Speakers

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Shaukat Ali joins Ascendia Pharmaceuticals Inc. as senior director of scientific affairs and technical marketing after having worked in the pharma and biotech industry for nearly 30 years. His areas of expertise include lipid chemistry, liposomes, surfactants base drug delivery systems, self emulsifying drug delivery systems (SEDDS/SMEDDS), Amorphous solid dispersions, oral, parenteral, topical and transdermal drug delivery, immediate and controlled release formulations. He received his PhD in Chemistry from the City University of New York and postdoctoral training from the University of Minnesota and Cornell University. Dr Ali has published over 60 articles in scientific journals and is inventor/co-inventor of several US and European patents. He is the recipient of IPEC’s Henk de Jong industrial research award. He has served as the USP panel of experts for the General Chapters- Physical Analysis (2010-2020), and continues to serve as a panel of experts for the USP Excipient Test Methods committee (2020-2025). He is also serving as the co-chair of AAPS Lipid Focus Group.

Luis Alvarez is the founder of Theradaptive and developed the concept for a targeted regeneration platform during and following a combat tour in Iraq where several of his soldiers suffered severe extremity injuries. Previously, Dr Alvarez was the co-founding Deputy Director of the Department of Defense Regenerative Medicine Program and led the department’s largest recombinant biologics program through Phase II. Dr Alvarez was a DARPA Service Chief Fellow and Academy Professor at the United States Military Academy, West Point. Dr Alvarez received his PhD in Biological Engineering from MIT where he was a Hertz Foundation Fellow.

Dr. Robert Amezquita is a leading computational immunologist in translational sciences. At Sanofi's mRNA Center of Excellence, he leads initiatives to enhance mRNA vaccine platforms using advanced AI/ML technologies and novel model systems. Previously at Pfizer, he spearheaded computational biology in immuno-oncology research, advancing candidates to first-in-human trials. His earlier work at Resolution Bioscience involved developing ML-based callers for microsatellite instability detection in liquid biopsies. Dr. Amezquita's academic background includes postdoctoral research at Fred Hutchinson Cancer Research Center, where he led the publication of "Orchestrating Single Cell Analysis with Bioconductor," and doctoral work at Yale University, focusing on computational approaches to deciphering CD8 T cell differentiation. He currently maintains an adjunct faculty position in immunology at Brandeis University. His unique expertise spanning computational immunology, data science, and translational research places Dr. Amezquita at the forefront of mRNA vaccine development and immuno-oncology in both industry and academia.

Julia Anthony brings experience, passion, and commitment as a successful entrepreneur, designer, and healthcare executive living with a rare medical condition to the life sciences. She is a graduate of the NASDAQ Entrepreneurship Program and Johnson and Johnson's prestigious JLABS Incubator, and a recipient of PPDC recognition from the Children’s Hospital of Philadelphia. She is the Founder and Chief Strategy Officer of SOLUtion Medical—a pharmaceutical company focusing on drugs requiring mixing at the point of care. SOLUtion is making patient-injected drug delivery safer, more efficacious, and easier by developing proprietary drug/device delivery platforms.

Scott Ariagno is Vice President of Engineering and Development Services at EdgeOne Medical and has over 25 years in medical device and combination product design, development and manufacturing. His expertise includes development and global launch of various single-use, disposable medical devices, infusion systems and combination products, strategic/technical development of device platforms and IP development. Throughout his career, he has held management roles in engineering including heading device development and external manufacturing at Shire (now Takeda). Mr Ariagno is a named inventor on over 20 patents and applications. Mr Ariagno has Bachelor of Science in Mechanical Engineering from Bradley University and a Master in Engineering Management from Northwestern University.

Jaspreet Arora, PhD, is currently the Director of Business Development at Seran. He has 8 years' experience in drug product development with a recent NDA submission and approval for Leqselvi (Deuruxolitinib). He has early to late-stage experience including commercial readiness and IND/NDA writing. His oral solid dosage form expertise includes formulation and analytical characterization with a focus on material science. Previously Jaspreet worked for Concert Pharma (acquired by Sun Pharma) and Lonza-Bend (Bend Research). Jaspreet has a PhD in Chemical Engineering from Tulane University and a bachelor’s degree in biotechnology from Panjab University. Jaspreet applies his technical experience and training to understand client problem statements and support tailored solutions that fit clients' needs.

Dr Aydt has been with Lipoid LLC for 2 years as Senior Manager of Business Development. He specializes in pharmaceutical formulations of all types. He lives in California and primarily supports West Coast customers.

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, adjuvant 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 Ph.D. 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 PDA, AAPS and Controlled Release Society, and has authored 8 patents, published over 30 articles in professional scientific journals, and presented more than 50 short papers, posters and talks.

Annette Bak, Ph.D., MBA leads Advanced Drug Delivery (ADD) 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, Dr Bak has been instrumental in delivering a variety of synthetic modality and mRNA drug delivery systems and formulations for preclinical & clinical studies. She has also built delivery chemistry and intracellular drug delivery capabilities within ADD.

Dr Bak 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. 

Dr Bak has published more than 50 articles, has more than 50 invited presentations, and serves on the editorial board for the Journal of Pharmaceutical Sciences and Molecular Pharmaceutics. 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 was the 2022 president for the association and responsible for leading implementation of the 2021-2025 strategic plan and ensuring that the AAPS communities are thriving. Dr Bak 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.

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

Manasi Baker, PhD, is a Senior Scientist in Secant Group’s Translational Product Development team which focuses on the development of the novel polymer platform, Hydralese®, for improved drug delivery applications. Dr Baker focuses on developing multiple long-acting Hydralese form types for both small and large molecule delivery, including microspheres, gastroretentive devices, and subcutaneous implants. She also manages the platform’s intellectual property and provides her polymer expertise to lead customer development projects to success. During her career, Dr Baker has specialized in preformulation and formulation development of various form factors spanning from drug delivery devices to home and personal care products. Dr Baker has a PhD in Pharmaceutics from Philadelphia College of Pharmacy, University of the Sciences, and a Bachelor of Pharmacy from the University of Mumbai.

TBA

Uri Baruch is an accomplished leader with extensive experience in the pharmaceutical industry, known for his strong focus on patient care and deep understanding of regulatory frameworks. As Vice President and General Manager of SMC Ltd.'s European division, he oversees a range of pharmaceutical services, driving innovation and operational excellence.

Tony Bedford is a Commercial Director, Platform Management & Innovation at Phillips-Medisize and has been involved in the design and development of medical devices for over 25 years. With a First Class Honours Degree in product design, his broad experience covers everything from innovation and market strategy to clinical research and product launch, with a focus on understanding market, stakeholder and user needs. Prior to joining Phillips-Medisize he held project management and business development roles in the consulting industry, working on a wide range of device programs. He has been specialising in drug delivery devices for a number of years.

Sean Bedingfield is a specialist in nonviral RNA delivery with work spanning multiple platforms. He is currently in Lilly’s Genetic Medicine division working in early discovery efforts for delivery platform technologies. He leads a small team in a blend of 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, Verve Therapeutics, Scribe Therapeutics, Entos Pharmaceuticals, Evox Therapeutics and acquisitions such as Prevail and Akouos. 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.

Dr Kerry Benenato joined Sail in February 2024 as Chief Platform Officer, bringing to the company a distinguished career in the development of mRNA products and product candidates. Prior to Sail, she served as Chief Scientific Officer of 76Bio, a startup focused on the development of a novel targeted protein degradation modality using mRNA/lipid nanoparticle (LNP) technologies. Prior to this, she spent eight years in positions of increasing responsibility at Moderna, most recently serving as Vice President, Platform Chemistry and Formulation Discovery, where she led the Platform team, with oversight for the discovery and development of mRNA delivery tools for multiple modalities (infectious disease, rare disease, immuno-oncology, auto-immune diseases) and the development of tools for LNP biophysical characterization.

In 2022, Dr Benenato was awarded the American Chemical Society Heroes of Chemistry award for her work contributing to Moderna’s mRNA-based COVID-19 vaccine (Spikevax™). She began her industry career in scientific research at AstraZeneca, after completing a research fellowship at Harvard University as a National Institutes of Health Postdoctoral Fellow. She holds a Ph.D. in Organic Chemistry from Boston College and a B.S. in Chemistry from Providence College.

Henrik Bengtsson is Senior innovation Lead at Novo Nordisk's Bio Innovation Hub on Kendall Square, Boston. Dr Bengtsson has worked for Novo Nordisk for 22 years and has received a lifetime award for producing 100+ patents. This has been done together with his team including many PhD & Postdoc students. Prior to entering the medical device field, Dr Bengtsson invented a new type of amplifier and was part of starting up the company Bang & Olufsen ICEpower A/S focused on bringing professional audio solutions to market. Today his main interests include innovative new medical device concept development, data science, modeling and digital health.

Mrs. Bhagwat has a Masters degree in Pharmaceutical Sciences along with several years of work experience in the pharmaceutical industry around generic product development and filing. With a degree in intellectual property, she also worked on developing IP strategies in her previous role. After an MBA degree in International Management and consulting experience in the pharmaceutical industry, she now works at Merck KGaA, Darmstadt, Germany as a Strategic Product manager. Her primary responsibility lies in the field of excipients used for solid formulation drug development. She is leading the digital strategy for solid formulation with its flagship product mPredict™.

Co-founder and patent co-author at Biotts, with a PhD in Pharmacy from the Medical University of Wrocław. A seasoned pharmaceutical technologist with over two decades of experience, specializing in the design of drug active ingredient nanocarriers, transdermal systems, and sterile, non-oral drug formulations. Renowned for contributions to numerous domestic and international scientific publications. At Biotts, excels in creating proprietary formulations and patents for innovative solutions.

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. 

Nathan is a dedicated life sciences professional with nearly 25 years of experience across biopharmaceuticals, medical devices, and combination products in individual contributor and leadership roles. He has experience in small-scale and large-scale manufacturers as well as professional services/consulting. He is passionate about commercializing safe and effective products that will improve the quality of life for patients and their caregivers. He considers himself a builder of strategy, teams, systems, and best practices to ensure internal and external stakeholders are successful. His career foundation was established in engineering, product and process development, manufacturing, continuous improvement, and program management roles. Over time, Nathan made a transition to focus on quality and regulatory affairs to complement my technical experience. In his current role, he build strategic solutions internally and externally to enable clients to accelerate the development and commercialization of new therapies. Nathan focuses on providing solutions that are not only technically sound, but also compliant with evolving regulations and industry best practices. He acquired the Certified Quality Auditor (CQA) designation through the American Society for Quality (ASQ) and hold a Regulatory Affairs Certification (RAC-US) through the Regulatory Affairs Professionals Society (RAPS). Additionally, he is currently a Board Member for the Parenteral Drug Association (PDA), Southeast Chapter.

Ross Blezard began his career at a UK-based CDMO specializing in inhalation and transdermal drug delivery, where he served as Head of Formulation Development. In this role, he gained extensive experience in industry partnerships. He then joined a multinational CDMO, leading particle characterization technologies for R&D centers and production sites across the globe. Here Ross also embraced opportunities to broaden he horizons, included a secondment in the US. In 2019, Ross relocated to the Netherlands to join DFE Pharma, where he currently leads global technical activities for their industry-leading inhalation and biopharma excipient portfolio.

Tommaso is a Director of Product Development of Drug Delivery Systems at Stevanato group. In his 15+ years long career he matured a comprehensive experience in the medical device and pharma industry, specializing in the development of in vitro diagnostic and drug delivery products with proven track record of creating and leading teams through the full product lifecycle from concept generation to commercialization.

He created partnerships with Italian universities and led programs with European research centers to bring cutting edge technologies into the market. He holds several patents and published research papers on international peer-reviewed journals.

Tommaso holds a PhD in Electrical Engineering from Politecnico di Milano.

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.

Dr. Niya Bowers joined the Bill & Melinda Gates Foundation in 2015, as a Senior Program Officer in Chemistry, Manufacturing and Controls (Integrated Development). She works closely with foundation’s strategy teams and partners and provides technical expertise and strategic guidance for therapeutic drug development in Global Health. Dr. Bowers has over 30 years of experience in pharmaceutical product development, including the end-to-end development of drug substances, drug products, and analytical. She also has in-depth experience in Process Analytical Technology (PAT), regulatory, and project management. Prior to joining the Foundation, she was a managing partner of Garden State Pharmatech, LLC, a CMC consulting firm. From 2010 to 2014, she was an executive director in Merck’s Global Science Technology and Commercialization organization. She was responsible for late phase analytical development for both drug substance and drug product and the head of Merck’s Global Process Analytical Technology. Before Merck, she was a director of Oral and Specialty Product Development in Schering-Plough Research Institute. She led the development, filing and approval of over 15 commercial products at Schering-Plough and Merck.

Strategic leader in multifunctional organizations and biopharmaceuticals with 13+ years experience in sterile injectables; proven track record of leading change utilizing technical knowledge, CDMO experience, customer service expertise, and results oriented approach. Technical transferred over 53 product skus across 14 customers.

Douglas Bryans, PhD is our Founder, President and Chief Executive Officer of Bryllan LLC with responsibility for the operating strategy and overall performance of the company. After a long career with Catalent Pharma Solution, he started Bryllan to support the growing need for clinical and commercial fill finish capacity of a wide range of complex drug/device products. Dr Bryans holds a PhD in Chemistry from the University of Paisley in Glasgow, Scotland and US Patent Number 6,156,339, Process for preparing solid pharmaceutical formulation, approved in 2005.

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. 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.

Mark is a product development consultant with over a decade of experience in the Medical Device and Pharmaceutical sectors. As the Director of Engineering at PSN Labs, Mark leads the engineering department, offering invaluable support to clients in new product development, test method development, functional prototyping, contract manufacturing, and on-market remediation. His team specializes in designing devices that incorporate various design principles, including manufacturing, assembly, sustainability, biocompatibility, reprocessing, and reliability. Mark’s background encompasses the development of innovative healthcare solutions in areas such as drug delivery, surgical robotics, pharmaceutical packaging, and catheters. His expertise ensures patient safety and regulatory compliance throughout the design process. Mark holds a Bachelor of Science in Mechanical Engineering from Purdue University and a Master of Science in Mechanical Engineering from the University of Cincinnati.

John is a Project Lead, specialising in the design and project management of complex drug delivery devices and systems. A designer by training with a strong grounding in medical device design and regulatory focused human factors, he regularly attends user studies in both Europe and the US.

On projects he seeks to balance technical, user and commercial requirements to produce simple elegant solutions. Over the years, John has worked on a range of parenteral device developments with leading pharma companies in both Europe and the US and has a good knowledge and understanding of the market, current devices and trends.

