Orally Ingestible Devices for Biologics Delivery

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.

Karsten Lindhardt has more than 20 years of experience from the pharmaceutical industry (the last 12 as an executive). He is the CEO and founder of Biograil developing a drug delivery device for effective oral delivery of biomacromolecules. Mr Lindhardt managed spin off Biograil from Egaletafter securing Seed funding from a strong syndicate of experienced investors. Mr. Lindhardt started to explore this technology with his team when he was CSO of Egalet where he was also part of the executive management team making a successful IPO on NASDAQ NYC. Mr. Lindhardt and the team were responsible for the world’s first injection molded oral product Arymo ER to FDA Approval. Through his career Mr. Lindhardt has worked in various biotech and pharma companies (Egalet, Curalogic, Prosidion, Ferring and Novo Nordisk) and has been involved in API upscaling,formulation development, pre-clinical screening and toxicology, phase 1, 2 and 3 clinical development, NDA, approval and launch, and business development pitching various technologies with great success. He was the main driver of initiating the Category 1 focus group working on behalf of the pharmaceutical industry to improve methodologies to evaluate abuse deterrent technologies and has participated in several FDA hearings as representative for the industry.

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

Chris Wahl, MD, MBA is Vice President of Strategy and Operations at Progenity, Inc. in San Diego, California. He has spent over 16 years in the pharmaceutical and biotech industries covering small molecules, biologics, combination products, devices and diagnostics. At Progenity, Dr Wahl leads a cross functional group that is responsible for the development of multiple drug device combination products. For the last 5 years he has focused on the development of ingestible medical devices for the oral delivery of therapeutics.He joined Progenity following Chief Operation Officer positions at two companies that developed the underlying technologies that are the focus of Progenity’s ingestible device platforms. In previous roles at McKinsey & Company and Merck, Dr Wahl has worked on product strategy, development and commercialization, sales and marketing, patient compliance and organizational structure. In addition to his current focus on gastrointestinal diseases, Dr Wahl has experience in oncology and cardiometabolic, neurologic, infectious and rheumatic diseases. Dr Wahl is an inventor on over 150 US and international patents and patent applications and holds an MD and an MBA from McGill University.