend Biotech.

Jack is a Co-Founder of Altaviz and well-established in the medical device industry. Jack’s passion is leading smart people to creatively solve real-world problems with innovative solutions that yield effective, high-demand products and processes. Prior to founding Picocyl, Jack worked extensively with retina surgeons to deeply understand their objectives, identify their needs and translate those needs into current market-leading, state-of-the art, handheld surgical instruments. His fifteen successful years in motorsports and specialty vehicle design/development with the Toyota off road racing team and MillenWorks taught Jack to flourish at solving challenging problems in fast-paced, team-centric environments. He currently holds 51 US and 100 International patents.

Jack graduated from Cal Poly, San Luis Obispo with a BS in Mechanical Engineering. He is happily married with two great twenty-something children, active in the outdoors with a passion for hiking, lightweight backpacking and riding motorcycles.

Saadyah Averick, PhD is driven by curiosity and a passion for solving complex challenges. As Senior Director of Oral Protein Delivery at Imagine Pharma, he leads a team dedicated to making peptide and protein therapeutics more accessible through oral delivery. Saadyah works at the crossroads of chemistry and biotechnology, developing innovative systems that help medicines reach patients more effectively. He’s published over 80 peer-reviewed papers, holds 12 issued patents, and earned his PhD in Chemistry from Carnegie Mellon.

As the Executive Director- Drug Product Design & Development, Advait leads the organization within Pfizer’s Biotherapeutics Pharmaceutical Sciences organization focused on identifying and developing formulations and processes to support Pfizer’s entire biotech & vaccine portfolio with accountability for novel delivery technologies, vaccines, RNA-based modalities. and microbial and mammalian produced proteins. The focus is on all things related to Drug Product from the early Research stages up to Licensure including Commercial and Life Cycle Management support. In his role as- Head of Nanoparticle Development, Advait’s accountability includes scientific, technical, strategic, and regulatory leadership of Pfizer’s mRNA/LNP and nanoparticle-based portfolio. Advait is accountable for establishing internal capabilities and expertise for formulation, process development, scale-up, and tech transfer to enable clinical and commercial supplies. In addition to this, there is a focus on external strategic alliances and collaborations.

Advait received his PhD in Pharmaceutical Sciences from the College of Pharmacy and Health Sciences, Mercer University (Atlanta, GA) and a MS in Pharmaceutics from Auburn University, Auburn, AL. He also has a BS in Pharmacy from Pune University (India). He is a member of AAPS and Controlled Release and is an inventor on more than 12 patents, published over 35 articles in professional scientific journals, and presented more than 50 short papers, posters, and talks.

Annette Bak, Ph.D., MBA leads Advanced Drug Delivery at Astra Zeneca and serves on the Pharmaceutical Sciences leadership team. Advanced Drug Delivery has the mission to transform diverse modalities, small molecules and new modalities alike, into investigational medicines and is a global organization based in Sweden, UK, and US.

Since joining AstraZeneca in 2016, Annette has been instrumental in delivering new modality formulations for clinical studies, notably VEGF mRNA for cardiac regeneration, building intracellular drug delivery capabilities, and sponsoring initiatives on augmenting drug discovery with artificial intelligence. 

Annette previously worked for Amgen and Merck in the US with responsibility for small molecule and peptide formulations, building outsourcing partnerships in China, in licensing and partnership evaluations, and contributing to getting small molecule therapies to the market.

Annette has published more than 40 articles, has more than 35 invited presentations, and serves on the editorial board for the Journal of Pharmaceutical Sciences. She holds several patents for pharmaceutical technologies enabling drug delivery of small molecules and biologics.

A key volunteer in American Association of Pharmaceutical Scientists (AAPS). She is the President for the association and responsible for leading implementation of  the 2021-2025 strategic plan and ensuring that the AAPS communities are thriving. Annette was the 2020 co-recipient of the AAPS Alice E Till Women in Pharmaceutical Science Recognition, honoring women who has made significant contributions to the to the mentorship, advancement, and support of women in the pharmaceutical sciences

Sam Barker is Chief Business Officer at ViaNautis Bio, where he leads the company’s commercial strategy, partnerships, and communications. ViaNautis is advancing polyNaut®; a novel non-viral delivery system for genetic medicines, designed for precise ex-hepatic, delivery to hard-to-reach tissues such as the brain and immune cells. The platform is helping to unlock new therapeutic opportunities in CNS and autoimmune diseases.

ViaNautis raised a $25 million Series A in 2023 and entered a strategic partnership with Eli Lilly in 2024, reflecting growing industry recognition of the platform’s potential. The company is actively working with partners to address long-standing delivery challenges in genetic medicine, particularly in extrahepatic tissues where alternatives to viral vectors and lipid nanoparticles are urgently needed.

With a background in molecular biology and a career spanning research, business development and strategy, Sam is passionate about translating platform innovation into clinical and commercial success. Prior to ViaNautis, he held roles in business development and drug discovery across both early-stage biotech and publicly listed companies.

He holds a PhD in Biological Sciences and has broad experience across early discovery, alliance management and therapeutic platform development.

Saran Baskaran is a combination product and medical device R&D leader with over 15 years of experience in taking products from concept to clinic and commercialization. For the last 7 years at Astra Zeneca he has led pipeline device development teams for parenteral combination products including autoinjectors, prefilled syringes, on-body systems, multidose pens spanning biologic and synthetic modalities across therapeutic areas such as immunology, respiratory, and weight management. Before that he worked in a startup on photodisinfection devices.

Saran holds degrees in Chemical and Biomedical Engineering from Cornell University and drives initiatives that accelerate product development including standardizing platform injection systems and more widely deploying computational modeling in early development.

Marly Bastiaansen is an experienced pharmaceutical professional with a strong business background and over 10 years of working experience at DFE Pharma, a global leader in excipient solutions. With a solid background in product management, she is dedicated to supporting the development and manufacturing of high-quality medicines through the application of DFE Pharma’s stabilizer solutions.

At this conference, Marly will share her perspective on the role of stabilizers in biopharmaceutical formulations, emphasizing their importance in ensuring product efficacy, safety, and shelf-life.

Over 20 years of industry experience in technical service, troubleshooting, and formulation development of topical, oral solids/liquids, ophthalmic, mucosal formulations, and solubility enhancement of injectable and amorphous oral solids.

In my current role, I am responsible for technical business development, working together with customers to enable acceleration of their drug development programs using Lubrizol technologies.

Clare leads the drug delivery sector at Cambridge Design Partnership. Her background is in researching and analysing the drug delivery industry via unmet needs exploration, technology scouting, due diligence and market strategy. Working with a broad spectrum of clients from early-stage start-ups to big, Clare is passionate about ensuring all those involved in drug delivery at CDP draw on experiences of all key stakeholders - particularly the user - in the design and development process, both to validate and advance applications of existing products or drive innovation and adoption of new concepts.

Sean Bedingfield is a drug delivery specialist bridging gene editing & gene therapy early discovery and clinical translation with work spanning multiple platforms and modalities. Currently in Lilly’s Genetic Medicine division, he leads a small team in a blend of specific portfolio projects, internal platform development, external collaborations and vetting external technologies. Lilly’s interests are broad and ambitious in genetic medicine, as highlighted by their public partnerships including Dicerna Therapeutics, Scribe Therapeutics and Sangamo Therapeutics and acquisitions such as Prevail, Akouos and Verve Therapeutics. Receiving his PhD in Biomedical Engineering from Vanderbilt University, his publications include high impact papers relating to intracellular assay development, RNA delivery leveraging targeted nanoparticles, protein engineering applications (now licensed by Anchor Biologics), and nanomedicine-related material science investigations. Prior to this role, he worked as a technical lead in business development for Pendant Biosciences.

Cathleen Bergin has been in the biotech industry 20 plus years with extensive experience in building and evolving patient support program strategy and support for patients,  as well as leading clinical educator field teams to meet both HCPs and patient’s educational needs. 

She has extensive launch experience in the rare disease markets of hematology, nephrology and neurology which include all formulation of therapy including large volume sub cutaneous injection.

Cathleen is presently responsible for leading a US field Clinical Educator Team which is responsible for the education of Sites of Care, HCPs and patients around dosing and administration of all indications and formulations for the neurology/neuromuscular community. 

Prior to argenx, Cathleen has worked in multiple positions on the commercial side of rare disease with increasing responsibility. 

She practiced as a Nurse Practitioner before entering the rare disease market with clinical expertise in Hematology, Oncology, Transplant and Neurology.

Deep S. Bhattacharya, PhD is a Principal Scientist in Drug Product Design and Development at Pfizer’s Pharmaceutical R&D site in Andover, Massachusetts, where he has been contributing since 2019. With over eight years of experience in CMC drug product formulation and biopharmaceutical sciences, Deep has led the development of high and ultra-high concentration biologics, gene therapies, recombinant proteins, and vaccine formulations from early-stage research through commercialization.

He specializes in subcutaneous delivery systems, combination product development, and biophysical strategies to enhance drug stability and patient-centric design. Deep has played a pivotal role in cross-functional collaborations across clinical pharmacology, regulatory affairs, market access, and strategic portfolio planning. He has also led regulatory submissions (INDs and BLAs) across global markets and driven successful tech transfers and manufacturing readiness for late-stage programs.

Deep is actively involved in strategic alliances with academic and industry partners, and leads initiatives within the Subcutaneous Consortium to advance IV-to-SC bridging strategies. He is a recognized thought leader with over 35 external presentations and publications, and currently pursuing an MBA to further strengthen his business development and innovation leadership.

His research interests include biophysical characterization of biologics, higher-order structural analysis, subcutaneous assessments, and the integration of scientific and business strategies to accelerate biopharmaceutical innovation.

Sherri joined AstraZeneca in 2018 and is Head of Device Development. She is responsible for parenteral drug delivery development including early-stage technology strategy, clinical device development and late stage scale-up for commercial manufacturing. Currently, her group is developing products such as prefilled syringes, autoinjectors, on-body delivery systems, and pen injectors as well as a range of new technologies to meet the AstraZeneca pipeline needs. A particular focus of her group is understanding user needs and business needs to design the right product for patients and health care providers. Prior to working at Astra Zeneca, Sherri was Director of Device Development at Genentech and Director of Product Development at Alexza Pharmaceuticals developing both injection and inhalation products. 

Sherri earned a PhD in Chemical Engineer from the University of Pennsylvania and a BS in Chemical Engineering from Rensselaer Polytechnic Institute. While in industry she has been active in various academic and industry-based organizations. She has taught several university engineering courses and publishes and presents frequently. 

In her role as Global Head Product Optimization, Dr Beate Bittner drives the development of customer-centric product optimization opportunities across the Roche portfolio. Dr Bittner joined Roche in 1998 and held numerous positions of increasing responsibility including Preclinical DMPK Project Leader, Laboratory Head Preformulation, Clinical Pharmacologist, Clinical Team Leader, Global Development Leader, Global Project Leader, Portfolio Strategy Director, and Product Optimization Franchise Leader. Since 2012 Bittner has been a Lecturer at the Baden- Wuerttemberg Cooperative State University in the field of Personalized Health Care, Developing New Drugs, and Pharmacology. She is trained as a Pharmacist with a PhD in Pharmaceutical Technology & Biopharmaceutics from the University of Marburg, Germany, and holds a Diploma in European Market Access from the Aix-Marseille University, France.

Lotte Bjerre Knudsen is a Danish national, born in 1964 in a small town near Copenhagen. She holds a degree in biotechnology from the Technical University of Denmark, and a Doctoral degree in Scientific Medicine from the University of Copenhagen, Denmark. Lotte has been with Novo Nordisk since her university graduation in 1989 and has since then held several positions within the company and is today Chief Scientific Advisor in Research & Early Development and heads up IDEA (Innovation and Data Experimentation Advancement). She has deep experience across the entire value chain of drug discovery and development and has published extensively. Lotte is an inventor on many patents, all fully owned by Novo Nordisk. She has been part of representing Novo Nordisk in five FDA Advisory committees. Lotte has received numerous awards. Most recently, she was the recipient the Paul Langerhans Award from the German Diabetes Association and a co-recipient of the American Association for the Advancement of Science Mani Bhaumik Breakthrough of the Year Award, the Lasker Foundation Lasker-DeBakey Clinical Award and the Breakthrough Prize in Life Sciences.

John Black M.Ed is an experienced healthcare executive with nearly 20 years in the medical industry, spanning leadership roles in both startups and global companies. He is currently CEO of Vitranu, a biotech company developing the Tunable Extended Release Microcapsule, a novel platform for sustained ophthalmic drug delivery. Previously, he founded MediView, advancing AR/VR surgical navigation, and holds foundational surgical navigation and medical imaging patents. John’s expertise covers strategy, commercialization, and early adoption of innovative medical technologies, with a focus on biologics, biomaterials, and drug delivery. He has secured regulatory clearances, advanced AI-based imaging solutions, and driven early-stage innovation into meaningful clinical pathways. Passionate about bridging technology and patient care, he is leading Vitranu toward strategic pharmaceutical partnerships to address unmet needs in retinal disease treatment.

Alessio Bonati is the Director Alba & Nexa Flex Programs for DCS Business Unit (Drug Containment Solutions) at Stevanato Group, specialized in drug containment, drug delivery, and diagnostic solutions to the pharmaceutical, biotechnology, and life sciences industries. Mr. Bonati holds a Master's Degree in Electronic Engineering from the University of Ferrara (Italy) and an MBA from Bologna Business School (Italy). He has worked for multinational companies in several different businesses; in Stevanato Group since 2016, he has held different managerial roles, in the area of ​​product portfolio management and research and development. His current role involves the global management of the two high-end syringe platforms of Stevanato Group: Alba (glass syringe) and Nexa Flex (CoC/CoP syringe).

Mandana Borna is the head of oligonucleotide drug product development at Biogen overseeing all aspects of drug product development from formulation design and container closure selection to process development, scale up and tech transfer to support Biogen’s expanding oligonucleotide portfolio. Her responsibilities encompass every phase of product development from preclinical, and clinical stages through to commercialization and life cycle management. Additionally, Mandana continues to lead the non-viral drug delivery activities at Biogen to advance new technologies and overcome challenges of delivery of oligonucleotide and other large molecule therapeutics. She plays a key role in shaping short-term and long-term drug delivery strategies to support Biogen’s pipeline. In addition to internal drug delivery formulation development, Mandana’s team identifies cutting-edge non-viral delivery technologies, design feasibility studies, performs technical assessment and leads project partnership. Mandana holds PhD degree in Materials Science & Biomedical Engineering from McGill University, and her research is focused on formulation development and drug delivery. She has been invited speaker in multiple drug delivery conferences and serves as a reviewer for several journals.

Nicolas Bralet is an Associate Business Director at BD Medical – Pharmaceutical Systems, within the Biologics PFS (Prefillable Syringe) platform. In this role, he is responsible for shaping the business and portfolio strategy for innovative primary drug delivery device platforms, with a focus on aligning investment priorities to long-term strategic goals. His work supports the development of solutions that meet the evolving needs of the biologics market.

With over two decades of experience at BD, Nicolas has built a diverse career across Technical Services, Marketing, and R&D. He has successfully led upstream strategy development and product implementation initiatives, contributing to the launch and growth of several key combination products. His expertise spans prefillable syringe systems, needle safety devices, and integrated drug delivery solutions, with a strong emphasis on cross-functional collaboration and customer-centric innovation. Nicolas earned his engineering degree from the Institut National Polytechnique (INP) in Grenoble, specializing in physico-chemistry and industrial engineering.

Ulrich Brüggemann has been working on the development of medical device and diagnostics technologies and products for over 30 years in the US and Germany. After graduation from the University of Applied Sciences, Frankfurt, he worked at Mass General Hospital, Nova Biomedical, Sanofi and has been working for 5 years at Takeda Pharmaceuticals. Over the last 18 years he focused mainly on the development of drug device combination products in various technical and management positions. He recently led initiatives to identify promising innovative technology at academic institutions and entrepreneurial startup companies. In his currently role he is leading early technology feasibility activities and device strategy focusing on rare diseases.

Dr Brent Buchine is the Co-founder and Chief Business Officer of Windgap Medical. With over two decades of leadership across the life sciences and semiconductor sectors, he brings deep expertise in innovation, technology development and company building. At Windgap,he has played key roles in shaping the company’s R&D and product strategy, leading cross-functional teams and establishing strategic partnerships across the pharmaceutical and biotech landscape. A materials scientist by training, Dr Buchine is known for translating breakthrough ideas into impactful products and fostering collaborations that shape the next generation of drug delivery innovation.

Dr. Stephen T. Buckley is Vice President of Advanced Drug Delivery at Novo Nordisk A/S with responsibilities spanning global sites in both greater Copenhagen (Denmark) and Boston (USA). In addition to his leadership responsibilities, he is responsible at Novo Nordisk for a cross-organizational team of scientific experts tasked with identifying and evaluating novel drug delivery technologies. During his time at Novo Nordisk, Stephen has contributed to development of multiple marketed drug products, including semaglutide, oral semaglutide, faster aspart and insulin icodec. He holds a degree in pharmacy from Trinity College Dublin (Ireland), and a Ph.D in biopharmaceutics and cell physiology from the same university. During this time, he also worked as a Visiting Fellow at the University of Southern California (USA). Prior to joining Novo Nordisk A/S, Dr. Buckley was a Postdoctoral Research Fellow at the University of Southern Denmark (Denmark). He is the recipient of honors and awards from the American Association of Pharmaceutical Scientists (AAPS) and the Scandinavian and German Physiological Societies. He is (co-) author of 30+ articles in peer-reviewed journals (including Science, Science Translational Medicine and Nature Biotechnology), and has been invited to give numerous presentations at research institutions, international conferences and workshops.

Ana Cadete is a CMC Leader at the mRNA Center of Excellence at Sanofi, where she leads the strategy and manufacturing of mRNA vaccines. With a background in pharmaceutical sciences and nanomedicine, Ana has dedicated her career to developing novel drug delivery systems. Ana holds a PhD in Nanomedicine and Pharmaceutical Innovation and completed her postdoctoral research at the Langer Lab at MIT. From 2017 to 2022, she worked as a formulation scientist at Moderna, developing CFTR mRNA lipid nanoparticles.

Beyond her scientific career, Ana is passionate about leadership and mentorship. She is the founder of The Non-Conformist Scientist, a nonprofit organization dedicated to elevating scientists' careers and inspiring the next generation of female scientists to become leaders.

Ester is a multidisciplinary scientist with a background in biotechnology, biochemistry, and bioengineering. She has held diverse roles across startups, pharma, and consulting, and currently serves as Director of Strategic Innovation at Chiesi USA. In this role, she scouts cutting-edge technologies and companies to advance treatments for patients with rare diseases.

At MIT, she developed an oral insulin pill, earning recognition as one of MIT Technology Review’s 35 Innovators Under 35. Ester advises international startups and academic programs, speaks seven languages, and advocates for women’s career development in science.

Tim is an accomplished commercial leader with over 20 years in the medical device and biotech industries, bringing specialized expertise from over 10 years in ophthalmology therapeutic delivery. He has a proven track record in medical device development and global commercial planning, spanning roles in Fortune 500 corporations like Johnson & Johnson (Ethicon, Janssen Pharmaceuticals), Novartis, and Genentech (Roche), as well as innovative startups such as Orbit Biomedical and Gyroscope Therapeutics. His experience spans sales, marketing, and business development for medical devices and pharmaceuticals, covering diverse product areas including endomechanical instrumentation, biosurgicals and therapeutic delivery systems across ophthalmology, cardiovascular surgery, orthopedics, gynecology, oncology, and pain management. Currently, Tim heads up Delivery Strategy and Surgeon Engagement for the Genentech device development team in King of Prussia, PA.

Andrea Casazza is the R&D Global Head of Technical Development for Chiesi Farmaceutici S.p.a.

He has more than 25 years of industry experience in developing pharmaceutical products for different therapeutic areas and patient populations via oral, injectable and inhalation delivery.

Andrea managed diverse teams of analysts, formulators, engineers, chemists and device experts in large, small and medium pharma companies he strongly believes in the value of integrating the different disciplines in developing new products. In his career Andrea contributed to the development and approval of oral, injectable and inhalation products for both EU and US markets.

Carla Castellar, PhD, is Scientific Manager at Nanomol Technologies, where she leads contract R&D projects in drug delivery and advanced nanoformulation technologies, with a focus on preclinical formulation development of complex biomolecules including peptides, proteins, and nucleic acids. With over 8 years of experience in pharmaceutical nanotechnology, she works closely with both global and emerging pharma and biotech companies. Carla holds a degree in Biomedical Sciences and a Master’s in Biotechnology from the University of Barcelona, and earned her industrial PhD in Chemistry from the Autonomous University of Barcelona, specializing in colloidal systems for drug delivery.

Dr. Chan Hee Chon is the Chief Technology Officer (CTO) of Inventage Lab, a South Korea–based company specializing in microfluidics-driven pharmaceutical manufacturing platforms. With over 20 years of research experience, Dr. Chon is a recognized expert in the application of microfluidics technology to drug delivery systems.

