Back to: FDA Regulatory Education for Industry (REdI) 2024 Conference – Biologics Track
Presenter
Larissa Lapteva, MD, MHS, MBA
Associate Director
Division of Clinical Evaluation General Medicine (DCEGM)
Office of Clinical Evaluation (OCE)
Office of Therapeutic Products (OTP)
Center for Biologics Evaluation and Research (CBER)
US Food and Drug Administration (FDA)
Larissa Lapteva, MD, MHS, MBA is the Associate Director in the Division of Clinical Evaluation, Office of Therapeutic Products, CBER, FDA. Dr. Lapteva is a physician with long-standing experience in clinical research with novel drugs and biological products, including cell and gene therapies and products developed for rare diseases. Prior to her work at the FDA, Dr. Lapteva served as a clinical investigator in clinical studies conducted at the National Institute of Arthritis, Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH). Since joining FDA in 2006, Dr. Lapteva has held review and supervisory positions in the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research and provided scientific and regulatory advice for clinical development programs with investigational products across different therapeutic areas. Dr. Lapteva received her degrees of Master of Health Sciences from Duke University and Master of Business Administration from R.H. Smith School of Business.
Abstract
Larissa Lapteva, Associate Director in the Division of Clinical Evaluation in the Office of Therapeutic Products in the Center for Biologics Evaluation and Research (CBER), welcomes attendees to the CBER track at the 2024 Regulatory Education for Industry (REdI) Annual Conference. She highlights the importance of the REdI conference for improving knowledge about CBER and FDA, and the products regulated by CBER. CBER regulates a wide variety of biological products, including cellular and gene therapy products, blood products, tissue products, vaccines, allergenics, xenotransplantation products, antivenins, and some devices used with biological products. Lapteva points out that a recent poll showed some attendees incorrectly thought CBER did not regulate devices, while certain antibodies regulated by the Center for Drugs and general devices regulated by the Center for Devices and Radiological Health are not under CBER’s purview. This year’s overarching theme is innovation, and the CBER track features talks on topics like genome editing technologies, advanced manufacturing, and the use of artificial intelligence in vaccine development. Communication and stakeholder engagement, especially patient engagement, are foundational for successful product development and are also discussed in the track. Speakers cover best practices for interactions between CBER and product sponsors, which is particularly relevant for smaller companies transitioning from academic research. Lapteva introduces the CBER track conference team, including online audience interactors Adriane Fisher and Ohio Dirisu, and moderators Graeme Price and Cecilia Crowley for day one, and Melek Sunay and herself for day two. All presenters are experienced reviewers or expert policy staff, basing their talks on real-world product programs and applications.