Overview
March 23, 2020 marked the Biologics Price Competition and Innovation Act transition date, on which nearly 100 drugs previously approved as new drugs under Food, Drug, and Cosmetic Act section 505 transitioned to approved biologics licenses under section 351 of the Public Health Service Act. What are some of the lingering issues associated with the transition and future approval pathways for these drugs and related biosimilar/interchangeable products? The webinar will address transition questions about chemistry, manufacturing, and control requirements; as well as labeling, exclusivity, compounding, and 505(b)(2) applications. The webinar will also discuss regulatory pathways and potential pricing implications for transitioned products and related biosimilar/interchangeable biologic candidates.
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Speakers
David V. Ceryak, Senior Director, Assistant General Counsel, Regulatory Legal Team, Eli Lilly and Company
Lee Rosebush, Partner, BakerHostetler
Moderated by Catherine M. Cook, Executive Vice President, Drug and Biological Products, Greenleaf Health, Inc.
DAVID V. CERYAK is Senior Director – Assistant General Counsel, Regulatory Legal Team at Eli Lilly and Company. In this role Mr. Ceryak leads the team that counsels on drug and device matters, including clinical development, registration, Hatch-Waxman, biosimilars, GMPs/manufacturing, diagnostics, and drug safety. Mr. Ceryak served as an industry representative for the negotiations with FDA to develop the 2017-2022 Biosimilar User Fees and Technical Agreement. He also served as the co-chair for the 2017 Food and Drug Law Institute (FDLI) annual meeting, and is a recipient of the FDLI Distinguished Service and Leadership Award. Mr. Ceryak has served as a subcommittee member on the HHS Secretary’s Advisory Commission on Human Research Protections and Chair of the FDA Focus Group of the Pharmaceutical Research and Manufacturers of America. Mr. Ceryak graduated magna cum laude from Miami University and received his JD magna cum laude from Indiana University School of Law.
KATE COOK is Executive Vice President for Drug and Biological Products at Greenleaf Health, a regulatory consulting firm. She previously worked at FDA in legal and policy positions in the Office of Chief Counsel, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health, where she served as associate director for regulations and policy. During her twenty+ years at FDA, she was involved in every aspect of policy development and provided legal review for important agency initiatives. Ms. Cook graduated from New York University School of Law, and was a New York County Assistant District Attorney and an attorney in private practice before joining FDA. 
Lee Rosebush is a Partner at BakerHostetler. With a background as a defense, regulatory, and registered patent attorney who has also worked as a registered pharmacist, Mr. Rosebush provides his clients with legal counsel that is grounded in first-hand experience. Whether his clients are confronted with legal issues related to the naming of a drug, clinical trials, marketing, promotions, or advertising, Lee possesses a strong understanding of the pharmaceutical industry which, combined with his attention to detail and experience working with biologics, medical device, and healthcare companies, gives clients a single source for regulatory and litigation counsel. With post-graduate degrees in finance and business, Lee is frequently sought out to help expedite corporate deals involving healthcare entities. He also advises private equity and public and private companies in due diligence matters and buy-sell transactions. Lee’s ability to smoothly shift between the legal, governmental, and pharmaceutical environments further helps him to efficiently secure operating licenses or assist drug manufacturers avoid compliance actions from governmental agencies. Active with the Drug Quality and Security Act (DQSA), as well as the Federal Food and Drug Administration’s (FDA) regulation of pharmacy compounding, Lee speaks and writes on both issues, and is passionate about orchestrating and advocating for pharmacists and pharmacies. Additionally, Lee is Leader of BakerHostetler’s Pharmacy and Reimbursement team and Co-Leader of the FDA, Products Promotion, and Defense team.
