Micromachines, Biologic Approaches and New Tools Pushing the Boundaries in Oral 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.

Ludwig Erik Aguilar, PhD, is a researcher and expert in the field of Biomaterials and Nanotechnology with a profound passion for advancing medical technologies. Growing up in the Philippines, he pursued his BSc in Nursing at Bulacan State University, which laid the foundation for his deep understanding of the healthcare industry. Driven by an insatiable curiosity, Dr Aguilar pursued further education in South Korea, obtaining his MSc and PhD degrees in Bionanosystem Engineering from Jeonbuk National University. Throughout his academic journey, he focused on the design and synthesis of cutting-edge nanobiomaterials, including nanoparticles, nanofibers, and nanocoatings, primarily for drug delivery and medical device applications. His research has been recognized by the scientific community, with over 20 peer-reviewed academic papers and an internationally published scientific textbook titled “Biomaterial Science, Anatomy, and Physiology Aspects.” Leveraging his clinical and biomaterials background, Dr Aguilar possesses invaluable insights into the development of biomaterials that are both safe and highly effective when deployed within the human body. His expertise led him to serve as an Assistant Research Professor at Jeonbuk National University, where he also taught anatomy and physiology at the graduate school of engineering. Currently, Dr Aguilar holds the position of Senior R&D Engineer at Novo Nordisk A/S, where his research is dedicated to revolutionizing drug delivery devices.