At Inventage Lab, Dr. Chon has led the innovation of proprietary manufacturing platforms, integrating microfluidic technologies into manufacturing systems and processes for drug delivery. His contributions have resulted in the development and commercialization of two breakthrough platforms: DrugFluidic, a manufacturing technology for long-acting injectables and GeneFluidic, a manufacturing platform for producing gene delivery nanoparticles used in gene therapy and vaccines.

His work continues to push the boundaries of next-generation drug delivery, bridging cutting-edge engineering with pharmaceutical science.

Kathleen Cohen, PharmD is Senior Vice President of Clinical Development Operations at Avalo Therapeutics. Prior to joining Avalo, she served as Vice President and Head of Clinical Development Operations at Marinus Pharmaceuticals and spent over 20 years at PRA Health Sciences in a variety of project management and operational oversight roles. Kathleen earned her PharmD from the University of the Sciences in Philadelphia and completed a post-doctoral fellowship in Pharmacoeconomics and Outcomes Research at Rutgers College of Pharmacy.

Dr. Steven Cohen is Co-Founder and Co-CEO of Akyso Therapeutics, a biotechnology company advancing long-acting, bioabsorbable subcutaneous drug delivery implants. He leads the company’s flagship program developing iSTEP-N, a sustained-release naltrexone implant for opioid use disorder, designed to provide therapeutic drug levels for 6–12 months with a single minimally invasive procedure. Under his leadership, Akyso has progressed from concept to clinical stage, completing IND-enabling studies, securing NIH funding, and completiong a first-in-human Phase 1 trial that has demonstrated safety, tolerability, and efficacy.

A surgeon, inventor, and clinical researcher, Dr. Cohen has over 30 years of experience translating innovations from bench to bedside. He has co-authored more than 100 peer-reviewed publications, contributed to over 100 FDA registration trials as a principal or sub-investigator, and is an inventor on multiple U.S. patents in drug delivery and surgical devices.

In parallel with his entrepreneurial work, Dr. Cohen is a Clinical Professor of Ophthalmology at the University of South Florida and a partner at Retina-Vitreous Associates of Florida. His dual career as a practicing physician and biotech founder informs his commitment to developing patient-centric therapies that address major gaps in care.

At Akyso, Dr. Cohen is spearheading efforts to leverage polymer science and device engineering to expand the reach of long-acting implants into addiction medicine and beyond, with the goal of improving adherence, reducing relapse, and ultimately transforming outcomes for patients with chronic conditions.

Dr Susan Conroy is the Chief Executive Officer of Therakind Ltd, a specialty pharmaceutical company dedicated to improving drug delivery and patient acceptability through proprietary technology and optimised dosing regimens. Since its founding, she has led the company’s strategic direction and operations, overseeing the development and regulatory approval of multiple products across the US and EU regions.

With over 20 years of experience in the pharmaceutical and biotechnology sectors, Susan has a strong track record in identifying, evaluating, and commercialising innovative therapeutic products. Prior to founding Therakind, she worked as an independent consultant supporting early-stage start-ups, with a focus on maximising scientific value, technology transfer, medical affairs, and the commercial exploitation of existing assets. She also served as an independent funding assessor for start-up programmes.

Earlier in her career, Susan held positions in both large and small pharmaceutical companies, including Bristol Myers Squibb, where she worked across clinical development, commercial strategy, and new therapeutic areas.

Susan holds a PhD in Molecular Biology from London University and conducted post-doctoral research in oncology at University College London. Her integration of scientific expertise and strategic business insight has been instrumental in driving Therakind’s development of patient-centric medicines.

Beyond Therakind, Susan is a Trustee of Anthony Nolan, a leading UK stem cell charity. She contributes her knowledge and experience as a member of the charity’s Audit & Finance and Governance & Risk Committees.

Chris Cooper is a Device Engineering Lead at Gilead Sciences, where he supports the development of long-acting injectable drug delivery systems for HIV prevention. He specializes in design control, combination product development, and supplier collaboration. Prior to Gilead, Chris led the technical development of a fully customized on-body delivery system for subcutaneous administration of a biologic oncology therapy, learning key insights into the use of wearable systems for extended drug delivery. Earlier in his career, he supported commercial biologics manufacturing at Bristol Myers Squibb, contributing to the launch and lifecycle management of immuno-oncology therapies. Chris holds an M.Eng. in Bioengineering from UC Berkeley and a B.S. in Chemical Engineering from UCLA. He brings a multidisciplinary background in drug-device development and is passionate about advancing patient-centered delivery technologies and enabling patient access to breakthrough therapies.

Eunice Costa joined Hovione in 2011 and currently leads the internal technology development R&D Programs in the fields of Respiratory and New Modalities. As Program Director, she leads a portfolio focused on advancing novel technology platforms in materials, drug product formulations and respective manufacturing processes as well as in medical device design for respiratory and advanced drug delivery systems, providing solutions to support Pharma bring innovative medicines to market. Throughout her tenure at Hovione, Eunice has held multiple leadership and management positions in R&D, assisting Pharma partners in numerous CMC development projects in respiratory and biologics. She has also actively researched the impact of particle engineering, particularly spray drying, formulation composition and processing on performance, stabilization and disposition of medicines, with a focus on biologics. She has collaborated in several consortia with academia & industry, having supervised multiple PhD and MSc thesis. Prior to joining Hovione, Eunice held research positions at Genentech, TNO and academic institutions, working on topics such as formulation development, physiology and engineering processes. She holds a PhD in Bioengineering Systems from the MIT-Portugal program, where she investigated polymer synthesis and processing for tissue engineering applications.

After receiving a B.S. in Chemical Engineering from Clarkson University Dr Lindsey Crawford completed a PhD from Cornell University in the school of Chemical and Biomolecular Engineering. Dr Crawford’s PhD thesis work was under Dr. David Putnam where she focused on targeted drug delivery to the blood brain barrier using P-glycoprotein as a target. She then joined the lab of Dr. Shelly Sakiyama-Elbert as a postdoctoral researcher at Washington University in St. Louis working on biomaterials for regenerative medicine prior to becoming a Senior Scientist at Pfizer. Since joining Pfizer Dr Crawford has been involved in drug product development of multiple modalities used to treat a variety of therapeutic indications. She has worked in development stages pre-clinical through commercial and now has a role where she facilitates strategic conversations between key stakeholders during the drug product development stages to ensure the best possible product is reaching our patients. Dr Crawford also has a passion for career development, and as a group leader aims to foster growth in those around her through the day to day work we do.

Michael Cucolo is an experienced Business Development Executive Director at Bristol-Myers Squibb Company (BMS) with a passion for partnering. With over 25 years in the pharmaceutical industry, Michael has held positions of increasing responsibility at American Cyanamid’s Lederle Pharmaceuticals, Cytogen, Ohmeda, and BMS. In his current role, he identifies and transacts opportunities to support, grow, and advance BMS's pipeline. Previously, he led a Research Enabling Technologies Team, seeking opportunities, establishing collaborations, and licensing novel platforms for BMS. Michael has structured deals, partnerships, and negotiated over 150 diverse transactions, including material transfers, evaluations, technology platform/asset in-licensing/out-licensing, and collaborations with industry, pharma/biotech, venture capital, and academic partners. His broad experience spans the searching, evaluation, and licensing of assets and technologies in support of pharmaceutical discovery, drug delivery, development, and manufacturing for both small and large molecules. He enjoys learning about the ever-evolving drug delivery approaches being developed to better administer medicines to patients. Michael began his career in formulation development and delivery of novel drug products, transitioning them to manufacturing for early clinical trials. As a scientific investigator, he worked extensively on the development of both small molecules and biologics, contributing to several marketed pharmaceuticals and holding two drug formulation patents.Michael Cucolo is an experienced Business Development Executive Director at Bristol-Myers Squibb Company (BMS) with a passion for partnering. With over 25 years in the pharmaceutical industry, Michael has held positions of increasing responsibility at American Cyanamid’s Lederle Pharmaceuticals, Cytogen, Ohmeda, and BMS. In his current role, he identifies and transacts opportunities to support, grow, and advance BMS's pipeline. Previously, he led a Research Enabling Technologies Team, seeking opportunities, establishing collaborations, and licensing novel platforms for BMS. Michael has structured deals, partnerships, and negotiated over 150 diverse transactions, including material transfers, evaluations, technology platform/asset in-licensing/out-licensing, and collaborations with industry, pharma/biotech, venture capital, and academic partners. His broad experience spans the searching, evaluation, and licensing of assets and technologies in support of pharmaceutical discovery, drug delivery, development, and manufacturing for both small and large molecules. He enjoys learning about the ever-evolving drug delivery approaches being developed to better administer medicines to patients. Michael began his career in formulation development and delivery of novel drug products, transitioning them to manufacturing for early clinical trials. As a scientific investigator, he worked extensively on the development of both small molecules and biologics, contributing to several marketed pharmaceuticals and holding two drug formulation patents.

Riet Dams leads the Global Pharmaceutical Product Development & Supply team within Johnson & Johnson Innovative Medicine’s Discovery, Product Development & Supply (DPDS) organization. She is responsible for shaping the strategic direction and providing oversight across a globally distributed team spanning the US, EU, and APAC regions. Her organization drives the development of innovative drug delivery solutions from early discovery through to commercialization, supporting the entire Synthetic Molecule Value Stream—including small molecules, oligonucleotides, peptides, and other complex bRo5 compounds. With over two decades of experience in pharmaceutical R&D, Riet has held both technical and leadership roles across several organizations, including MDS Pharma Services (UK), GlaxoSmithKline (Italy), and Aptuit (Italy). Since joining Johnson & Johnson in 2014, she has taken on progressively broader leadership roles in CMC development.

Riet holds a PhD in Pharmaceutical Sciences from Ghent University, completed in collaboration with the National Institutes of Health (USA), and is a trained pharmacist.

Allison Dane, PhD, has over twenty years of experience in the development of AAV gene therapies for genetic disease. As a Senior Director within R&D at AskBio, Bayer’s wholly owned gene therapy and gene editing subsidiary, she leads the Capsid Development team and contributes to the drug development pipeline across multiple therapeutic areas including cardiovascular, central nervous system and neuromuscular conditions.

Allison earned her PhD at the University of Sydney, Australia, exploring liver targeted gene therapies using AAV and lentivirus, before completing postdoctoral work at University College London (UCL). Having published in Nature, Nature Genetics, Molecular Therapy and the New England Journal of Medicine, her work has contributed to improving our understanding of potency and durability of gene therapy vectors. In addition, she has contributed to identifying unique promoter/enhancer elements of the AAV genome and to successful clinical trials for Haemophilia and Gaucher disease. Her career across three continents has allowed her to bridge between academia and the biotech industries, earning a reputation as a strong and astute leader who excels at collaboration and innovation with diverse scientific teams.

Dr. Frederic Dargelas is the Chief Commercial Officer of DelSiTech. He is both a business-alliance and scientific veteran with 25 years of experience in the pharma industry, especially in drug delivery technologies. Previously, he held managing positions at diverse international companies such as GSK, UCB and Orion Pharma. Dr. Dargelas holds a PhD in Physical Chemistry of Polymers and an MBA.

Shawn P. Davis, Ph.D., is the CEO of Liberate Bio, a pioneering biotech company building the next generation of immune-cell therapies—delivered in vivo.  With over 20 years of experience spanning startups to global biopharma leaders, Dr. Davis has built and led high-performance teams at AstraZeneca and Amgen, advancing programs from discovery through clinical development. A recognized expert in drug delivery, he has authored foundational research, holds over 20 U.S. patents, and chairs multiple industry-leading conferences. He is known for bridging scientific innovation with commercial strategy to transform therapeutic possibilities into patient impact.

Charlie specialises in integrating sustainable principles into novel medical device development. He has experience across a broad range of drug delivery device products, combining analytical and mechanical design engineering expertise to optimise devices for high-volume production and regulatory submission. At Cambridge Consultants, Charlie leads the Sustainable Medical Technology capability, providing technical overview to on-going projects and provides thought leadership on sustainable healthcare via conferences and publications.

Dan Deaton is Executive Director and Head of Device Development and Innovation at AstraZeneca, where he leads a global team of scientists and engineers developing innovative therapies. Under his leadership, the team has successfully brought breakthrough products like Breztri AEROSPHERE® and AirSupra® to market, contributing to AstraZeneca's respiratory business that serves millions of patients worldwide. This includes AstraZeneca's industry-leading propellant transition initiative, a groundbreaking effort for environmental sustainability of inhaled products.

His expertise spans the complete product lifecycle from innovation and strategic portfolio planning to global market implementation, with particular focus on next- generation drug delivery platforms including inhaled biologics. With over 25 years of leadership in the pharmaceutical and medical device industries, Dan combines a deep engineering focus with strategic business acumen. His innovation-driven approach has resulted in over 30 published patents across diverse device technologies and connected digital health solutions.

Before joining AstraZeneca, Dan held senior roles at multiple successful companies including Oriel Therapeutics (acquired by Sandoz) and Kos Pharmaceuticals (acquired by Abbott), where he managed device development and supported commercialized products. He holds an MBA from Kenan-Flagler Business School at UNC Chapel Hill and MS/BS degrees in Mechanical Engineering from North Carolina State University. Dan remains active in innovation ecosystems as a Techstars mentor and angel investor, continuing to advance patient-focused healthcare solutions.

David DeSalvo serves as Vice President of Combination Product Development at Kindeva Drug Delivery, where he leads the development of drug-device combination products that connect life-changing therapies with patients around the world. With over 25 years of experience in drug delivery innovation and commercial leadership, David plays a central role in driving Kindeva’s mission of Manufacturing More Tomorrows™ by advancing combination product solutions from concept to launch.

A purpose-driven leader and award-winning innovator, David has led the creation, development, and successful market introduction of dozens of combination products collaboration with the world’s leading pharmaceutical and biotech companies. His work has contributed to several of the most commercially successful and clinically impactful drug delivery devices in the industry. In addition to his technical leadership, David has negotiated and secured numerous licensing, development, and manufacturing agreements that have delivered measurable enterprise growth and value to partners and patients.

Before joining Kindeva, David held senior roles at global life science and medical device organizations, including Emergent BioSolutions, Nuance Designs, SHL Medical, and Becton Dickinson (BD). Throughout his career, he has combined deep technical expertise with business acumen to guide cross-functional teams and advance pioneering combination products.

David holds a Bachelor’s and Master’s degree in Mechanical Engineering from Rensselaer Polytechnic Institute and an MBA from Marist College. His broad technical background, strategic mindset, and commitment to collaboration reflect Kindeva’s identity as a purpose-fueled, people-centric CDMO dedicated to advancing client projects, partner ambitions, and the future of drug delivery.

Dr Ketaki Deshmukh is a pharmaceutical professional with over a decade of experience in academia and industry, her expertise encompasses the design and development of novel lipid-based, polymer and inorganic nanoparticles for drug and gene delivery. She currently serves as a Senior Scientist at Novo Nordisk, where her work focuses on advancing novel lipid nanoparticle formulations for therapeutic applications. Dr Deshmukh holds a PhD in nanomaterials from BITS Pilani, her academic foundation, combined with industry experience, provides her with a holistic perspective on the challenges and opportunities in lipid nanoparticle-based drug delivery.

Mark DeStefano is the Director of Global Technology Innovation, Combination Products and Devices R&D for Teva Pharmaceuticals focusing on strategic planning for Teva’s future combination products including new device and drug delivery technology identification and development for Teva pipeline drugs and platform combination products. He is an experienced device development professional with a demonstrated 35 yr. history of product innovation, design, development, and launch in many areas of the medical device industry from surgical devices to drug delivery devices. Mr. DeStefano has spent the last 26 years in drug delivery device development, including 13 years in the development of implantable sensors, insulin pumps and infusion sets for Type 1 Diabetes and 13 years in the development of injection devices for parenteral drugs.

Julie DEVALLIÈRE, Ph.D., is a Senior Manager at Nanobiotix, a clinical-stage biotechnology company based in Paris, France. The company specializes in developing nanomedicine-based therapeutic solutions for cancer treatment and other challenging diseases.

Dr. Devallière has over ten years of experience at the crossroads of cell biology, drug delivery, and nanotechnology, with a strong focus on translational science. She holds an engineering degree in Bioengineering and a Ph.D. in Cell Biology. She pursued postdoctoral research at Yale University and Harvard Medical School, where she worked on the development of advanced delivery systems for therapeutic proteins and nucleic acids. Her research focused on designing multifunctional nanoparticle platforms to overcome biological barriers, improve intracellular delivery, and enhance therapeutic efficacy.

At Nanobiotix, Dr. Devallière contributes to preclinical biology research, supporting the design, optimization, and biological evaluation of nanoparticle-based therapies. Her work includes targeting strategies, mechanistic studies, efficacy assessments, and toxicological evaluations, helping to drive the company’s efforts in advancing candidates toward clinical application.

Bryan is a seasoned professional in the medical device industry with over 20 years of experience spanning early-stage startups to global corporations. He has held diverse technical and leadership roles across product development and sustaining operations within the life science space. Bryan is currently with UCB focusing on the operational management of the UCB device portfolio.

Dr Anil Diwan is President & Executive Chairman of NanoViricides, Inc, a public company (NYSE-Amer.: NNVC; founded 2005). He co-invented a bio-mimetic drug delivery platform, nanoviricides™ polymeric micelles, enabling site-specific targeting, multi-point attack, & encapsulation. Its orally available, broad spectrum antiviral therapeutic drug NV-387 has completed Phase 1 successfully and is Phase 2-ready. It has shown strong pre-clinical efficacy in COVID, RSV, FLU, Monkeypox, and Measles. Nanoviricides define a new paradigm “Re- Infection Inhibition”, going beyond antibodies and small chemicals. The platform enables potential cures of viral infections by encapsulating orthogonal APIs ex: Remdesivir, Ribavirin, Cidofovir, etc. Dr Diwan designed and established the company’s fully-owned facility in Shelton, CT (R&D to Clinical Trial Drug Product Manufacturing). Dr. Diwan holds a PhD, (Bio)Chemical Engineering, Rice University and a BTech, Chemical Engineering, Indian Institute of Technology, Bombay (IITB).

Brian Doherty is the Senior Manager of Business Development at Lipoid, Inc., a global leader in the production and supply of high-purity phospholipids for the pharmaceutical and biotechnology industries. Since joining Lipoid in 2023, Dr. Doherty has played a role in supporting formulation innovation across a range of therapeutic platforms, including lipid-based drug delivery systems, liposomes, and lipid nanoparticles. With a Ph.D. in Chemistry from the University of Miami (2019), he brings both technical insight and commercial perspective to his role. Dr. Doherty works closely with scientists, formulators, and procurement teams to support drug development from early-stage discovery through commercialization. Passionate about bridging science and business, he is committed to advancing the use of lipid-based excipients in both established and emerging therapeutic areas.

With over 20 years of experience, Ryan leads the Small Molecule and Biologics Chemistry, Manufacturing, and Controls (CMC), Sterilization Engineering, Lab Operations, and Analytical Services Practice Areas for Kymanox. He is a seasoned, strategic leader in the areas of CMC Regulatory and Pharmaceutical Development.

Ryan’s expertise includes program and portfolio management, global CMC regulatory requirements and strategy, CDMO/CMO selection and management, product development (including formulation, process, and analytical), technology transfer (pre- and post-approval), and clinical supply manufacturing and distribution. He has a passion for identifying, developing, and delivering practical and innovative solutions for complex, non-conventional product formulations and drug delivery systems throughout a product’s lifecycle. Ryan also has extensive experience in the areas of Quality Operations and Management for manufacturing, release, and distribution of pharmaceutical, biologics, and combination products.

Before joining Kymanox, Ryan worked at Novan, GSK, Stiefel, and DSM Pharmaceuticals. Ryan holds a Bachelor of Science in Biochemistry from East Carolina University.

Steven Duddy is a seasoned MedTech executive with over 25 years of experience leading innovation in drug delivery, medical devices, and biopharmaceuticals. He has served as CEO, COO, and board member for multiple early- and mid-stage companies, successfully guiding them through product development, regulatory approval, commercialization, and M&A.

Throughout his career, Steve has built a reputation for transforming complex concepts into market-ready technologies, often under aggressive timelines. He has led successful fundraising efforts, securing millions in capital to advance emerging health technologies.

At RheoTek Medical, Steve is advancing a platform of ultra-precise needle and needle-free drug delivery technologies aimed at improving therapeutic outcomes in immunotherapy, vaccines, and pain management. His leadership is helping position RheoTek as a critical player in reshaping how drugs are delivered—especially in settings that demand accuracy, consistency, and ease of use.

Steve’s background includes leadership roles at major companies such as Johnson & Johnson and 3M, as well as with high-growth startups. He brings deep cross-functional expertise in strategy, operations, fundraising, and global market development.

Dr. Duong has 15 years’ experience performing polymer and lipid nano/microparticle drug delivery research and experience building agile biomedical research teams with competitive intellectual property strategies. He has authored six peer-reviewed publications on nanoparticle delivery vehicles and coauthored a book chapter on nanoparticles for nucleic acid delivery. In the last year, he has led his teams to file >25 inventions in genomic technology and named on 13 patents, four have been granted.

