Califf’s FDA, 2023 and Beyond

The first months of 2023 have been dramatic ones for the FDA: the normalization of COVID-19, staff return to the office, the beginning of implementation of PDUFA VII, the issuance of new guidances for the drug, biologics and device industries, and so much more.

Commissioner Robert Califf has ended his first year as commissioner in the Biden Administration and is now navigating the agency toward his goals: reforms to the product development process, greater reliance on real-world data, more emphasis on orphan drugs and devices, new requirements for accelerated approval drugs and increased discussion on the role of advisory committees.

How have these initiatives changed your business? More importantly, what new initiatives are on the horizon and how can you influence them?

This special extended webinar does a deep dive into what’s happened and what the future may hold at the FDA.

The FDA is in the process of implementing new user fee programs and an enlarged budget authorization. It must deal with a new Congress and with new committee chairs in both the Democratic-controlled Senate and the Republican-controlled House.

Your presenters will provide a detailed analysis of the latest actions in 2022 under Biden/Califf leadership and keen insight on what to anticipate in the future. They will focus especially on 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.

Among the many topics they will cover:

Adoption of new administrative and personnel practices post-pandemic
How the new provisions in the user fee legislation will affect your daily business
How key personnel changes in the FDA are impacting policy
How CDER, CBER and CDRH are rethinking the R&D process and their own review and approval standards
What to expect in terms of emergency authorizations, accelerated approvals, breakthrough and fast-track programs, OTC drug monograph reviews, adaptive trials, drug importation initiatives
Expanded opportunities in cell and gene therapy products and regenerative medicine
Regulation of AI and software, including digital therapeutics as a medical device
Inspection policies and procedures
Advertising and promotion policies and enforcement
And much more!

Want to ready yourself for what the FDA has in store for the rest 2023? This special extended webinar is how to do it.

Wayne L. Pines
President, 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. Pines 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.

Steven A. Grossman
President
HPS Group

Steven A. Grossman is the president of HPS Group, a policy and regulatory consulting firm. He is also 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, Grossman was the health staff director of the Senate Labor and Human Resources Committee (now HELP), where he helped negotiate the Orphan Drug Act and the Drug Price Competition and Patent Term Restoration Act (known as Hatch-Waxman). After leaving the Senate, Grossman was a deputy assistant secretary for health at HHS.

Lowell M. Zeta
Partner, Life Sciences and Global Regulatory Practice
Hogan Lovells US LLP

Lowell M. Zeta, is a partner in the Life Sciences and Global Regulatory practices at Hogan Lovells US in Washington, DC. 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 the FDA's COVID-19 PREPP initiative to help guide the agency's response and strategic planning.

Cathy Burgess
Partner
Alston & Bird LLP

Cathy Burgess leads the firm’s FDA compliance and enforcement team and co-leads the firm’s FDA practice. Burgess advises clients on a range of matters affecting prescription and OTC drugs, biologics, medical devices, foods and cosmetics. She has extensive experience regarding current good manufacturing practice regulation and supply chain management. Burgess conducts liability risk assessments and works with clients to identify and analyze potential legal risks associated with their products. She advises clients on quality systems, adequacy of SOPs, investigation reports, inspection management, recalls, and responses to Form FDA 483s and warning letters.

Nancy Bradish Myers, JD
President
Catalyst Healthcare Consulting, Inc.

Nancy Bradish Myers, JD, president of Catalyst Healthcare Consulting, Inc., is a Washington-based attorney with deep expertise in healthcare law and regulation, policy development and government relations. She has been closely involved in cutting edge drug, biotechnology and medtech regulatory issues from a range of vantage points over the past two decades. Ms. Myers advises clients from the Board room, to executive leadership teams, to regulatory affairs groups on regulatory and health policy matters, ranging from crisis management to long-term strategy development.

Among the many topics they will cover:

Meet Your Presenters