Name: #517: Navigating the New FDA: Insights from Former FDA Chief of Staffs
Start: 2026-06-16T10:15:00-0400
End: 2026-06-16T11:30:00-0400

#517: Navigating the New FDA: Insights from Former FDA Chief of Staffs

Tuesday June 16, 2026 10:15am - 11:30am EDT

204AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-638-L04-P; CME 1.00; RN 1.00

The session will feature former FDA Chief of Staffs discussing their contributions to regulatory policies, patient engagement, and innovative technologies, offering insights into the evolving regulatory landscape and helping stakeholders navigate FDA

Learning Objectives

Identify key initiatives and challenges described by former FDA Chief of Staffs; Explain how the regulatory landscape is evolving and how these changes may influence future drug approval processes; Discuss FDA organizational dynamics and strategic decision-making factors that shape public health outcomes, helping stakeholders to navigate the new FDA more effectively.

Chair

Elizabeth Lange, MPH, MS

Speaker

Panelist
Susan Winckler, JD

Panelist
Elizabeth Jungman, JD, MPH

Panelist
Kalah Auchincloss, JD, MPH

Panelist
Lauren Silvis, JD

Panelist
Julie Tierney

Speakers

Kalah Auchincloss

Canal Row Advisors, United States

Kalah is a consultant to pharma, biotech and medical device companies providing strategic regulatory advice. Prior to her consulting and legal roles, Kalah spent six years at the FDA, including as Deputy Chief of Staff to Commissioner Robert Califf, and in senior positions in CDER’s... Read More →

Elizabeth Jungman

Partner, Global Regulatory, Hogan Lovells US LLP, United States

Elizabeth Jungman is a Partner at the global law firm Hogan Lovells where she advises life sciences companies on high-stakes regulatory strategy and engagement with the FDA. Prior to joining Hogan, Elizabeth was FDA’s Chief of Staff, where she oversaw the day-to-day management of... Read More →

Elizabeth Lange

Executive Director/ Head of Regulatory Scientific Policy, EMD Serono, United States

Elizabeth Rosenkrands Lange is an experienced regulatory policy leader located in Washington DC. She is an Epidemiologist with a MPH. She has 18+ years of experience working in drug development, regulatory policy and patient advocacy. She began her career at the Danish Medicine Agency... Read More →

Elizabeth Rosenkrands-Lange

VP & Head, RQC, Science, Policy & Intelligence (SPI), Novo Nordisk Inc., United States

Elizabeth Rosenkrands Lange is an experienced R&D policy leader located in Washington DC. She is an Epidemiologist with a MPH. She has 18+ years of experience working in drug development, regulatory policy and patient advocacy. She began her career at the Danish Medicine Agency and... Read More →

Lauren Silvis

Senior Vice President, External Affairs, Tempus, United States

Lauren Silvis serves as Senior Vice President of External Affairs at Tempus, overseeing regulatory, public policy, government affairs and strategic communications. She has held a number of senior career public health roles, serving as a Senior Advisor at the Department of Health and... Read More →

Julie Tierney

Principal, Leavitt Partners, United States

Susan Winckler

Chief Executive Officer, Reagan-Udall Foundation For the FDA, United States

Prior to accepting her post as CEO for the FDA’s Foundation in May of 2020, she served as President of Leavitt Partners Solutions. She advised corporate executives on policy and business matters. As CEO of the Food & Drug Law Institute, she provided attorneys, regulators, industry... Read More →

Tuesday June 16, 2026 10:15am - 11:30am EDT
204AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Forum

Audience Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Regulatory
Tags Forum

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