He has authored multiple peer-reviewed publications for use of nanoparticles for vaccine applications including subunit vaccines, and host-cell directed therapeutics with mammalian cell and mouse models. His experiences in academia and industry have enabled a unique understanding of nanoscience combined with knowledge of patent landscape to form competitive intellectual property strategies.

At Battelle, he has served five years on leadership councils, three years on emerging scientists and engineering council, two years on the Technical Council advising leadership, driving growth strategy, and contributed to 10+ R&D programs, both as a researcher and an advisor.

Oliver serves as the Senior Business Unit Director at Jabil for their Pharmaceutical Solutions division. He works closely with our largest pharmaceutical customers to provide strategic manufacturing solutions at Jabil sites around the world. Oliver brings experience from previous roles at Nypro (now Jabil) and Catalent Pharma Solutions.

He holds a Ph.D. in biomaterials engineering and master’s in mechanical engineering from the University of Exeter. With a robust skill set that includes pharmaceuticals, forecasting, new business development, product development, biotechnology and more. Oliver is based in Malmesbury, England where he lives with his family

Pete has been involved in the development of novel drug delivery devices for more than 25 years, including inhalers and pen injectors. With a career including roles in both consultancy and industry, he understands the challenges faced across the entire product development lifecycle from conception to commercialisation. He has led projects through the innovation and design phases into validation and industrialisation including device platforms as well as combination product developments.

Pete’s current role is leading the device development team at the SMC Ltd. site in Cambridge, UK developing innovative injection devices with the capabilities to inject the challenging drug formulations that are increasingly prevalent, due to the growth in biologics and long-acting treatments. SMC Ltd., with its complementary capabilities in device manufacture and assembly, and aseptic fill-finish, collaborate with drug development and pharmaceutical companies to bring new autoinjector-based drug treatments onto the market with a focus on delivering challenging formulations with increased reliability and high patient-compliance.

Saudat Fadeyi is a science-driven executive leader with 20+ years of experience in the pharmaceutical and biotechnology industry. She brings deep expertise across global drug development, corporate strategy, business development, and licensing, with a focus on advancing transformative therapies from discovery through commercialization.

As Head of Business Development & Strategy at Samyang Biopharm USA, Saudat leads strategic initiatives to advance a pipeline of novel non-viral gene delivery platforms into the clinic through external innovation, partnerships, and licensing. She is focused on building high-value collaborations that accelerate next-generation genetic medicines.

Previously, she led Business Development at Ovid Therapeutics, where she executed impactful transactions across multiple stages of development for rare neurological diseases. Saudat began her career at Schering-Plough and has held progressive leadership roles at multiple companies including Pfizer and Sage Therapeutics. She has driven programs across diverse therapeutic areas including oncology, metabolic disorders, infectious disease, inflammation, and neurology and played a critical role in advancing early- and late-stage assets, including several marketed products. Leveraging a background in translational research and clinical development, she bridges science, strategy, and value creation in dealmaking. Saudat holds a PhD in Cancer Biology, an MBA in Pharmaceutical Management, and completed postdoctoral training at the National Institutes of Health (NIH), NCI Cancer Vaccine Branch, specializing in immuno-oncology and vaccine development.

William Ferreira Andrén is the Founder & CEO of Aperya, a Stockholm-based biotech Startup developing a transdermal excipient that creates temporary micro-pores in the skin to enhance uptake of peptides, proteins, nucleic acids, and small molecules. The company’s Rolling Spiked Microspheres (Orbica) have shown up to 100× higher penetration in early studies.

William earned his MSc at KTH Royal Institute of Technology, with a thesis at Stanford University’s Dauskardt Lab, researching skin mechanics and transdermal drug delivery. Aperya is advancing a pre-clinical eczema program with the LEO Foundation and Karolinska Institute, while building partnerships across cosmetics, longevity, and pharma.

At PODD, he will highlight how excipient-based micropore technology enables topical delivery of biologics and small molecules.

uMr. Ferrier’s team supports combination products in late-stage development and throughout lifecycle management at BMS. Prior to BMS, Mr. Ferrier worked in Research & Development at Becton Dickinson (BD), leading new product development and supporting lifecycle management projects in BD’s Medication Delivery Solutions business. Mr. Ferrier received a BS in Mechanical Engineering from Loyola Marymount University, and a MEng in Biomedical Engineering from Stevens Institute of Technology.

Dr. Fitzgerald is a board-certified head and neck surgeon with nearly three decades of clinical experience in a high volume practice in rhinology and endocrine surgery. He previously served as Chief Medical Officer of Intubrite, LLC, where he led design, testing, and commercialization of novel airway technologies, culminating in acquisition by Salter Labs. At Pituvia, he drives vision, strategy, and clinical translation of the company’s direct-to-pituitary drug delivery platform.

Rebecca Ford is VP of Strategic Development at Veranex, a medical device end to end design and development consultancy. With 15+ years of experience in product development and program management, she can take a high-level view of a project and manage the detailed components from a technical and holistic view to support multidisciplinary teams on a path to success. Her ultimate ambition is to provide the best solutions to patients and medical professionals to maintain a constant improvement in healthcare.  Rebecca has led cross-functional medical device development teams from concept through release across medical device and pharmaceutical industries.

Rebecca received her BS in Biomedical Engineering from the University of Texas in Austin and immediately entered into development of medical devices. She started her career as a design engineer working for SpineSmith in Austin, TX designing spine implants and instrumentation for intervertebral body replacements. After that she worked for Smith and Nephew in their advanced wound care division, leading the technical team to the launch of Smith and Nephews first connected wound care device amongst development of other wound care drug delivery devices working both for Smith and Nephew in US and UK.

Seth Forster is passionate about making better medicines by inventing and developing new pharmaceutical products and drug delivery technology.

Seth has a BS in Chemical Engineering from Purdue, MS & PhD in Pharmaceutical Sciences from Temple, and recently completed a MEng program in Polymer Science & Engineering from Lehigh. He has more than 19 years of experience in drug product development. He previously worked on the islatravir long-acting implant program and scale up of a tablet process for oral peptide delivery.

As a member of the Discovery Pharmaceutical Sciences group at Merck Research Laboratories at West Point, PA, he conducts early stage physical and chemical characterization of drug candidates, particularly for long-acting injectable (LAI) formulations.

Charles Fortier, PhD is an Expert Researcher in Drug Product Development at Adocia in Lyon, France, where he has been contributing since 2015. With over ten years of experience in CMC drug product formulation and in physical chemistry, Charles has supported the development of insulin and weight management peptides-based co-formulations from early-stage research through Phase 2 clinical batches.

He specializes in difficult-to-formulate peptide combinations, and biophysical strategies to enhance drug stability and pharmacokinetics. Charles has played a pivotal role in cross-functional collaborations across pharmacology, regulatory affairs, physical chemistry, chemistry and analytical science. He has also been in charge of CMC sections in regulatory submissions (INDs and IMPDs) and driven successful tech transfers and manufacturing readiness for clinical-stage programs with our trusted CDMO partners.

Charles is actively involved in proprietary formulation technology evaluation with academic and industry partners.

Morgan Fox has over a decade of experience supporting innovation in healthcare through advancements in polymer science. He joined Corbion Biomaterials in 2023, where he is responsible for building partnerships to develop the next generation of drug delivery technologies. Corbion specializes in GMP resorbable polymers, with its versatile PURASORB® portfolio based on the proven building blocks of lactide, glycolide, caprolactone, and PEG. Morgan began his career as a biomedical engineer after earning an MSE from the University of Pennsylvania and BSE from Duke University

With a keen business mindset and over 25 years of experience in pharmaceutical development and GMP manufacturing, Okke Franssen excels at forging strategic partnerships and driving commercial growth. Throughout his career—spanning start- ups, biotech, and large pharmaceutical organizations—he has successfully led business development initiatives, negotiated complex deals, and advanced innovative injectable technologies from concept to market. Since 2015, Okke is leading Nanomi, where his expertise and visionary leadership have guided the company from laboratory innovation to GMP-compliant commercial production, attracting key pharma and biotech collaborators worldwide. Okke holds a PhD in pharmaceutics and is trained as a physical organic chemist, underpinning his commercial success with deep scientific expertise.

Reenal Gandhi is Global Business Development Director within Aptar Pharma’s Prescription division, where she is responsible for driving the assessment of potential new opportunities, with a specific focus on new technologies. Ms Gandhi has over 15 years’ experience in both the drug delivery device and pharma industries, developing and commercializing drug delivery solutions for biotech, vaccines and pharma. Throughout her career, Ms Gandhi has been active in business development activities related to nasal devices and injectable devices such as pre-filled syringes and autoinjectors. Her interest lies in developing combination products with drug delivery devices, balancing formulation, technology, and commercial potential. Before joining Aptar Pharma in 2020, Ms Gandhi worked for drug delivery device company and global pharma/Rx company with a focus on licensing and acquisition of innovative and generic products.

Sudhakar Garad, PhD, received his PhD from the Bombay College of Pharmacy, University of Mumbai, India in 1998 in Pharmaceutical Drug Delivery Technology with Dr M S Nagarsenker. Soon after completion of his PhD, he worked with Pfizer, India for less than a year in clinical research. Taking into consideration his excellent credentials during his PhD, he was selected as a postdoctoral fellow at the University of Connecticut to understand micro-environmental properties above dissolving surface of the polymers with Dr Robin Bogner. After his post-doctoral fellowship, Dr Garad worked with Vertex Pharmaceuticals for a period of three years as Senior Investigator in the formulation development group. After Vertex, he joined Novartis as a Group Head. Dr Garad worked with Novartis for 9 years and joined as a Director of formulation development at Cubist Pharmaceuticals/Merck for 2.5 years. Currently Dr Garad is working as a Global head of Chemical and Pharmaceutical profiling (Discovery Pharmaceutics/Novel Drug Delivery) and Disease Area Head (New Indications) at Novartis. His primary role is to collaborate with research colleagues and build the right biopharmaceutical properties into new chemical entities, if not enable them via solubility/dissolution enhancement technologies to expedite molecules into tox and clinical studies. He is also responsible for enabling research, clinical and commercial molecules via novel delivery technologies (Brain targeting, permeability enhancement, TI improvement etc). He has many publications, book chapters and patents. In last 20 years of his career he has taken more than 200 new chemical entities in clinical studies across dozen disease areas ( CVM, Oncology, ATI, MS, Respiratory, NS, GI, Antibacterial, Tropical diseases, HCV etc), via oral, parenteral, inhalation and transdermal route of administration.

Amir is the CEO of Aktiv Medical Systems, developing the PenPal autoinjector platform. He is an accomplished serial entrepreneur and inventor in the drug delivery device space. To date Amir has formed a number of medical startup companies and served in a variety of roles for these companies including CEO, CTO, and as a Board member and advisor. In 2006 Amir co-founded SteadyMed (NASDAQ STDY, acquired by United Therapeutics in 2018), a clinical stage specialty pharma company that developed drug-device combination products based on a proprietary disposable, prefilled on-body pump.  Along his professional career Amir helped several leading healthcare companies innovate and address unmet needs in the drug delivery device space,  and several of the products that he invented and developed have become commercial successes. He is a named inventor on over 100 patents and the co-inventor of MAP Pharmaceutical MDI Inhaler (acquired by Allergan in 2013 for $983 million). Prior to his innovation and entrepreneurship career Amir has been in cleanroom manufacturing positions of drug delivery devices.

Scott Gibson is the Director of Systems Engineering at Amgen with responsibility for combination product development.  Since joining Amgen in 2012 he has held multiple roles directing device innovation and product development.

Scott has more than 30 years of experience in organizational development, medical device development, and combination product development with focus in cardiac rhythm management, diabetes, pain management, and subcutaneous and intravenous therapeutic delivery.  His experience includes start-ups acquired by Medtronic and Boston Scientific. 

Scott studied at California Polytechnic State University, San Luis Obispo, and holds more than 50 US patents. He has served as a member and chair of several industrial advisory boards.

Brian Ginn is the Manager of Biomaterials Research at Secant Group, LLC., a company focused on implantable biomedical textiles and polymeric-based delivery systems. His background includes work developing materials for tissue engineering of cardiac, ocular, and neural tissue, bioresorbable polymers, and polymeric nanoparticle delivery systems. His current work at Secant is focused on utilizing resorbable polyplex nanoparticle systems for applications including cell and gene therapy, ocular indications, bioprocessing, and in vivo payload delivery.

Dr Ana Lúcia Gomes dos Santos is a global leader in drug product development with 20+ years in macromolecule drug product development, self‑assembling systems, and nature‑inspired long‑acting therapies. As Director, Pharmaceutical Sciences External Evaluation at AstraZeneca (Cambridge HQ), she leads a cross‑functional team that scouts, triages, and evaluates emerging technologies across drug delivery, data science and modeling, drug product, and drug substance to accelerate and innovate development. Her cross‑functional leadership drives collaboration across internal teams, staying ahead of industry trends through continuous competitive market analysis and delivering transformational drug product strategies aligned with corporate objectives.

She has led highly successful teams in peptide developability, parenteral formulations, and discovery‑to‑early‑clinical drug product development, advancing more than 10 molecules to the clinic by bridging early discovery and clinical development. She holds a PhD in Pharmaceutical Sciences (Université Paris XI) and previously served as Professor and Head of the Department of Pharmaceutical Sciences at UFSC-Brazil, with 20+ peer‑reviewed publications, multiple patents, and international presentations.

With over two decades of experience in the CDMO space, Hector Gonzalez has built and led high-performing sales organizations that support the evolving needs of pharmaceutical OEMs. His career has spanned vertically integrated CDMOs, where he has collaborated closely with top-tier pharmaceutical companies to bring innovative drug delivery solutions to market—including auto-injectors, wearable devices, and ophthalmic delivery systems.

As Sr. Director of Sales & Marketing at Weiss-Aug Group, Hector oversees a dynamic team responsible for driving strategic growth across eight world-class manufacturing facilities. Under his leadership, Weiss-Aug continues to expand its capabilities in precision metal stamping, insert molding, and complex assembly, delivering integrated solutions that support the full product lifecycle from concept to commercialization.

Hector is passionate about building long-term partnerships and helping OEMs accelerate time-to-market through engineering excellence, operational agility, and a deep understanding of regulatory and market demands.

Brad is a distinguished medical device and combination product engineer committed to translating technical innovation into meaningful clinical impact. Since 2015, he has been an integral part of AbbVie's research and development team, leading programs in delivery system platforms and combination product clinical studies. Currently, Brad plays a pivotal role in Landscape and Platform Definition, where he assesses delivery system technologies to meet pipeline needs. His educational background includes a Bachelor of Science in Mechanical Engineering from the University of Illinois at Urbana and a Master of Engineering in Bioengineering from the University of California at San Diego.

Brad has over two decades of experience in med tech program leadership across startups, corporate settings, and design firms. Notably, he was the first employee hired at a startup that achieved a successful exit in under four years. His expertise spans a wide range of medical device applications, including combination products, cancer detection, cardiovascular systems, critical care, infection control, and obstetrics. Brad's dedication to advancing medical technology is reflected in his ability to guide complex projects, fostering collaborations, and driving innovations that bridge the gap between technology development and clinical application.

Andreja is the Head of the Process Analytics Development department at Sartorius BIA Separations. She leads a team focused on advanced chromatographic solutions, involving the development of innovative chromatographic analytical methods for analyzing biological molecules, including viruses, pDNA, mRNA, and LNPs. Throughout her career with biotech companies, she has gained extensive experience in protein chemistry, including characterisation of biosimilars and biologics. She holds a Master of Science in Biochemistry from the University of Ljubljana, Slovenia.

Dan has over 25 years of experience in biopharma, medical devices, and engineering consulting. He is currently a Director of Engineering in Amgen’s Combination Products Development organization, leading teams in drug delivery solutions. Dan’s areas of responsibilities include early engagement with therapeutic product delivery teams for device strategy, design controls for clinical and commercial combination product development, and risk management across all stages of product lifecycle. His nearly 10 years at Amgen include establishing a device presence at Amgen’s Cambridge, Massachusetts facility where Dan is the head of the device and final product organization. Prior to his career at Amgen, Dan held various positions at GE Healthcare where over a 15-year period he led an Advanced Technology function, developed and commercialized class II medical devices, and represented the engineering organization in medical advisory boards and patent evaluation boards. Dan holds a PhD and BS in Mechanical Engineering from Tufts University and an MS in Aerospace Engineering from Virginia Tech. He sits on the industrial advisory board for the UMass-Lowell Biomedical Engineering Department and has more than 25 issued and pending patents, as well as numerous publications.

E is a passionate leader in building device development capabilities and improving combination product development processes. He has 20+ years’ experience in delivery device technology assessment, combination product development, manufacturing process development, commercial scale-up and life cycle management. E currently holds the position of Head of Injection Systems at Takeda. Previously he was Director of device development with AstraZeneca. He built a very strong device team and managed multiple combination product programs in the therapeutic areas of respiratory, inflammation, autoimmune, cardiovascular, renal, and metabolic diseases. Prior to AstraZeneca, he was device lead with Janssen Pharmaceuticals and Becton Dickinson, where he led and launched/relaunched injection device and combination products. E obtained his Bachelor and PhD degrees in mechanical engineering and a master’s degree in polymer physics.

Dr Manish Gupta is passionate about connecting biology and product design to create the best medicine for the patient. Dr Gupta has championed science and risk-based development for multiple oral and parenteral commercial drug products and has successfully led regulatory filings and interactions across agencies. Dr Gupta has 20 plus years of industrial experience and is currently serving as Vice President, Portfolio and Technology Delivery Vaccines at GSK.

For over 25 years, Brent has been recognized as a leading authority in the micro molding and materials industry, specializing in precision medical devices and innovative drug delivery systems. Throughout his career, Brent has led miniaturization strategies for groundbreaking micro advancements. His industry  achievements include developing solutions for the thinnest micro catheter, leadless pacing, minimally invasive eye surgery, and micro drug eluting devices. As a recognized Subject Matter Expert, Brent has educated audiences worldwide with his expertise in micro molding and product miniaturization. He has been regularly featured in industry articles, conference expert panels, and as a keynote speaker. With a background as a Plastics Engineer and an MBA from Pittsburg State University, Brent has excelled in engineering, business development, and marketing with leadership roles across resin, life sciences, micro injection molding contract manufacturing, and medical and drug delivery devices. He played an important role as CEO during Isometric’s acquisition by Nissha Medical Technologies and has recently joined Gram Medical as CEO. Brent’s leadership accomplishments have focused on communication, alignment, and creativity which has enabled the teams he has built and guided to over $1 billion in sales with medical device and drug delivery OEM’s. 

With a background as a Plastics Engineer and an MBA from Pittsburg State University, Brent has excelled in engineering, business development, and marketing with leadership roles across resin, life sciences, and micro injection molding contract manufacturing. He played an important role as CEO during Isometric’s acquisition by Nissha Medical Technologies and now serves as Senior Vice President with responsibility for Isometric Micro Molding, a Nissha Medical Technologies company. Brent’s leadership accomplishments have focused on communication, alignment, and creativity which has enabled the teams he has built and guided to over $1 billion in sales with medical device and drug delivery OEM’s.

Dr. Jeff Haley established and leads a team of scientists and engineers working on long-acting drug delivery. He is also responsible for groups focused on polymer development, technical service, and quality assurance. Dr. Haley received a B.S. in Chemical Engineering from The University of Texas, a Ph.D. in Chemical Engineering from the University of Minnesota, and was a postdoctoral fellow in the Chemistry department at the University of Toronto. He started his industrial career developing new polymer products for the Lyondell Chemical Company before joining Celanese in 2011. Dr. Haley has held various positions at Celanese working on product development and technical service, and began focusing on drug delivery systems in 2018, ultimately founding the VitalDose® lab. He has coauthored over 20 scientific publications and is a coinventor on 11 granted US patents.

Laxman Halleppanavar is currently the Head of Portfolio Strategy and Management at Credence MedSystems, leading the Injectable Device Portfolio Strategy and Management team for internal and external customer endeavors. Previously, Laxman was the Director & PharmSci Technical Team Lead at Pfizer. He came to Pfizer upon its acquisition of Hospira where Laxman was responsible for combination product development from early-stage development to manufacturing scale up leading to commercial launch. Prior to Pfizer, Laxman was the Program Manager at GE Healthcare Monitoring Solutions leading development, manufacturing, service engineering and commercialization of multiple medical devices / patient monitoring platforms namely, patient worn devices, blood pressure cuffs, bedside monitoring devices, networked central & remote monitoring stations.

Dr. Matthew Hancock is a Principal at Veryst Engineering, a technical consulting firm in the Boston area. Dr. Hancock has extensive experience in fluid mechanics related to product design and performance, with core areas including microfluidics, surface tension and wetting, heat transfer, species transport, and mixing. He consults in microfluidic and fluidic devices in biopharma, biotechnology, medical devices, combination products, process technologies, and consumer products. For combination products, he and his team consult on a range of topics including autoinjector performance, syringe stopper lubrication and motion, vial fogging, lyophilization, dense suspension jamming, drug product drying, water ingress, and leakage.