Gaurav is a co-inventor of Piezo’s novel platform and founding CEO of Piezo Therapeutics. Prior to Piezo, he’s served in a variety of roles at Moelis and Company, Capital One, and Elevance Health. He’s a published scientist with a background in drug delivery and synthetic biology. He holds a BS in Industrial and Systems Engineering from Georgia Institute of Technology.

Ester is a multidisciplinary scientist with a background in biotechnology, biochemistry, and bioengineering. After working in different roles across startups, pharma, and consulting, she is now the Director of Strategic Innovation at Chiesi USA, where she is scouting companies for partnerships or acquisitions that have innovative technologies to treat patients with rare diseases. 

At MIT, Ester developed a pill to administer insulin orally, and was recognized by the MIT Technology Review as one of the 35 Innovators Under 35 in 2019. She is also a Lecturer at MIT, and serves as an advisor and mentor to various international startups and academic programs. She speaks seven languages and is passionate about advocating on career development for women in science.

Alessandro Cavecchi is the Head of the Pharmaceutical Technology Section within Chiesi Farmaceutici’s R&D department, holding a Magister degree in Industrial Chemistry from the University of Parma (IT). With over 20 years of experience in developing inhalation dosage forms, Alessandro has specialized expertise in Dry Powder Inhalers (DPIs) and pressurized Metered Dose Inhalers (pMDIs). In his current role, he ensures the scientific integrity and robustness of formulation and process development for the dosage forms in Chiesi Farmaceutici's R&D pipeline.

Before joining Chiesi, Alessandro served as Senior Formulation Manager at Zentiva (Sanofi Generics), where he was responsible for the formulation and manufacturing development of generic inhalation products. He also worked at Novartis as a Formulation Fellow, supporting the establishment of the Breezhaler® portfolio.

Andrew Clark is the Director of Pharmaceutical Science at digiM solution where he leads the scientific team focused on the structural characterization of complex drug products. He earned his PhD in experimental physics from Tufts University where he specialized in material characterization of polymeric systems. He has an extensive background in condensed matter physics, polymer physics, and materials science with an emphasis on experimental characterization methods including electron microscopy, X-ray computed tomography, spectroscopic characterization, and thermal analysis. Since joining digiM, he has focused on advancing quantitative imaging as a regulatory tool through close collaboration with the Office of Generic Drugs (OGD) as well as the Office of Product Quality (OPQ) within the FDA. His previous analytical and material characterization expertise, combined with his continued advancement of new cutting-edge tools for regulatory science aims to provide more targeted tools to effectively and accurately develop complex dosage products.

Gil Cohen brings more than 20 years of experience in R&D, leadership roles in various fields, including Medical devices, Bio-tech, and Clean-tech. As the VP R&D of the company he brings a vast scientific and managerial experience including in product development, data analysis, IP, and the development of Manufacturing and QC methods. Before joining Epitomee in 2018, Mr Cohen was Chief Scientific Officer in Dune Medical Device (Acquired by Dilon Technologies). He holds a B.Sc. in Physics and Mathematics and Ph.D. in Physics from the Hebrew University, Jerusalem with a post doc in Biology.

Alba Córdoba, PhD oversees Technology Transfer and Business Development activities at Nanomol Technologies, where she heads scale-up, engineering, IPR and business development activities. Since 2017 she has been leading the DELOS nanoformulation unit of the company, defining and implementing the strategic plan for business consolidation & growth of the company, bringing this novel nanoparticle technology up to the GMP pilot manufacturing and securing several contract pharmaceutical development projects for pharma & biotech. Dr Córdoba garners 15-plus years of experience in R&D and technology transfer projects for pharma, biotech and chemical companies, in the fields of drug delivery, biomaterials, formulation, nanoparticles and nanomedicine, mainly in small biotech companies working closely with both global and small pharma and biotech partners and customers. She is Chemical Engineer from the Polytechnic University of Catalonia, Postgraduate in Tech Transfer and Innovation Management and holds a PhD in Chemical Science and Technology.

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.

Dr Alexander Curreri is currently a Senior Scientist in the Discovery Pharmaceutical Sciences group within Merck Research Laboratories. His work focuses on designing drug delivery technologies for a breadth of therapeutic modalities across various disease areas. Dr Curreri drives formulation design and evaluation to support preclinical and FIH studies across the Merck discovery portfolio and into development. Dr Curreri holds a Ph.D. in Bioengineering from Harvard University and B.S. in Chemical Engineering from Rensselaer Polytechnic Institute. In his thesis work, performed in the lab of Professor Samir Mitragotri, he developed novel deep eutectic solvent-based delivery systems for parenterally administered proteins and nucleic acids. During his doctoral studies he also performed research to use deep eutectics for delivery across the skin, gastrointestinal tract, and led a team to evaluate venture creation for a microparticle-laden cell therapy technology.

Yogev Debbi is the co-founder and CEO of Mana.bio. Previously, after working for years at the tech industry at Intel Corporation (Nasdaq: INTC), he co-founded and was the COO of Genome Compiler, a software gene editing company which was acquired by Twist Bioscience (Nasdaq: TWST), where he then led Twist's Israel R&D center through its IPO. Yogev brings deep expertise in launching and scaling successful bioengineering startups. As a repeat entrepreneur, Yogev is excited about the integration of software and biology and he is focused on leveraging the integration of the two fields to create disruptive technologies to positively impact human health.

Dominick DeGrazio is an Early Device Project Engineering Lead in the Early Engagement and Deviceability Group at GSK. He’s been in this role since Fall 2022 and focuses on the assessment of early-stage large and small molecule products within the portfolio intended for combination product development. With over a decade of industry experience, Dominick has previously held roles at PTC Therapeutics, Janssen R&D, Oncobiologics, and West Pharmaceutical Services. His expertise spans across end-to-end drug product development, tech transfer and fill/finish, analytical development, primary packaging, and device/combination product development. He has successfully partaken in the commercial launch of multiple gene therapy and biologic drug products approved on the market including Upstaza, Darzalex Faspro, and Tremfya to name a few. Dominick graduated from Franklin and Marshall College in 2012 with a B.A. in Biochemistry & Molecular Biology and Neuroscience.

Mike is an entrepreneur/investor in the drug delivery field for 17 years, starting-up DSM BioMedical, InGell Labs, Hy2Care and MyLife Technologies, and now his new venture OncoLize. He has initiated and raised over €120 Mln public and private funding to do so.

Before, Mike worked for 20 years with DSM-Pharma, DSM-China, SHELL-BioTech and UniLever, and he holds degrees in Molecular Biology/Tumor Virology (Leiden) and Business Administration (RSM, IMD). Mike has a special interest in making cancer therapies more bearable for both patients and their loved ones. Based on his extensive experiences in China, India and Indonesia, his drive extends to ensuring Triple A products: Affordable and Accessible for All, wherever.

TBA

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.

Dr Anil Diwan is President & Executive Chairman of NanoViricides, Inc, a public company (NYSE-Amer.: NNVC; co-founded 2005). He co-invented a bio-mimetic drug delivery platform, nanoviricides™ polymeric micelles, enabling site-specific targeting, multi-point attack, & encapsulation. Orally available nanoviricide drug NV-CoV-2 is in Phase 1 for COVID and has shown strong pre-clinical efficacy in COVID and RSV, attesting to its broad-spectrum, reminiscent of antibiotics. Nanoviricides define a new paradigm “Re- Infection Inhibition,” going beyond antibodies and small chemicals. The platform further enables cures of viral infections by encapsulating orthogonal APIs ex: Remdesivir, Ribavirin, Cidofovir, etc. Dr Diwan was instrumental in designing and establishing the NanoViricides campus in Shelton that comprises R&D to Clinical Trial Drug Product Manufacturing facility of our nanomedicines. Dr. Diwan holds a PhD, (Bio)Chemical Engineering, Rice University and a BTech, Chemical Engineering, Indian Institute of Technology, Bombay (IITB).

Dany Doucet is Director of the Early Engagement and Deviceability group in GSK’s Packaging, Device and Design Solution department. He leads a team of engineers and scientists supporting deviceability efforts to improve probability of technical success of development programs through early evaluation and design of suitable molecules, formulations, primary packaging and devices for complex drug device combination products. He has over 20 years of experience working across all stages of the product and process development lifecycle, from the discovery interface through concept design and selection, registrational submission and commercial supply.

Mr Dundon leads Drug Delivery Systems Strategy at Jabil Pharma Delivery Solutions. Jabil Pharma Delivery Solutions is the largest supplier of drug delivery systems to our Pharma partners. Mr Dundon has responsibility for monitoring our pharma partners clinical pipelines and business strategies to understand our pharma partners drug delivery opportunities/challenges to identify potential drug delivery systems technologies and/or services that Jabil can offer to realise our pharma partners business objectives.

Prior to working with Jabil, Mr Dundon had a 30-year career at GSK where he assumed various position of increasing responsibility culminating in leading the Device Engineering R&D Group. He was responsible for the design, development, registration & industrialisation of a series of drug delivery systems across a range of routes of administration. He created a process for the implementation of Quality by Design for drug delivery devices utilising mechanistic modelling and in-silico simulation tools, that has been endorsed by an external industry consortia. In addition, Mr Dundon was responsible for the proposal and implementation of a Change Management Process for Drug Delivery Systems that has been developed as an ISO Standard.

Dr Anthony Duong has 14 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 co-authored 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+ IR&D programs, both as a researcher and an advisor.

Jason Durkin is the Vice President of Supply Chain at Windgap Medical having worked in the combination product industry for nearly 30 years. With experience in both injection and inhalation products, Mr Durkin has spent his entire career bringing life changing technologies to patients in need.

Camilla has ten years’ biotech start-up experience as CEO and COO working exclusively on hydrogel-based medical devices. Originally a veterinary surgeon, she has run veterinary clinical trials and launched the veterinary arm of a biotech company. Following on from this she moved into the human biotech sector where she has been involved in all aspects of start-ups including, R&D, fundraising, regulatory, pre-clinical and clinical trials for medical devices.

Adam Edelhauser is the Director of Research & Development at KORU Medical, a role he has held since September 2023. With a career in the medical device industry that began in 2008, Adam has developed a reputation as a leader in medical device design and innovation. A graduate of Mechanical Engineering from Rutgers University, Adam’s expertise lies in both single and multi-use medical devices, as well as in strategic portfolio development, and intellectual property generation. Throughout his career, Adam has been instrumental in the development of award-winning medical devices, accumulating over 30 patents that span both software and hardware innovations. His extensive experience includes work in orthopedic trauma, deformity correction, specimen collection & diagnostics, and medication delivery systems. Now, as the head of R&D for KORU Medical, Adam continues to drive innovation in the medical field, contributing to the advancement of patient care through cutting-edge technology.

As Chief Operating Officer of R&D and Cofounder of Pendant Biosciences, Dr Elmquist is transforming the way the pharma market uses polymers (starting with whether they’re using them at all). He received his PhD in Chemistry at Vanderbilt University, where his research focused on oligonucleotide synthesis containing site-specific food mutagens. He continued his cancer research as a Postdoctoral Fellow at MIT in the Department of Biological Engineering where his research focused on the role of inflammation and endogenous DNA damage as drivers of carcinogenesis and age-related diseases. He currently holds a seat on the board of BioTN Foundation, Tennessee’s leading non-profit focused on STEM in education, workforce development, and entrepreneurship. He previously held a scientist role at BioMimetic Therapeutics developing therapeutic products with platelet-derived growth factor, followed by a Business Development Role at the Cool Springs Life Sciences Center.

Dr Engelhardt is Co-Founder and CEO of Kano Therapeutics, a biotech startup enabling cell and gene therapies based in Cambridge, MA. She holds a PhD in Biophysics from the Technical University of Munich, with a focus on DNA nanotechnology and started the company based on her postdoctoral research work in Mark Bathe’s BatheBioNano lab at MIT. She was awarded with MIT’s 2020 Innovative Woman in Entrepreneurship Award, Activate Global fellowship, Pillar VCs Founder to watch in Biotech Award 2021, and most recently the Termeer Fellowship for first-time CEOs.

Matthew Fordham has more than 10 years’ experience developing products for a wide range of markets; from industrial machinery and consumer electricals to wound care and diagnostics devices and sterile injectables. Over the past 5 years, he has focused exclusively on developing products in the medical and healthcare space. Mr Fordham has led major projects in wound care and parenteral drug delivery for some of the global leaders in the medical device and pharmaceutical industries; including mechanical development from concept to clinical trial units for a negative pressure wound care device, design and development of a novel pen injector platform mechanism and device, execution of design verification testing of an autoinjector platform device, design and development of a novel orally administered drug delivery device. Mr Fordham has a master’s degree in aerospace engineering, specializing in the aerodynamics of subsonic, sonic and hypersonic airflows within the context of aircraft, spacecraft and wind energy systems. After graduating, he spent several years training other engineers to design effectively, using 3D CAD systems and computational numerical modeling systems. He is a keen sportsman and fitness enthusiast, which parallels his passion for developing products in the medical, healthcare and wellbeing markets.

Mr Fox is passionate about developing partnerships that improve healthcare through the integration of innovative polymer technologies. His background as an orthopedic product development engineer highlighted the pivotal role that materials advancement plays in enhancing patient outcomes. Most of his career has been dedicated to supporting the adoption of novel polymer technologies in medical device and drug delivery applications, forming collaborations across industry and academia to create and commercialize the next generation of medical therapies.

Dr Bruce Frank, DelAQUA Pharmaceuticals President and Chief Scientific Officer, is a seasoned and successful scientific leader in the areas of pharmaceutical drug product development, project management, and business development. He holds over fifteen patents and pending applications and is recognized for achievements in applying broad scientific and executive leadership experience to problems of scientific and commercial importance in vibrant, growing companies. He has extensive experience at the nexus of medicinal chemistry, biological chemistry, analytical chemistry, and formulation science.

Matt joined Phosphorex in May 2023 as a senior scientist. In this role, Matt focuses on the development and optimization of novel drug delivery systems including lipid and polymeric nanoparticles.

Prior to joining Phosphorex, Matt completed his Ph.D. in chemical engineering at the University of Rhode Island. His doctoral work focused on the development and characterization of novel polymeric nano and microparticles for pulmonary drug delivery applications. Matt also holds a Bachelor’s Degree in Chemical Engineering and a Bachelor’s Degree in Chinese Language from the University of Rhode Island.

