FDA in 2024 and Beyond: What Election-Year Changes Mean for Your Business – Webinar Recording/Transcript
Product Details
In this election year, FDA priorities will be discussed on the national stage. How will a new budget alter policies? And, as the agency continues to adapt to technologies such as artificial intelligence (AI), innovations in cell and gene therapies, and changes in how medical products are developed and tested, what will the future bring?
Prominent FDA-watchers and regulatory experts Wayne Pines, Jim Czaban, Betsy Foss-Campbell, Nimi Chhina and Sarah Blankstein explain it all. In this robust three-hour presentation led by Pines, they looked at recent developments in the drug and device environment and predict what we can expect from the FDA as we head into 2025. The outcome of the presidential election in November will impact the FDA, and companies need to plan now for all possible contingencies.
Presentation Takeaways:
- Dig deep into current and future issues and challenges for the FDA.
- Understand the role that this year’s election outcomes will play in FDA policies and decisions.
- Consider how the consumer/patient voice will continue to impact FDA product decisions.
- Examine how the FDA will use newly appropriated and user fee money for ongoing activities and new initiatives.
- Understand CBER’s strategy and commitment to advance cell and gene therapies.
- Discuss the status of the OTC monograph review process and how Rx-to-OTC switches will transform the marketplace.
- Examine how AI will be used to modernize product reviews, inspections, and other FDA activities.
- Assess current FDA policies on product shortages, imports, supply chain issues and promotional efforts.
In an ever-changing political and regulatory environment, please listen to this unfiltered examination of what the FDA is facing and what it means for your business.
Meet Your Presenters
Wayne L. Pines, member of APCO Worldwide’s International Advisory Council and president of health care for the consultancy, provides strategic counsel to clients facing crises or media, legislative, regulatory or marketing challenges. Mr. Pines has worked on health care and regulatory issues; litigation; product approvals; advertising issues; recalls; and congressional issues involving the regulation of pharmaceuticals, medical devices and food. Mr. Pines served 10 years in senior positions at the FDA. He was FDA’s chief of consumer education and information, chief of press relations and associate commissioner for public affairs. He was the chief media spokesman for the FDA for seven years and also was the founding editor of FDA consumer magazine. In 2004, Mr. Pines was named the FDA’s Alumnus of the Year. He has authored or edited a dozen books about crisis communication and the FDA.
James Czaban is co-chair, Life Sciences and chair, FDA Legal and Regulatory Strategies at Loeb & Loeb. Czaban has more than 30 years' experience in government regulation of pharmaceuticals, biotechnology, food, dietary supplements and medical devices. He maintains a strategic focus on compliance and enforcement proceedings involving the FDA, FTC, DEA, DOJ, CPSC, and state AGs, private advertising disputes and transactional matters for regulated entities.
Betsy Foss-Campbell is a regulatory policy strategist at Catalyst Healthcare Consulting. With prior experience leading regulatory and public policy advocacy for the American Society of Gene and Cell Therapy, Betsy now works alongside clients to advance policy solutions to regulatory issues, primarily in the cell and gene therapy space.
Nimi Chhina is head of global R&D and regulatory policy at BioMarin Pharmaceutical. She also currently serves as vice-chair of the U.S. regulatory advisory group of the Alliance for Regenerative Medicine (ARM). Prior to joining BioMarin in 2017, Nimi spent 7 years at the FDA, where she served in multiple roles including as team lead in CDER’s Division of Medical Policy Development.
Sarah Blankstein is counsel in Ropes & Gray’s life sciences regulatory and compliance practice. Sarah provides legal and strategic advice to pharmaceutical, biotechnology and medical device companies on a wide array of FDA regulatory matters, with a focus on promotional and post-approval compliance, regulation of digital health tools, product development, and lifecycle management. Sarah also provides regulatory counsel for transactions as well as complex internal investigations and government enforcement matters involving FDA-regulated companies.
Who Will Benefit
- Drugmakers
- Devicemakers
- Biologics companies
- Cell and gene therapy companies and researchers
- Distributors and importers