Dr. Hancock has worked in academic, medical, and industrial settings, both as project lead and as a model-based engineering consultant. He earned his PhD in environmental fluid mechanics from MIT. Prior to joining Veryst, he worked with the Broad Institute, the Wyss Institute, Brigham and Women’s Hospital, Harvard Medical School, and the Department of Applied Mathematics at MIT. Dr. Hancock has coauthored dozens of peer-reviewed research articles in journals such as Nature Materials, PNAS, Lab on a Chip, Small, and Biomaterials.

Stephen Harhen is the Chief Technology Officer at Rx Bandz, where he leads the design and development of MiniJect® and oversees drug development to create the next-generation autoinjector platform. With over 15 years of experience spanning combination products, drug-device integration, and medical device R&D, Stephen brings a uniquely cross-functional perspective to solving complex technical challenges at the interface of engineering and therapeutics.

Dr. Anya Harry currently serves as the Vice President and Chief Medical Officer at West Pharmaceutical Services. With more than 25 years of experience spanning roles as a physician, a drug and device regulator at FDA, and a leader in the pharmaceutical and packaging industry, Dr. Harry spearheads the Applied Research and Clinical Affairs team at West, focusing on innovative solutions for the containment and delivery of injectable medicines.

Before joining West, Dr. Harry was Global Head of Global Demographics and Diversity at GlaxoSmithKline. In this role, she built a comprehensive framework facilitating diverse and clinically relevant representation in clinical trials across the company's portfolio. Her tenure at GSK also saw her excel as a Clinical Development Director within the Respiratory Therapeutic Area, where she managed both early and late phase assets from candidate selection through to approval and successful commercial launch.

Her time at FDA saw her in multiple leadership roles including Respiratory Devices Branch Chief and Acting Clinical Deputy Director at CDRH. Dr. Harry's clinical experience extends to being an Attending Intensivist at Inova Fairfax Hospital's ICU, a Level 1 trauma center in Falls Church, VA.

Dr. Harry earned her M.D. and Ph.D. from the Mount Sinai School of Medicine, completed her Internal Medicine Residency at Yale University. Her specialized training in Pulmonary and Critical Care Medicine was through a combined fellowship at the National Institutes of Health and the University of Pennsylvania.

Almost 30 years of design experience across a variety of industries; including medical devices, automobiles, and consumer products/packaging. Chief advocate for the user on projects, ensuring their needs and perspectives are understood and prioritized throughout the design process. Specializing in making complex technologies simple and intuitive through a deep understanding of human factors and ergonomics and by performing rigorous research and usability studies. This user-centric approach is fundamental to Key Tech development teams.

Ashley Hawson is Senior Vice President of Innovation and Operations at Cambridge Consultants, where she leads both the Healthcare business unit and the company’s North America operations. She heads a multidisciplinary team of over 100 engineers, scientists, and designers specializing in the creation of Class II and III medical devices distinguished by their technical novelty and transformative potential.

Ashley is recognized for driving innovation at the intersection of strategy, experimentation, and product development. She sponsors Cambridge Consultants’ internal R&D investments, fostering cutting-edge advances and generating intellectual property for licensing and spinouts. This portfolio spans fields as diverse as photonics, human–machine understanding, and fully regulated medical AI applications.

A graduate of Georgia Tech, Ashley began her career engineering human-integrated systems for hospital environments. She has since held leadership, operational, and academic roles at GE, Tufts University, and Cambridge Consultants. Known for her ability to cultivate top talent and guide clients toward breakthrough outcomes, she is committed to advancing technologies that meaningfully improve patient lives—while ensuring the complex machinery of a people-driven business runs seamlessly.

Matthew Huddleston serves as Chief Commercial Officer for Enable Injections. He is an experienced medical device professional with more than 20 years of experience in startup environments with emphasis in project management, design, development, manufacturing, regulatory, and intellectual property. He has several issued and pending patents in the medical device field, including soft tissue and cardiovascular fixation devices and delivery instruments, histologic automated embedding systems, laparoscopic visualization devices, and automatic injection devices. He is a professional engineer and a licensed patent agent. Matt holds a Bachelor of Science in Mechanical Engineering from Purdue University and a Master of Science in Biomedical Engineering from The Ohio State University.

Fady is leading the groups of Biopharmaceutics and formulation in Sanofi USA to develop a strategy for DP development for successful transition into human and subsequent market launch. He obtained his PhD from the University of Houston and completed post-doctoral training at the University of British Columbia, Vancouver Canada. He led the translational Biopharm group in Pfizer and then moved to Sanofi to lead the Early Development Biopharmcy group. Fady is passionate about the transition of molecules into clinics and developing innovative strategies for drug product development.

Shirish Ingawale is a Director of Device & Combination Product Development at Takeda. With over 20 years of diverse experience in medical devices, drug delivery technologies, and combination products, Shirish is acclaimed for his strategic vision, innovative approach, and steadfast commitment to transforming patients’ lives. He blends a robust background in R&D with a strategic perspective shaped by roles in academia and leadership positions in the medical device, biotechnology, and pharmaceutical sectors.

At Takeda, Shirish spearheads strategic and collaborative innovations, motivating cross-functional teams to set new industry benchmarks in device and combination product development. Before joining Takeda, Shirish spent a decade at Amgen, where he led multidisciplinary teams and managed the lifecycle of drug delivery devices and breakthrough combination products. He played a vital role in successful development and commercialization of drug delivery technologies including reconstitution kits, pre-filled syringes, autoinjectors, and on-body delivery systems along with establishing device platforms. Previously, Shirish contributed to advancement in the medical device industry and academia, with a focus on implantable devices.

Shirish earned a Bachelor’s degree in Instrumentation Engineering from the University of Mumbai, India, and a Master’s and PhD in Biomedical Engineering from Wright State University, Ohio, USA.

Russell Johnson, PhD is Head of Delivery Sciences at Moderna Therapeutics, where he leads efforts to advance next-generation medicines that power the company’s growing portfolio of therapeutics and vaccines. He drives innovation and strategic execution across nanoparticle delivery systems to guide and enable early pipeline. Dr Johnson and his team at moderna have a central role in shaping Moderna’s delivery strategy and cultivating a culture of scientific excellence within its research organization. With more than 15 years of experience in RNA, nucleic acid, and protein delivery at small and large pharma and biotech, his work pushes the cutting edge of the next-generation healthcare and medicine.

Christian Jones is the Chief Commercial Officer at Nanoform, a publicly listed NASDAQ company. As part of the management team, he leads all global commercial activities including sales, marketing, business development, partnering and licensing. He works with pharmaceutical and biotech companies to enable improved drug performance by creating high drug load patient-centric medicines through Nanoform's proprietary API nanoparticles and novel formulation technologies. With over two decades of experience spanning the pharmaceutical value chain—from drug discovery to commercial manufacturing—Christian brings a strategic, results-driven approach to accelerating drug development for patients' benefit.

He has held senior commercial roles in organizations including Johnson Matthey, Dr Reddy's Laboratories, Prosonix, Tripos Discovery Research, consistently delivering growth across Drug Substance and Drug Product development and manufacturing services. 

Christian is a chemist by training, holding a Master of Chemistry degree from the University of Leeds, and is a Fellow of the Royal Society of Chemistry. He possesses a deep technical foundation in crystallization science, particle engineering, and respiratory drug delivery, and is passionate about leveraging cutting-edge technologies to advance healthcare innovation.

A proven leader with a global perspective, Christian is recognized for his ability to identify and unlock commercial potential, guiding organizations to strategically capitalize on their strengths in an increasingly complex and competitive industry landscape.

His ultimate ambition is to touch the lives of a billion patients through the application of Nanoform's technologies. With a wide range of partnerships already established across US, Europe and Japan the company now works with 12 of the top 20 pharma companies globally and are on track to reaching this important milestone!

Konrad Kauper has led the core device development programs for Neurotech’s Encapsulated Cell Technology (ECT) for the past 15 years. During this period Neurotech has successfully completed several Phase I, Phase II clinical trials and recently completed enrolment of two-Phase III US and multinational clinical trials investigating ECT as a treatment for eye disease including wet macular degeneration, retinitis pigmentosa, dry macular degeneration and macular telangiectasia.

Konrad has over 23 years of experience in biotechnology and pharmaceutical companies having held research and development positions at WR Grace Biomedical, CytoTherapeutics, and Genetics Institute, contributing multiple patents, peer-reviewed scientific articles and oral presentations related to the fields of drug delivery and cell-based therapeutics. Konrad received his undergraduate and graduate degrees in Chemical Engineering from Northeastern University.

Ravi Kaushik is the VP, Global Head of Device and Digital Development and Product Strategy where he is responsible for driving innovation for Plasma Derived Therapies and leads a team of engineers, digital and product management organization. Ravi joined Takeda in 2021 as the VP, Global Program Leader, PDT Integrated Care Solutions where he has formed a Global Program team (GPT) to cross-functionally drive patient and donor centered integrated care solutions with devices/digital innovations to help drive better patient outcomes while growing the PDT business

Earlier, Mr Kaushik was the CEO for TransAsia Biomedical Ltd. (a large IVD company) where he led & drove the Strategy, Product Development & Launch Execution, Leadership Team Management, Business development & growth with P&L Responsibility (~ $120MM) and 1200 employees globally.

Earlier, Mr Kaushik was with Medtronic as the Group Marketing Director, APAC & Country Director, India for the Diabetes business (insulin pump & CGM). He drove strategic growth for the ~$100 MM business and led innovative patient centric business models to improve solutions and services for Diabetes patients (value-based healthcare) across the APAC region.

Prior to that, Mr. Kaushik was at Baxter International (Baxalta-Shire) as Director for Strategy & Healthcare Innovation function for the Emerging Asia/India markets. He provided strategic leadership, identifying, and executing key market and patient centric innovation programs while aligning these initiatives with the global company strategic plan. He also led the commercial (P&L) of the $70MM Baxalta India with a 100+ member team when it was spun off from Baxter in 2015.

Earlier, Mr. Kaushik was at GE Healthcare as the Director of Global Upstream Marketing (Maternal Infant Care), Emerging Markets leading multiple teams of product managers for disruptive medical device product innovation, driving market creation with organic growth across Asia & Africa. Prior to that Mr. Kaushik was with GE LED Lighting as a Global Product Marketing Manager, in Cleveland, USA leading several new product innovations in LED lighting for retail display.

Overall, Ravi has 25+ years of global leadership experience in P&L Management & strategic innovation in various roles/industries ranging from Healthcare (MedTech & Pharma), LED Lighting, & Industrial companies globally. Ravi has proven himself as a disruptive innovator, strategic thinker, inclusive and execution driven leader in business analytics, strategic planning, global marketing, new product & business model innovation. Over the past decade, Ravi has been recognized globally as India’s Top 20 Healthcare CEOs (Transasia) in 2020, Global transformative leader award (Medtronic) in 2018, Emerging Market Growth Leader award (Medtronic) in 2018, Healthcare Innovation speaker at World Federation of Hemophilia Congress (2016), Global CEO Award for “Imagining the possibilities” Business Model Innovation at Baxalta (Shire) (2015), CEO Award for Patient Centricity (GE Healthcare, India) in 2012 Mr. Kaushik holds an MBA from the prestigious Kellogg School of Management (Northwestern University) in Chicago.

Mr Kaushik also has graduate degrees of Master’s in mechanical engineering from the University of Wyoming and Bachelor’s in mechanical engineering from MS University, Baroda, India.

Since 2014, Tom Kelleher has been the CEO of Xylome Corporation where he engages in research and business development. Tom holds a doctorate in Industrial and Applied Microbiology from Rutgers University (1981) He is an SIMB Fellow and past president of the Pacific NW Chapter of the SIMB and past elected board member of the Puerto Rico Chapter of the Parenteral Drug Association. Between 2003 and 2014 at Amgen, Tom was Director in Global Process Engineering at Thousand Oaks and Puerto Rico sites. Between 1998 and 2003, Tom was the lead inventor of the current commercial process for Daptomycin (an antibiotic of last resort) that resulted in FDA approval of this new class of antibiotic for “super bugs”, including Vancomycin Resistant Enterococcus (VRE) and MRSA with sales exceeding $1-billion/year. Since 1980, Tom has held positions of increasing responsibility in process development and industrial microbiology at other biopharmaceutical companies, including ZymoGenetics/Novo Nordisk, Apha-1-antitrypsin at Chiron and Worthington Biochemicals. During his career, Tom was the owner representative or leadership team member for the construction, operation and successful FDA licensure of six GMP biopharma production plants.

As a person living with multiple myeloma since 2017 and an active patient and research advocate, Todd strives to leverage his lived experience as a cancer patient with his 30+ years of professional experience in the pharmaceutical industry, to advance patient-centered cancer research, education, empowerment and access.  He is a support group leader, cancer coach, author, and advisor on numerous research collaboratives and clinical trials. He believes that early and ongoing integration of patient and care partner perspectives is essential for strategic success and optimal outcomes.

Asmita Khanolkar has a Master’s degree in Materials Science and Engineering from Worcester Polytechnic Institute, Worcester, MA. With over two decades dedicated to the healthcare industry specializing in the Medical Device and Pharmaceutical industry, she has engineered, managed, and led various products from concept to commercial launch. Her product portfolio includes single-use, on-body and implantable devices, drug-device, device-biologic combination products for bio-therapeutics and pharmaceutical applications. Her current responsibilities include a corporate leadership role supporting multiple sites for bringing complete pharma solutions, working from early technical engagement through commercialization for combination products and pharmaceutical services. Asmita is an invited speaker, keynote, chair, panelist, and advisor for various domestic and international conferences. She has published multiple thought leading articles and co-authored Medical Device Validation Handbook.

Tamás Kiss is a Formulation Project Manager at CarboHyde advancing pharmaceutical and biopharmaceutical product development through innovative formulation strategies and drug delivery solutions. At CarboHyde, he leads the development of cyclodextrin-based solutions for various dosage forms, driving their application in pharmaceutical formulations to enhance solubility, stability, and therapeutic performance.

Beyond R&D, he contributes to business development and strategic positioning, bridging the gap between science and market needs to bring novel solutions closer to patients. His work integrates scientific rigor with translational impact, aiming to accelerate the development of safe, effective, and sustainable therapies

Allergist/Immunologist/Pediatrician. Chair, and Co-Founder of VGSK Technologies, Inc. Research Interests and objectives are to develop sustained respiratory and oral drug delivery for therapeutics to increase efficacy, safety and patient compliance.

Łukasz Koroniak (Luke) is a Global Biomaterial Director Drug Delivery Solutions at dsm-firmenich, where he is focused on extending application of our portfolio including proprietary, biodegradable TheraPEA™ platform in the development of long-acting therapies. For the past 15 years at dsm-firmenich, Luke has been a part of innovation and business teams focused on development and commercialization of novel long-acting therapies. These efforts have led to commercial launches of partner products in cardiovascular, and more recently, a phase I/II development of novel product in ophthalmic space.

Luke holds a PhD in Organic Chemistry from University of Florida and EMBA from Alto University. In his 20-year tenure, he has developed a broad experience in drug discovery, medicinal chemistry, drug delivery and has authored several scientific publications and patents.

Mateja Kramer received her bachelor’s degree in microbiology in 2002, followed by a master’s degree in 2005 and a doctoral degree in 2010 from the University of Ljubljana, Faculty of Pharmacy, Slovenia, in the field of rapid microbiological technologies. She moved in 2002 to the Microbiology Analytical Science & Technology (AS&T) at Novartis, Slovenia, as a research fellow, and in 2010 became Head AS&T, responsible for managing microbiological quality systems, testing and release of the bulk and finished dosage forms. In 2015, she joined Novartis solid dosage forms Packaging site in Lendava, Slovenia, where she was responsible for a batch certification and release. In 2018, she joined Technical Research Development Biologics and Cell & Gene Therapies where she was responsible for managing innovation projects. Currently, she is a Global Head of Innovation in Technical Research Development responsible for leading the global enterprise innovation system across the drug development process for both biologics and chemical molecules. She has authored and co-authored 16 publications and mentored over 10 graduate students and research fellows. For 13 years she was an Expert in Water for pharmaceutical purposes nominated by European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe. She received the Best of the Best business practice award 2022 granted by the American Chamber of Commerce. Under her leadership, Innovation Council received the 2024 Innovation Impact Award for the best sustainable innovation program.

Vinu Krishnan, PhD, is a Principal Research Scientist in AbbVie’s Synthetic Molecules CMC R&D organization, where he leads the early CMC development of nucleic acid formulations. Dr. Krishnan has more than 10 years of post-PhD and postdoctoral experience in developing drug delivery systems for small molecules and gene therapies. Before AbbVie, he was at Intellia Therapeutics, where he led projects in the discovery and development of targeted LNPs for applications in gene editing. At Fount Bio, an early stage start up, he led projects on developing hydrogels for topical delivery. Dr. Krishnan did his postdoctoral research in drug delivery, advised by Professor Samir Mitragotri at Harvard University. In his research career, Dr. Krishnan has worked with various drug delivery modalities, including polymeric nanoparticles, polymer-drug conjugates, liposomes, LNPs, hydrogels and nanocrystal drugs. He has authored over 25 peer-reviewed publications in scientific journals including Nature BME, Science Advances, PNAS, Angewandte Chemie, Advanced Drug Delivery Reviews, Bioengineering & Translational Medicine, and Advanced Therapeutics. Dr. Krishnan received his PhD degree from the University of Delaware, and Master’s degree from the University of Akron, Ohio.

Vijay Kudchadkar serves as the Director of Plastics & Sales Engineering at Nissha Medical Technologies - Isometric, bringing over 20 years of experience in injection molding and an additional 9 years of expertise in extrusion, thermoforming, and blow molding to his role. He is dedicated to developing innovative solutions tailored to the specific needs of medical OEMs, aiming to reduce costs and enhance operational efficiency. Vijay is widely regarded as an expert in precision molding, proficiently handling micro and larger parts.

Beyond his responsibilities at Isometric, Vijay actively contributes to his professional community as the Golf Chair for SPE Ontario and holds the position of newsletter editor for the SPE Medical Plastics Division. His contributions to the field are underscored by numerous publications and an impressive portfolio of 9 patents in the domain of polymer processing.

Dr. Jose M. Lagaron is a Full Professor, Founder, and Group Leader of the Novel Materials and Nanotechnology for Health Applications group at CSIC (Spanish National Research Council). He also serves as CEO and CSO of BioNanoPharma S.L. According to Scopus, Dr. Lagaron has authored 373 peer-reviewed publications, holds 78 patents, and has an h-index of 80—reflecting his significant impact in the fields of biopolymers and nanobiotechnology. He is a member of the editorial boards of several prominent scientific journals and currently serves as Vice-President of BIOVAL, the Bioregion of the Valencian Community in Spain. In addition to his academic and executive roles, Dr. Lagaron has founded multiple nanobiotech spin- offs, including Bioinicia S.L. and BioNanoPharma S.L., contributing to the translation of advanced technologies into commercial applications.

Mr. Lake has worked in vaccine manufacturing and commercialization for 30 years developing diverse experience at global leaders Merck and GlaxoSmithKline. Mr. Lake's background includes live virus and recombinant vaccine bulk production, sterile filling, and quality control, before moving into product management and business development roles. He served as the manufacturing Alliance Manager between Merck and Sanofi Pasteur during the startup of their European Joint Venture and worked for several years as a senior level commercialization consultant in the vaccine industry.

Matt Lanchantin is the Head of Corporate Development at Syntis Bio, a biopharmaceutical company revolutionizing oral therapies for obesity, diabetes, and rare metabolic diseases. He oversees portfolio development and strategic partnerships, with a focus on identifying and advancing novel therapeutic applications for the company’s SYNT™ technology platform. Matt is also a co-founder of Nucleate, a global nonprofit dedicated to empowering the next generation of biotech leaders and entrepreneurs. Since beginning his career at the bench, Matt has held roles across research, strategy, and business development, leading licensing and M&A transactions spanning oncology, cardiovascular, and metabolic diseases. Matt holds an MBA from the MIT Sloan School of Management and a BS in Chemical and Biological Engineering from Tufts University.

Robert Langer is one of 9 Institute Professors at the Massachusetts Institute of Technology (MIT); being an Institute Professor is the highest honor that can be awarded to a faculty member. He has written over 1,500 articles, which have been cited over 400,000 times; his h-index of 315 is the highest of any engineer in history and the 2nd highest of any individual in any field. His patents have licensed or sublicensed to over 400 companies; he is a cofounder of a number of companies including Moderna. Dr Langer served as Chairman of the FDA’s Science Board (its highest advisory board) from 1999-2002. His over 220 awards include both the United States National Medal of Science and the United States National Medal of Technology and Innovation (he is one of 3 living individuals to have received both these honors), the Charles Stark Draper Prize (often called the Engineering Nobel Prize), Queen Elizabeth Prize for Engineering, Albany Medical Center Prize, Breakthrough Prize in Life Sciences, Kyoto Prize, Wolf Prize for Chemistry, Millennium Technology Prize, Priestley Medal (highest award of the American Chemical Society), Gairdner Prize, Hoover Medal, Dreyfus Prize in Chemical Sciences, BBVA Frontiers of Knowledge Award in Biomedicine, and the Balzan Prize. He holds 41 honorary doctorates, including Harvard, Yale, Columbia, and Northwestern, and has been elected to the National Academy of Medicine, the National Academy of Engineering, the National Academy of Sciences and the National Academy of Inventors.

