Dr Stefanie Johns brings over 12 years of comprehensive regulatory experience across medical devices, pharmaceuticals, biologics, and combination products. Stefanie has provided strategic global regulatory guidance from concept through commercialization and life cycle management. Previously, Dr Johns served as Chief Scientific Officer at Hoth Therapeutics where she contributed to the invention and development of several therapeutic drug and diagnostic products. Dr Johns served as Director of Regulatory Affairs at Enable Injections, a device-constituent part developer and manufacturer of large-volume on-body infusion systems. As Scientific and Regulatory Manager at Camargo Pharmaceutical Services, Dr Johns provided strategic guidance on over 20 different drug-device combination product programs spanning therapeutic divisions at CDER and CDRH. Early in her career, Dr Johns assisted with the Integrity of Supply Initiative including members of the FDA and Senate HELP Committee Staff as the Program Manager of Xavier Health Initiatives. Dr Johns, graduated from the University of Cincinnati College of Medicine with a Doctorate degree in Molecular Genetics, Biochemistry, and Microbiology. She graduated from the Wright State University magna cum laude with a Bachelor’s degree in Biological Sciences.

Eduardo Jorgensen studied medicine, with special interest in Neurosurgery until a young girl with diabetes refused to keep injecting insulin because she had a poor quality of life. He then moved from the clinical path to medical innovation, creating 3 products for chronic diseases and obtaining recognition as the Spanish innovator of the year by MIT or the Forbes 30 under 30. He spends his free time in music festivals and taking care of two Sulcata Tortoises.

Rasmus Just joined Novo Nordisk in 2022 as Vice President, Device Innovation. In this role he is overall responsible for research and innovation activities to support future delivery solutions. Before Novo Nordisk, Mr Just held various leadership positions within the medical device industry. He has worked within MedTech innovation and development, helping people with intimate healthcare needs, developing a broad range of devices from single use disposables and electro-mechanical durables to implants and surgical instruments. Mr Just holds a MSc in Applied Mechanics and an eMBA in Management of Technology and serves as an external examiner at several universities and research institutions.

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

For the last 35 years, Ramesh Kashi has been involved in the development of diverse biologics drugs and modalities including Clotting Factors, Autologous Cancer Vaccines, Targeted Radiotherapies, Checkpoint Inhibitors, Antibody Drug Conjugates, Monoclonal and Multi-Specific Antibodies, Gene Therapies etc. He has held scientific leadership and advisory positions in large pharma, mid-sized biotech, start-up companies and was involved in development of three marketed therapeutic protein medicines for the treatment of cancer, auto-immune and hemophilia. He is passionate about evaluating external innovation and technologies and internalizing them for the development of high concentration protein formulations to enable delivery of large doses by subcutaneous route of administration.

Bo Kowalczyk has an extensive career spanning more than 25 years in the biopharmaceutical industry encompassing the entire spectrum of pharmaceutical drug development, and currently serves as the Chief Commercial Officer. Mr Kowalczyk brings a wealth of expertise to ApiJect and is spearheading the company’s efforts to develop and commercialize its injectable drug delivery technology platform. Prior to joining ApiJect, Mr Kowalczyk was the Vice President of Sales, North America, at Syngene International's Chemical Development and Manufacturing division. He skillfully aligned operational excellence with targeted prospecting, identifying optimal business opportunities and enhancing client satisfaction. As Global VP at Eurofins Biologics Bioanalytical Services, Mr Kowalczyk's leadership seamlessly integrated services crucial for clinical trial logistics and sample testing support by merging Bioanalytical Services with Eurofins Central Lab Services. He served as Vice President, Business Development and Marketing at AIT Bioscience, where he achieved remarkable sales and profitability growth over five years. Notably, he established a network of third-party preclinical toxicology service providers, strategically positioning AIT Bioscience for early access to promising therapeutic candidates transitioning into clinical trials and future commercial launch. Mr Kowalczyk's client-centric, solution-oriented approach to business development with a robust network in the drug development industry to connect sponsors with service providers have solidified his industry reputation.

Nagisa Kobashi joined SHL Medical as a Product Manager of Digital Health, working cross-functionally with the global emerging technologies and digital health teams, as well as with the global product management team. In this newly created role, Ms Kobashi leads product strategy for SHL Medical’s digital health solutions and oversees leading customer projects based on the company’s emerging digital health platforms. She has a master’s degree in Human Movement Sciences from the ETH (Zurich, Switzerland) as well as a Swiss Federal Diploma as a marketing expert.

Andrew Kroetsch is an Associate Director at Takeda responsible for leading business development for CMC. He represents CMC on due diligence teams with the scope of evaluating external opportunities, and builds teams to conduct confirmatory diligences. The range of his work spans all modalities and therapeutic areas of interest to Takeda. Prior to joining Takeda, Dr Kroetsch was a technical lead in CMC for C> compounds at Sanofi. There he was a drug product leader for key programs in the rare hematology and oncology spaces. He obtained a PhD in Chemical Engineering from the University of Buffalo with a dissertation in antibody engineering, and a BS in Chemical Engineering from the University of Delaware with a thesis studying protein aggregation.

Michael LaBarre has over 28 years of experience across all aspects of biopharmaceutical research and drug development. Dr LaBarre joined Halozyme in 2008 and has held leadership positions in product development, alliance management, research, and regulatory affairs during that time. He is currently Senior Vice President, Chief Technical Officer providing technical leadership across all Halozyme programs and is the lead expert on Halozyme’s ENHANZE® drug delivery technology. Previously, Dr LaBarre served from 1995 to 2006 in various research and development positions at IDEC, later Biogen Idec, where he was involved in numerous IND and BLA submissions, including those for the commercial products RITUXAN® and ZEVALIN®. Dr LaBarre began his career at Hybritech in San Diego in 1992 and taught chemistry laboratory for several years as an adjunct professor at Mesa Community College earlier in his career. Dr LaBarre received his BS in Chemistry from Southampton College of Long Island University and his PhD in Chemistry from the University of Arizona.

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