Dr Shawn Fu is currently the Head of CorpDev and Strategy at SonoThera, a venture backed non-viral, ultrasound based gene therapy company. Prior to joining SonoThera, Shawn was a Vice President at Vertex Ventures HC focusing on platform technologies and genetic medicines where he led investments and held board positions across both biotech & medtech opportunities, including, among others, SonoThera, Allay Therapeutics, and SpyGlass Therapeutics. Previously, Shawn also served as Vice President on JP Morgan’s Equity Research desk covering large / SMid Cap Biotech.

Dr Fu obtained his medical degree at UT Southwestern Medical School and his bachelor’s in biology/economics at Duke University.

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.

Gabrielle is a Philadelphia-based Scientific Support Manager who joined Datwyler Pharma Packaging in 2022. From 2015 to 2019, she attended Widener University and completed her Bachelors' and Masters' degrees in Biomedical Engineering. She has since worked in the pharmaceutical packaging industry, helping major drug companies determine how to safely and effectively package their drug products. Gabrielle has taken a special interest in many related topics, including the process of PERFECTing delivery systems, as well as the benefits of increased degrees of automation in the manufacturing process.

Matthieu is the head of Curadigm platform at Nanobiotix. He holds a doctorate in biotechnology. He has joined Nanobiotix in 2004. With over 15 years in nanomedicine, he is the author of more than 15 publications and scientific communications and is the inventor of 15 patents. He has held multiple positions in Nanobiotix and managed both domestic and international projects before taking the lead at Curadigm in 2018.

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.

Mary Lou Glotzbach is a Business Development Executive for Grand River Aseptic Manufacturing (GRAM). Mary Lou’s career experience ranges from diagnostic and drug delivery devices through the manufacturing of injectable drugs. She is currently focused on combination products and the role of aseptic fill and finish manufacturing in the development and supply of drug delivery devices.

Steve leads the Drug Delivery & Digital Health business at TTP, a product development partner that has been pioneering innovative drug delivery devices for over 35 years. With a strong background in human-centered design, Steve has dedicated his career to making these devices intuitive and engaging. He excels at navigating technical trade-offs and collaborating with multi-disciplinary teams to bring these devices from concept through to manufacture and scale-up.

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.

Michele Guasti is Global Product Manager at the Pharmaceutical Solutions Division of Terumo Medical Care Solutions. He graduated from the University of Brescia (Italy) and holds a Master’s degree in Mechanical Engineering. Mr Guasti has more than nine years of experience in primary packaging within the pharmaceutical industry. In the last five years, he has acquired expertise in fill-finish processes for injectable drugs and associated technologies.

Mr Guasti has extensive experience in establishing strong partnerships and collaborations between companies and supporting pharma customers in finding solutions to their daily challenges. Previously, he worked in strategic product management at Stevanato Group.

Dr Manish Gupta is passionate about connecting biology and drug product design to create the best medicine for the patient. Dr Gupta has championed science and risk-based product development for multiple oral and parenteral commercial drug products (across small molecules and biologics) and has successfully led regulatory filings and interactions across agencies. Dr Gupta has 20 plus years of industrial experience and is currently serving as Executive Director, leading Drug Product Development Steriles (~100 team members).

Alex Guth is a Managing Director and Partner in LEK Consulting’s Boston office and a member of the Life Sciences practice. He supports clients throughout the life sciences industry, including biopharma, manufacturing and academic partners. Alex advises clients across a range of strategic needs, including therapeutic area strategy, portfolio prioritization, due diligence, and opportunity forecasting and valuation. Prior to joining LEK, Alex had over 15 years of experience in biological research. He holds a bachelor’s degree with highest departmental honors in biology and a PhD in virology, both from Harvard University.

For over 25 years, Brent has been widely acknowledged as a micro molding and materials industry expert, particularly in precision medical device and drug delivery platforms.

Throughout Brent’s career, he 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.

Brent is a degreed Plastics Engineer with an MBA from Pittsburg State University and President of his university’s SPE chapter. Throughout his career, he has held engineering, business development and marketing leadership positions in the resin, life science, and plastics micro molding industries.

Stéfan Halbherr holds a degree in biochemistry and immunology from the University of Bern, Switzerland. During his PhD, he developed innovative self-amplifying RNA vaccines targeting influenza A viruses. A founding member of InnoMedica, Stéfan was instrumental in transforming the company into a leader in nano-drug delivery technologies. Since 2013, he has led the R&D department, successfully advancing research concepts into clinical-stage therapies with significant market potential. In 2019, Stéfan assumed the roles of Country Manager and President of the Board at InnoMedica Switzerland AG, while continuing to spearhead R&D efforts that have resulted in a diversified pipeline of clinical-stage products. Notably, InnoMedica's oncology portfolio features Talidox, an advanced therapy aimed at reducing severe side effects of widely-used drugs while enhancing antitumor efficacy. Stéfan is also the inventor and patent holder of Talineuren, a novel nanodrug currently in Phase IIb trial (randomized, placebo-controlled, multicenter) for the treatment of Parkinson’s disease. Under his leadership, InnoMedica has evolved into a vertically integrated, advanced clinical-stage pharmaceutical company, raising over CHF 80 million in funding and building a team of more than 50 employees.

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, Mr Halleppanavar was the Director - PharmSci Technical Team Lead at Pfizer. He came to Pfizer upon its acquisition of Hospira where Mr Halleppanavar was responsible for combination product development from early-stage development to manufacturing scale up leading to commercial launch. Prior to Pfizer, Mr Halleppanavar was the Program Manager at GE Healthcare responsible for development, manufacturing, and commercialization of multiple medical device/patient monitoring platforms namely, patient worn devices, blood pressure cuffs, bedside monitoring devices, networked central & remote monitoring stations.

Robert has over 20 years of experience in the medical device, biotech and pharmaceutical industries. He oversaw development and launch of over 10 different products while at Boston Scientific and Medtronic. He worked as Global Project Manager for Genentech, focused on biologics for the treatment of HER2+ breast cancer, including Perjeta, Herceptin and Kadcyla, where he oversaw the APHINITY and KATHERINE clinical trials. Robert holds a graduate degree in Industrial Engineering from the University of Costa Rica and an MBA from Harvard Business School. He currently serves as Senior Vice President of Finance and Operations at Portal Instruments.

Josh Horvath is the Head of Device Engineering at Genentech in South San Francisco, CA where he leads a team of engineers and scientists responsible for developing novel medical device/combination product technologies.  He joined Genentech in 2013 and previously spent seven years with Becton Dickinson in a variety of R&D and product development roles.  He is listed as an inventor on 45+ issued U.S. patents and is the author or co-author of more than 20 peer-reviewed journal articles.  Josh holds a B.S. in Chemical Engineering from the University of Florida and a Ph.D. in Chemical Engineering from Carnegie Mellon University. 

Mohammed Irfan Syed is an Associate Director at Formulation Application Services Lab of Evonik at Piscataway, NJ, USA. He currently heads the formulation group, focused on developing novel oral drug delivery systems of immediate, delayed and sustained release products using Eudragit and Eudraguard line of Polymers. During his career, he has held several positions in CRO’s, CMO’s, Generic and OTC organizations and has developed several complex solid and liquid oral modified release dosage forms. Some of his work on oral transmucosal and self-emulsifying drug delivery systems for specific diseases, which has been patented.

He holds bachelor’s in pharmaceutical sciences, master’s in chemistry and PhD in pharmaceutical sciences. During his academic journey he has presented his work on gastro retentive drug delivery systems, nanoparticles/solid dispersion formulations in several scientific organizations. His recent research is on improving solubility of weakly ionic drugs by using the concept of Acid-Base Supersolubilization and its application in development of personalized medication as Immediate release 3D Printed tablets by fused deposition modeling technique. He believes lygometry is the way to grow oneself and as a team.

Kasumi Ito is a R&D scientist of NOF CORPORATION. She has been developing LNP formulations. She has made contributions to the development of mRNA-LNP platform using proprietary ionizable lipids.

Aly Jackson is a Business Development Project Leader within the Pharma Partnering organization at Genentech/Roche. In this role, Aly leads diligence efforts and deal discussions with potential partners to enable collaborations on drug discovery and development. Her primary focus is on platform partnerships, such as those that enable target discovery, lead identification, and drug delivery. Prior to this role, Aly served as a Human Factors Engineer in Device Development at Genentech, supporting the development of combination products such as large on-body injectors, autoinjectors, and pre-filled syringes. She’s also held various roles within Pharma Technical, including manufacturing, regulatory, and MSAT. Aly received her Bachelor’s and Master’s degrees in Bioengineering from UCLA, and her MBA from UC Berkeley. In her free time, she enjoys playing soccer, mountain biking, and traveling the country to explore national parks. 

David Johnston is a career leader in injectable drug and drug delivery product development at Abbott, Baxter and Medtronic. In his various roles in industry, David's teams have delivered IV, epidural, intrathecal and sub-q devices, along with specialized systems for inactivating pathogens in blood products. As a consultant, David has contributed to product development in delivering insulin, monoclonal antibodies, continuous glucose monitoring, and others, along with regulatory process optimizations and design transfer strategies. David is a graduate of the University of Michigan in Biochemical Engineering.

Christian Jones is Chief Commercial Officer at Nanoform, an innovative nanoparticle medicine enabling company. Nanoform works to improve the lives of patients globally by overcoming drug development and delivery challenges through its cutting-edge technologies to NanoImprove drug loading, bioavailability, administration and patient experience for small and large medications.  

Previously, Christian held senior commercial roles at leading CDMOs including Dr Reddy’s Laboratories and Johnson Matthey Plc., and led global business development for Prosonix Ltd, where he helped to transform their offering from a crystallization platform into a particle engineering/drug delivery business, which was later sold for £100 million.  Christian holds a master’s in chemistry from the University of Leeds, UK, and is a Fellow of the Royal Society of Chemistry.

Alexander (Alex) Josowitz is currently a member of the New Technologies Team in the Formulation Development Department at Regeneron Pharmaceuticals Inc. His work focuses on new technologies including formulation, drug delivery and device evaluations for biologics. Previously, Alex earned his PhD in Biomedical Engineering at Yale University under Mark Saltzman, where he tackled drug delivery to the brain from multiple angles. He investigated the use of polymeric nanoparticles to allow for sustained release of hydrophobic drugs in the tumor microenvironment, local infusion systems and techniques such as Convection Enhanced Delivery (CED), and combination therapies between alkylators and DNA-repair inhibitors to lower systemic toxicity associated with high clinical doses. This is Alex’s first experience with PODD and he is excited to be introduced to this growing community that brings together cross-functional experts to address drug delivery challenges.

Dr Kantor is a scientist, entrepreneur, and company builder with over 10 years of experience in the genetic medicines field. He is Senior Vice President and leads Business and Corporate Development at ReCode. Previously, Dr Kantor served as an entrepreneur in residence at Oxford Science Enterprises, where he led company creation efforts and financings for several Oxford spinouts. Prior to Oxford, Dr Kantor was an investment banker with Evercore Partners and a management consultant at Headland Strategy, advising on corporate strategy, M&A, and ECM transactions. Dr Kantor has co-founded multiple companies in the fields of gene editing and RNA biology. In recognition of his technology developments, he was recognized in 2023 Forbes 30 under 30 in Science and Health Care. Dr Kantor graduated from Duke University summa cum laude with a B.S. in bioengineering and finance and received his PhD in Clinical Neuroscience from Oxford University, where he was a Rhodes Scholar.

Mark Kastantin is the Vice President of Manufacturing Technology at Serán Biosciences. His team blends a creative and fundamentals-based mindset with practical problem solving to develop and scale pharmaceutical processes. Additionally, through internal R&D efforts and partnerships with pharmaceutical companies, he works to translate promising new technologies into practice for clinical manufacturing. His work is guided by expertise in nanoparticle drug delivery systems, colloidal and interfacial phenomena, thermodynamics, and the physical chemistry of proteins, nucleic acids, and polymers.

Prior to joining Serán, Mark worked at Lonza (Capsugel/Bend Research – Bend, OR) on bioavailability enhancement and pulmonary delivery technologies and served as an Assistant Research Professor at the University of Colorado Boulder. Mark holds undergraduate degrees in Brain and Cognitive Sciences and Chemical Engineering from the Massachusetts Institute of Technology and a PhD in Chemical Engineering from the University of California Santa Barbara.

With nearly two decades of medical device design experience, Matthew Keiser has driven innovative medical device development in the arenas of orthopedic spine implants and self-administration injection devices. Most recently, he led a large technical team in the development and launch of EMD Serono’s new connected electromechanical autoinjectors. These devices are connected to EMD Serono’s healthcare provider and patient facing software applications and transmitting device related information in markets world-wide. He leads all technical aspects as well as the coordination of regulatory, data privacy, patient training and internal business franchise stakeholder management related to these connected devices. Matt also leads the Industrialization Organization for medical devices within EMD Serono which ensures supply continuity, capacity management and close supplier management of EMD’s medical device manufacturing partners and its internal assembly plants. Matt is part of the leadership team of EMD’s device group and provides strategic directional support and general mentorship to the broader organization. Matt holds a B.S. and M.S. in Mechanical Engineering from Bucknell University and Stevens Institute of Technology respectively.

Elisa Konofagou is the Robert and Margaret Hariri Professor of Biomedical Engineering and Professor Radiology as well as Director of the Ultrasound and Elasticity Imaging Laboratory at Columbia University in New York City. Her main interests are in the development of novel theranostic and therapeutic ultrasound methods for the advancement of therapeutic ultrasound. Elisa has co-authored over 300 published articles in the aforementioned fields. Elisa Konofagou is the Robert and Margaret Hariri Professor of Biomedical Engineering. Elisa is a Member of the National Academy of Medicine (US), an Elected Fellow of the International Society of Electrical and Electronic Engineering (IEEE), the American Institute of Biological and Medical Engineering (AIMBE) and the Acoustical Society of America (ASA). Elisa is recipient of the CAREER award by the National Science Foundation (NSF), the Nagy award by the National Institutes of Health (NIH), the Technological Achievement Award by the IEEE Engineering in Medicine and Biology society (EMBS), the Carl Hellmuth Hertz Ultrasonics Award by the IEEE Society in Ultrasonics, Ferroelectrics and Frequency Control (UFFC), the Janette and Armen Avanessians Diversity Award by Columbia university and the Elisabeth Papazoglou Inspired Leadership Award by Drexel University as well as additional recognitions by the American Heart Association, the Acoustical Society of America, the American Institute of Ultrasound in Medicine, the American Association of Physicists in Medicine, the Wallace H. Coulter foundation, the Bodossaki foundation, the Society of Photo-optical Instrumentation Engineers (SPIE) and the Radiological Society of North America (RSNA). Elisa also serves as President-Elect of the International Society of Therapeutic Ultrasound.