Clayton T. Larsen is President and CEO of Vesselon and leads the development and translation of novel co-formulations of lipid microspheres and various drugs to dramatically increase biodistribution of biomolecules and viral transduction in target tissues. Prior to his pharma experience, Clay worked for 20 years as a Senior Executive in ultrasound for Acuson (acquired by Siemens), and Fujifilm Medical, currently the world leader in point-of-care ultrasound. Clay led the development and commercialization of Fujifilm’s SYNAPSE, the industry’s leading image-enablement solution, now managing 80 billion objects for 6,200 facilities across six continents. His degree in Molecular Biophysics & Biochemistry from Yale has given him the motivation and insight to synthesize these fundamental areas of science into a revolutionary therapeutic opportunity.

Dr. Latour joined PharmaJet as Chief Executive Officer in 2024. He brings more than 30 years of vaccine and biopharmaceutical industry executive experience to PharmaJet, most recently as CEO, President and Director, and Chairman of the Board at Vaxart, Inc., a clinical stage biotechnology company developing oral recombinant vaccines based on its proprietary oral vaccine delivery platform. Previous roles include CEO and Director at Trinity Biosystems, Global Strategy and Business Development roles at Novartis Pharma and SmithKline Beecham Biologicals (now GSK Vaccines), and strategic advisor for several mid-size vaccine companies. Wouter holds Doctor of Medicine and Bachelor’s degrees from the University of Amsterdam and an MBA from Stanford University.

Dr. Lee began his research career in sustained-release injectable drugs delivery in 2006 as a formulation and process scientist. Over the past 19 years, he has led the development and clinical trials of various sustained-release injectable microsphere products. Leveraging this deep expertise, he joined G2GBIO in 2019, where he conceived and led the development of InnoLAMP, a proprietary microsphere platform design to overcome the key limitations of conventional PLGA-based technologies- namely, low bioavailability, high injection site reactions, and poor scalability. Dr. Lee has played a pivotal role in advancing once-monthly injectable formulations of donepezil and semaglutide using the InnoLAMP platform. Under his leadership, G2GBIO has expanded it’s business model from proprietary product development to include CDO/CDMO services, capitalizing on its large-scale GMP manufacturing infrastructure and technology capable of achieving peptide drug loading exceeding 50%.

• 19 years of experience in sustained-release drug delivery
• Ph.D in Pharmacy, Kyungsung University, South Korea
• Head of Business Strategy at G2GBIO, South Korea
   

Sergie Letser joined Nanoform in 2020 and is currently the Deputy CCO and SVP of Business Development. Sergie started his career as a process chemist and was involved in scaling operations from kilo through to commercial scale API and drug product before transitioning to a customer facing roles. He has broad experience in pharmaceutical development and manufacturing and has previously held senior business development positions at Porton Pharma Solutions, Johnson Matthey, and Cambridge Major Laboratories.

Junwei Li is an innovation leader with extensive experience across the pharmaceutical development spectrum, including research, clinical, and product supply functions. With a strong foundation in global, cross-functional collaboration, Junwei has successfully led initiatives spanning drug development and device innovation. Junwei’s expertise includes advancing injectable, oral, and software-based therapeutics, with a particular focus on combination product development. Junwei has also played a key role in strategic partnerships, business development, and alliance management.

Patrick Lim Soo, PhD, is currently a Group Lead and Senior Principal Scientist at Pfizer. He is a member of the management team in the Drug Product Design & Development group within Pfizer’s Biotherapeutics Pharmaceutical Sciences organization focused on identifying and developing drug delivery solutions to support Pfizer’s entire biotherapeutics portfolio (including mammalian and microbial fermentation derived candidate molecules, vaccines, gene medicine, nanomedicines, targeted delivery strategies, and novel delivery device development). Dr Lim Soo is the current Chair and Co-Founder of the IQ Consortium Nanotechnology and Nanomaterial Working Group. The mission of this group is for the member companies to collaborate on CMC challenges facing industry in characterizing, developing and manufacturing nanomaterials and align with regulatory/government agencies as partners to better understand what is needed to approve nanotechnologies in a pre-competitive manner. Prior to his position at Pfizer, Dr Lim Soo was Research Leader at Tarveda Therapeutics where he led efforts for the filing of two IND applications to the U.S. FDA and was co-leading the formulation group in the development of targeted drug conjugates. He received his PhD in polymer chemistry from McGill University and completed his postdoctoral research fellowship in pharmaceutics from the University of Toronto. Dr Lim Soo has co-authored 16 peer-reviewed papers (four of those publications while working in industry) and is an inventor on eight patents or patent applications.

Roger Liu has over 30 years in industry and possesses a track record of commercializing and launching combination products supporting key pharmaceutical franchises. He has cultivated a reputation as an innovator, collaborator and partner advocate for delivery technology developers and manufacturers.

Roger currently serves as Director-Combination products and leads the technology scouting, feasibility, and delivery system integration efforts within AbbVie, matching external innovation with internal drug product assets. He has particular focus and passion on making things easier and more intuitive for the patient while managing expectations for the corporation on strategies, timelines, and execution.

Roger's history includes patents, papers, and experience through roles at AstraZeneca, West, Biogen, Amgen and Lilly. He is a recipient of AbbVie’s Chairman's Award, the highest honor at AbbVie. Roger holds a BS in Mechanical Engineering from the University of Illinois at Urbana-Champaign and an MBA from the Kelley School of Business at Indiana University.

Nathan Lockwood is Director of R&D at ProMed Pharma, LLC, where teams develop processes to manufacture long-term complex dosage forms for women’s health, ophthalmology, oncology, and other clinical indications. A focus of his team’s work has been the formulation of bioresorbable implants for sustained release applications and scale up for clinical and commercial manufacturing.  Prior to joining ProMed Pharma, he held roles at Boston Scientific and Surmodics leading pharmaceutical aspects of combination medical devices for the treatment of vascular disease and cancer.  He also worked on teams to develop lubricious and drug delivery coatings for medical devices.  Nathan holds Ph.D. and B.S. degrees in Materials Science and Engineering from the University of Minnesota and Northwestern University, respectively.

Jake Lombardo has been Co-Founder and CEO at Anodyne since its inception in early 2019, leading the company through its first successful clinical trial and into clinical development for its lead GLP-1 asset. He brings a unique combination of biomedical engineering expertise and entrepreneurial acumen. Under his leadership, Anodyne has also secured substantial venture capital funding and advanced from concept to a platform company developing multiple, next-generation cardiometabolic treatments.

He holds a B.S. in Biomedical Engineering from Union College and an M.Sc. in Innovation and Management from Tufts University. Jake is also one of the key inventor of Anodyne’s proprietary technology.

After starting her career in New Jersey at Merck as a Research Biologist, Karen Lowitz changed direction and moved into Regulatory Affairs. In 2009, she relocated to beautiful Colorado where she joined Sandoz with responsibility for generic drug regulatory submissions. Most of her professional time in CO was with Terumo BCT supporting blood collection and cell processing devices, which provided opportunities to manage a team and travel to Japan, Northern Ireland, Vietnam, and India to support combination product manufacturing. In 2023, she joined Biogen to work on a Phase 3 clinical therapy to be presented in multiple drug/device combinations. In 2025, sunny California became her home, and she continues to support the complex program for which Biogen plans to commercialize. Global regulation of combination products is ever evolving, which is why it is exciting to work in this space.

Dr Suman Luthra is currently Director in Discovery Pharmaceutical Sciences at Merck Boston site and is responsible for providing strategic and technical leadership at the discovery-development interface to enable the discovery of new drug candidates including small molecules, peptides and biologics. She oversees preclinical drug product development activities that include nomination of candidate for clinical development through developability risk assessment and application of insights to assess and mitigate CMC drug product developability risks. Dr Luthra’s team enables the transition of the right molecules from discovery to clinical formulation development with clinical formulation strategies in place. With 30+ active programs including various modalities and stages of development, she provides scientific oversight and make strategic decisions for acceleration. She is passionate about advancing patient friendly drug delivery solutions of diverse modalities including macrocyclic peptides which is the focus of the panel discussion today.

Dr Alex Lyness joined SHL Medical in January 2025 as Head of Applied Research & Innovation. He is responsible for identifying and evaluating technologies and trends that may improve SHL’s current and future goals in drug delivery. Alex is building an interdisciplinary research team to collaborate with medtech start-ups and high-caliber academic institutions. This research program will enhance both the current understanding of subcutaneous injection science, as well as explore newer adjacent areas for SHL such as different routes of administration and emerging formulation technologies.

Manfred Mäder is VP Global Device & Packaging Development in TRD (Technical Research and Development) at Novartis.

Prior to this, he held the position Head of Global Compliance & Audit for Devices & Combination Products overseeing all Alcon, Pharma, and Sandoz sites producing this type of products and Global QA Head of Technical Research and Development at Novartis Pharma starting in February 2011.

Prior to this position he was Senior VP of Quality Management & Regulatory Affairs, at Ypsomed, a company producing Medical Devices and Combination Products starting in 2007. Previously, he was responsible for Quality Assurance Management at Sanofi-Aventis for the Frankfurt Injectables site. Before then, being based in Kansas City/ US, he had a global responsibility for Quality and Regulatory for one of the Aventis Blockbuster products. Prior to that, he held several positions in QA and QC.

By training he is pharmacist and holds a doctorate in pharmaceutical analytics and statistics by the University of Wuerzburg/ Germany.

Bernd Mahlmann, Executive MBA, is a senior business development executive with over 15 years of experience in the international pharmaceutical and medical device industries. He specializes in driving customer-centric transformation and supporting strategic growth. At Ypsomed, he focuses on advising pharmaceutical partners in selecting optimal drug delivery systems tailored to their therapeutic assets—ensuring effective treatment outcomes and improved patient experience. Bernd combines strategic insight with hands-on expertise to support companies navigate complex challenges and seize growth opportunities across global markets.

James has experience in setting up key operating functions in early-stage companies and delivering strategic analysis projects. Before moving into the medical device industry, James was a medical device investment analyst for more than 8 years, covering the US and European medical device markets at Atlantic Equities and prior to that at US investment bank, Stifel. James has a degree in Biology from the University of Bristol and is a CFA Charterholder.

Hicham holds a PhD in Bioengineering and Biotechnology and an MSc in Microtechnology from EPFL (CH), as well as a Certificate of Business Administration from Babson College (US) and joined Novartis in 2017 as Device Manager. Currently, Hicham serves as the Associate Director, GDPD Innovation Lead. In this role, he leads the GDPD Innovation Focus Group and innovation portfolio. Hicham is a member of the TRD Innovation Council since 2023 leading Science & Technology Cluster. Hicham contributed on many activities include leading cross-functional teams for multiple combination product projects, establishing device and packaging clinical readiness processes for new modalities projects: Biologic, Chemistry and Cell and Gene therapy.

Hicham has a proven track record of creating and implementing innovative solutions for devices and packaging to improve patient life, with already multiple international patents, scientific publications and one book chapter. During his career, Hicham leads device development in medical and no medical fields from idea to commercialization.

Throughout his career, Hicham has held various positions, including Device Manager, R&D Project Leader, General Manager and Founder of start-up Labssed SA start-up developing a novel surface treatment for implantable device to improve the biocompatibility and bio-integration. He has also been involved in academic interactions, supervising Master thesis and being a member of the PhD Thesis Jury.

Hicham has received several awards and multiple grants from the Swiss National Science Foundation and Venture Kick. He has also been recognized for his contributions to the entrepreneurial field with prizes such as the IMD start-up competition and Venture 2010 Business Idea and Plan.

Mr. Mallon has 25 years of corporate development experience in the biopharmaceutical and medical device industries, where he has successfully identified market opportunities and stimulated product/business growth. He brings specific expertise in corporate strategy and development, alliance management, product marketing and government contracting. Prior to joining PharmaJet, Dan served in business development leadership positions at Ellume USA, RRD International and Emergent BioSolutions. He holds a Bachelor of Arts degree in Zoology from Miami University, and an MBA in Finance from the University of Maryland.

Shawn Marcell is a Founder of SemPresto and serves as the company’s Executive Chairman. He has nearly three decades of diverse executive, commercial, and operational experience in life science and technology businesses. Previously, while serving as Entrepreneur in Residence at the Wyss Institute, he co-founded and spun-out Torus Biosystems in 2020 and ReadCoor in 2016, serving as Chairman & CEO for both companies. ReadCoor was acquired in 2020 by 10X Genomics. Shawn has founded and chaired several other early-stage venture-backed life sciences companies including RedPoint Bio which went public in 2005, Sensigen which was acquired by Sequenom, Lifecodes division of Hologic acquired by Immucor/TPG, and Metamark Genetics acquired by LabCorp. Mr. Marcell earned a BA degree in Economics from The George Washington University.

Bryan Mazlish is the co-founder and CEO of Surf Bio, a biopharmaceutical company launched in 2021 to commercialize a novel drug formulation technology developed at Stanford University. He entered the life sciences industry in 2012 following a family health diagnosis, co-founding Bigfoot Biomedical, a medical device company focused on diabetes care. Bigfoot’s first product, Bigfoot Unity, received FDA clearance in 2021. Mr. Mazlish served as President of Bigfoot until 2020 and remained on its Board of Directors until the company’s acquisition by Abbott in 2023. Earlier in his career, Mr. Mazlish built a successful track record in quantitative finance, managing trading desks at Citi and later founding Overlook Capital, a fully automated trading firm. He earned his A.B. magna cum laude from Harvard College.

Beth McBride DiLauri is Director of Portfolio Marketing for BD Medical, Pharmaceutical Systems. Her responsibilities include developing portfolio strategies and leading commercialization of drug delivery solutions for biologics. She is passionate about developing insights and solutions to help pharmaceutical company partners achieve their combination product commercialization goals while enabling patient care.

Beth has dedicated her tenure at BD to developing and executing portfolio strategies based on deep market and customer insights across drug-device combination products, medical devices, diagnostics and healthcare IT. Beth spent the early part of her career focused on structuring strategic partnerships, venture investments and acquisitions within BD and at Transcend Therapeutics. Beth received a Masters in Business Administration from the Tuck School of Business at Dartmouth College and a Bachelors degree from Boston College.

Shrenik Mehta is a Senior Principal Scientist at Genentech, where he leads efforts in biologics formulation and drug delivery technology development. With extensive expertise in sustained delivery of biologics, he has pioneered innovative technologies for ocular and subcutaneous administration. His work also encompasses the development of ultra-high concentration formulations and factors impacting subcutaneous bioavailability, significantly advancing the field of subcutaneous biologics delivery. Shrenik earned his PhD in Pharmacology from Baylor College of Medicine, providing him with a robust foundation in drug development. He is excited to share his insights on "Accomplishing Sustained Release and Long Acting Delivery" as a panelist at the PODD Conference.

John A. Merhige is Chief Commercial Officer at Credence MedSystems. Previously, Mr Merhige was Vice President, Market Development at Sanofi BioSurgery. He joined Sanofi upon its acquisition of Pluromed, Inc, where Mr Merhige was the third employee and member of the executive management team. Pluromed developed and commercialized rapid transition polymers for use in cardiovascular and other surgical procedures.

Previously, Mr Merhige founded Prelude Devices to identify early stage medical device ventures and gained general management and commercial leadership experience at Ford and Avery Dennison. Mr Merhige graduated from Dartmouth College with a mechanical engineering degree and returned to Dartmouth for a Masters in Engineering Management from the Thayer School of Engineering and the Tuck School of Business. Mr Merhige is a member of MassMEDIC, MassBio and has served on the board of directors of the MedDev Group (MDG).

Sean Michael Carroll is Director of Business Development at Manifold Bio, where he supports external partnering and portfolio development for the company’s drug discovery engine and tissue-targeted medicines. Prior to Manifold, Sean advanced portfolio strategy and business development at Axcella Health and Corbus Pharmaceuticals. A PhD scientist by training, Sean specializes in translating scientific advancements into strategic opportunities that bring novel therapies closer to patients.

Dr. Yngve Mikkelsen is an experienced physician, health economist, and biotechnology executive with over 25 years of leadership in pharma, medtech, and translational R&D. He currently serves as Chief Medical Officer at AlgiPharma, where he leads the company’s clinical, regulatory, and partnering strategy for novel alginate oligosaccharide technologies. Dr. Mikkelsen previously held senior roles at Pfizer, Biogen, Akershus University Hospital, and the Norwegian Medical Association, successfully leading multiple regulatory programs through the FDA and EMA. His work focuses on advancing non-injectable delivery of complex therapeutics, including peptides and lipid nanoparticles, via mucosal and oral routes. Yngve also holds a Doctor of Business Administration from Cranfield University, an MSc in Health Economics from the London School of Economics, and an Applied Data Science certificate from MIT. He is a regular contributor at ISPOR and serves on the expert review panel of the Norwegian Research Council.

Dr. Brad Minrovic, PhD, has been a Technical Account Manager since 2021 for Ashland’s injectable excipient portfolio, which includes Viatel bioresorbable polymers, such as PLGA, PLLA and PCL.  He focuses on customer support by supplying functional excipients and technical solutions to support the development of medical devices and long-acting injectable formulations.

Dr. Minrovic started his educational background in chemistry, obtaining a B.S. from Baldwin Wallace University (Cleveland, Ohio, USA).  He went on to graduate from University of Notre Dame (Notre Dame, Indiana, USA) with a PhD in organic, medicinal chemistry.

He started his industry career at Oakwood Labs (Cleveland, OH, USA), spending several years formulating, analyzing, and aseptically producing microsphere formulations.  He managed several long-acting injectable projects, where formulations encapsulated various APIs into biodegradable polymers, including Ashland’s Viatel offerings.  Currently, he leverages these past experiences to technically support Ashland’s injectable customer base. 

Victor Mishin joined Solesis in 2022 as a Scientist. In this role, he focuses on the research and development for long-acting implantable drug-delivery solutions based on the Hydralese® polyglycerol ester platform. His work involves designing, developing, and testing innovative biodegradable polymeric drug delivery devices and coatings that advance patient care.

With a background in biomaterials and tissue engineering, Victor has experience in exploring novel polymeric materials for drug delivery and biomedical device applications. His graduate research focused on developing tunable hydrogel cardiovascular shunts for pediatric patients.

Victor earned both his Master’s degree in Biomedical Engineering and a Bachelor’s degree in Bioengineering and Biomedical Engineering from Drexel University in Philadelphia, PA.

Mr. Masashi Miura is a researcher of Hiratsuka Research Laboratory. He gained a Diploma in Science in 2020 and a Master Degree of Science in 2022 from Osaka University. In University, he majored in applied chemistry and studied crystalline porous materials. Since April 2022 he has been working for Mitsubishi Gas Chemical Company, Inc. Since May 2022 he has joined a development team of multilayer plastic vial & syringe for biologics.

Dr Yumiko Mizuno is the Head of Plasma-Derived Therapies Drug Product Development at Takeda, where she leads global teams in advancing innovative therapies through drug formulation, primary container, and drug-device combination product development across all phases of drug development. In addition to her functional leadership, Dr Mizuno also serves as project lead for an early-phase global development program, driving cross-functional strategy and execution. With over 15 years of R&D CMC expertise, she is recognized for her scientific depth, cross-functional leadership, and commitment to delivering transformative therapies to patients.

She has also led global R&D strategic initiatives, gaining hands-on experience in portfolio strategy and organizational transformation. Dr Mizuno holds a PhD, MS, and BS in Pharmaceutical Sciences from Kyoto University and broadened her global perspective as a visiting scientist at Brown University.

Randall has served as Serina’s CDO since March 2024. He served as Serina’s President, CEO, and member of Serina’s board of directors from September 2010 to March 2024. Prior to Serina, Randall served in executive leadership roles including CDO at Nektar Therapeutics, CMO of Cardium Therapeutics, CMO at Renovis, and President / co-Founder of ThromboGenics (now Oxurion). Dr. Moreadith received his M.D. from Duke University and is trained clinically in Internal Medicine and Cardiovascular Diseases. Following his Fellowship in Cardiology at Duke University, he joined the laboratory of Professor Philip Leder where he was a Howard Hughes Medical Institute Fellow in Genetics at Harvard Medical School. Dr. Moreadith received his Ph.D. from Johns Hopkins University.

Dr Edel Mullen is the Director of Pivotal Biologics Drug Product Technologies at Amgen, holding a PhD in Biochemistry and an MBA from UMass Amherst, plus a Lean Six Sigma Black Belt. With expertise in process development, regulatory affairs, and external manufacturing, she has led numerous projects on process optimization and formulation changes. Dr Mullen is an expert in regulatory affairs for clinical trials and a strategic consultant for approvals. She is dedicated to aligning strategies with organizational goals to drive innovation and deliver advanced therapeutics to patients.

Dr Javier Muñoz has over 15 years of experience in the pharmaceutical industry. Dr Muñoz is currently Technology Evaluation Leader in the Global Strategy department at Roche (Basel, Switzerland), where he is responsible for the strategic evaluation of formulation and device technologies to improve access to innovative drugs through development and commercialization of customer-centric solutions. 

