This two-hour educational program for patient advocates working for 501(c)(3) organizations brings together law, industry, and FDA experts with deep advocacy experience to equip patient organizations with an understanding of the legal tools and strategies available for interacting with the FDA during the COVID-19 pandemic and afterwards. Learn about continuing opportunities and challenges to effective engagement with FDA, including individuals, coalitions, and public meeting and advisory committees. The public policy-focused course is designed for and offered only to 501(c)(3) patient organizations.
Speakers:
Chad A. Landmon, Partner, Axinn, Veltrop & Harkrider LLP
James E. Valentine, Associate, Hyman, Phelps & McNamara, PC
Beth P. Weinman, Counsel, Ropes & Gray LLP
CHAD A. LANDMON is a partner at Axinn, Veltrop & Harkrider LLP, where he chairs the FDA and IP Practice Groups. Mr. Landmon has extensive experience in food and drug law and patent litigation and counseling. FDA matters involve client counseling and petitioning FDA and litigating issues relating to the Biologics Price Competition and Innovation Act (BPCIA), including the requirements for the demonstration of biosimilarity and the patent resolution provisions, and the Hatch-Waxman Act, including marketing exclusivities, patent listing, certification and notification requirements, bioequivalence, labeling and other issues. His patent litigation practice is national in scope and concentrates on the life sciences industry. He has litigated a wide variety of FDA and Paragraph IV cases in numerous jurisdictions, including cases involving blockbuster drugs. Mr. Landmon’s practice also includes matters involving the intersection of the antitrust and patent laws, such as issues arising from the settlement of patent and Hatch-Waxman exclusivity disputes.
BETH P. WEINMAN is a member of Ropes & Gray’s life sciences regulatory and compliance practice group, and focuses her practice on FDA regulation and enforcement of laws governing pharmaceuticals, biologics, medical devices and foods, including dietary supplements. Beth represents clients in False Claims Act (FCA) and Federal Food, Drug, and Cosmetic Act (FDCA) investigations, and other enforcement actions before state and federal regulators, and also represents clients in administrative litigation matters. Beth also provides counseling on issues related to marketing practices, current good manufacturing practices, good clinical practices, compounding, medical product development and approval, and product recalls and withdrawals. Prior to joining Ropes & Gray, Beth spent nearly eight years as Associate Chief Counsel for Enforcement within FDA’s Office of Chief Counsel. In that role, she worked closely with FDA’s Office of Criminal Investigations, the Department of Justice and other government agencies to investigate and, when appropriate, prosecute alleged violations of the FDCA and related crimes under Title 18 (including, e.g., mail fraud, wire fraud, healthcare fraud, and conspiracies to defraud). She also worked on numerous parallel and independent FCA investigations involving FDA regulated drugs and devices, including biologics. Before starting at FDA, Beth spent more than seven years as an associate in the litigation department of a large New York law firm, where, among other matters, she represented a number of pharmaceutical companies in government investigations and securities class action lawsuits.Preliminary Agenda
subject to change
- Overview of FDA’s COVID-19 Medical Product Response
- Emergency Use Authorizations & Enforcement Policy
- Coronavirus Treatment Acceleration Program: Therapies for COVID-19-Related Use
- Enforcement
- COVID-19 Impacts on Medical Product Development and FDA Priorities/Personnel
- Conduct of Ongoing or New Clinical Trials During COVID-19
- Drug and Device Facility Inspections
- Impact on Guidance Development Priorities
- Virtual or Reduced Public Meetings and Events
- Panel Discussion and Q&A
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