Gina Schweizer is Vice President, Head of Strategy, Operations and Analysis & Reporting at Genmab. She oversees integrated functions including Medical Writing, Programming, and Development Operations Strategy & Execution, with a focus on driving excellence across clinical development, having a leadership role or contributing to more than 20 original and supplemental health authority submissions leading to drug approvals in her career. With 25 years of experience at Merck, Janssen, and Genmab, Gina brings deep expertise in Regulatory Affairs Operations, Medical Writing, Trial Disclosure & Transparency, clinical trial processes, and global submission planning and execution. Since joining Genmab in 2018, she has built and scaled a global Medica Writing and Clinical Trial Disclosure & Transparency organization and played a key leadership role in the approvals of TIVDAK and EPKINLY. Gina is enthusiastic about leading high-performing, purpose-driven teams and fostering a culture rooted in accountability, inclusion, and innovation. Her strategic mindset and operational leadership are guided by the mantra, “Anything is possible,” which inspires her approach to transforming complex challenges into scalable solutions.

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

Dr Stefan Yohe is an Associate Research Fellow at Pfizer within Pharmaceutical R&D, where he and his team focuses on the development of ADCs and drug delivery innovation. Stefan joined Pfizer in 2023, with prior roles at Seagen, Genentech, and Bayer. He has 15 years of experience in drug product development, delivery and device technology innovation, and material science.

Dr Yohe is an author or co-author on 20 peer-review journal articles. He received his PhD in Biomedical Engineering and Pharmacology from Boston University, and a BS in Material Science and Biomedical Engineering from The Pennsylvania State University.

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

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

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

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

Azia Tariq is a Senior Manager in Clinical Trial Analytics & Visualization at Genmab. At Genmab, she is leading the efforts for GenSignal and other applications by providing digital solutions to support clinical development programs in the efficient and timely review and analysis of clinical and operational data. She has previously worked in various roles in analytics, programming, and clinical development at BMS, AbbVie, GSK, Merck, and Mount Sinai Hospital. She holds an MPH in Epidemiology from New York University and is a certified PMP.

Charlie Semenchuk is the Head of Business & Technology Capabilities for Global Clinical Development Operations at Jazz Pharmaceuticals. He currently oversees a number of functions within GCDO covering technology, data innovation, analytics, and various business functions such as TMF Operations and Learning & Development. Charlie has spent over 20 years working in the pharmaceutical development space, specializing in the intersection of science and technology. With experience at sites, technology service providers, industry consortiums such as TransCelerate, and sponsor companies both big and mid-sized; he has a wealth of knowledge and experience from all sides of pharmaceutical development with a passion for the advancement of innovative medicines.

Amanda Baer, MBA, has been at Penn for 17+ years and has broad experience in a diverse range of therapeutic areas. She has extensive experience managing phase I—IV clinical trials and leads a highly productive DOM Clinical Trials Unit consisting of research project managers, coordinators, assistants, and regulatory manager. She has served on the Penn IRB as well as on numerous advisory committees and task forces to improve clinical research and human subjects protection. She brings her entrepreneurial spirit to the team and specializes in Research Operations, Strategy, Process Improvement and Mentoring.

Gavin Corcoran is the Chief Development Officer at Formation Bio. He is a board certified infectious disease physician and leads the development organization that provides the medical and scientific input to all aspects of drug development at Formation Bio, from product licensing to regulatory approval. Prior to joining Formation Bio, he held several senior leadership roles including CMO at Allergan and Stiefel. He attended medical school at the University of the Witwatersrand in South Africa and internal medicine/infectious diseases training at the University of Texas Health Sciences Center in San Antonio, TX where he was on the faculty prior to joining the pharmaceutical industry over 20 years ago.

Scott Gottlieb, MD, is a physician and served as the 23rd Commissioner of the U.S. Food and Drug Administration. Dr Gottlieb is currently a senior fellow at the American Enterprise Institute for Public Policy Research and a partner at the venture capital firm New Enterprise Associates. Under his leadership, the FDA advanced new frameworks for the modern oversight of gene therapies, cell-based medicines, and digital health devices. The agency implemented new reforms to standardize drug reviews and made historic improvements in post-market data collection and the use of real-world evidence. He promoted policies to reduce death and disease from tobacco, improve food safety, and aggressively confront addiction crises. The agency’s prolific advances in new policy distinguished his tenure as FDA Commissioner, along with a record-setting number of approvals for novel drugs, medical devices, and generic medicines. Previously, Dr Gottlieb served as the FDA’s Deputy Commissioner for Medical and Scientific Affairs and, before that, as a Senior Adviser to the Administrator of the Centers for Medicare and Medicaid Services. He is the author of the New York Times bestselling book “Uncontrolled Spread: Why Covid-19 Crushed Us and How We Can Defeat the Next Pandemic” and is a regular contributor to CNBC and CBS News’ Face the Nation. Dr Gottlieb serves on the board of directors of publicly traded companies Pfizer, Inc., Illumina, Inc., and TempusAI. Dr Gottlieb is an elected member of the National Academy of Medicine and completed medical school and a residency in internal medicine at the Mount Sinai School of Medicine, where he currently serves on the executive committee of the Mount Sinai Health System’s board of directors and co-chairs the board’s education committee. He graduated from Wesleyan University, where he majored in economics, and currently serves on the university’s board of directors. Dr Gottlieb lives in Connecticut with his wife and three daughters.

With over 30 years of international leadership and accountability in the biopharmaceutical industry, Elspeth Carnan is an accomplished global executive, specialized in clinical development, implementing strategy and operational execution of a portfolio of pre-clinical and clinical stage programs, across a variety of therapeutic areas, including, oncology, immunology, and rare disease. In her roles at Alkermes and Regeneron, as SVP and VP of clinical operations, Carnan was accountable for driving global clinical trials, improving efficiency and consistency of performance as well as implementing an improved delivery of risk based strategic monitoring. At Merck KgA/ EMD Serono, Carnan drove the R&D Strategic Sourcing & Vendor management function being accountable for global outsourcing strategy for clinical development, developing and negotiating strategic alliance partnerships, critical issue management and executive governance. While at Amgen (2005 to 2015), Carnan was instrumental in shaping the Amgen clinical monitoring platform; first successfully driving the global implementation of the Functional Service Provider, with 12 providers and across 56 countries. With her wealth of clinical operations experience, she was instrumental in the design and support of the centralized monitoring initiative. During her Amgen tenure, she made a significant impact in shaping Amgen’s approach to innovation. Through her commitment to driving Operational Efficiency and supporting the scoping of the Streamline Clinical Trials initiative, Carnan ensured a focus on transforming the approach to clinical trial execution, most notably in study design and study start up. Her dedication to the establishment of the R&D Global Network framework to enhance end to end process development added value to Amgen’s approach to knowledge sharing. Carnan holds a PhD in Physiology from University Newcastle Medical School and a Bachelor of Science (Physiology) from University of Glasgow. 

Carnan lives in Lexington MA, an ‘empty nester’ as her twins attend the University of Toronto.