Prior to his current role Dr Muñoz has held different positions in Drug Development. His extensive expertise in clinical development includes the design, management and evaluation of clinical studies, the marketing authorization application and the management of the portfolio of global strategic projects to enable efficient drug development processes. In addition to his work in the industry, Dr Muñoz is a lecturer in the Complutense University (Madrid, Spain) and the University of Navarra (Pamplona, Spain) focusing on the areas of industry outlook and business intelligence, product strategy, market access and clinical development. He holds a degree in Pharmacy from the Complutense University of Madrid. Dr Muñoz obtained a PhD in Pharmaceutical Chemistry from the same university and an MBA from IE Business School.

Medical education at Leiden University Medical School. President & CEO of SQ Innovation (novel furosemide formulation for subcutaneous delivery). Founder of scPharmaceuticals (NASDAQ: SCPH). Founder of G3 Pharmaceuticals (galectin-3 inhibitors for cardiac and neurodegenerative disease). Co-Principal Investigator of the BioImage/BioImage-2 studies to identify novel methods to identify those at risk for major cardiovascular events. Career has spanned executive roles in global pharmaceutical companies and early-stage private and public pharmaceutical and device companies.

Dr. Wendy Naimark is CTO and Co-founder of Ripple Therapeutics, a clinical stage ophthalmology company. Dr. Naimark’s career has focused on leading teams in the development of local drug delivery products across a broad range of pharma and medtech applications. Dr. Naimark is an inventor of 35 patents in the local drug delivery field.

Courtney Nicholas Sutton is the Head of Portfolio Strategy at SHL Medical where she leads the strategy for current and future drug delivery systems. She previously worked for AstraZeneca and Regeneron where she led device development teams, new technology evaluation, primary container development, and drove the device strategy for early stage molecules. Courtney holds a Bachelor of Science in Biomedical Engineering from Rensselaer Polytechnic Institute.

tbd

Tom leads engineering and scientific teams developing new injection devices, pumps, and inhalers. He has been the named inventor on dozens of patents throughout his 25 years’ experience in the industry.

His most recent work focusses on developing robust device strategies and plans for a wide range of clients from the largest multinationals to the most dynamic start-ups.

Tom is a regular speaker at various international conferences on innovation and medical device development. He read Engineering at Cambridge University before becoming the Choate Fellow in Human Physiology and Pathology at Harvard University.

Jimi is an advocate redefining what’s possible for people living with Sickle Cell Disease. Born with SCD, he has spent his life pushing past limitations, most notably becoming the first person with SCD to summit Mount Kilimanjaro. Beyond his personal achievements, he is deeply committed to advancing care and awareness for the Sickle Cell community. Through his advocacy, he amplifies the voices of warriors worldwide, driving conversations that lead to real change.

David Opie has extensive medical device experience with both start-up companies and industry leaders, including Johnson & Johnson and Cook Medical. He has developed a thorough knowledge of Good Laboratory Practices, Good Manufacturing Practices, and design control procedures. At Noxilizer he leads the technology development and sterilization science initiatives. In addition to membership in several industry organizations, he participates in AAMI standards committees related to sterilization and decontamination. Dr. Opie holds a Ph.D. and an M.S. in physics from the College of William and Mary in Virginia, and a B.A. in Physics from the University of Delaware.

Dr. Shira Orr is the founder and CEO of Envoya, a biotechnology company pioneering AI-designed polymer nanoparticle (PNP) delivery systems for gene therapies. With a background in molecular biology and biotechnology, Shira has over a decade of experience in translational research and polymer science in combination with immunology. She completed postdoctoral work at Harvard Medical School when her project was accepted as a clinical trial for pancreatic cancer patients. Motivated by a genetic disorder in her family—Shira founded Envoya to develop safer, more effective delivery technologies that can unlock the full potential of genetic medicine.

Dr. Smrithi Padmakumar is an Associate Principal Scientist in the Sterile Product Development group at Merck. As an experienced scientist in pharmaceutical product development, she has contributed to the formulation and advancement of drug products across diverse modalities, including gene therapies, vaccines, biologics, and small molecules. At Merck, she plays a key role in the development of novel vaccine formulations aimed at addressing critical global public health challenges.

Prior to joining Merck, Dr. Padmakumar held a key role at Spark Therapeutics (Roche), where she led innovative efforts in the development of AAV-based gene therapies, contributing to pipeline programs. Dr. Padmakumar has developed novel AAV formulations with enhanced stability and established advanced biophysical characterization methods to deepen product understanding. As a Drug Product lead in the CMC space, she has played a pivotal role in advancing gene therapies for neurodegenerative diseases. Her work has been highly collaborative, integrating efforts across drug substance, manufacturing, preclinical, clinical, and regulatory teams to ensure seamless translation from the lab to the clinic. She brings specialized expertise in the targeted delivery of gene therapies via routes such as CNS and ocular administration. Guided by scientific rigor and a strong translational focus, her work is dedicated to delivering impactful therapies that address critical unmet medical needs.

Dr. Padmakumar holds a PhD in Nanomedical Sciences from Amrita Vishwa Vidyapeetham University, India, building on her foundational training as a biotech engineer and a postgraduate engineering degree in nanomedicine. Her doctoral research on intraperitoneal therapy for late-stage ovarian cancer using sustained drug-eluting nanotextile implants was carried out in collaboration with the Department of Pharmaceutical Sciences at Northeastern University, Boston. She went on to complete her postdoctoral research at Northeastern through a collaborative project with Harvard Medical School focusing on the development of long-acting formulations and innovative administration strategies for delivering oligonucleotide-based therapeutics to the brain for neurodegenerative disease therapies. Dr. Padmakumar has granted patents for her innovations and has published extensively in high-impact, peer-reviewed journals such as the Journal of Controlled Release, Biomaterials, ACS Applied Materials & Interfaces etc.

Greg Panebianco is the Senior Director of Engineering and Customer Success at Flex, a $26 billion design and manufacturing company dedicated to helping a diverse range of customers create products that enhance the world. With more than 17 years of experience in medical device product development, Mr. Panebianco has a deep expertise in R&D, strategy, and manufacturing, particularly in the medical device, medical equipment, and pharmaceutical sectors.

He has successfully consulted with clients to navigate complex challenges, including incompatible designs, supply chain disruptions, quality variations, and other scientific hurdles. Renowned for his results-oriented leadership, Mr. Panebianco is committed to improving operational efficiency and fostering predictability within organizations.

Prior to joining Flex, he spent 14 years at Siemens Healthineers, where he held progressively responsible positions, ultimately serving as the Global R&D Head for Point of Care Critical Care Systems.

Devan joined Pii in 2012 and was recently appointed Site Vice President (General Manager). Over the years, he has held leadership roles in Business Operations and Sterile Manufacturing, experiences that provide him with both a technical and strategic foundation to guide the site forward. In his current role, Devan’s primary objective is to support client success and advance patient outcomes through reliable, high-quality execution.

Known for his collaborative style and ability to anticipate challenges, Devan works to create an environment where teams are empowered to solve problems, innovate, and deliver with excellence. He places strong emphasis on mentoring and developing talent, believing that cultivating people is central to sustaining long-term success. By fostering a culture of accountability, transparency, and teamwork, he ensures that employees feel both supported and challenged to grow.

Devan is deeply committed to ensuring that Pii not only meets client expectations but also strengthens its impact on the patients who depend on the medicines manufactured at the site. His leadership philosophy centers on alignment — aligning people with purpose, teams with strategy, and execution with patient needs.

Devan earned his Bachelor’s degree in Cell Biology and Molecular Genetics from the University of Maryland and an M.B.A. from Johns Hopkins University.

Duncan Paterson has over twenty years of technical leadership experience in the development of inhalation and parenteral devices for pharmaceutical combination products. Currently a Senior Director with AstraZeneca, and previously with Novartis and Nektar Therapeutics, Duncan has led device development project teams in all stages of the product lifecycle as well as technology development and sustainability initiatives. Duncan holds bachelor’s and master’s degrees in engineering as well as an MBA and is a professional engineer with the UK Institution of Engineering and Technology (CEng). He is based in the US in the San Francisco Bay Area.

Fran has over 5 years of experience in drug delivery device design from concept generation to design verification testing and manufacturing scale-up, with a focus on injection devices. She has led multiple drug delivery projects, from design of novel electromechanical injectors through to due diligence of On-Body Delivery systems. Fran forms part of Cambridge Design Partnership’s core sustainability group, where she is responsible for identifying opportunities for sustainable innovation within the drug delivery sector. She has a master's degree in Mechanical and Bio-Engineering from the University of Cambridge.

Steve is the Senior Director of Device Product Assessment and Innovation at Merck. His group is responsible for identifying and building delivery device strategy for assets with combination product enabled target product profiles. This includes supporting all BD&L, technology scouting and device competitive intelligence, and early innovation and front end development of novel concepts. Steve is known for his forward-thinking approach and proven ability to identify opportunity, formulate strategy, and lead the development of innovative but relevant device initiatives. He has experience with all phases of development across many therapeutic areas, including oncology, immunotherapy, cardiometabolic, infectious disease, and neurology. He holds a Bachelors and Masters in Mechanical Engineering from The Cooper Union and an MBA from NYU Stern School of Business.

Breck’s 30-year career spans a variety of roles in consumer, industrial, and life science product development. He has served in engineering, project management, engineering leadership and client advocacy roles in over 100 projects. A core tenant of his approach is understanding and meeting both the end-users’ and clients’ wants and needs. He shares his expertise in product planning, realization, operational leadership, and commercial strategizing in his role at Battelle and as an advisor to specific startups within the innovation and accelerator communities.

Breck’s current objectives include building a deep understanding of the implantable drug delivery device space, and in facilitating partnerships between the pharmaceutical industry and suitable development partners.

Ameya is a biomedical engineer-turned strategist-turned dealmaker-turned innovation executive. In his current role as Sr Director, Non Pharma Solutions at Chiesi Group, a large multinational pharmaceutical company. In this role, he is responsible for identifying opportunities to enhance Chiesi's portfolio with non-pharmacological offerings including digital health solutions to further Chiesi's mission on patient impact- and bring those opportunities to reality via leading collaborations with external partners, via structures ranging from commercialization agreements to equity/LP investments.

Prior to Chiesi, Ameya's career has spanned R&D, strategy and business development at organizations ranging from high growth startups in life sciences to F100 Medtech companies. He holds a PhD in Bioengineering from UC San Diego and a Bachelor's degree in Bioengineering from the University of Pennsylvania.

Charles has more than 30 years experience in the drug delivery industry. He has been employed as a Project Leader for the last five years at Chiesi, an Italian family owned pharmaceutical company with a turnover of ~€3.5bn. Chiesi is a leader in respiratory medicines and has an expanding range of rare disease products which utilize a range of delivery technologies. Charles is working on a range of projects requiring the administration of small molecules, peptides and proteins.

Much of Charles’ career has focused on novel injectable technologies. Following an engineering degree and PhD, Charles joined PowderJect Pharmaceuticals and saw it grow from 4 to >1,000 employees. He then founded and was CEO of Glide Pharma for 12 years before working as an independent consultant with a portfolio of companies which were either developing a proprietary drug delivery technology or were selecting a delivery technology for their novel compound.

Liz Proos is the Vice President of Product Development at Daré Bioscience, a company focused on accelerating innovation in women’s health. In this role Liz is responsible for technical and strategic product development, leading a cross-functional R&D and product development team and key strategic external partners, including development of the proprietary DARE-IDDS (Intelligent Drug Delivery System) platform technology, which is designed to provide programmable, precise, long-term drug delivery from a subcutaneously implanted device. Liz joined Daré as part of the acquisition of Microchips Biotech in November 2019.

Throughout her career Liz has developed and advanced novel products for numerous applications and therapeutic areas through clinical development, including bone substitute materials, pulmonary therapies, injectable sustained release products, and implantable drug delivery devices.  During her 15-year tenure at Microchips Biotech, she advanced the legacy company to its First-In-Human clinical study with parathyroid hormone, a treatment for osteoporosis. Liz also has significant preclinical testing experience and has worked closely with clinical, regulatory affairs, and marketing as a technical expert to advance complex product development and incorporate the end user perspective.

Liz has also held leadership and technical positions at BD, Lantheus Medical Imaging, Epic Therapeutics (a wholly owned subsidiary of Baxter Healthcare), and Etex Corporation. She has more than 26 years of experience in drug delivery science and product development of combination products and medical devices. Liz graduated from Wellesley College with a degree in Chemistry.

Mireia is a Manager at Phillips Medisize, specializing in the formulation and delivery of biologic molecules via inhalation and nasal routes. She holds a PharmD from the University of Barcelona and a PhD from the University of Strathclyde, where she focused on inhaled nanomedicines. With over 15 years of experience, Mireia leads a team developing innovative formulation strategies, including particle engineering techniques such as spray drying. She is also interested in liquid nebulization and formulating colloidal systems for both small molecules and biologics. Her passion lies in overcoming formulation challenges to advance biologic therapies in airway drug delivery, believing in their potential to transform respiratory medicine.

Dr Sanyogitta (Sanya) Puri is currently Senior Director & Head of Non-viral Delivery with the RNA & GT organization at Novo Nordisk. She leads a global department with multidisciplinary teams across Denmark and Boston, that are accountable for a portfolio of nucleic acid therapeutics with novel delivery systems within Novo Nordisk. Prior to this role, Dr Puri was Director of the Advanced Drug Delivery team, AstraZeneca Cambridge, UK, where she led a team of multidisciplinary drug delivery, formulation and clinical development scientists. Over her 10+ years & industrial career, Dr Puri has worked on design and development of oligonucleotide, peptide, mRNA and targeted nanomedicine products across oncology, cardiovascular, respiratory and rare disease areas. Dr Puri holds a degree in Pharmacy from India and PhD in Nanoparticle drug delivery from Nottingham University, UK. Dr Puri is known for being passionate about innovative drug delivery and has a track record of preclinical to clinical translation of novel medicines through both internal capability build and external partnerships.

Development Director at Crux with over 12 years of device development experience. Tim has worked across a wealth of medical device & combination product platforms including asthma inhalers, pre-filled syringes, pen/autoinjectors, on-body/large volume and connected devices. With a focus on evidence-led device development, he champions early-stage feasibility assessment through data-driven design and quantitative evaluation. This work includes computational simulation and modelling and early-adoption of enabling technologies. Today, Tim leads both off-the-shelf platform selection and novel device development programmes, acting as a trusted advisor and technical reviewer to support the wider Crux team.

Parthi is an Innovation Lead with the vaccines business unit of Sanofi. In this role, he engages with early-stage innovators and entrepreneurs via a sponsored research framework to help groom emerging ideas into matured licensable products. Parthi also contributes to the broader Boston Innovation Ecosystem as a judge, mentor, and/or a grant reviewer for organizations such as Mass Innovation Network, Mass Life Sciences Center, and Mass Ventures. In his previous industry roles, Parthi has helped first-hand in the generation of more than $10M in revenue across 5 different product lines while working with the sales and business development teams of 2 different life sciences tools companies (Bio-techne and Quanterix) as a technical expert. Before moving to the industry, he was a research assistant professor at the University of Central Florida working on developing alternatives to antibiotics. He has published over 30 scientific articles including 3 patents. The recombinant vaccine platform developed as part of his PhD dissertation work won the AVMA award for the perceived impact in containing microbial resistance. Parthi holds a PhD in infectious diseases and immunology from Virginia Tech and a BVSc (Doctor of Veterinary Medicine) from Madras Veterinary College.

Karthik is the CEO of Persist AI. A company that’s using AI x Robotics to accelerate drug formulation development. He previously received his PhD from the University of Utah, where his research focused on sustained drug delivery to the brain. Most recently he held an automation role at Zymergen, where he helped develop a modular and reconfigurable automation lab for synthetic biology. Persist AI is a venture backed company supported by YCombinator, Spero Ventures, 2048, Innospark.

In her role at AstraZeneca, Dr. Stephanie Reed contributes to biopharmaceutical formulation drug product development across the pipeline, leading scientific teams and advanced strategic initiatives. Of particular interest are technologies to enable high-dose or complex subcutaneous delivery, encompassing formulation, device, and in silico/in vitro tools that predict protein interactions, bioavailability, and immunogenicity. Her career spans parenteral, intraocular, and oral administered drug products, drug delivery using novel formulation and device approaches, long-acting implants and injectables, gastroretentive dosage forms, polymers and novel excipients, additive manufacturing, stem cell tissue engineering, and biomaterial biocompatibility. With 12 years of industry experience across pharma and med device, 11 years of academic research, 17 issued patents, 12 regulatory approvals, and 25+ technology partnerships, Dr Reed is keen on mapping strategic pathways to translate innovations for investment and commercialization. Dr Reed earned her PhD and MS in biomedical engineering from UCLA and BS in mechanical engineering from MIT.

John Reid brings over 25 years of experience in business development, drug discovery, technology transfer, and biotechnology start-up operations to focus on developing new therapeutics based on breakthrough medical research. He is currently Chief Business Officer at QurCan Therapeutics, leveraging its unique nanotechnology to realize the full potential of genetic medicine. Prior to joining QurCan, he was Head of Commercialization at the University Health Network (Toronto), Director of Strategic Partnering and Business Development at AstraZeneca (USA), and Director of Molecular Sciences at AstraZeneca (USA). He previously had scientific roles at GSK (CH) and Genentech (USA). He obtained his PhD from the University of California (Berkeley), MBA from Le Bow-Drexel, and Executive Education from Wharton.

Philippe Rogueda is the Chief Business officer and a co-founder of Merxin Ltd. Merxin Ltd makes inhalers. He is an inhaled formulation expert with a global reputation and an enviable track record of developing pMDIs, DPIs, Nebules, Nasal and soft mist inhalers for both generic and originator companies.

Dr Rogueda trained in Physical Chemistry at the Universities of Bordeaux (France) and Bristol (U.K.), where he obtained his PhD. He subsequently worked for AstraZeneca, Novartis, Actavis before founding Inhalation Asia (Hong Kong) and Merxin Ltd (U.K.).

Merxin Ltd designs and supplies inhaler devices. We redefine Inhaler Technology: Multidose Dry Powder Inhalers, Capsule Dry Powder Inhalers, and Soft Mist Inhalers. Our soft mist inhaler MRX004 (www.mrx004.com) is spearheading a renaissance in inhaled biologics product development. Our DNA is in the pharma industry, our reputation is built on excellence. We develop inhaler devices used in local and systemic inhaled therapies. We make inhaled therapies and inhaled devices better for use from bench to commercial launch.

Dr Rogueda’s current interests lie in enabling inhaled biologics. With 4 products approved and 119 assets in development in the US only, inhaled biologics is a market poised to expand. His recent publications include: Sorting through Soft Mists: Generics, Biologics and Beyond (2024), Soft Mist, Strong Impact: Enhancing Inhaled Biologics Drug Delivery (2024), Dornase Alpha Soft Mist Inhaler (2024), Soft Mist Inhalers vs Nebulisers Delivery Equivalence (2024), Transitioning pMDIs to SMIs (2023), Open File Close: A Guide To Making A Generic Triple DPI (2023).

Patrick has over twenty years of experience advancing sustained-release drug delivery systems across therapeutic areas including cardiovascular, ophthalmology, gastrointestinal, ENT, transdermal, and surgical applications. His expertise lies in controlled release of active pharmaceutical ingredients from biodegradable polymeric platforms within drug–device combination products.

He has held senior leadership roles driving innovation in the pharmaceutical industry, including Chief Technology Officer at Allay Therapeutics and Chrono Therapeutics, and Vice President of R&D at CV Ingenuity (later acquired by Covidien). Earlier roles at Xtent Inc., Cook Group, and Navigant Biotechnologies broadened his experience developing next-generation delivery systems. Patrick’s career reflects a commitment to improving patient outcomes through novel technologies that provide sustained therapeutic benefit. His multidisciplinary knowledge enables him to address complex challenges across diverse medical fields. Trained as a physical-organic photochemist, Patrick has contributed extensively to both academic and patent literature. He earned undergraduate degrees in chemistry from Galway-Mayo Institute of Technology and Trinity College Dublin, followed by a Ph.D. from University College Dublin. Postdoctoral fellowships at the University of Toronto, Johns Hopkins University, and The Ohio State University expanded his expertise in photochemistry, with research spanning reactive intermediates, controlled nitric oxide release, and pathogen inactivation in blood products. Patrick’s ability to translate advanced photochemistry into practical biomedical applications highlights his unique blend of scientific depth and translational impact. His work continues to shape the evolution of sustained-release drug delivery, offering new possibilities for patient care and improved treatment outcomes.

Ana Rusetski is a combination product development lead with deep expertise in medical devices for biologics. She currently leads the development of a combination product platform at Astria Therapeutics, where she is responsible for device development from early-stage design through verification, validation, and into commercial readiness. Her work spans core CMC strategy, design control, risk management, human factors, and regulatory support. Prior to her current role, Ana held positions of increasing responsibility at Amgen, where she oversaw lifecycle management of electromechanical combination products. There, she led cross-functional projects to improve reliability, implement configuration changes, qualify new manufacturing lines, and support global regulatory submissions. Ana holds a MSc in Nanotechnology for Medicine and Healthcare from the University of Oxford. In 2024, she also served as co-lead of Astria’s Inclusion & Belonging committee, driving employee engagement and advancing equity in the workplace. During her time at Amgen, she co-founded WISE Wednesday’s, a speaker series highlighting women in STEM to enhance inclusive leadership.