Christopher Kovalchick, PhD, is the Director of Systems Engineering within the Research Development (R&D) organization for Abbott’s diabetes care business, based in Alameda, California. 

He joined the company in 2023 when Abbott acquired Bigfoot Biomedical and has since played a pivotal role leading the Systems Engineering strategy and execution across Abbott’s FreeStyle Libre portfolio including sensor-based glucose monitoring products, as well as their associated applications and cloud software. 

Dr Kovalchick has spent his career developing connected and combination product technologies within several medical device, drug delivery and pharmaceutical organizations including Becton Dickinson and Eli Lilly. He has led development activities from innovation through commercialization across nearly all aspects of diabetes management including glucose monitoring, algorithm development, and closed-loop/open-loop insulin delivery.

Dr Kovalchick earned his PhD in mechanical engineering and his master’s degree in Aeronautics from the California Institute of  Technology, and his bachelor’s degree in engineering mechanics from the Johns Hopkins University.

Mr Kram is an Engineer and pharmaceutical business development professional and is presently the Managing Director for Rommelag Engineering’s US office. For more than 20 years he worked with companies to develop aseptic product fill/finish solutions using Blow/Fill/Seal technology. This work includes container development, clinical trials, regulatory filings, combination device development, primary drug packaging, machine sizing, validation/qualification, and commercial/contract manufacturing. For ten years he has worked to introduce temperature sensitive biotech and vaccine products to BFS technology and has received two foundation grants for the testing of injectable vaccines with BFS technology and CPAD device development. Mr Kram regularly consults and gives presentations to BFS operators, industry groups and regulatory organizations: PDA, ISPE, DCVMN, FDA, Gates Foundation and PATH. He received a B.S. in Electrical Engineering from the Missouri University of Science and Technology.

Uli Kuchenbrod is a distinguished professional with over 20 years of experience in the pharmaceutical industry. With a career that has traversed numerous roles and responsibilities throughout the value chain, he bundles a comprehensive Fill & Finish CDMO perspective. His educational foundation in mechanical engineering, coupled with strategic insights gained from an MBA in Perth, Australia, has equipped him with a robust skill set. Mr Kuchenbrod is deeply passionate about innovation, focusing on packaging and drug delivery systems. His expertise has been instrumental in shaping end-to-end processes and identifying innovation opportunities, always with the needs of both the pharma customer and the patient in mind.

Sindhuja Kuchibhatla is a Senior Manager in the Device Technology & Innovation team at GSK. Her role involves leading new technology developments and innovation processes of complex and emerging combination products to suit the evolving GSK pipeline. Prior to GSK, Sindhuja worked at Regeneron, where she led the New Technologies Management team to strategically enable new drug delivery technology opportunities across key therapeutic areas such as Oncology and Immune & Inflammation. She also spent her early career at West Pharmaceutical Services on their Innovation & Technology team, designing novel connected drug delivery solutions. Sindhuja's background is in Biomedical Engineering. She attended The College of New Jersey for her undergraduate program and Cornell University for her Master’s program.

Dr Parnian Lak has spent years conducting drug discovery research, including at UCSF and as a consultant for Pharma. She has assembled a world-class team of experts dedicated to transforming brain drug delivery. Driven by a passion for scientific innovation, Parnian's vision is to enable the delivery of challenging drugs to the brain, unlocking new possibilities for treating neurological diseases.

Ben Lane is part of the management team at Key Technologies and serves as the company’s VP of Product Development. He has consulted for clients in the medical, industrial, and energy industries for more than 30 years, and his work has contributed to the advancement of precision diagnostic instruments, therapeutic devices, and drug delivery systems across a range of applications and markets. He has managed projects ranging from early-stage technology assessment and product architecture definition to full scope product development, resulting in successful FDA approval and launch. Recent examples include an at-home molecular diagnostics product, a novel large volume drug delivery platform, and a sample-to-answer sequencing instrument. Ben is named on numerous patents in the IVD, MedTech, and drug delivery markets, and has authored several technical articles. He holds an MS in Mechanical Engineering from the University of Pennsylvania and a BS in Physics from Haverford College.

Nigel Langley, Global Technical Director, Life Sciences, Gaylord Chemical Company LLC, provides technical support to the pharmaceutical industry and helps solve drug formulation challenges. Prior to joining Gaylord Chemical Nigel has held various senior technical and marketing positions with BASF and Croda International PLC. Nigel has also worked in Japan and England with Croda. He gained his Chemistry (Hons) degree and PhD (liquid crystals) from the University of Hull (UK) and an MBA from Leeds University (UK). He also took a 2- year Postdoctoral research position at Leeds University (UK) in natural product synthesis. He has over 100 scientific publications and has co- edited 3 books. Nigel is an adjunct professor at the University of Mississippi and a Fellow of the Royal Society of Chemistry (UK). In 2018 he was awarded the Industry Research Achievement Award in Excipient Technology by the IPEC Foundation. He has been a member of the Executive Committee at IPEC- Americas since 2010, Chair (2022/23) and is currently Immediate Past Chair. Nigel is on the Medicine Maker’s Power List for 2020, 2021 & 2022.

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 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 1,800 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 Pauline Lau has worked in the medical industry for 25+ years and has expertise in both pharmaceutical and in-vitro medical device (IVD) product development. She founded Suntec Medical in 2005 to market biosimilars and key pharmaceutical products. Under her leadership, Suntec has successfully registered and exported pharmaceutical products globally. Suntec actively markets its products in pharmaceutical emerging countries. Suntec currently has over 1,500 formulated products from 400 suppliers with an emphasis on biosimilars and advanced formulations. Many of these products are either EU-registered or manufactured under EMEA or PIC/s GMP quality system. Suntec currently has 30+ pharmaceutical products registered for sale or under registration in various countries. We have a distribution channel of 800 customers in 40+ countries.

In 2016, Suntec started to enter the new drug development business. Currently, Suntec is focused on developing a portfolio for treating cancer, neurodegenerative diseases and more central nervous system diseases using “Multi-pathway, Immune-modulating, Nanocomplex, Combination-therapy” (MINC) technology platform.

Dr LeBel is the founder of CPL Bioconsulting, LLC., a consulting firm that assists biotech clients with their corporate and drug development strategies. He also serves as Chief Executive Officer for pacDNA, Inc., a Northeastern University spinout focused on improving the potential of oligonucleotide therapeutics. From 2018-2023 Dr LeBel served as Chief Development Officer for Frequency Therapeutics, Inc., a development stage biotech company focused on treatments for sensorineural hearing loss. Before that he was Entrepreneur-in-Residence and Affiliate Associate Professor in the Bouvé College of Health Sciences at Northeastern University, where he assisted faculty, students, and alumni with forming and guiding their startups. Prior to that Dr LeBel was the Chief Scientific Officer at Otonomy, Inc., from 2009-2017 where he was responsible for all R&D activities focused on discovery and development of biotherapeutics to treat conditions of the ear. Before that he was President and CEO at Akesis Pharmaceuticals, Inc., a public metabolic disease firm. Additionally, he held numerous R&D management positions during a 14-year tenure at Amgen Inc. Prior to that he held pharmacology/toxicology positions at Alkermes, Inc. and Arthur D. Little, Inc. Dr LeBel obtained a BS in Chemistry from the University of Detroit, a PhD in Biomedical Sciences/Toxicology from Northeastern University, and he was a NIEHS postdoctoral fellow in Community and Environmental Medicine at the University of California, Irvine.

Dr Lee initiated his research in the field of sustained-release injectable drugs as a postdoc at the University of Kentucky, College of Pharmacy in the United States in 1995. Since then, for about 20 years, Dr Lee has been involved in the development and clinical trials of various sustained-release injectable microspheres, including the commercialization of Lupron depot generics using either the emulsion process or ultrasonic spray drying process. Based on this experience in developing injectable microspheres, he founded G2GBIO in 2017 and conceived and advanced InnoLAMP technology, a proprietary technology that addresses the limitations of existing PLGA microsphere technologies, such as complex and difficult to mass-produce processes, and issues related to manufacturing microspheres with low bioavailability and high injection site reactions. Dr. Lee has been developing one-month long-acting donepezil and semaglutide microspheres using InnoLAMP technology. Recently, he has expanded G2GBIO’s business from developing its own products to CDO and CDMO services by utilizing its established infrastructure and advanced technology, which enables the manufacturing of microspheres containing more than 50% peptide drugs such as semaglutide and tirzepatide.

John Lewis is the Bird Dogs Chair in Translational Oncology at the University of Alberta in Edmonton, Alberta. As a scientist and serial entrepreneur, he pioneered the use of intravital imaging in the in vivo study of tumour cell invasion and metastasis to discover key targets for cancer therapeutics. Dr Lewis also develops novel nanotechnology, nanoparticle drug delivery technologies, and imaging-based treatments for chronic diseases, such as aging and cancer, as well as for early detection of cancers. Dr Lewis trained at The Scripps Research Institute and received a Ph.D. in biochemistry from the University of Victoria.

Dr Andrew (Andy) Lewis is the Chief Scientific Officer at Quotient Sciences. As the leader of Quotient Sciences' scientific teams and drug development consultants, Andy is responsible for driving efficiency and innovation within our scientific organization, both to better serve our customers and drive growth for the Company. Andy has over 15 years of experience in the pharmaceutical and drug delivery industry and is a member of the Academy of Pharmaceutical Scientists of Great Britain. Additionally, Andy has served on the board of directors of the Controlled Release Society, most recently as secretary.

Prior to joining Quotient Sciences, Andy was Director of Novel Drug Delivery Technologies at Ipsen. He holds a Ph.D. in Tissue Engineering and a Bachelor of Pharmacy, both from the University of Nottingham.

Andrew holds a First Class Combined Honours in Biochemistry and Chemistry and a PhD in Polymer Chemistry from Aston University along with over 34 years in R&D. His early work at ICI led to novel chlorine-resistant reverse osmosis membranes. At Johnson & Johnson, he patented a non-woven polymer fabric, contributing to the success of ob® ProComfort® tampons. From 1996, he developed advanced biomedical polymers at Biocompatibles UK Ltd, culminating in the award-winning Drug Eluting Bead (DEB) Technology, acquisition by BTG, and subsequent acquisition by Boston Scientific where Andrew became a VP of R&D. Andrew formerly was R&D Director at Owen Mumford, leading to the creation of a COVID-19 vaccine autoinjector. He has published 259 peer-reviewed articles, holds 57 patents, and is a Fellow of multiple prestigious scientific societies. As Principal Scientist at Calla Lily Clinical Care, Andrew leads the research and development efforts of the company's novel vaginal drug-device combination products.

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.

Jake has been with Anodyne as co-founder and CEO since its inception in early 2019. He has a unique combination of biomedical engineering experience and entrepreneurial acumen. He holds a B.S. of Biomedical Engineering from Union College and an M.Sc. of Innovation and Management from Tufts University. He couples this experience with leadership qualities developed over a lifetime of team sports to set the direction of Anodyne.

Dr Loudon is a Board certified General and Pediatric Neurosurgeon, with 20 years of clinical and biomedical research experience. Graduate training at NINCDS/NIH and MD Anderson Cancer Institute.

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 Korbinian Löbmann is CSO and co-founder of Zerion Pharma, which was established in January 2019 in Copenhagen, Denmark. He authored more than 120 peer-reviewed publications. Prior to his role in Zerion Pharma, Dr. Löbmann had an appointment as Assoc. Prof. at the University of Copenhagen, Denmark. He received his PhD degree from the University of Otago, Dunedin, New Zealand in 2013.

Hicham Majd, PhD is leading device and packaging innovation in Global Device & Packaging Development (GDPD) at Novartis Pharma AG as Associate Director Science and Technology in Novel Solutions and Technologies and member of TRD Innovation Council. He has received his Master degree in Micro-Engineering and his PhD in Biotechnology and Bioengineering at EPFL, Switzerland and Business Certificate from Babson College, USA.

Mr Majd has a proven track record in technology innovation, with already multiple international patents, scientific publications and one book chapter. During his career, he leads device development in medical and no medical fields from idea to commercialization. Mr Majd developed and managed of novel bioreactor for cell culture that increases by 10-folds cell growth and preserves stem cells pluripotency.

Mr Majd worked at Helbling Technik Bern AG as specialist in bioengineering and material sciences. He founded and managed labseed SA, start-up developing a novel surface treatment for implantable device to improve the biocompatibility and bio-integration.

Dr. Majmundar is a seasoned physician executive with over two decades of experience across the public, private, pharmaceutical and payer sectors, including clinical practice serving in multi-specialty group practice, FQHC,  emergency room and academic settings. She recently served as Chief Medical Officer for a startup commercial health plan and prior to this role served as a medical director for a large managed care organization. She holds dual board certifications in Family Medicine and Health Care Quality and Management. Connect with her on LinkedIn. 

Dr Christoph Marschall is a pharmacist by training, having studied at the University of Heidelberg. His academic journey continued at LMU Munich, where he pursued a PhD in Pharmaceutical Technology. His research, conducted in collaboration with Novaliq Heidelberg, concentrated on ocular drug delivery and high concentration formulations of New Biological Entities (NBEs). After earning his doctorate, Dr Marschall took on the role of Laboratory Head at Abbvie. His responsibilities included container closure system and combination product development. Dr Marschall’s journey then led him to Boehringer Ingelheim, where he currently heads an early-stage pharmaceutical development laboratory. His work primarily revolves around ocular drugs, with a particular interest in sustained release formulations. In addition to his regular duties, Dr Marschall has shown a keen interest in external innovation and partnering. He recently initiated an open innovation call for sustained release ocular formulations, demonstrating his commitment to fostering collaboration in the field. 

Jérôme Marzinski is a seasoned medtech leader, board member and investor in Life sciences, having held a variety of senior roles over a more than 25-year career, with significant experience in scaling and exiting venture capital projects, private equity-funded businesses in the sector, and having completed 15 M&A transactions and raised over €50m of growth capital.  

He is the CEO of OxSonics Therapeutics, a medtech spun off from the University of Oxford, which has developed SonoTran, an ultrasound-triggered drug delivery platform. Early efficacy and safety of the SonoTran was demonstrated in the first feasibility clinical trial run in Oxford, United Kingdom, on mCRC (metastatic colorectal cancer) patients.

