The Biden administration has brought in new policies and personnel to the federal health care team. The FDA remains in the news every day as it exercises its vast responsibilities over drugs and devices. At the same time, the FDA must restore its reputation, show that it has learned from the pandemic, manage some of the most challenging issues and decisions it has ever faced, and be prepared to effect still further changes.
All of which means we all need to gain perspective and understanding what’s happened thus far in 2021 and anticipate, understand and then comply with what’s coming for the rest of the year and beyond.
This special extended edition webinar features five expert speakers with decades of experience working for and with FDA. Their interactive session will enable you to gain insights into what the Biden team has done so far and the policies and changes it will bring to new drug and device development and approvals.
How will recent and ongoing policy changes and controversies affect your business? What permanent changes will we see as we again shift gears into how FDA interacts with industry, Congress, the media and the patient/consumer communities?
Wayne L. Pines, president of health care at APCO Worldwide and former associate commissioner of the FDA, will lead a team that will explain what we have seen in the first six months of the Biden administration and what to expect going forward, including the answers to your burning questions.
Please note that this workshop will not be
Amounts & Deadlines
2 September 2021: Member $300.00 | Nonmember $335.00
Learning Objectives/Webinar Takeaways:
- What has changed at the FDA under Biden that has and will affect what you do every day?
- How should you plan now for upcoming changes to be ready for developments later in 2021 and in 2022 in drug and device regulation, enforcement, drug pricing and health care innovation?
- What new guidances are likely to be issued this year and next?
- What role will HHS and the White House play under Biden?
- How important are politics in FDA decision-making?
- What is the agenda for the new CDER director?
- What are the agendas for the CBER and CDRH directors?
- What regulatory and policy revisions initiated under the pandemic will continue as we return to normal?
- What are the key elements from CBER’s five-year plan?
- How will enforcement under Biden compare to that under the previous administration?
- What have we learned from recent drug approvals?
- Will there continue to be extensive use of EUAs?
- How will the timetables for drug and device approvals change as a result of the experience with vaccine development?
- What is the plan for virtual inspections and catching up on delayed inspections?
- Will there be expanded opportunities in regenerative medicine?
- What will happen in cannabis regulation?
- What is the current status of software as medical devices?
- What is the status of harmonization efforts with the EU?
- What enforcement and policy changes will occur for the promotion of drugs and devices?
- What will PDUFA 2022 bring in terms of new fees but especially new authorities and new responsibilities for FDA?
- And much more!
12:45 PM EST - Attendees logged into the webinar and placed in a virtual waiting room
1:30 - 1:40 PM EST - Welcome & Introduction
- What are the key issues being faced by FDA in this first year of a new administration?
- What the key areas where we can expect change?
1:40 - 2:10 PM EST - Biden Administration White House/HHS/FDA Team: New Personnel, New Policies
- What have been the key personnel changes in Biden’s first year thus far?
- Who are the new people and how these personnel changes play out in the long run?
- Who exactly is now calling the shots?
- What is the relationship between the White House, HHS, FDA & Congress?
2:10 - 3:00 PM EST - Drug and Device Development and Approval
- What lessons are we learning from the accelerated approval of Aduhelm for Alzheimer’s disease?
- What are the most important recent policy developments in the pharmaceutical and medical device development, approval, and regulatory space?
- How have these developments affected the drug approval process?
- Will the relationship between CDER, CBER, CDRH and the Office of Regulatory Affairs change?
- What changes have we seen and will we see in the future in these centers/offices?
- What has been the impact of COVID-19 on drug and device approval?
- What has been the impact of EUAs, and what does a transition plan look like?
- Will we see a shift in CDRH policy regarding diagnostics/LDTs?
- Will there be a new normal for remote/virtual FDA interactions?
- What’s the impact of COVID-19 policies on clinical trials, including use of RWE, and adaptive/decentralized trials?
- What about new Centers of Excellence?
3:00 - 3:10 PM EST - Break
3:10 - 4:30 PM EST - Challenges Facing a New Commissioner
- What can we expect will be the main issues/provisions of PDUFA 22?
- How will FDA continue to address the opioid crisis?
- What steps may FDA take to increase access to generic drugs and biosimilars?
* Agenda is subject to change.
Who Should Attend?
Anyone who is currently working with the FDA and needs better understanding of the Biden's Administration’s FDA.
Wayne Pines is a member of APCO Worldwide’s International Advisory Council and president of healthcare at APCO Worldwide. He has served as a trusted advisor to FDA leadership for several decades. He 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.
Andrea Chamblee is Senior Counsel in the Washington, D.C., office of Wilson Sonsini Goodrich & Rosati, where her practice primarily focuses on representing FDA-regulated companies, small and large alike, in efficiently navigating local and national regulatory requirements for research, clinical trials, manufacturing, commercializing, advertising, and promotion. She brings unique first-hand experience with the development and application of complex regulatory programs across regulated commodities to counsel clients at all stages of the medical product life cycle.
Kellie Combs, Partner at Ropes & Gray LLP, provides legal and strategic advice to pharmaceutical, biotechnology, medical device, food and cosmetic manufacturers, as well as hospitals and academic institutions, on a broad range of issues under the Food, Drug, and Cosmetic Act and the Public Health Service Act. She is a partner in the FDA regulatory practice group and is also a co-chair of the firm’s cross-practice Digital Health Initiative. Kellie is currently advising a number of clients on issues related to the COVID-19 pandemic, including the deployment of digital health and telemedicine tools, the manufacture and distribution of personal protective equipment, and the 3D printing of medical devices and components.
Allison Fulton is a partner in the Sheppard Mullin Washington, D.C. office. She is the Leader of the Life Sciences and FDA Team. Allison advises life sciences companies, including pharmaceutical, medical device, dietary supplement, food and cosmetic companies, in matters relating to the development, manufacture and marketing of products regulated by the U.S. Food and Drug Administration (FDA)..
Marc Scheineson is a partner in the Alston & Bird Washington, D.C. office, where he heads Alston & Bird’s Food & Drug Law Team. He advises companies on a wide range of issues, including product approvals, marketing, clinical studies, and enforcement. Previously, he served as the associate commissioner under then-FDA Commissioner David Kessler for legislative affairs of the Food and Drug Administration. He was involved there in many agency innovations, including prescription drug user fees, debarment, medical device amendments, and nutritional labeling.
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