With her global training and end-to-end development experience, Ana brings a system-level view to combination product innovation and clinical-to-commercial scale-up.

Brent Rutland is Vice President of Global Medical and Clinical Affairs at Koru Medical Systems, where he leads clinical and data generation strategies. With over 25 years of experience in the biotechnology and pharmaceutical industries, Brent specializes in health economics and outcomes research (HEOR), market access, and clinical development. He holds a Master of Public Health in Epidemiology from the University of North Carolina at Chapel Hill and an MBA in International Business from the University of Houston.

Michael J. Sailor is Distinguished Professor at the University of California, San Diego, Director of the UC San Diego Materials Research Science and Engineering Center (an NSF MRSEC), and Director of the UC San Diego Institute for Materials Discovery & Design. He holds Affiliate Appointments in the UC San Diego Bioengineering Department, the Nanoengineering Department, and the Materials Science and Engineering program. He has co-founded several biotech startups, and he currently serves as the Chief Scientific Officer for SiCare Bio. He is an expert in the chemistry, electrochemistry, and optical properties of nanomaterials, with an emphasis on drug delivery, imaging, and sensing applications of porous silicon-based systems.

Karla Sanchez leads a team of subject matter experts at CDP, supporting the Healthcare sector across a broad range of bioengineering specialties. With over thirteen years of experience in medical device development, she brings technical depth and strategic insight to complex health innovation projects. For the past six years, Karla has focused on drug delivery, with particular expertise in targeting the central nervous system (CNS). She leads efforts in drug delivery to the brain, working at the intersection of biology, engineering, and clinical need to overcome barriers to effective CNS therapies. She holds a PhD focused on the distribution of blood and cerebrospinal fluid in the brain and spinal cord, and has collaborated with clinicians and academics to develop physiological models of the brain, kidneys and lungs.

Karla is also an honorary researcher at Imperial College London, maintaining active links with academia and providing guidance to postgraduate students.

Svilen leads TTP’s work in inhaled drug delivery. He has run some of TTP’s largest and most complex device development programmes, having taken several technologies from concept through detailed development and manufacturing scale-up. Svilen’s skillset combines navigating crowded IP spaces and global supply chains with a deep understanding of fundamental physics and device design. Svilen holds a PhD in Engineering (fluid dynamics) from the University of Cambridge.

Andrew Schaefer is a Program Manager at Congruence Medical Solution, LLC. He is passionate about solving unmet, emerging and hard-to-solve problems in drug delivery. He responsible for the development of novel devices, including devices for implantation of solid drug depots. Andrew is a mechanical engineer by training.

Theresa Scheuble is Head of Enterprise Design & Innovation for Johnson & Johnson. She is an expert on combination product requirements and considerations supporting all segments of Johnson & Johnson.

Prior to her current role, Theresa was Head of the Combination Product Drug Delivery Systems Development for the East Coast team in Janssen, a Johnson & Johnson Company. While at Janssen, Theresa was responsible for Combination Product Device development and led cross-sector initiatives. Theresa has been with Johnson & Johnson for greater than 25 years, working in all Segments of Johnson & Johnson with 18 years specifically in the Medical Device Segment. She was the project lead and technical lead for greater than 20 portfolio enhancing products by Johnson & Johnson companies. She also has experience in the Automotive and Aerospace industries.

Nicholas (Nick) Schill, PhD is an experienced pharmaceutical and combination product development professional with a passion for developing and implementing innovative solutions. Nick started his industry career with Baxter Healthcare supporting exploratory and early phase R&D programs, bioanalytical development, biologics process development, and a Phase 3 cell therapy clinical development program. At Baxalta, and later with Shire, Nick led or supported numerous combination product development and device development programs for Baxalta/Shire's hematology and immunology franchises. After departing Shire, Nick led the Product Development & Commercialization team at Kymanox, a life sciences consulting firm which provides program strategy and technical leadership for the development of drug-device combination products and medical devices, including injection, infusion, reconstitution, nasal delivery, and electromechanical devices. In April 2025, Nick joined AbbVie to lead the Landscaping and Product Definition team which identifies and evaluates novel and established delivery system technologies of interest from potential third-party partners to support AbbVie’s development pipeline. Nick holds a BS from St. Norbert College and a PhD in Cellular and Molecular Biology from the University of Wisconsin at Madison.

Farid Seddighi, PhD, joined Haselmeier, a medmix Brand in august 2025 and leads the Technology and Operations department. In the past he has been Head of the Device Project Group at Gerresheimer  Advanced Technology and was responsible for the development of medical devices in the regulated area. Dr Seddighi studied Physics in Kiel (Germany) and Bern (Switzerland). He has experience in development processes in basic research (NASA), as well as in the laser and semiconductor industry (Carl Zeiss AG), and in the development and lifecycle management of insulin pens and autoinjectors for biologics (Sanofi).

Amin is the Senior Director of Device Development & Technology at Merck, leading cross-functional teams to develop and commercialize drug-device combination products. Previously, he was the Director of Device Development at AstraZeneca, leading the entire product development for complex delivery devices and combination products, from concept to regulatory submission and launch. He also spearheaded the integration of digital solutions for injectable biologics to enhance patient experience.

Before joining AstraZeneca, Amin worked in Delivery, Device and Connected Solutions organization of Eli Lilly and Company, where he led design and development of connected solutions for drug delivery devices. Amin holds BSc, MSc, and PhD degrees in Mechanical Engineering.

Kurt Sedo serves as Executive Editor of PharmaCircle’s Drug Delivery & Formulation Newsletter, which has over 5,000 subscribers worldwide.  Kurt is also responsible for the PharmaCircle formulation and drug delivery databases. Kurt received his B.S. in Chemistry and Mathematics from the University of Wisconsin Stevens Point in 1992. Prior to joining PharmaCircle in 2003, Kurt held various positions and responsibilities within Pharmaceutical Sciences and Analytical Development departments at Searle/Pharmacia.

Jaymin Shah is a Senior Research Fellow in Pharmaceutical Sciences and heads a global biopharmaceutics group in Pfizer R & D. He also holds an adjunct faculty appointment at the University of Houston and University of Connecticut. He obtained his PhD in Pharmaceutics from University of Houston. From 1988-1999 he served as Associate Professor (Tenured) of Pharmaceutical Sciences at Medical University of South Carolina, where he led a lab developing sustained release parenteral delivery systems and modeling of skin transport and mentored 7 PhD and 2 MS graduates. Jaymin joined Pfizer in 1999 where he has led formulation groups and project teams supporting development of various candidates as parenteral/ophthalmic dosage forms, peptide and oligonucleotides development and research initiatives in parenteral and ophthalmic delivery including LAI, depots, sterile suspensions, implants, and nanoparticles. Jaymin has been recognized with achievement awards for leadership and innovation in Pfizer. Jaymin has published 70 papers, 10 patents/patent applications, 75 abstracts and made more than 114 presentations at various scientific forums such as Arden House Conference, AAPS symposia, CRS, FDA and academic centers. His current research interests include PBPK modeling and in vitro translational studies to predict biopharmaceutics risk for drug candidates, topical drug delivery, parenteral sustained release (depot), nanoparticles, ophthalmic delivery, and topical formulation development. Currently he leads a global biopharmaceutics group providing biopharma risk assessment and strategy for biopharmaceutical aspects for drug development using in vitro performance and PBPK modeling.

Kinsuk Shah is currently Sr. AD, Combination Product Steward at Boehringer Ingelheim, responsible for device lifecycle management and strategy for Cyltezo. Mr. Shah is accountable for continuing development and oversight of CP manufacturing + supply, leading an interdisciplinary team of internal SMEs (e.g., drug product, packaging, final assembly, device, quality). Prior to joining BI, Mr. Shah was Director of Device Development at Viridian Therapeutics, responsible for device strategy and development, including establishing internal and external capabilities within the device space, evaluation and selection of wearable and auto-injector devices. Mr. Shah has over 10 years of drug-device combination product experience from Janssen, West and Alexion. Prior to Viridian, Mr Shah was at Alexion, where he was responsible for Strategy and Program Management for ongoing device dependent programs. At West Mr Shah was the Business Development lead for the SmartDose and SelfDose platforms, successfully partnering with multiple pharmaceutical companies in establishing joint combination product programs for each product.

Dr Lipa Shah is Director Science and Technology, leading Novel Delivery Technologies (NDT) at Novartis Pharmaceuticals Corporation. In her matrix leader role, Dr Shah engages with Novartis teams to implement novel drug technologies to bring value to the drug products. She holds a PhD in Pharmaceutical Sciences from Northeastern University, Boston USA. In 17+ years with Technical Research and Development at Novartis in USA and Switzerland, Dr Shah achieved deep understanding of drug product development, made significant contributions as Team Lead and Project Lead, role modeling inclusive and collaborative culture in the teams.

Dr. Ruchi Shah is a seasoned professional with more than 10 years of experience in the field of nucleic acid delivery, gene editing, vaccines, vaccine adjuvant development, and biologics. Her area of expertise lies in pharmaceutical development of non-viral gene therapies with a focus on formulation and analytical strategies.

Ruchi started her career as Scientist at GSK Vaccines in 2015, focusing on SelfAmplifying RNA delivery for vaccines. In the following year, she continued her path at Intellia Therapeutics in delivering CRISPR Cas9-based therapeutics with lipid nanoparticles for hepatic and extra-hepatic delivery. She also worked at Moderna Therapeutics to enable high throughput screening in their platform group. Ruchi’s career progressed rapidly at Eli Lilly and Company where she led internal and external projects to develop lipid nanoparticle formulations for pre-clinical work to deliver a diverse portfolio of RNA therapeutics. In April 2023, Ruchi joined EMD Millipore Corporation within the Targeted mRNA Delivery team as the LNP Formulation Director, heading a lab team that is capable of both lipid design innovation and high throughput experimentation, advancing research and development in this rapidly expanding field.

In February 2025, Ruchi Shah joined GSK as the Head of US Drug Product within the Vaccines Technical and Development with a focus on developing mRNA vaccines and therapeutics.

Mansuo Shannon, PhD, is a visionary drug hunter and seasoned pharmaceutical executive with over 18 years of experience at Bayer, Eli Lilly, Roche/Chugai, and Merck. As Chief Scientific Officer at AskBio, Bayer’s wholly owned gene therapy and gene editing subsidiary, Mansuo is recognized for her expertise in advancing breakthrough therapies spanning small molecules, biologics, and cutting-edge genetic medicines.

Throughout her career, Mansuo has demonstrated a passion for tackling the most challenging disease indications, strategically targeting high-conviction biological pathways with optimal modalities. Her leadership has been instrumental in driving multiple programs into clinical development, most notably the Phase 2 proof-of-concept study for Zagotenemab in Alzheimer’s Disease. At AskBio, she leads the design and execution of a robust gene therapy and editing pipeline and champions the development of novel delivery platforms that power the next generation of transformative medicines.

Mansuo earned her PhD in Molecular Biology from Princeton University and completed her postdoctoral fellowship at MIT under Nobel Laureate Dr. Susumu Tonegawa, grounding her executive leadership in rigorous science and visionary innovation.

Philip Sheridan serves at Sr. Director Business Development for Nitto BioPharma Inc. overseeing partnering and licensing business opportunities as well as collaboration alliance management activities pertaining to the licensing of Nitto’s DDS LNP Platform for the delivery of nucleic acids.  Prior to joining Nitto BioPharma in 2021, Dr. Sheridan held several R&D director and leadership positions in start-up and mature biopharmaceutical organizations in the areas of gene therapy, protein biotherapeutics, and biotherapeutic delivery. 

Dr. Michael Sherman is Principal at Sherman Healthcare Solutions, LLC, a consultancy providing consulting services, fractional executive-level support, and independent board service to the healthcare industry. He also holds a faculty appointment in the Department of Population Medicine at Harvard Medical School.

Prior to assuming the role of advisor in May 2025, he spent two years as a full-time venture partner at RA. Prior to joining RA, Dr Sherman was Executive Vice President and CMO at Point32Health, formed by the merger of Harvard Pilgrim Health Care and Tufts Health Plan. Prior to Point32Health, he served as CMO of Harvard Pilgrim Health Care. Past roles include Corporate Medical Director at Humana, Vice President of Network and Consumer Solutions for UnitedHealth Group’s subsidiary Ingenix (now part of Optum), Vice President and General Manager at Thomson Medstat (now part of IBM Watson Health), as well as management roles at Immusol, a San Diego-based biotechnology company, HealthAllies, an organization created to provide discretionary medical benefits to the cash-pay market, and Da Vita, a national provider of dialysis services.

Before pursuing an MBA at Harvard Business School, Dr Sherman received his MD from Yale and practiced as a cardiac anesthesiologist. He also holds a BA in Anthropology and Natural Sciences and an MS in Biomedical Anthropology from the University of Pennsylvania. Dr. Sherman has served on boards of multiple commercial and nonprofit organizations.

Liat Shochat is Vice-President of Combination Product Development and has over 20 years of experience in design and development management of combination products and medical devices. Her expertise includes strategic and technical development, lifecycle management and global launch of various single-use, disposable electro-mechanical drug delivery platforms, drug-device combination products and medical devices.

Throughout her career, Ms Shochat has held management roles in R&D, engineering, project management, regulatory, human factors and clinical trials.

Mr. Ilan Shopen is the Marketing Director of E3D and has a background in mechanical engineering, with over 24 years of experience in the medical device industry. He possesses extensive expertise in the design and development of disposable and electromechanical medical devices, as well as in manufacturing process development, qualification, and cross-functional management. Over the past 20 years, Ilan has held various positions at Elcam Medical, including Mechanical Engineer, R&D Manager, and Manufacturing Engineering Manager. Seven years ago, he transitioned into his current role as Director of Marketing and Business Development at E3D – Elcam Drug Delivery Devices, where he focuses on driving innovation and fostering global partnerships for advanced drug delivery solutions.

Dr Manmohan Singh is currently Chief Technology Officer at Beam Therapeutics in Cambridge, MA. Dr Singh has over 28 years of R&D experience in drug product development, novel delivery systems, genetic medicines and vaccine research. He previously led technical teams overseeing early and late stage development programs at Takeda and Novartis. His team was instrumental in approval of several novel vaccines (FluAd®,Bexsero®,Menveo®,Flucelvax®). Dr Singh has authored over 140 peer reviewed papers and is the editor of 6 Books on vaccines and drug product development. He was elected as a Fellow of the American Association of Pharmaceutical Scientists (AAPS) in 2011.

Benjamin Smith, PhD, is a scientific leader in biologics drug discovery and development specializing in tissue-targeted delivery technologies and applications across modalities, particularly for neurodegenerative disease. With 12 years of industry experience (at Voyager and Biogen) in blood-brain barrier penetrant technology, novel target discovery, and antibody engineering/optimization, he has advanced neurotherapeutic drug candidates from concept to clinical development. Dr Smith obtained a PhD in biophysics from McGill University and apply knowledge of protein-protein interactions and cellular mechanisms to connect the molecular and pharmacological functions of drug candidates.

Jatin Sood is an accomplished formulation scientist with over a decade of experience in the development of topical, transdermal, and oral drug delivery systems. Throughout his career, he has specialized in innovative dosage forms, with particular expertise in films, film-forming systems, and microemulsion systems. His primary focus has been on enhancing bioavailability to improve therapeutic outcomes. In his current role, he is dedicated to advancing film-based delivery systems for buccal, sublingual, and oral administration. Holding a Ph.D. in Pharmaceutical Sciences, Jatin applies his deep knowledge of pharmacokinetics and pharmacodynamics to design and optimize next-generation drug delivery platforms.

Dr Tycho Speaker’s comprehensive background in pharmaceutical and materials sciences, coupled with a doctorate in physical chemistry, has contributed to a career marked by significant achievements and contributions to drug delivery technology. Over the past two decades, he has worked primarily in the field of transdermal and intradermal drug delivery, with numerous patents and engagements that contribute to advancements in this sector, including work as part of the PATH Microneedle Array Patch (MAP) Center of Excellence. Currently serving as the Director of Drug Delivery and Biomaterials at AbbVie, Dr Speaker continues to drive the development of innovative drug delivery systems. 2025 marked the publication of his work on a post-driven “patchless” microneedle delivery system to bridge microneedle delivery with existing aseptic fill line infrastructure for global public health.

Colin Spencer is a project manager and the head of the technology transfer group at Oakwood Laboratories. At Oakwood, he has worked on a variety of technology transfer projects, leading the transfer of both commercial and developmental products into Oakwood's FDA approved, GMP, aseptic manufacturing facility. Colin also has experience at Oakwood working on long-acting injectable products, working both on the initial feasibility of new products and the scale-up and large-scale manufacturing of clinical materials. His other roles include leading the process improvements initiative at Oakwood, investigating new technologies that can further enhance Oakwood's development and manufacturing capabilities.

Dr Srini Sridharan is currently the Head of Drug Delivery & Product Strategy at Bristol Myers Squibb. Dr Sridharan has 25 years of experience in the area of CMC, drug delivery and combination products in a variety of roles from R&D, Manufacturing, Business Development and Product Development. He has developed and launched numerous products worldwide ranging from coronary catheters, drug eluting stents, glucose sensors, insulin delivery devices, prefilled syringes, sub-cutaneous injection devices and pharmaceuticals. Dr Sridharan is passionate about addressing unmet needs through a Patient Centric mindset to develop the best possible therapies. He is a Chemical Engineer and received his Bachelors from the Indian Institute of Technology, Madras and a MS and PhD from Georgia Tech, Atlanta. Dr Sridharan enjoys all outdoor sports & activities, traveling and is also a home brewer.

TBD

Rob Steendam, PhD, is co-founder and Chief Technology Officer at InnoCore Pharmaceuticals, a biopharmaceutical drug delivery company specialized in the development of long-acting injectables  for the treatment of chronic and site-specific diseases. At InnoCore he heads the development of InnoCore’s innovative biodegradable polymeric sustained release drug delivery technologies and oversees the execution of InnoCore’s partnered drug delivery product development programs. He is an inventor of several patents related to novel biodegradable multi-block copolymers and their application in parenteral drug delivery and drug eluting implants. Prior to founding InnoCore in 2004, he worked for Polyganics, a venture capital funded biosurgical start-up company, where he played a key role in developing the company and managed the pre-clinical and clinical development of novel bioresorbable implants and tissue regeneration products in the fields of peripheral nerve repair and general surgery. He holds a MSc degree in Polymer Sciences and a PhD in Pharmaceutical Technology and Biopharmacy, both from the University of Groningen in The Netherlands.

Jill Steinbach-Rankins, Ph.D., is a Senior Associate Director of Innovation Technology at Boehringer Ingelheim and an Adjunct Professor of Pharmacology & Toxicology at the University of Louisville. She joined Boehringer in 2022 after serving as a tenured Associate Professor in Bioengineering. Her research on emerging delivery technologies, including nanoparticles, fibers, and 3D-bioprints, from conception to preclinical studies, was supported by multiple NIH and foundation grants. In industry, she leads efforts to evaluate external technologies, with a keen focus on drug delivery systems, predictive capabilities, and novel R&D platforms. She is particularly passionate about identifying and connecting opportunities to improve drug delivery and accelerate their translation to enhance patient outcomes. Jill has been honored to receive ~25 scientific and leadership awards, and has guided her previous research group to achieve more than 50 domestic and international research awards. She currently chairs the Controlled Release Society's Skin and Mucosal Delivery (SMD) Focus Group, and leads an industry team bridging academic and industry interests in SMD.

Dr Anand Subramony is Vice President of the DDCS (Delivery, Device, and Connected Solutions) group at Lilly and he provides leadership to early development of combination products and novel drug delivery technologies. Prior to Lilly, Dr Subramony was Vice President within the Biologics Engineering and Targeted Delivery group, at AstraZeneca where he led various cross-functional teams in the areas of nanomedicine, drug conjugates, and drug delivery of new modalities including implantable cell therapy devices. He also provided leadership to external innovation and CoSolve, an open innovation platform. Prior to that Dr Subramony headed the Drug Delivery & Device Development at Medimmune and built an internal team that focused on combination product development, connected devices, digital biomarkers/sensors, as well as advanced novel delivery technologies including oral peptide delivery and other novel controlled release technologies. 

In other roles, Dr Subramony was Principal Fellow and Head of Novel Delivery Technologies at Novartis (NIBR, Cambridge, MA), head of the Materials Science group at Alza /J&J (Mountain View, CA), and Director of Materials Science & Drug delivery at Dr. Reddy’s Laboratories (Bridgewater, NJ). 

With his broad experience in pharma biotech, Dr Subramony brings innovation and scientific rigor coupled with execution excellence and sense of urgency to create patient centric products. He has established and managed high-performing teams in all his roles. Dr. Subramony holds an M.S. degree in Materials Science Engineering (IIT, Bombay) and a Ph.D. degree from Purdue University. With several refereed publications and patents, he is a sought-after Key Opinion Leader in the areas of drug delivery and product development.