Most recently Jérôme was the Interim Chief Executive Officer of Cimon Medical, overseeing the CE mark clearance for the Company’s lead product under new Medical Device Regulations. He is currently the Chairman of Cimon Medical. Prior to this, he spent three years as Chief Executive Officer at Visiometrics (Trade sale completed to a privately held ophthalmic company in the UK), spent six years in senior positions at ev3, and was Chief Operating Officer at Vexim. Jérôme has an MA in corporate financing and accounting from the University of Lille, and in 2012 completed the TRIUM Global Executive MBA, jointly issued by New York University Stern School of Business, London School of Economics and Political Science, and HEC Paris School of Management.

Vince Masciopinto is currently a Customer Solutions Director at SHL Medical, where he is responsible for supporting pharma and biotech customers in the adoption of customized, complex, and bespoke solutions. Vince works closely with business development, product management, and other teams to guide customers in selecting the right drug delivery solution. He brings with him decades of experience in the healthcare industry, having previously worked at companies like Eitan Medical and West Pharmaceutical Services.

Dr. Abhijeet Maurya is a pharmaceutical scientist with a diverse background in product development and process optimization. Currently serving as a Process Development Principal Scientist at Amgen, he is an integral part of the synthetics prepivotal team, focusing on enabling technologies to overcome challenges associated with the dosing properties of complex drug molecules. Dr. Maurya has held key positions at Adare Pharma Solutions and Bend Research and began his career as an ORISE Post-doctoral fellow at the U.S. FDA's Office of Pharmaceutical Quality. He is a member of the Editorial Advisory Board of AAPS PharmSciTech and has published numerous articles and book chapters.

Bryan Mazlish co-founded Surf Bio in 2021 to commercialize a novel drug stabilization technology developed at Stanford University. He joined the life sciences industry a decade ago when a family diagnosis led him to co-found Bigfoot Biomedical, a diabetes-focused medical device company, in 2014. In 2021, FDA cleared Bigfoot’s first product, Bigfoot Unity. Mr Mazlish presently serves as a Board Member of Bigfoot after leaving his role as President in 2020. Prior to making the transition to life sciences, Mr Mazlish led a successful career in quantitative finance, where he managed trading desks at Citi and subsequently founded a fully automated trading company, Overlook Capital. Mr Mazlish graduated magna cum laude from Harvard College.

Bruce McCormick is a visionary problem solver and inventor dedicated to pushing the boundaries of innovation in biotechnology. With a passion for identifying and addressing unmet needs, McCormick has developed novel solutions and holds dozens of U.S. and foreign patents. His inventions have ranged from medical devices with FDA clearance to real-time motion analysis equipment, garment-measuring equipment, insulated insoles, a solar ice-making system, cryogenic phase change material, a range of cutting-edge equipment and software used for vaccine delivery in cell and gene therapy sciences. Some of his products have been featured in Popular Science Magazine, exhibited at the U.S. Patent Museum, and written about in publications like The New York Times.

McCormick is now the CEO of Mercury Bio, where he and his team are working on an advanced drug delivery system utilizing extracellular vesicles from yeast (yEVs). Previously, he was the Senior Vice President of Cold Chain Technologies at BioLife Solutions and President and Chief Technology Officer at SAVSU Technologies. 

Dr Colin McKinlay is the senior director of chemistry and delivery technologies at Nutcracker Therapeutics. He has significant expertise in nucleic acid delivery through his doctoral research at Stanford University with professors Paul Wender and Robert Waymouth. Dr McKinlay’s research involved preparation of synthetic delivery vehicles through organocatalytic ring-opening polymerization; their characterization; and in vitro and in vivo evaluation for the delivery of DNA, RNA, and other biological macromolecules. He holds over five patents and has nine peer-reviewed publications on chemical delivery technologies. Dr McKinlay has led the delivery efforts at Nutcracker Therapeutics since 2018, including the establishment of its unique peptoid-based Nutshell® delivery platform.

Joan Melé, Chief Commercial Officer at Dara Pharma, with Technical Background as Engineer together with master’s in marketing & Sales.

With a working experience of more than 20 years on International Sales Management & business development for Fill and Finish Machinery and Pharmaceutical Process Equipment, has been managing specific market requests in Asia, Middle East, Latin American, North American, Russia and Europe.

Directly involved on Key Accounts needs for Pharmaceutical Process Equipment in a B-to-B market and multilateral agreements between OEM, Devices Manufacturer’s, CDMO and Pharma Industry.

Dr Mendelsohn has served as a member of the Vivani Medical Board and the Chief Executive Officer since the company’s merger with Nano Precision Medical was completed in August 2022. Prior to the merger, Dr Mendelsohn was a co-founder of Nano Precision Medical and its Chairman of the Board and Chief Executive Officer, setting the strategic vision for the company since 2011.

Dr Mendelsohn received his Ph.D. in bioengineering at the UC San Francisco/UC Berkeley Joint Graduate Group in Bioengineering, Class of 2011, during which he was awarded an NSF fellowship to perform research at Kyoto University and published multiple peer-reviewed articles describing new treatment options for Type 1 diabetes through the immuno-isolated transplantation of insulin-producing cells under the direction of Professor Tejal A. Desai. While in graduate school, Dr. Mendelsohn served as the director for the Venture Innovation Program in Life Sciences and completed his certificate in Management of Technology with the Haas School of Business.

Dr Mendelsohn has served as a Technical Advisor to the Alfred E. Mann Institute for Biomedical Engineering at USC, a fellow of the Startup Leadership Program, the President of UCSF’s Graduate Division Alumni Association, and is currently a board member of the Maestro Foundation.

Dr Sreejit R Menon is the Head of Life Sciences Research & Development at Croda Inc., where he spearheads innovative projects in the development of specialty chemicals and ingredients for drug delivery and crop protection. He earned his Ph.D. in Chemistry from the University of Toledo, Ohio, and has built a diverse portfolio of experience through previous roles at BASF, Mitsui Chemicals, and PeroxyChem. His professional background spans several key areas, including dyes and pigments, crop protection chemicals, and pharmaceutical excipients. In addition to his primary responsibilities, Dr Menon serves as a Life Sciences Champion and Industry Partner with the New Jersey Department of Labor (NJDOL), engaging in workforce development and industry collaboration to foster the growth of emerging professionals in the life sciences sector.

A dedicated contributor to the scientific community, Dr Menon has presented his research at prestigious international conferences, including ACS, AAPS, AIChE, and SDC. His work has been published in numerous scientific journals, and he has authored an invited book chapter on the pivotal role of surfactants in biopharmaceuticals. Passionate about sharing his expertise, Dr Menon is committed to driving innovation and supporting the professional development of the next generation of innovators in the field.

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).

George Mihov PhD is a Principal Scientist at dsm-firmenich Biomedical who specializes in Biomaterials and Local Drug Delivery. He obtained his MSc in Chemistry at the Sofia University, Bulgaria, and earned his PhD in Polymer Chemistry and Pharmacy at the Max Planck Institute for Polymer Research in Mainz, Germany. George joined DSM in 2007 as a researcher in the field of medical biomaterials. Since then, George’s work has been mostly focused on degradable biomaterials, local drug delivery, and translation research, where he has over 20 patents and 30 peer-reviewed publications. Some of his notable achievements include his leadership in the technology implementation of TheraPEA biomaterial platform at dsm-firmenich Biomedical, extending the polymer family with tailor-made biomaterials for ophthalmology and contribution to the development of drug delivery concepts for cardio-vascular, pain-management, metabolic disorders, and ophthalmic therapeutic areas. The focus of his current research are long acting injectables and extended release of biologics.

Greg Moakes, an analytical chemist by training, received his PhD in Chemistry from Georgia Tech and later his MBA from Southern Methodist University in Dallas. He started his career working in the specialty materials business, spending time in global procurement, innovation leadership, sales leadership, and business development roles. Dr Moakes has over 15 years’ experience in launching products in the biomaterials, medical polymers, and drug-eluting implant fields. Dr Moakes currently leads commercial activities for the Sorrel wearable drug delivery device platform. He is passionate about partnering with pharmaceutical companies to ensure their combination products give the most intuitive, stress-free experience for patients.

Adi Mohanty is an experienced biotech business leader with a track record of successful product development and approval. He is CEO of Biora Therapeutics, Inc., a clinical- stage biotech company developing smart pill-based therapeutics platforms. Previously, Adi served as CEO of BioTime, a stem cell therapy company. Prior to that, he held several executive positions at Shire, spanning global technical operations, product development, and commercial operations, culminating in the role of President, Regenerative Medicine. He was previously a vice president at Transkaryotic Therapies, which was acquired by Shire PLC. Earlier in his career, he held a variety of management positions in the bioscience division of Baxter Healthcare. Mr. Mohanty received his MBA at Saint Mary’s College, California and he holds a Master of Science in Chemical Engineering from Clarkson 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.

Vidya has over 14 years of experience in the cell and gene therapy field, ranging from R&D, Field Application Scientist, Product Management and Global Strategic Marketing.

She is passionate about transformative and innovative science and in her current role she develops, leads and executes West Pharma’s marketing and communication to ensure a strong presence in the Advanced therapies market.

She works closely with R&D, Product Management and Commercial teams to define an overall product and technology marketing communication that will enable customers to utilize West Pharma’s products and solutions to efficiently get the drug therapy approved and bring to market.

Vidya holds a PhD in Neuroscience and completed her post- doctoral training in Neurogenetics from Harvard Medical School, Boston, MA.

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.

Yoshiyuki Nakagawa, PhD, is an Assistant Manager at Asahi Kasei Corporation. He brings six years of academic research experience in biomaterials (2012-2018), during which time he also served as a Japan Society for the Promotion of Science (JSPS) Research Fellow from 2016 to 2018. Having earned his PhD degree from The University of Tokyo in 2018, he transitioned to a pivotal role in the development and commercialization of an innovative pharma excipient: hyaluronic acid nanogel, Sonanos™, at Asahi Kasei. Leveraging his background in Biomaterials, Polymer Science, and Chemical Engineering, he is passionate about driving advancements in drug delivery technologies.

Namal Nawana is a business leader and Healthcare Investor and Entrepreneur with a particular focus in the Medical Devices and Diagnostics industry. Mr Nawana is the Chairman and Founder of Neoenta, a wholly owned private company with ownership interests and intellectual property assets in healthcare. He is the Executive Chairman and Founder of Sapphiros (www.sapphiros.com) a consumer diagnostics company in partnership with leading global Private Equity firm KKR. He has previously founded or co- founded several medical technology and in-vitro diagnostics companies including Graphene-Dx, Satio and Neoenta Design. He is the author of extensive US and international patents and select peer reviewed scientific articles.

Through his design firm Neoenta Design, he has personally led the design of numerous technologies most recently the blood draw and detection patches and drug delivery and self-vaccination patches that form the portfolio of the Satio corporation.

Before joining Alere, he spent more than 15 years at Johnson & Johnson in progressively senior leadership roles globally, including the role of Worldwide President of Johnson & Johnson’s multibillion dollar DePuy-Synthes Spine business. Mr Nawana is a member of the advisory board of JHPiego, a Johns Hopkin affiliate supporting maternal care in low income countries. He is a past member of the Board of Directors of Hologic, Inc. a Nasdaq listed company, Advamed and separately Advamed -Dx the peak industry associations of the Medical Device and Diagnostics industries and Malaria no More an organization dedicated to the reduction in mortality and eradication of Malaria.

Mr. Nawana holds an undergraduate degree in Mechanical Engineering and a Master’s degree in Medical Science from the University of Adelaide, South Australia, as well as an MBA from Henley Management College.

Brett Newswanger has been COO at ClostraBio since 2021 where he has helped spin the company out of the University of Chicago and build a strategy and team focused on advancing the company's novel nanoparticle drug delivery platform. Previously, Brett spent 9 years at Xeris Pharmaceuticals where, as the first non-founding hire, he oversaw development of the combination product Gvoke HypoPen® (glucagon injection), the first liquid-stable glucagon formulation in an autoinjector for treatment of severe hypoglycemia. Brett was involved in all aspects of Gvoke drug development including CMC, preclinical, clinical, regulatory, human factors and medical affairs, leading to the product's approval by FDA in 2019 (and EMA in 2021, as Ogluo™). Earlier in his career Brett worked at Merck & Co. in bacterial vaccine manufacturing and at GSK in monoclonal antibody manufacturing. He holds a BS in Chemical Engineering from Columbia University and an MBA from the University of Texas at Austin.

Courtney Nicholas Sutton is an Associate Director in Device Development at AstraZeneca where she leads device programs at various stages of maturity and is responsible for leading the technology development strategy. Prior to joining AZ, she led the Combination Product New Technology team at Regeneron. Dr Nicholas Sutton holds a Bachelor’s of Science in Biomedical Engineering from Rensselaer Polytechnic Institute.

Jonathan Nolasco is a Senior Scientist at Novo Nordisk. Mr Nolasco holds a B.S from UC Berkeley (2016) and a Master’s from Harvard University (2020). Although formally trained as a cell biologist, he has worked extensively on developing non-viral delivery vehicles for prophylactic and gene therapy applications. He has worked on delivery vehicles for mRNA, self-amplifying mRNA, circular mRNA, siRNA, and Cas9/sgRNA. Mr Nolasco has worked on several projects ranging from early discovery to clinical. Prior to joining Novo Nordisk, he led a small team in the development of inhalable LNPs for the treatment of Cystic Fibrosis at Omega Therapeutics.

Dr. Alireza Nomani is a Pharmaceutical Scientist with experience in drug and gene delivery using polymeric and lipid nanoparticles (LNP) for cancer therapy, mRNA vaccines, and gene editing. He received his Doctor of Pharmacy in 2003 and earned two PhDs in Pharmaceutical Chemistry and Pharmaceutical Sciences in 2010 and 2021, respectively. Before joining Regeneron and current role in new technology development for biologics delivery, Alireza also experienced two postdoctoral fellowships in non-viral gene therapy and molecular pharmaceutics and worked on projects related to quantitative image analysis, such as quantitative magnetic resonance imaging (qMRI) for theranostics applications. During his more than 15 years of research career, he has also gained extensive experience in macromolecular analytical method development and in-depth characterization of mRNA drug substance, LNPs, protein therapeutics, and long acting injectable manufacturing. Furthermore, his track record of industrial and academic collaborations has resulted in 38+ publications in various reputable journals, such as Science, Biomaterials, Journal of Controlled Release, and US patents.

