Agenda: The Biden Administration’s FDA

1:30 PM - 1:40 PM Welcome & Introduction	Are there noticeable differences between the Trump FDA and the Biden FDA? What the key areas where we can expect change?
1:40 PM - 2:10 PM Biden Administration HHS/FDA Team: New Personnel, New Policies	What have been the key personnel changes in Biden’s first six months? How will these personnel changes play out in the long run, and who exactly is calling the shots? What is the relationship between the White House, HHS, FDA & Congress?
2:10 PM - 3:00 PM Drug and Device Development and Approval	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 are the most important recent policy developments in the pharmaceutical and medical device development, approval, and regulatory space? What is the impact of COVID-19 on drug and device approval? What is 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 PM - 3:10 PM	Break
3:10 PM - 4:30 PM Challenges Facing a New Commissioner	What can we expect with PDUFA 22? How will FDA continue to address the opioid crisis? What steps may FDA take to increase access to generic drugs and biosimilars? How will FDA support innovation in gene therapies and products to treat rare diseases? What developments are on the horizon for regulation of digital health technology? How will FDA manage inspections and clear the backlog post-pandemic? Can we expect to see changes in FDA’s approach to oversight and enforcement related to advertising and promotion?

Wayne L. Pines
President of Healthcare
APCO Worldwide

Wayne L. 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
Senior Counsel
Wilson Sonsini Goodrich & Rosati

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
Ropes & Gray LLP

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.

Marc Scheineson
Partner
Alston & Bird

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.

Agenda

Meet Your Presenters