Kanika Suri, PhD, is passionate about developing innovative, effective, and patient-friendly therapies that address debilitating health conditions. At Takeda, she leads the CMC development of pipeline drug products, spanning proteins, peptides, nucleic acids, and synthetic small molecules, and tackles formulation and delivery challenges across oral, topical, and parenteral routes. Drawing on deep experience in research and development, Dr. Suri excels at translating scientific insight into pragmatic, patient-centric phase-appropriate solutions that advance seamlessly through clinical trials. Her academic journey reflects her commitment to solving complex drug-delivery problems: during her PhD, she developed a novel oral delivery platform for nucleic acids, adding another dimension to her Master’s work investigating bioactive permeation enhancers to improve drug absorption of macromolecules. A champion of innovation and a dedicated advocate for Women in STEM, Dr. Suri combines scientific rigor with purpose-driven leadership to advance the next generation of therapies.

Dr Shankar Swaminathan is a Team Lead at Astellas Institute for Regenerative Medicine leading drug product development activities for multiple preclinical and clinical cell therapy candidates. Dr Swaminathan obtained his doctoral degree in pharmaceutics focusing on creating new polymer based drug delivery formulations for cancer nanomedicine and delivery of labile small and large molecules. Soon after his PhD, he joined the pharmaceutical industry to work on drug eluting long-acting combination products. He later went on to complete his postdoctoral training in ophthalmic drug product development at the College of Medicine at University of Tennessee health science center, where he focused on creating new treatment approaches for debilitating eye diseases. As a young ophthalmology investigator, he obtained independent grant funding for supporting his ideas before successfully transitioning to the biopharmaceutical industry. Dr Swaminathan has supported CMC activities for multiple products/INDs submitted for approvals to various agencies. He has about 15 years of combined industry and academic experience and has successfully overseen product development from early-stage discovery through late-stage submission. He has been associated with ophthalmic drug delivery and development for over 10 years. He is vastly experienced in aseptic drug product development, quality-by-design, advanced drug delivery, cryopreservation technology, CTM campaign execution and management, fill-finish, modified release solid orals and ocular drug delivery. He is an editorial board member in Scientific Reports and serves as a reviewer for over 20 peer reviewed journals. He has published 15+ peer reviewed publications, commentaries and blogs.

Through his current position at Lifecore and more than five years at Bristol-Myers Squibb, Dr Swanson has over 10 years of industry experience working on a wide range of projects (early- and late-stage, commercial, injectables, medical device, combination, topicals) for a variety of products (biologics, small molecule, polymers, peptides, hydrogels, suspensions/emulsions, ADC) across multiple subject areas (process development, GMP manufacturing, tech transfer, scale-up, analytical development, raw materials).

Dr Swanson earned his Ph.D. in Chemical Engineering from Iowa State University and his Bachelor of Science degree in Chemical Engineering from Rensselaer Polytechnic Institute.

Dr. Monica Swinney has more than 20 years of experience in the design and development of medical devices, pharmaceuticals, and combination products. She is currently the Sr. Director of New Product Planning and Drug Delivery Innovation for Gilead Sciences. Prior to Gilead, she held both strategic and technical leadership roles with Eli Lilly, Becton Dickinson, Johnson & Johnson, and Dexcom. Dr. Swinney holds a Ph.D. in polymer science from MIT a B.S. in chemistry from the University of Massachusetts, is the recipient of many industry awards in innovation and product development, and is an inventor on over 75 patents.

Yuki Takeuchi is Global Product Manager for the PLAJEX Ready-to-Fill syringe platform at Terumo Medical Care Solutions – Pharmaceutical Solutions Division. With extensive knowledge in pharmaceutical science, he has worked in research and development of injectable drug products, such as intravenous solution bags and prefilled syringes, and has contributed to the launch of various products into the market. Leveraging his experience in formulation engineering and industrialisation of injectable drug products, he currently has product management responsibilities for PLAJEX platform.

Sarah Tao, PhD, is the Head of Search & Evaluation, Technology Platforms within Global Business Development & Licensing at Sanofi. In this role, she is responsible for identifying and evaluating external technologies that align with Sanofi’s strategies for its therapeutic modalities. Dr. Tao joined Sanofi in 2017 as Technology Lead for Biologics Research with successive roles in Research before shifting to Business Development in 2021. Prior to Sanofi, Dr. Tao was a Senior Manager of New Technologies at CooperVision leading external research programs, and was also a Senior Member of the Technical Staff in the MEMS Design Group at Draper Laboratory. She received her Ph.D. in Biomedical Engineering from Boston University with a research focus on MEMS-based devices for oral drug delivery, and has received numerous accolades for her contributions to the field of drug delivery, including the Controlled Release Society Grand Prize.

Daniele Tartini is a key account manager at SCHOTT Pharma. He has over 8 years of experience in the primary packaging and drug delivery industry, consulting pharma companies in choosing the right primary container and devices to de-risk the development of their combination products. Daniele supports pharmaceutical companies with their projects from early development, through clinical phases, and up to commercial launch and ramp-up. In this role, he’s helped pharma and biotech companies bring to market multiple vaccines and biologics in a pre-filled syringe and auto-injector presentation. Daniele holds degrees in Chemical Engineering from the Swiss Federal Institute of Technology in Zurich, and Business Administration from the Zurich University of Applied Sciences.

Rigwed is a materials and biocompatibility consultant with over a decade of experience in medical devices and drug delivery systems. As the Extractables and Leachables Program Lead at PSN Labs, Rigwed leads the chemical characterization and material testing programs, interfacing with and supporting clients on material selection and development, screening evaluations and biocompatibility risk mitigation and root sourcing. His team consists of experts who review, characterize and risk assess materials in the resin stage and the final device stage. Rigwed’s passion lies in assessing patient risk, by studying front-end material decisions to gain a vantage point for back-end biocompatibility outcomes. Rigwed’s background embodies the development of innovative materials for surgical implants, catheters, and pharmaceutical therapies. Rigwed holds a Master of Science in Materials Science and a Ph.D. in Biomedical Engineering from the University of Cincinnati.

Dr. Sean Teller is a Principal Engineer at Veryst Engineering, a technical consulting firm in the Boston area. Dr. Teller has extensive experience in testing and modeling the mechanical behavior of materials to help clients improve product performance, understand failure modes, and manufacture robust, high-performing devices.  He consults in medical devices and technology, combination products, consumer products, automotive, and consumer electronics industries, and applies his knowledge of polymer material behavior and failure to help clients solve their R&D and design problems. 

Dr. Teller’s consulting focuses on polymer material testing, material modeling for finite element (FE) simulations and failure analysis. He has extensive experience in advanced FE modeling, and often solves problems involving sealing and leakage, ageing and degradation of materials, design verification studies of engineered systems, verification and validation studies, and manufacturing and assembly of medical devices and combination products. Dr. Teller earned his Ph.D. in Solid Mechanics from Brown University, where he worked on a project to characterize the high-frequency mechanical behavior of soft tissues for tissue engineering applications.

Dr Ruchi Thakkar is a Senior Scientist in Drug Product Development at Bristol Myers Squibb, where she supports oral small molecule programs from first-in-human studies through commercialization. She works at the interface of formulation/process development and biopharmaceutics, leading cross-functional teams and contributing to both early- and late-phase development strategies. She is passionate about integrating biopharmaceutics principles into drug product development by conducting biopharma risk assessments and supporting biorelevant dissolution studies to enhance in vitro–in vivo predictability and guide formulation design.

Dr Thakkar earned her PhD in Pharmaceutical Sciences from the University of Mississippi, where her research focused on advancing ophthalmic drug delivery systems. She developed multiple delivery platforms—including lipid nanoparticles, in-situ gels, and sustained-release inserts—designed to enhance ocular bioavailability and enable targeted delivery to both anterior and posterior segments of the eye. Her work included in vivo studies evaluating ocular distribution, permeability, and pharmacodynamic outcomes in animal models, providing key insights into how formulation design can directly influence therapeutic performance in ocular diseases.

Dr Rashmi Thakur is Director of GPS (global product strategy) Business Development and CMC strategy in the Portfolio Strategy and Integration group at Bristol Myers Squibb. She provides guidance for evaluating in-licensing/ co-development opportunities, M&As, collaborating closely with Search and Evaluation, R&D, Commercial, and Finance teams.

She recently served as a key interface in the due diligence and post-agreement integration of BioNTech-BMS deal for co- development and co-commercialization of BioNTech’s investigational bispecific antibody across numerous solid tumor types.

With over two decades of experience in the pharmaceutical industry, Rashmi brings deep expertise in drug development and cross-border collaboration. Rashmi joined BMS in 2023 as a cross-functional matrix team lead for multiple programs. She also spearheaded the initiative to develop a delivery device strategy playbook.

Prior to BMS, she spent 15 years at Johnson & Johnson Innovative Medicine, where she held roles in formulation development, MS&T and CMC/Value chain leadership. She led projects in continuous manufacturing, oligonucleotide development, and completed an international assignment in Asia focused on CRO management. Earlier in her career, she held scientific roles at McNeil Consumer (now Kenvue), Hoffmann-La Roche, and marketing roles at Alkem labs and Wyeth.

Rashmi holds a PhD in Pharmaceutical Sciences from Rutgers University and an MBA with a marketing focus from the University of Mumbai.

Dr Charles Theuer has been Chief Medical Officer at Halozyme since 2024 and is responsible for providing leadership and guidance to Halozyme and its partners/collaborators in subcutaneous drug development with ENHANZE® technology and auto-injectors. Dr Theuer leads clinical development, regulatory affairs, drug safety, medical affairs and bioanalytical and non-clinical sciences strategy and operations, including interactions with regulatory authorities.

Before joining Halozyme, Dr Theuer served as Chief Executive Officer, Chief Medical Officer, and Director of TRACON Pharmaceuticals, where he worked to transform outcomes for cancer patients and optimize clinical development operations. His career includes senior medical leadership positions at TargeGen Inc. where, as Chief Medical Officer, he directed the development of Inrebic®, Pfizer where he led the clinical development of Sutent® in renal cell carcinoma and IDEC Pharmaceuticals where he oversaw clinical trials of Rituxan® and Zevalin®. Charles practiced as a board-certified general surgeon for more than 10 years.

Dr Theuer earned his B.S. in Molecular Biology from the Massachusetts Institute of Technology and his M.D. from the University of California, San Francisco. He received his PhD in epidemiology from the University of California, Irvine, and completed his general surgery residency at Harbor-UCLA Medical Center.

Dr. Ramachandran “TR” Thirucote, is an accomplished pharmaceutical scientist, specializing in drug design and formulation. As an entrepreneurial thought leader with over 30 years of experience, he has a proven track record in the pharmaceutical industry, translating novel science into approved pharmaceutical products.

As the founder and innovator at TesoRx Pharma and Lipac Oncology, he has a proven record of securing funding, building high-performing teams, and advancing promising clinical candidates.

His career is distinguished by significant achievements in driving products from concept to commercialization:

• Full Lifecycle Success: He successfully led the entire product lifecycle of SPRIX™ (ketorolac nasal spray), from early development through to its successful FDA approval while at ROXRO Pharma.
• Strategic Leadership: During his tenure at SRI International, he was instrumental in directing teams, contributing to early development of numerous drug candidates, helping to launch over 25 separate biotech and pharmaceutical companies, solidifying his status as a respected industry consultant at SRI's Business Consulting Group.
• Innovation & Early-Stage Development: Leading oncology product development efforts at Agouron Pharmaceuticals.

TR's comprehensive expertise covers the entire product development lifecycle, from preclinical development and clinical trials to successful commercial launch. He brings deep technical knowledge across diverse dosage forms such as oral, parenteral, topical, and nasal products. A valued government collaborator, he has held the role of Principal Investigator (PI) on contracts with both NIAID and NCI, thereby cultivating robust and enduring relationships within the National Institutes of Health (NIH).

Terrence Tormey is the Director of Business Development at TSG. His responsibilities are to adapt the Company’s newest UltraSound products for commercial introductions, partnerships, and strategic alliance transactions.

Terrence received a BS degree at St. Vincent College, with additional studies at The Wharton School (The University of Pennsylvania) and The Fuqua School/Duke Law (Duke University).

Mr. Tormey is a Fellow at The American College of Healthcare Trustees. He has extensive experience in introducing new medical devices, pharmaceuticals, and biotech products to the global markets. He has served several stints as CEO at such firms as Xenon-VR, Inc., The Medical Phone Company (a Division of Publicis, Paris), Kibow Biotech, and Omax Health. 

He has launched and or supported dozens of pharmaceuticals, medical devices, and O-T-C healthcare products in the US, and globally, including some of the most iconic medical products (e.g., Aricept®, Cipro®, Imitrex®, Imodium®, Lamictal®, Monistat®, Toprol® XL, Ultram®, Advil®, Tylenol®, Nasacort®, Nicorette®, Primatene®, Refresh®, Replens™, Robitussin® Products, and 60 other products).

At TSG, Mr. Tormey has been instrumental in the introduction of the U-Pen and U-Strip Drug Delivery products. Tormey also has extensive experience in structuring licensing deals with academic tech-transfer offices and major pharmaceutical companies.

Timothy S. Tracy is an expert in clinical pharmacology and a Fellow with the American Association of Pharmaceutical Scientists, Dr. Tracy holds three patents related to drug delivery systems and has published over 100 scientific manuscripts, fifteen book chapters and edited two books. Dr. Tracy’s expertise is in the areas of drug metabolism, pharmacokinetics and pharmacogenetics, as well as the larger field of clinical pharmacology and he has conducted numerous clinical trials. He has served as CEO of Aprecia Pharmaceuticals, a 3D printing pharmaceutical company and Koru Biopharma, a biotech company specializing in large molecule therapies for oncology indications.

Dr. Tracy has also served as a consultant to the pharmaceutical industry since 2003, providing subject matter expertise with respect to drug metabolism, pharmacokinetics and clinical pharmacology for both pre-clinical and clinical studies.

Dr. Tracy received his bachelor’s degree in pharmacy from Ohio Northern University, his PhD in clinical pharmacy from Purdue University, and completed a postdoctoral fellowship in clinical pharmacology at Indiana University.

Michael Travanty serves as Vice President of Product Development, Engineering at Halozyme Therapeutics, where he provides technical and strategic leadership in the development of autoinjector systems and combination products. With +20 years of medical device development and over 13 years of industry experience at Antares Pharma and Halozyme, he has played a pivotal role in the development and commercialization of multiple drug delivery platforms, contributing to advancements in patient-centric therapeutic solutions.

Michael’s academic background includes a bachelor’s degree in aerospace engineering and mechanics from the University of Minnesota and an MBA from the University of St. Thomas.

Puneet Tyagi, PhD, is an Associate Director in the Dosage Form Design and Development group at AstraZeneca, based in Maryland, USA. His work focuses on the design and development of biologic formulations, with emphasis on long-acting injectables, transdermal systems, and oral delivery. His recent work involves advancing mRNA CMC strategies to enable rapid response to emerging infectious diseases and other high-impact indications. He plays a key role in advancing innovative drug delivery technologies and enabling translation from early discovery to clinical development.

Puneet earned his PhD in Pharmaceutical Sciences from the University of Colorado, after completing his bachelor’s and master’s degrees in India. He is a co-inventor on several U.S. and international patents and has published extensively in the areas of drug delivery and formulation science. With over 15 years of experience in pharmaceutical R&D, Puneet contributes strategically to AstraZeneca’s pipeline by driving innovation in formulation platforms and patient-centric delivery approaches.

Konstantinos Tzortzakis is a Co-Founder and the Chief Business Officer of Anodyne, where since the company’s inception in 2019 he has led pharmaceutical partnerships across multiple modalities and built a pipeline of next-generation cardiometabolic treatments.

An engineer-turned-entrepreneur, Konstantinos holds a Diploma in Electrical and Computer Engineering from the National Technical University of Athens and an M.Sc. in Innovation and Management from Tufts University. He is also one of the key inventors of Anodyne’s proprietary technology.

Sho Ueno is a R&D scientist of NOF CORPORATION. He has been developing LNP formulations and dosage form design. He has made contributions to the development of mRNA-LNP platform using proprietary ionizable lipids.

Chris is currently Executive Vice President of Business Development for HCmed, based in the UK. His responsibilities include helping customers in Europe, North America and the rest of the world to progress their inhaled medicines using HCmed’s proprietary mesh nebuliser device technologies.

Chris is a Chemist by training and holds a master’s degree in Medicinal and Pharmaceutical Chemistry from Loughborough University. He also holds a master’s degree in Executive Leadership from Imperial College Business School.

Chris has worked in technical, commercial and senior leadership roles across a variety of respiratory focused CRO’s and drug delivery companies, including Nanopharm, Intertek, Aptar Pharma and Vectura (now Philips-Medisize).

He is incredibly passionate about inhaled drug product development and regularly advises companies on technical and commercial strategy for their programs. Recently, he helped to set up and chair the Inhaled and Nasal Biologics and DNA Forum, an annual conference located in Cambridge, UK, now in its fourth year. He was also previously the Chair of the Inhaled and Nasal Biologics Steering Committee in the IPAC-RS (International Pharmaceutical Aerosol Consortium – Regulatory and Science) group.

Thomas von Erlach, PhD co-founded Vivtex and joined as its Chief Scientific Officer when Vivtex was formed as a MIT spin-off in 2018. Prior to that he led the interdisciplinary efforts around gastrointestinal model systems for oral drug delivery applications at the Laboratory of Prof. Robert Langer and Prof. Giovanni Traverso at MIT. Dr von Erlach obtained his PhD from Imperial College London in Bioengineering and a BSc and MSc in Biochemistry and Biotechnology from ETH Zurich in Switzerland. His research interest include advanced in vitro models for drug development, oral drug delivery and gastrointestinal pharmacology. His work is published in several high impact journals such as Nature Materials, Nature Biomedical Engineering, and Nature Communications.

Frank Walsh is the founder and CEO of Ossianix a privately held Biotechnology company that focuses on single domain VNAR antibodies with with a major interest in brain shuttles for Neurodegenerative diseases. Formerly, Frank was head of Discovery Research worldwide at Wyeth Pharmaceuticals in Collegeville, PA (2002-2009). Prior to joining Wyeth, he was SVP at GlaxoSmithKline UK and Head of the Neurology CEDD from 2000. From 1997-2000 he was VP of Neuroscience Research at Smith Kline Beecham UK. Before joining the pharmaceutical industry, Frank had a distinguished academic career in Neuroscience as the Sir William Dunn Professor of Experimental Pathology at London’s UMDS, Guy’s Hospital. He is the author of over 200 scientific publications and is a Fellow of the Royal Society of Edinburgh and the UK Academy of Medical Sciences.

Chun Wang is a co-founder and Chief Scientific Officer of Trekka Therapeutics, LLC (http://trekkatherapeutics.com), a startup company developing next-generation healthcare products based on the proprietary CAPRO TM polymers, a novel class of excipients. He is also on the faculty of the Department of Biomedical Engineering, University of Minnesota, and directs the Polymeric Biomaterials Lab at Minnesota (http://biomaterials.umn.edu). His past and current research covers a broad range of topics, including polymeric hydrogels, micelles, nanoparticles, biointerfaces, stimuli-responsive and biodegradable polymers for controlled release and drug delivery. He has published over 100 research articles and reviews and given over 130 invited talks. He holds numerous patents (5 issued, 2 pending). He served on the editorial board of the Journal of Controlled Release (2006-2016) and is currently on the boards of Advanced Drug Delivery Reviews, Pharmaceutics, and Frontiers in Biomaterials Science as the Specialty Chief Editor for Delivery Systems and Controlled Release. He was a recipient of the NSF CAREER Award, a Wallace H. Coulter Foundation Early Career Translational Research Award, and the UMN McKnight Land-Grant Professorship. He received his Ph.D. in Bioengineering from the University of Utah and was an NIH NRSA Postdoctoral Fellow at the Massachusetts Institute of Technology.

Mr Welch has been with PCI, a large, global CDMO, providing integrated end-to-end drug development, manufacturing and packaging solutions throughout the product lifecycle, since 2022. Prior roles include serving as Chief Technology Officer of Phillips-Medisize, a Molex Company, until December 2021. Phillips-Medisize is a leading, global contract development and manufacturing organization focused on drug delivery devices, combination products, and connected health. Mr Welch led their global pre-production services organization, a team spanning front-end innovation, development, and new product introduction. He was active in the company’s merger and acquisition activity, including leading the search, acquisition, and integration of locations in China and Denmark. Mr Welch received a B.S. in Industrial Engineering from University of Minnesota Duluth.

David Westberg has many years of experience in the pharmaceutical industry, including roles at Pharmacia, Pharmacia-UpJohn and Orexo. He has worked as a global project manager for development projects and was Head of Product Development (Pharmaceutical and Analytical Development) at Pharmacia amongst many other roles. David was also the main project manager who was responsible for taking two major Orexo products (Edluar and Zubsolv) from the early development phase through formulation development and clinical studies and onto registration and market approval with the FDA in the US. David has also worked as a consultant on a range of business development projects in the pharmaceutical industry