Dr Derek O'Hagan is currently a Senior Advisor in GSK Vaccines R&D and a Senior Fellow. Prior to Dr O'Hagan’s current role he was the Global Head of Discovery Support and New Technology in GSK Vaccines. Previously, he was VP, Global Head of Vaccine Chemistry and Formulation for Novartis Vaccines. Dr O'Hagan has extensive experience on Vaccine Adjuvants, including R&D on several included in licensed products, and he was a member of the Team that initiated RNA vaccines in Novartis Vaccines (2009). Additionally, Dr O'Hagan is a Fellow of the American Association of Pharmaceutical Scientists. He was awarded the Conference Science medal of the Royal Pharmaceutical Society of Great Britain, and the Young Investigator Research Achievement Award of the Controlled Release Society. Dr O'Hagan was once named as the ‘most inventive scientist’ in Chiron. He proudly has 175 peer reviewed publications (h-index 104, Google Scholar) and has been named inventor on >70+ patents.

Shira Orr is a pioneering force in the domain of drug delivery systems. She has been developing biopolymers for 25 years starting in the Israeli Technology Intelligence unit at the age of 18. Following her military service Shira completed her BSc and MSc - cum laude at Tel Aviv University. Throughout her PhD studies she received the distinguished Kraitman excellence scholarship, followed by a postdoc at Harvard Medical School. Following her postdoctoral work, Dr Orr has gained experience in the pharma industry. Dr Orr believes that the non-lipid bio-polymer based nanoparticles delivery system is the answer to gene therapy and will reshape the boundaries of gene therapy and patient care.

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 15 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.

With 25 years of experience in manufacturing and operations, Jon has a proven track record across various sectors, including drug delivery, medical devices, automotive, and aerospace. At CDP, he leads a team of 20 skilled manufacturing engineers dedicated to advancing product and process development in both the healthcare and consumer markets. The team specialise in delivering sterilised devices ready for design verification testing and clinical evaluation. Jon's expertise in drug delivery encompasses a diverse array of product types, including parenteral and respiratory devices, as well as intraocular and intrathecal delivery systems.

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.

Darren Quinn is the Head of Business Development at BDD Pharma where he leads the global business development and licensing activities.

Darren earned a master’s degree in chemistry from the University of Strathclyde in Glasgow, Scotland, where his industry experience began with a placement as an Organic Chemist at Technologie Servier. He furthered his career at Lonza and Next Pharma, where he specialized in oral solid dosage (OSD) formulation development of BCS Class II and IV molecules.

At BDD, Darren leverages his commercial and scientific expertise to address complex drug development challenges for BDD’s partners and clients.

Nelson boasts over 27 years of experience in groundbreaking technology development, covering diverse areas such as medical devices, drug delivery, semiconductors, and robotics. As a seasoned mechanical engineer, Nelson is passionate about smaller, high-performance/impact companies, contributing leadership in scientific research, engineering, product development, project management, and innovation. With a background spanning design, manufacturing engineering, quality engineering, and R&D, he has built world-class engineering teams. Nelson’s expertise includes successfully commercializing over 12 products, enhancing marketability for previously unfeasible technologies. Holding over 70 patents, his contributions range from diabetes sensing to smart capsule drug delivery.

Karthik Raman is the CEO of Persist AI, a company that seeks to use AI x Robotics to accelerate drug forumulation development. He holds a PhD in Bioengineering from the University of Utah, focused on sustained drug delivery to the brain. Most recently he held an automation lab for synthetic biology. Persist AI is a venture backed company supported by YCombinator, 2048, Innospark and Fellows Fund.

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.

Darren Reid is Director of the Synthetics Enabling Technologies group in Pre-Pivotal Drug Product Technologies at Amgen and is responsible for synthetics Dev-Molecule Assessment and form selection, end-to-end solid state process support, and synthetics formulation development for preclinical and parenteral FIH studies. Before joining Amgen, Dr Reid received his PhD in physical organic chemistry from McMaster University and held Postdoctoral positions at the University of Calgary and Pfizer, developing approaches to assess oxidative stability.  He has co-authored over 30 external articles, reviews, and book chapters, and several patents/applications, including for the LUMAKRAS(R) commercial form. His research interests include drug stability, developability assessment, and formulation strategies. Dr Reid is a founding steering committee member for Lhasa Ltd’s Zeneth drug degradation prediction program and an active member of ACS and AAPS.

Philipp Richard has been with Ypsomed since 2009 in various roles in product and key account management with pharma companies to develop and bring to market innovative self-injection systems. He studied electrical engineering at the Federal Institute of Technology in Lausanne, Switzerland. Before joining the world of medical devices, he has worked in the area of contactless bearing technology for high-speed turbomachines. Since 2011, his main focus has been on defining platform-based product offerings and on implementing customized injection devices with a growing base of pharma customers. As key account manager, he has managed the transition from project to market supply including ramp-up with several autoinjector customers. Ypsomed Delivery Systems continues to focus on the development and manufacture of next generation pens, autoinjectors, patch injectors, smart device technologies and therapy management services.

Prior to joining MedinCell in 2008, Dr Christophe Roberge graduated a PhD in polymer science from a Research Institute (INRS) in Montreal, QC and then held the position of Technical Director in a medical device company, from 2003 to 2008, where he was responsible for scaling-up processes and technical transfer to other sites. At MedinCell, he has been involved in several long-acting formulation development projects including the product UZEDY™ now approved in US. As partnering director in the business development group, Christophe now endorses responsibilities in partnering in the oncology therapeutic area along with scouting drug delivery technologies for licensing/acquisition.

Adam Rock is Strategic Partnerships and Commercialisation Manager at Pharma Latch. Mr Rock’s core interest and expertise is around identifying and evaluating high-value partnership opportunities across the pharmaceutical and drug delivery industry. Prior to joining Pharma Latch, he spent a number of years in a research setting, focused on drug development at various institutes including The Francis Crick Institute in London, UK. Mr Rock holds a Masters by Research (MRes) in Drug Discovery and Development from Imperial College London, and a BSc (Hons) in Pharmacology (University College Dublin).

Chris Rodricks is a Strategic Partnerships Lead in Pfizer Ignite, a new end-to-end developmental and clinical service model for biotech innovators to help advance novel therapies to market. In the past, Chris worked in Strategy and Consulting working across the R&D continuum from idea to launch and has been involved in and led a number of efforts across the drug development value chain from organizational redesign (e.g. creation of a new clinical organization, enabling functions), integration efforts (e.g. Wyeth, Allergan) and unit level strategies (e.g. GTx operations) to productivity analyses (e.g. productivity, metrics analyses, cost per POC), forecasting (e.g. pre-launch milestone forecasting) and competitive analyses linked to overall strategic priorities. 

Chris’s career is fueled by a relentless curiosity and a passion for forging meaningful connections with the extraordinary individuals he encounters. He is a proud alumnus of Stevens Institute of Technology, where he obtained a bachelor’s degree in Chemical Biology, and Rensselaer Polytechnic Institute, where he earned his MBA.

Chris’s personal life is just as fulfilling as his professional one. He resides in Mystic, CT, with his wonderful wife, their spirited son, and two exuberant huskies, who bring joy and a touch of chaos to their home.

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).

With over two decades of experience, Patrick Ruane has significantly advanced sustained release drug delivery systems across various medical fields such as Cardiovascular, Ophthalmology, Gastrointestinal, and more. His expertise is notable in achieving controlled, prolonged release of Active Pharmaceutical Ingredients from biodegradable platforms, benefiting drug-device combination products. Holding key roles at major pharmaceutical companies like Allay Therapeutics, Chrono Therapeutics and CV Ingenuity, he has played an integral part in enhancing patient care and outcomes through his innovations. Additionally, as a skilled physical-organic photochemist, Dr Ruane has contributed to academic and patent literature through his publications. His educational background from prominent institutions like Trinity College Dublin, University College Dublin and others laid the groundwork for his research, particularly his work at The Ohio State University that led to a commercial product for pathogen inactivation in blood products. His expertise successfully bridges scientific research and real-world application, underlining his dedication to scientific advancement.

Steven Russell, MD, PhD is Chief Medical Officer of Beta Bionics, Associate Professor of Medicine at Harvard Medical School, and attending physician at Massachusetts General Hospital. He received a BS in Biochemistry from Trinity University, and a PhD in Biological Chemistry and an MD from the University of Texas Southwestern Medical Center. He completed a residency in Internal Medicine and fellowship in Endocrinology, Diabetes, & Metabolism at the MGH, and a postdoctoral fellowship at the Joslin Diabetes Center. He is an adult endocrinologist and diabetologist with more than 20 years of experience and currently maintains a clinical practice managing diabetes in the outpatient and inpatient settings at MGH on a part-time basis. Dr. Russell collaborated with Dr. Edward Damiano’s group at Boston University to develop a wearable bionic pancreas for automated blood glucose control, testing and refining it over 20 pre-pivotal clinical trials he directed, including in type 1 and type 2 diabetes and cystic fibrosis-related diabetes. He was the Clinical Director for the Insulin-Only Bionic Pancreas Pivotal Trial published in the NEJM in September, 2022. Dr. Russell joined Beta Bionics as CMO in November, 2022. The bionic pancreas, now the iLet Bionic Pancreas system, was cleared for use by the FDA on May 19, 2023. Beta Bionics announced the 10,000th iLet patient start on the August 15, 2024.

Gail Ryan is the Director of Pharmaceutical Transformation at Point32Health.  Point32Health, a health services company serving over 2.2 million lives in the New England area, is the parent company of two legacy organizations, Harvard Pilgrim Health Care and Tufts Health Plan. Dr Ryan earned her BS and her PharmD from the Massachusetts College of Pharmacy and Health Scieånces, and she has almost 20 years of managed care experience with proficiency in clinical pharmacy, medical policy, trend analysis, cost management initiatives, new and emerging technologies, and innovative payment models.

With a comprehensive background in drug delivery sciences and biomaterial design spanning six years, Dr Eileen Sadeghi has developed a strong foundation of expertise in the field. Dr Sadeghi earned her PhD in Chemical and Biological engineering from Tufts University, where her research focused on the design and synthesis of smart polymers, specifically targeting the separation of pharmaceuticals based on their chemical structure. This pioneering work, chemoselective membranes, has been recognized and featured in esteemed journals. Notably, it was acknowledged as one of the "50 discoveries looking forward to the next 50 years of innovation in engineering" by The Bridge 50th Anniversary Issue, published by the National Academy of Engineering in January 2021. Additionally, Dr Sadeghi patented a new approach for fabrication of ultrathin, multifunctional hydrogel selective layers. She was honored to receive the Outstanding Academic Scholarship from the School of Engineering, distinguishing these efforts among all engineering schools. Continuing her pursuit of scientific excellence, Dr Sadeghi embarked on a postdoctoral research position at the Langer lab at MIT. Here, her primary focus revolved around the development of nano/microparticles for vaccines and adjuvants, with the overarching goal of enhancing vaccination strategies. She successfully led two prominent projects funded by the Gates Foundation, which aimed to achieve mucosal immunity through the peripheral administration of adjuvant nanoparticles and the creation of self-boosting vaccine microparticles. Currently, Dr Sadeghi holds a Senior Scientist II position at Abbvie in the Drug Delivery and Biomaterial Department. Her expertise lies in the sustained delivery of small molecules for the treatment of back of the eye diseases. Additionally, she has been spearheading the genetic medicine effort for ocular applications, further expanding my knowledge and proficiency in this rapidly evolving field. Throughout my career, Dr Sadeghi has gained extensive experience in executing innovative drug delivery platforms tailored to a broad spectrum of therapeutics, including small molecules, active biologics such as vaccines, proteins, and neurotoxins, as well as nucleic acids.

Luis Santos, PhD, is currently the Senior Director of RNA & LNP Product Development at Prime Medicine, where he leads a team of scientists and engineers working on developing mRNA and LNP processes, LNP formulation, and drug product development to bring Prime Editing to patients. He also heads cross-functional and CMC teams. Prior to joining Prime Medicine, he held multiple roles of increasing responsibility in AstraZeneca's Biopharmaceutical Development organization. There, he was a team leader with focus on intracellular delivery, drug delivery technologies for nucleic acid and biologics, and technology strategy. He was responsible for mRNA-LNP development programs and was a CMC team leader for early-stage programs. Before that, Dr Santos led the implementation and development of an artificial antigen-presenting cell platform at NexImmune to enable an adoptive cell therapy pipeline. More broadly, he has contributed to several industrial consortia, has published over 40 articles, and holds several patents in drug delivery, process to manufacture, and enabling the development of nanomedicines.

Dr Samantha (Sammy) Sarett is a Senior Director in the Genetic Medicine department at Eli Lilly. In her graduate research at Vanderbilt University, she designed effective and varied strategies for delivery of nucleic acid drugs. She built upon this foundation in postdoctoral work at AbbVie formulating diverse nanoparticle carriers before joining biotech Exicure. Since then, Dr Sarett has concentrated on design and evaluation of approaches to achieve extrahepatic delivery of nucleic acids. In her current research at Eli Lilly, she focuses on driving innovative and meaningful advances in this challenging and high-impact delivery space.

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, medical device, and combination product development professional with a passion for developing and implementing innovative solutions to complex technical, quality, and compliance challenges. His diverse background, including biopharmaceuticals and medical devices, provides a unique, holistic perspective on product development and life cycle management. Dr. Schill’s experience includes early phase discovery, formulation, downstream process development, container closure development and validation, analytical and bio-analytical method development and validation, and preclinical development. He has experience across a wide range of therapeutic products, including blood plasma-derived therapies, recombinant novel biotherapeutics, biosimilars, small molecules, autologous cell therapies, and viral vector-based gene therapies. Dr. Schill provides program, strategy, and technical leadership in the development of combination products and Class I/Class II medical devices, including injection, infusion, reconstitution, nasal delivery, and electromechanical devices. Dr. Schill also provides technical leadership for the development of regulatory and clinical strategies and submissions, external vendor and contract manufacturer management, process and design validation, and device labeling and instructions for use development. Prior to Kymanox, Dr. Schill held positions at Shire, Baxalta, Baxter, and the University of Wisconsin. Dr. Schill holds a PhD in Cellular and Molecular Biology from the University of Wisconsin at Madison and a Bachelor of Science in Natural Sciences from Saint Norbert College where he graduated Magna Cum Laude.

Kevin G. Schmid combines over 23 years of experience in medical device senior management following a 21-year career high technology and high-volume global manufacturing operations. Previously, he had been involved in a number of companies in the medical device, telecommunications, and consumer products industries holding positions including Chief Executive Officer, Chief Operations Officer and board member. From 2018 through June, 2021, Schmid was the Chief Executive Officer for Common Sensing, Inc., a disposable injector pen dose monitoring and reporting technology company and board member since 2015. From 2016 to 2017, he was Vice President of Drug Delivery Systems for the Stevanato Group, a provider of innovative packaging and drug delivery solutions for the pharmaceutical industry. From March 2003 to April 2015, he was Vice President of Manufacturing, Operations, and Drug Delivery Systems for Insulet Corp., a company that designs and manufactures revolutionary, quality of life enhancing drug delivery systems. Schmid is also currently a director of Eitan Medical, an Israel based provider of connected infusion and wearable drug delivery solutions. He has a BSME undergraduate degree from Clarkson University and an MBA from Scared Heart University.

