From Lab to Patient: Guidance on the FDA Approval Process for University TTOs
Join our panel of FDA and life sciences experts (including special guest former FDA Principal Deputy Commissioner Dr. Namandjé Bumpus) as we provide an overview of the FDA Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), and Center for Biologics Evaluation and Research (CBER) approval of clinical investigations and marketing approval of new products for TTOs. Understand the process and explore options for taking your innovations from the lab into the hands of patients and physicians, as our experts guide you through the FDA approval pathways for drugs, medical devices, and biologics followed by expert panel advice and discussion regarding strategies, best practices, possible risks and challenges, and more.
Date: Thursday, May 29, 2025
Time: Noon – 1 p.m. ET
Cost: AUTM Members-$0 / Non-Members-$225
Learning Objectives
- Apply an understanding of FDA approval pathways for your innovations
- Assess some of the possible benefits, risks, and challenges for TTOs
- Effectively utilize the help of regulatory experts and leaders in investing in and funding life sciences innovations
Moderator
Instructors
- Namandjé Bumpus
- Michael Ehlers
- Beverly Lorell
- Christina Young
Moderator
Karthik Gopalakrishnan, PhD, joined the Harbert Institute in 2019 and leads all University of Alabama at Birmingham (UAB) licensing and intellectual property management efforts as Director of Licensing and New Ventures. Karthik holds almost three decades of broad experience in science and business development, marketing, and negotiating agreements in university technology transfer. Under his direction, the Harbert Institute started the successful Innovate Fellows program, which offers graduate students and postdoctoral fellows the opportunity to learn about technology transfer and commercialization and participate in the decision-making process. The institute has also seen increased numbers of intellectual property disclosures under his leadership. Before coming to UAB, Karthik was an associate director at the Duke University Office of Licensing and Ventures. He is also a consultant with a biotechnology startup in the oncology space, leading their strategic planning and business development efforts. He earned a Master of Science in biotechnology from the Maharaja Sayajirao University of Baroda and a PhD in biochemistry from the Tata Institute of Fundamental Research in Mumbai. Karthik also completed a postdoctoral fellowship at the National Institute of Environmental Health Sciences in Research Triangle Park, North Carolina.
Instructor Bios
Namandjé Bumpus, PhD, serves as a strategic advisor on regulatory science and policy. She is also a member of the Board of Directors of Recursion Pharmaceuticals, a clinical stage techbio company. Namandjé served at FDA from 2022-2024 first as the Chief Scientist and then as the FDA's Principal Deputy Commissioner. Before joining the FDA, she was on the faculty at the Johns Hopkins University School of Medicine where she was the E.K. Marshall and Thomas H. Maren Professor and Chair of the Department of Pharmacology & Molecular Sciences. Namandjé earned a PhD in pharmacology at the University of Michigan and completed a postdoctoral fellowship at the Scripps Research Institute. She is a member of the National Academy of Medicine.
Michael Ehlers, MD, PhD, is Entrepreneur Partner at MPM BioImpact, a leading life sciences fund. He holds MD and PhD degrees from the Johns Hopkins University School of Medicine. At MPM, Michael helps direct the fund’s science-driven investment and biotech company creation strategy. Prior to joining MPM in 2024, he was General Partner and CSO at Apple Tree Partners (ATP). Before ATP, Michael was Executive Vice President for Research & Development at Biogen, Senior Vice President for BioTherapeutics, and Chief Scientific Officer for Neuroscience at Pfizer. Collectively, he has led teams that have advanced more than 40 compounds into clinical development including six approved drugs in neurology and rare disease. Before entering his industry career, he was George Barth Geller Professor and an investigator of the Howard Hughes Medical Institute at Duke University.
Beverly Lorell, MD, is the Senior Medical and Policy Advisor with the firm’s FDA and Life Sciences Practice in Washington, D.C. Beverly specializes in the areas of clinical trial design of studies for drugs, devices, and biologics; review of pre-market submissions; recalls; and assessment of matters involving a risk to health. She also specializes in the area of physician and industry relations and the development of independent scientific panels to advise health industries.
Christina Young, PhD, is a technical advisor on the Innovation Protection and Intellectual Property teams and as well as a consultant on the FDA & Life Sciences team at King & Spalding. She holds a PhD in chemistry from the Georgia Institute of Technology and leverages her unique interdisciplinary background in chemistry, applied physics, and electrical engineering to provide technical expertise for all aspects of patent litigation and FDA matters. With more than half a decade of experience as a reviewer at FDA, Christina supports clients with valuable experience navigating the FDA application process including, but not limited to, strategies for stakeholder engagement, in-depth regulatory and scientific advice on potential challenges, experienced review and advisement of FDA applications, and consultation on site at client manufacturing facilities for FDA inspection preparation.