FDA Under the Biden Administration: What’s to Come and What It Will Mean – Webinar Recording/Transcript
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Things are changing at the FDA. With the Biden administration comes a new commissioner and likely shifts in the agency’s approach. You’ll need to learn how to navigate these adjustments to effectively move your drugs or devices forward — and you’ll want to get the best understanding of these updated policies and procedures as possible.
What will be required now for new product approvals? Will there be changes to the inspection process? How will the FDA play a role in drug pricing and user-fee programs?
This FDA Under the Biden Administration presentation will cover expected changes at the agency and programming that organizations can begin to implement to prepare for the new policies. You’ll dig into the day-to-day adjustments your team should consider making and practical guidance around any regulation, enforcement and pricing changes.
FDA experts — Wayne L. Pines, President, Health Care, APCO Worldwide — Marc Scheineson, Partner, Alston & Bird LLP — Esther Krofah, Executive Director, FasterCures — Lowell Schiller, Chief Legal and Regulatory Officer, Aetion; Former Principal Associate Commissioner for Policy and Acting Chief Counsel, FDA — will share the changes they expect to see from the agency’s administrative shift. They will also provide guidance on what you can do to navigate these shifts head-on and successfully gain approval for products in development.
Key Presentation Takeaways:
- What changes are expected at the FDA with the new administration
- Policies and programs organizations should consider implementing
- Day-to-day adjustments that could help your team navigate the changes
- Expert insights into shifts around drug and device regulation, enforcement, drug pricing, and health care innovation
- Specific, practical guidance for preparing for FDA changes
- Considerations around user fees and the user-fee legislative process
Policies and processes at the FDA may be shifting with the Biden administration, but you can be prepared for any long-term and day-to-day changes that come your way. With this presentation, you’ll learn what experts predict for the coming months and years — and you’ll discover how you can meet those challenges.
Meet Your Presenters
Wayne L. Pines, a member of APCO Worldwide’s International Advisory Council and President of Health Care for the consultancy, provides strategic counsel to clients facing crises or challenges around media, legislative, regulatory or marketing issues. He has worked on health care and regulatory concerns, litigation, product approvals, advertising issues, recalls and congressional issues involving regulation of pharmaceuticals, medical devices and food. Pines served in senior positions at the FDA for 10 years, including as its Chief of Consumer Education and Information, Chief of Press Relationships and Associate Commissioner for Public Affairs. He was the Chief Media Spokesman for the FDA for seven years and was the founding editor of the FDA consumer magazine. He was also named the FDA’s Alumnus of the Year in 2004.
Marc Scheineson is a Partner at Alston & Bird LLP and heads the firm’s food and drug law practice. He previously served as an associate commissioner for legislative affairs at the FDA, a regulatory FDA lawyer for a national law firm and a senior vice president and government relations principal at Ketchum Communications. He also worked as a Legislative Assistant and Counsel to Representative Bill Gradison (R-OH), the ranking member of the Health Subcommittee of the House Ways and Means Committee. Scheineson is a former Co-chairman of the American Bar Association’s Committee on Food and Drug Law.
Esther Krofah is the Executive Director of FasterCures, a center of the Milken Institute. She has deep experience in the government, nonprofit, and for-profit sectors, where she has led efforts to bring together diverse stakeholder groups to solve critical issues and achieve shared goals that improve the lives of patients. Most recently, Krofah was the director of public policy leading GlaxoSmithKline's engagement with the U.S. Department of Health and Human Services (HHS) and relevant Executive Branch agencies on broad healthcare policy issues, including leadership in improving vaccinations and care for people living with HIV.
Lowell Schiller is the Chief Legal and Regulatory Officer of Aetion, a health care technology company that provides decision grade real world evidence analytics to biopharma companies, payers, and regulatory agencies. Previously, Schiller served in several senior leadership roles at the U.S. Food and Drug Administration, most recently as the Principal Associate Commissioner for Policy. In this role, Schiller led the FDA’s Office of Policy, managed agency-wide development of regulations and guidance and provided policy leadership on cross-cutting and high-profile issues across FDA’s jurisdiction. Earlier in his tenure at FDA, Schiller served as the FDA’s Acting Chief Counsel and as the Senior Counselor to the Commissioner.
Who Will Benefit
- Companies regulated by the FDA
- Companies that make or develop medical products, drugs, and devices
- Quality professionals
- Regulatory affairs professionals
- Compliance professionals
- GMP professionals
- Inspections and audit teams
- Postmarket safety professionals
- Submissions and approvals professionals
- Research and development teams
- Commercial operations staff
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Feb. 10, 2021