Rob Schulz has over 18 years of multifunctional FDA regulatory experience with 16 years of Management experience and 12 years of Global Quality and Regulatory Affairs experience. Mr Schulz, has hands on experience in Quality and Regulatory compliance for Class I, II, and III, devices including combination, IVD/companion Diagnostics, sterile, software, and implantable products for both design and manufacturing. As a thought leader, Mr Schulz, has leveraged his vast project management, leadership and combination product experience to build effective teams, drive and deliver projects on time and troubleshoot challenges to execute projects.

Academic & Professional Qualifications:

• BS, Biology, California State University, Chico
• Graduate Coursework in Regulatory Science / Quality Systems / Device Regulations, University of Southern California

Training, Quality Systems, & Specialties:

• Regulatory Affairs/Submissions/Strategy
• Quality System Management
• ISO 13485, including completion of audit training
• ISO 14971
• IEC 60601
• ISO 10993
• IEC 62366
• IEC 62304

Kurt Sedo is Vice President of Operations at PharmaCircle, a leading provider of authoritative information, global insight, and expert analysis on the pharmaceutical, biotech, drug delivery technology and device, and animal health industries. Mr Sedo received his B.S. in Chemistry and Mathematics from the University of Wisconsin Stevens Point in 1992. Prior to joining PharmaCircle in 2003, Mr Sedo held various positions within Pharmaceutical Sciences and Analytical Development at Searle/Pharmacia.

Laura Sepp-Lorenzino, Ph.D. joined Intellia Therapeutics in 2019 as Chief Scientific Officer and is responsible for Research and Early Development. Intellia is harnessing CRISPR-based technologies to revolutionize the future of medicine. Laura previously held leadership positions at Vertex, Alnylam and Merck. She serves on the Board of Directors of Taysha Gene Therapies and the Alliance for Regenerative Medicine, and on the Scientific Advisory Boards for Thermo Fisher Scientific, the U.K. Nucleic Acid Therapies and Arsenal Capital Partners. She received her professional degree in Biochemistry from the University of Buenos Aires, Argentina, and both her M.S. and Ph.D. in Biochemistry from New York University.

Lisa Shafer, PhD, serves as Biogen’s Global Head of Product Development and Reg CMC, Medical Devices and Packaging. In this role Dr. Shafer oversees technical packaging design and development, device development and digital integration, lifecycle management, and regulatory engagement and filings, while driving innovation and technology specific to drug delivery and continuously enhancing the overall patient experience. Dr. Shafer brings deep scientific and device expertise in neuro-immunology with more than twenty-five years of experience across the medical device and pharmaceutical industry, most recently as the Chief Scientific Officer at Cerebral Therapeutics. Prior to Cerebral Therapeutics, she was the Chief Scientific Officer, an early-stage biopharma company in neurological disorders. Dr. Shafer has also held various positions with increasing technical and leadership responsibilities at Teva Pharmaceuticals, Upsher-Smith Laboratories, and Medtronic. She also has a wealth of experience building and leading high-performing teams with a passion for developing people. Dr. Shafer is a neuroscientist by training with a Ph.D. from Loyola University Chicago in Neuroscience/Neuroimmunology and a Bachelor of Science from the University of Minnesota in Genetics, Cell Biology and Development.

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 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. He obtained his Ph.D. 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 Ph.D. and 2 MS graduates. Dr Shah 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. Dr Shah has been recognized with achievement awards for leadership and innovation in Pfizer. Jaymin has published 63 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 topical drug delivery, parenteral sustained release (depot), nanoparticles, ophthalmic delivery, and topical formulation development. Currently Dr Shah leads a global biopharmaceutics group providing biopharma risk assessment and strategy for biopharmaceutical aspects for drug development using in vitro performance and PBPK modeling.

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.

Harshal Shah is Head of Device Strategy & Innovation at Sanofi with the responsibilities of setting medium to long term device strategy for Sanofi’s global portfolio of R&D pipeline, driving innovation and IP generation, managing new device technology research and supporting technical due diligences. He has spent 17 years in medical device and drug delivery technology industry in strategic leadership roles. He has BS in Mechanical engineering from Nirma Institute of Technology, MBA in Supply Chain and Finance from Syracuse University, and Post-grad in Cancer Biology & Therapeutic Development from Harvard Medical School.

Milin Shah has more than 14 years of pharmaceutical development and business experience. He has hands-on experience developing many treatments in oncology, virology and immunology for clinical and commercial drug products. Milin has vast experience with modalities such as small molecules, peptides, nucleotides, recombinant fusion proteins and mAbs. He's an expert on nano and complex injectable drug product and process development. Milin is a pharmacist by training and completed his PhD research focused on cancer therapy development with RNA therapeutics and LNPs.

Dr Shanmugam has more than 20 years of experience in designing and development of conventional, NDDS/alternate, advanced/modified drug delivery systems, and pharmaceutical platform technologies for oral and other routes of administration. His expertise includes stability, solubility/dissolution, permeability, and bioavailability enhancement techniques/technologies for challenging drugs. Additionally, Dr Shanmugam has published numerous research articles, holds multiple patents, and is a reviewer/editorial member of various prestigious journals. In his current position, Dr Shanmugam is involved in the development and expansion of Adare's pharmaceutical technology portfolio and facilitates product development and co-development opportunities.

Armon Sharei, PhD, is the Founder and CEO of Portal Biotechnologies, a cell engineering platform company enabling next generation cell engineering and cell analytics across research and clinical applications. The company is implementing a simplified intracellular delivery approach, focused on accelerating advances enabled by the new generation of RNA, gene editing, and molecular design technologies. Armon was previously founder and CEO of SQZ Biotech and led the company from invention to post-IPO with over $300M in equity financing, a $1Bn Roche collaboration and three clinical trials. Armon received his BS in Chemical Engineering from Stanford and his PhD in Chemical Engineering from MIT in the labs of Klavs Jensen and Robert Langer. Dr Sharei has authored 20+ peer-reviewed publications and is the inventor on 20+ patent families. He has been recognized in INC. Magazine’s 30 under 30, Endpoints 40 under 40, and Forbes Magazine’s 30 under 30 in Healthcare.

Michael Sherman is a Venture Partner at RA Ventures. Prior to joining RAVen, Dr Sherman was the Executive Vice President and CMO at Point32Health, formed by the merger of Harvard Pilgrim Health Care and Tufts Health Plan. Prior to Point32Health, Dr Sherman served as CMO of Harvard Pilgrim Health Care, the Corporate Medical Director at Humana and also served as Vice President of Network and Consumer Solutions for UnitedHealth Groups subsidiary Ingenix (now part of Optum). Dr Sherman has also previously held the position of Vice President and General Manager at Thomson Medstat (now part of IBM Watson Health), as well as held 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 is chair of the Board of Managers of the Harvard Pilgrim Health Care Institute. He holds additional board appointments with several well-respected nonprofit organizations, including the Institute for Clinical and Economic Review (ICER), the Personalized Medicine Coalition, the Harvard Business School Healthcare Initiative, NEHI (Network for Excellence in Health Innovation), and the Massachusetts Rare Disease Advisory Council.

With a career spanning ~18 years in the drug delivery space, Gautam is passionate about advancing device technologies to address unmet and hard-to-solve problems in injectable drug delivery. He has authored numerous patents in the injectable drug delivery device space covering ocular drug delivery systems, pen injectors, wearable injectors, autoinjectors and other custom novel delivery systems. Gautam Shetty is the founder and CEO of Congruence Medical Solutions, LLC. Previously, Gautam held leadership and management positions at Unilife Corporation and with Becton Dickinson & Co. (BD). Gautam holds a PhD in Biomedical Engineering.

Tal Sines serves as Biond’s VP BD since 2021 and brings vast experience in business development and Intellectual property skills, working for both pharma corporate and startup companies. Prior to Biond, Dr Sines was senior Alliance Management at CytoReason, where he managed several significant collaborations with 1st tier Pharma companies and was IP project manager for biological products at Teva pharmaceuticals.

Dr Sines holds a PhD in molecular Biology from the Weizmann Institute of Science and is a certified Israeli patent attorney by training.

Peter Skutnik is the Business Director responsible for the BD Medical - Pharmaceutical Systems Advanced Drug Delivery Solutions wearables portfolio and large-volume drug delivery innovation, including the BD Libertas™ Wearable Injector, BD Evolve™ On-body Injector. Mr Skutnik has dedicated his focus on this space for over seven years, and his perspective is backed by 25 years of medtech product development experience spanning from strategic innovation through market introduction in the drug delivery, diagnostics, and interventional segments.

Mr Skutnik received his Bachelor of Engineering in Chemical Engineering and Master of Science in Management degrees from Stevens Institute of Technology.

TBA

Dr Smith’s career is centered on driving scientific innovations to patients. She creates effective teamwork among scientists, entrepreneurs, and legal teams, driving enterprise value. With her assistance, dozens of biopharma companies have raised over $50 MM non-dilutive funding plus licensing and partnership deals. Dr Smith first engaged with Fzata, Inc. in 2016 as a consultant. In 2022, inspired by the world-changing potential of the BioPYM platform, she joined full time as Chief Business Officer to lead fund raising and partnering efforts. She works closely with the CEO to define and execute corporate vision and strategy. Company 2024 highlights: $10MM in non-dilutive NIH funding, FZ002 lead asset will enter phase 1, and winner of “Finalist” at Bio International Startup Stadium. From 2013-2021, Dr. Smith was CEO at SoMax Consulting. While at SoMax she worked with dozens of biotech startups through the Maryland life science incubator system; BioHealth Innovations; Johns Hopkins Univ.; and Univ. of Maryland, Baltimore. Prior to SoMax, Dr. Smith was Associate Director of Technology Search and Development at Celsion Corp., an oncology therapeutics company. Dr Smith earned a PhD in Biochemistry and Molecular Biology from the University of Chicago (1999). An interest in expediting the transition of scientific discoveries to patients led her to a position as project manager at the University of Chicago Technology Transfer Office -redirecting her career to early stage pharma strategic business development and licensing. Dr. Smith earned an MBA from University of Chicago Booth School of Business (2006).

Dr Michael Song leads the Device and Packaging plus Shipping Validation function at Moderna overseeing development, submission, and on-market support activities. Prior, he has held positions as Director of Sterile Packaging at GSK and Associate Director at Takeda. Through Dr Song’s career, also formed and led the Device Functionality, Safety and Digital Connectivity group at AstraZeneca as well as Device, Package, and Process Engineering group at Adello Biologics, a member of Amneal Pharmaceutical. He also has held key engineering lead and toxicology SME positions at Stryker, Kavlico, and other companies. Dr Song holds a BS in Electrical Engineering from Purdue University and PhD in Neuroscience and Toxicology from Iowa State University.

Stephen Spagnol is a Director of Business Development & Licensing, Enabling Technologies at Merck. He leads Search & Evaluation efforts related to Drug Delivery & Formulation, Discovery Vaccines, Vaccines & Biologics Bioprocess as well as Genetic Medicines spanning Cell & Gene Therapy, mRNA/RNA Therapeutics and Gene Editing. Prior to Business Development & Licensing, Dr Spagnol led Research & Development efforts spanning novel and new modality therapeutics including mRNA Vaccines, RNA Therapeutics and Viral Vector Platforms for Cell & Gene Therapy. He has led development of novel platforms for mRNA/RNA drug delivery technologies and viral vector platforms. He has also led formulation and process development including for late stage/Phase 3 clinical programs. He received a Ph.D. in Chemical Engineering from Carnegie Mellon University and a B.S. in Chemical Engineering from the Pennsylvania State University.

Dr. Speaker has worked in various science and engineering roles related to medical devices and drug delivery for the past three decades, accumulating a wide variety of experience and numerous patents and publications. At the startup TransDerm he developed a dissolvable microneedle platform that led to a long-term passion for innovation specific to Global Health and especially the needs of LMIC populations. As the recipient of a Gates Foundation Grand Challenges Exploration grant, he led a team that produced the first demonstration of a microneedle-administered antimalarial CSP vaccine. In his present role at AbbVie, he continues to drive a culture of patient-centered innovation within the Combination Products Development group. Dr. Speaker is also a member of the Microneedle Array Patch (MAP) Regulatory Working Group, part of the PATH Center of Excellence for MAP technology, a consortium of experts that seeks to expedite clinical translation of microneedle patch technology into meaningful patient benefit. He plays various additional roles, primarily advising small companies involved in rapid diagnostic tests and prevention of insect-borne disease, especially as relevant to LMIC.

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.

Sylvain Stamper, R&D System Integration Leader at BD, has over 10 years of expertise in the research, development, manufacturing and commercialization of medical devices, drug delivery technologies and drug/device combination products. As part of the BD R&D Team, Sylvain supports customers in the technical aspects of PFS integration in systems and secondary devices.

Before joining BD in 2020, Sylvain worked at Baxter and Nemera, where he was accountable for the development, launch and lifecycle management of combination products, including autoinjector platforms, insulin pens, powder inhalers, and I.V. sets.

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 injectable medicines for the treatment of chronic and site-specific diseases. At InnoCore he heads the development of InnoCore’s bioresorbable polymer-based LAI 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 multiblock 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 medical devices and tissue regeneration products in the fields of peripheral nerve repair and general surgery. He holds a PhD in Pharmaceutical Technology and Biopharmacy and a MSc degree in Polymer Sciences, 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 Prof. of Pharmacology & Toxicology at the University of Louisville (UofL). Dr Steinbach-Rankins joined Boehringer-Ingelheim in May 2022, after holding a tenured Associate Professor appointment in Bioengineering for 8.5 years. Her academic research focused on the development of polymeric nanoparticles, electrospun fibers, and 3D-bioprints as new multipurpose delivery technologies to enhance delivery and treatment for cancer, viral, and bacterial applications, to the female reproductive tract and oral cavity. In industry, she now investigates a variety of external technologies, focused on drug delivery, predictive capabilities, and novel platforms to support Research & Development. She received her Bachelor’s degree in Materials Science Engineering from the University of Illinois Champaign-Urbana, and Master’s degree at Arizona State University (ASU) while working full-time in industry. She earned her Ph.D. in Bioengineering (ASU) and was fortunate to conduct her Postdoctoral training at Yale University. During Dr Steinbach-Rankins’ career, she has been honored to receive more than 22 scientific/leadership awards, ~50 domestic/international research awards earned by her trainees, multiple NIH R01, R21, and other funding opportunities. She currently serves as co-Chair of the Skin and Mucosal Delivery Focus Group (SMD) and is co-leading a new industry team focused on bridging academic-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.

