Califf’s Post-PDUFA, Post-COVID FDA Agenda: Key Developments, Insights and Analysis – Webinar Recording/Transcript
With a new commissioner and his staff on board at the FDA, with PDUFA VII about to be implemented, with a new normal developing as the pandemic wanes, there will be significant changes at the FDA that will affect every stakeholder. What can you expect and how will it affect you and your business? This special extended webinar does a deep dive into what the future may hold
As Robert Califf takes the FDA reins a second time, he’s facing a whole new world and setting new priorities for the agency. Newly reauthorized user fee programs, a new and enlarged budget authorization, a new Congress and possible new leadership anticipated for 2023 — not to mention the challenges of transitioning out of a pandemic — Califf has all of this in front of him, and you need to know what is likely to happen
Your presenters will provide a close analysis of 2022 under the Biden and Califf regimes, keen insight on what to anticipate in the future and practical guidance on how you can adapt to the new FDA.
Wayne L. Pines, president of healthcare at APCO Worldwide and former associate commissioner of the FDA — along with a panel of experts — will share what you must know and do to get ahead of the changes
They will look back at the crucial developments of 2022 and look to what will likely come in 2023, including how the multiple lessons of the pandemic will be applied to daily FDA activities, what enforcement will look like, likely inspection process innovations … and much more, such as:
- What new provisions in the user fee legislation will affect your daily business
- Importance of the recent drug importation guidance and the impact of new guidances
- How key personnel changes in the FDA will impact you
- Impact of drug-related “crises” on CDER’s approach to R&D and approvals
- What to expect in terms of more use of emergency authorizations, accelerated approvals, breakthrough and fast-track programs, OTC drug monograph reviews, adaptive trials
- Key elements of CBER’s five-point plan
- Expanded opportunities in regenerative medicine
- Regulation of AI and software as a medical device
- Harmonization efforts with the EU
- Inspection policies and procedures
- Advertising and promotion policies and enforcement
- And much more!
Want to ready yourself for what the FDA has in store into 2023? This special extended webinar is how to do it.
Meet Your Presenters
Wayne L. Pines is a member of APCO Worldwide’s International Advisory Council and president of health care at APCO Worldwide. He has served as a trusted advisor to FDA leadership for several decades. Mr. Pines provides strategic counsel to clients facing crises or media, legislative, regulatory or marketing challenges. He served for 10 years in senior positions at the FDA, including as chief media spokesman and associate commissioner for public affairs. He has authored or edited a dozen books about the FDA and was a co-founder and long-term president of the Alliance for a Stronger FDA.
Deborah Livornese is a Director at Hyman, Phelps & McNamara, P.C. Ms. Livornese more than 18 years of experience in a broad range of FDA regulatory issues. She assists pharmaceutical drug companies of all sizes on regulatory requirements and strategies related to obtaining FDA approval and other paths to market, as well as on post-marketing regulatory issues, including promotional activities. Ms. Livornese also assists clients by conducting FDA regulatory due diligence on behalf of regulated companies and potential investors or purchasers.
Steven A. Grossman, JD, is a policy and regulatory consultant whose experiences cross all areas of public health and FDA. He is the executive director of the Alliance for a Stronger FDA, a 150-member stakeholder coalition that advocates for increased resources for the FDA. Prior to becoming a consultant and association executive, Mr. Grossman spent a decade in public service. He was the health staff director of the Senate Labor and Human Resources Committee (now HELP). Notably, he was one of the chief Senate negotiators for the Orphan Drug Act (ODA) and for the Drug Price Competition and Patent Term Restoration Act (known as Hatch-Waxman). After leaving the Senate, Mr. Grossman was a deputy assistant secretary for health at HHS.
Lowell M. Zeta, is a partner in the Life Sciences and Global Regulatory practices at Hogan Lovells US LLP, in Washington, DC. He provides legal counsel to emerging and established life science companies and their investors on critical regulatory and compliance matters, while navigating an ever complex and evolving regulatory landscape. Mr. Zeta previously served senior counselor to the FDA commissioner, where he provided leadership on the agency’s cross-cutting and high-priority initiatives promoting innovation and addressing public health issues. He was responsible for leading FDA's COVID-19 PREPP initiative to help guide the agency's response and strategic planning.
Eva Temkin is a partner in the King & Spalding FDA and Life Sciences practice, Eva provides strategic counsel to clients on a wide variety of FDA-regulated products, ranging from biosimilars to cell and gene therapies and complex combination products. Eva advises pharmaceutical and biotechnology companies at every stage of product development and life-cycle, from data generation (including clinical investigations and real-world evidence) to application submissions, exclusivity matters, and dispute resolution.
Before joining King & Spalding, Eva acted as Director for Policy at the FDA’s Office of Therapeutic Biologics and Biosimilars, where she oversaw regulatory policy related to biosimilars and other therapeutic biologics. Additionally, as Associate Chief Counsel at the FDA’s Office of Chief Counsel, Eva provided strategic counseling to FDA’s biomedical product centers on a wide range of drug, biologic, and combination product issues.
Who Will Benefit
- Quality professionals
- Regulatory professionals
- Legal professionals
- Compliance professionals
- PR/advertising personnel
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Sept. 15, 2022