Eric Sugalski has over two decades of experience developing novel devices for pharmaceutical and medical device applications. His cross-functional experience spans engineering, human factors, regulatory affairs, and commercial strategy. Eric has led teams in the development of novel autoinjectors, pre-filled syringes, infusion pumps, inhalers, and novel drug delivery technologies. He holds a B.S. in mechanical engineering from the University of Colorado and an M.B.A. from MIT.

Kanika Suri is dedicated to developing and advancing creative, efficacious, and patient-compliant therapies to alleviate patients from debilitating conditions. With a strong focus on overcoming barriers to drug delivery for oral, topical, and parenteral routes of administration, she has established herself to lead the CMC development of pipeline drug products at Takeda. Leveraging her experience in research and development, Dr Suri brings a unique perspective to devising patient-centric pragmatic solutions. She is pursuing a PhD in Bioengineering and holds a Master's in Chemical Engineering from Carnegie Mellon University. Dr Suri's passion for ideation and her staunch advocacy for Women in STEM further underscore her commitment to driving excellence in the field.

Dr Shankar Swaminathan is an associate director at Astellas Institute of Regenerative Medicine leading drug product development and technical transfer activities for multiple preclinical cell therapy candidates. Dr Swaminathan obtained his doctoral degree in pharmaceutics focusing on creating new polymer-based drug delivery formulations for cancer nanomedicine. 

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 investigator, he obtained independent grant funding for supporting his ideas before successfully transitioning to the biopharmaceutical industry. Dr Swaminathan led 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 submissions and validation. He is currently supporting multiple cell therapy projects, including immuno-oncology modality from development through GMP technical transfer and manufacturing. 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.

Ms. Tharby has served as the Koru Medical System’s Chief Executive Officer and President since April 2021. Ms. Tharby has over 25 years of executive leadership experience building and leading strong-performing global organizations that develop and commercialize products and service innovations while delivering solutions to patients in the home setting. Prior to joining Koru Medical Systems, Ms. Tharby spent 24 years with Becton Dickinson (“BD”). Ms. Tharby was a member of the Executive Leadership team of BD that transformed the company from an $8 billion medical supplies company to an $18 billion global medical technology company. During her time at BD, she held numerous global business leadership roles at BD, including Chief Customer Experience Officer, Chief Human Resources Officer, Executive Vice President and President of Life Sciences, Group President of Pre-Analytical Systems and Biosciences, Worldwide President of Diabetes Care, and Vice President/General Manager of Pharmaceutical Systems. Ms. Tharby has an Honors Bachelor of Business Administration from Wilfrid Laurier University in Waterloo, Ontario, Canada.

Richard (Rich) Tillyer, Ph.D., is Global Head of the Johnson & Johnson Discovery, Product Development & Supply (DPDS) organization within Innovative Medicine Research & Development (IM R&D). He is also a member of the IM R&D Leadership Team, the Johnson and Johnson Group Operating Committee and serves as the R&D Executive Sponsor for the Scientist Mentoring & Diversity Program within IM as part of his strong belief in the importance of diversity in science. 

As the head of DPDS, Dr Tillyer leads a global team of multi-disciplinary scientists – drug hunters, drug developers and clinical supply experts – who work end-to-end to invent transformational therapeutics and optimal manufacturing processes.

Johnson & Johnson’s DPDS organization targets the hardest-to-treat diseases, inventing novel therapeutics with a modality-agnostic strategy using small molecules, proteins, RNA, cell and gene therapies. Its purpose is to be the fastest at advancing the best concepts, regardless of source, into a differentiated product, with the best conceivable manufacturing process and product at launch. DPDS partners seamlessly with a range of internal and external stakeholders to deliver on this commitment across all therapeutic areas. 

Dr Tillyer joined Johnson & Johnson in 2018 after 25 years at Merck where he led large and varying aspects of Merck Research Labs, including Process Chemistry, Toxicology, Drug Metabolism and Pharmacokinetics, Formulation, Biologics and Vaccines Process Development, High Throughput Screening, Discovery Biology, Medicinal Chemistry, Computational Chemistry and various platform groups.

Dr Tillyer earned a Ph.D. in chemistry from the University of British Columbia, Canada, completed a post-doctoral research fellowship in chemistry from the University of Cambridge, UK, and earned a bachelor’s degree in chemistry from the University of Exeter, England. He is a subject matter expert in synthetic chemistry, has published more than 70 scientific articles and publications, and holds several patents.

Tim Tracy is a clinical pharmacologist 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. Prior to his work with Triastek, he served as CEO of Aprecia Pharmaceuticals, a 3D printing pharmaceutical company.

Paul Upham is the Global Head of Smart Devices at Roche / Genentech. Paul has 20+ years of experience in medical device R&D, strategic marketing, product management, clinical research, and medical informatics. Prior to Roche / Genentech, Paul was with Becton Dickinson(BD), as Worldwide Director of Strategic Marketing in their Pharmaceutical Systems business.

 Mr Upham was also the head of Product at WellDoc, Inc., where he led the product management activities for WellDoc’s portfolio of mobile health solutions. He was responsible for WellDoc’s landmark BlueStar™ product, a class II medical device and the world’s first reimbursed, prescription-only software for diabetes.

 Mr Upham’s prior experience includes 10 years in BD’s Diabetes Care business. Mr Upham was responsible for the award-winning BD InterActiv® Diabetes Software, and was a member of the BD / Medtronic team that launched ParadigmLink®, the world’s first wireless blood glucose meter.

 Mr Upham holds four issued patents in medical software and drug delivery devices and has multiple patent applications. He is also an author of numerous peer-reviewed articles in medical informatics and diabetes. His education includes undergraduate studies in cognitive science and graduate work in health informatics and finance at the University of Minnesota and New York University.

Dr Stella Vnook is a distinguished pharmaceutical executive, serial entrepreneur, highly respected CEO and founder of multiple biotech companies and visionary leader with a proven track record of success in the biotechnology and life sciences industries. With over 25 years of experience, Dr Vnook has played a pivotal role in shaping the future of Companies, such as Merck and Co, Jazz Pharmaceuticals and Catalent, and small start-ups through her leadership, innovation, and commitment to advancing medical science.

Dr Vnook's journey in the biotech industry began with her groundbreaking research in molecular biology and drug discovery research at Temple School of Medicine Emergency Medicine. Vnook earning her a Doctorate in Public Health/ Healthcare Economics, as well as Degree in Pharmacy specializing in Pharmacology and Oncology, Master of Business Administration focusing in Global Marketing in addition to her portfolio of degrees in Biology, Anthropology and Mathematics. Her passion for translating scientific innovation into tangible therapeutic solutions led her to found her first biotech startup, MaiCell and later NAKI Therapeutics, where she served as CEO and Founder and Diverse Biotech BioSciences where she served as CEO.

As a CEO of Likarda, Vnook is poised to propel the company to new heights by leveraging her extensive experience and innovative vision. Under her leadership, Likarda aims to expand its presence in the biotech industry by pioneering groundbreaking solutions in cell therapy and regenerative medicine.

Chung-Hsin Wang holds a Ph.D. in Biomedical Engineering from Tsing Hua University and has over 15 years of experience researching lipid-based ultrasound contrast agents and ultrasound imaging and drug delivery technologies. Dr Wang is the founder of Trust Bio-sonics, which currently has several new drug candidates, including a next-generation diagnostic ultrasound contrast agent (in Phase III clinical trials), targeted/molecular ultrasound contrast agents, and an ultrasound drug delivery platform designed to enhance conventional chemotherapy and immunotherapy for wide-range oncology applications.

Trust Bio-sonics aims to provide comprehensive medical solutions from early diagnosis to treatment throughout the patient care cycle, helping patients access treatment more quickly and return to a fulfilling life.

Dr Kenneth Waterman received his B.S. degree with honors in Chemistry from UCLA, his Ph.D. in Physical Organic Chemistry from UC Berkeley and conducted post-doctoral studies in physical and photo-chemistry as an NIH Research Fellow at Columbia University. Dr Waterman’s distinguished career includes 12 years as a scientist at Polaroid working to develop imaging products, and 13 years as a Research Fellow at Pfizer working on drug stability, drug delivery, biopharmaceutics and prodrugs, before founding FreeThink Technologies, a laboratory and software company with unique expertise in stability, packaging and formulations. In addition, FreeThink produces and licenses its advanced accelerated stability software, ASAPprime®. He is an AAPS Fellow and the author of over 75 publications/patents.

Andre Watson is a nanoscientist and biomedical engineer, inventor, founder, and CEO of Ligandal Inc. His life’s mission is to create precision, personalized, curative, and preventative medicine with global impact and potential that can address underlying disease states of some of the world’s most difficult-to-treat diseases. During his undergraduate research at Rensselaer Polytechnic Institute, he developed a gene editing delivery technology for shuttling technologies such as CRISPR into specific cell types. He subsequently founded Ligandal in 2014 to develop and commercialize cell-, tissue- and organ-specific drugs and gene delivery systems; more recently, much of this focus has shifted towards AI prediction of binding agents (ligands). He is an inventor on 80 pending patents globally across 16 patent families (21 approved, 7 allowed), and is listed on Forbes 30 Under 30 for Healthcare (2021).

Molly is currently the Chief Operating Officer at ApiJect where she leads the development of their platform of BFS based products. Molly’s 15 years of experience in medical technology engineering and leadership includes serving as Vice President for Containment Systems & Portfolio Management at West Pharmaceutical Services. Prior to West, she was VP of Quality & Regulatory and Chief Compliance Officer at Unilife Medical Corp. At Becton Dickinson’s Medical Surgical Systems, she spent three years as Principal Engineer, analyzing new business opportunities and leading a new concept development team. Molly has a B.S. in mechanical engineering from Brown University and a PhD in mechanical engineering materials science from Duke University, where she was a founding member of the Nanooptics Laboratory.

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, CEO at Nanexa since 2015, 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. Mr Westberg 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.

Will joined Zephyrus as COO in 2020. Prior to this, Will was CEO of a direct-to-consumer business, The London Sock Company. He began his career as a management consultant for Accenture where he advised a number of clients on Technology Transfer Programmes. Over the course of his career, Will has held a number of Senior roles focussing on strategy, estimation, planning and delivery with a wide variety of clients including Deutsche Bank, BBC, Thales, and BT. Will studied Natural Sciences at Bath University and went on to study law at University of London.

Benjamin Winkeljann is an engineer and entrepreneur, specializing in the development of drug delivery systems for RNA delivery and the optimization of pharmaceutical processes. He conducted his PhD in bioengineering within the Technical University of Munich’s Munich School of Bioengineering. Following a short postdoctoral phase at the same institution, he shifted his focus towards pharmaceutical technology by accepting a postdoctoral scientist position at the Ludwig-Maximilians-University Munich's Department for Pharmacy. Here, his work concentrated on simulation-assisted optimization for the formulation of RNA therapeutics. In 2023, he advanced to become a Group Leader and started pursuing a University Lecturer Qualification in Pharmaceutical Technology and Drug Delivery. In the same year, Winkeljann co-founded RNhale GmbH in Munich, where he currently serves as CEO. He is also a Principal Investigator at the Comprehensive Pneumology Center Munich (CPC-M), German Center for Lung Research (DLZ), Munich.

As leader of the Pharma Development Team, Mr Wojcik is responsible for overseeing the successful completion of client development projects, from lab-scale early phase through late-stage development. In addition, he manages client engagement and provides support for combination device programs, including non-GMP feasibility, drug product formulation and compounding, and business planning to help clients achieve their goals.

With over 17 years of experience in drug development and delivery, Mr Wojcik specializes in formulation, tech transfer, fermentation, purification, sterile-filtration, and product development in Blow-Fill-Seal (BFS) aseptic packaging technology. He is considered a Subject Matter Expert at ApiJect and has played a role in designing and building an automated particulate inspection machine for the company’s novel drug delivery device for sterile injectables. He supported the launch of a new BFS Research & Development center and managed contract manufacturing organizations for their part in manufacturing and packaging.

Dr Christopher P Worrall joined Nanoform as the Vice President of US Business Development in May 2021. He is an expert in the area of crystallization and physicochemical modification, having spent the last 15 years specializing in the pharmaceutical solid form, including 13 years with Pharmorphix. Dr Worrall has been involved in the development of 11 commercial pharmaceutical products and is an inventor on numerous patents in the areas of liquid crystals, organic semi-conductors, and pharmaceutical solid form. He has previously held business and scientific positions at Johnson Matthey, SAFC and Merck KGaA.

With more than 25 years of experience in med tech and pharma, Dr Justin Wright currently serves as VP of Device, Packaging, and Process at Gilead, where he is responsible for leading the product system strategy and development activities for Gilead’s portfolio of biologics and small molecules. Before joining Gilead, Dr Wright led enterprise innovation and Connected Health development at Novartis, helped launch, and then led Lilly’s Cambridge Innovation Center, tasked with building Lilly’s next-generation delivery and connected product systems. In prior roles, Dr Wright worked at BD, where he served various roles focused on developing and commercializing drug delivery systems for the biotech, vaccine, and pharmaceutical industries. He began his career at Merck & Company, working in manufacturing, product commercialization, and franchise management. Dr Wright holds a PhD in Bio-Organic chemistry from Clemson University and completed a research fellowship at Harvard Medical School. He is the author of more than 50 patents and publications.

TBA

Liping Zhou, PhD, is currently a senior director at AstraZeneca Boston R&D center. She is heading the new modality formulation development and delivery science team, developing preclinical and clinical formulations and supporting AstraZeneca internal pipeline projects as well as external collaborations. Dr Zhou has 20 years of post-PhD technical and managerial experience in research and development functions in the biotechnology/pharmaceutical industry. She has diversified expertise especially in pre-formulation, formulation development and drug delivery technologies focusing on peptides, nucleic acids and small molecule drug candidates. She has been actively involved in preclinical and clinical programs, life-cycle management and due diligence projects in multiple therapeutical areas as well as efficiently and strategically managing external collaborations in the US, Europe and Asia. Dr Zhou’s previous employment includes but not limited to Novartis, Ipsen, and Ra Pharmaceuticals (now UCB). She co-authored more than 20 scientific publications in the leading biomedical journals and book chapters.

Dr Zhou received her Ph.D. degree in Chemistry from University of Connecticut and her bachelor’s degree from Peking University.