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Monday, June 19 • 11:00am - 12:15pm
#114: PDUFA at 25: A Historical View of the Prescription Drug User Fee Agreement and a Look to the Future - PDUFA VI

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Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

Development and approval timelines for drugs and therapeutic biologic products affect us all. This will be the first reauthorization occurring in parallel with a new Congress and a new administration. This session will focus on how PDUFA has affected both the regulator and regulated industry and what we can expect in the sixth iteration of the agreement.

Learning Objectives

Discuss a historical review of PDUFA from expediting approvals to expediting development; Identify what's new in PDUFA VI and the impact on sponsor and regulator.

Chair

Kim M. Quaintance-Lunn

Speaker

Panelist
Theresa M. Mullin, PhD

FDA Perspective
Patrick Frey

Industry Perspective
Sandra A. Milligan, JD, MD

Panelist
Lucy Vereshchagina, PhD



Moderators
avatar for Kim Quaintance-Lunn

Kim Quaintance-Lunn

Vice President and Head, US Regulatory Policy, Bayer
Kim Quaintance-Lunn serves as the Vice President and Head, US Regulatory Policy at Bayer. She works with colleagues to analyze regulatory policy and advocate for changes in the regulatory environment, serves on global and US Regulatory Leadership teams, and assists in the develop... Read More →

Speakers
avatar for Patrick Frey

Patrick Frey

Chief of Staff, Office of New Drugs, CDER, FDA
Patrick Frey is the Chief of Staff in CDER's Office of New Drugs. He has played leadership roles in the reauthorization of PDUFA V and VI as well as BSUFA II. He was also the CDER lead in developing and implementing CDER's structured framework for benefit-risk assessment. Patrick... Read More →
avatar for Sandra Milligan

Sandra Milligan

Senior Vice President, Head of Global Regulatory Affairs and Clinical Safety, Merck Research Laboratories
Sandra Milligan, MD, JD, is Senior Vice President ande Head of Global Regulatory Affairs and Clinical Safety, consisting of the global regulatory, safety and CMC functions of Merck Research Laboratories. In addition to serving on the board of directors and past president of the D... Read More →
avatar for Theresa Mullin

Theresa Mullin

Director, Office of Strategic Programs, CDER, FDA
Dr. Theresa Mullin plays a lead role in a number of CDER’s strategic initiatives including the human drugs international program, drug user fee negotiation and implementation, regulatory informatics, and major program evaluations and other initiatives. She is currently serving... Read More →
avatar for Kim Quaintance-Lunn

Kim Quaintance-Lunn

Vice President and Head, US Regulatory Policy, Bayer
Kim Quaintance-Lunn serves as the Vice President and Head, US Regulatory Policy at Bayer. She works with colleagues to analyze regulatory policy and advocate for changes in the regulatory environment, serves on global and US Regulatory Leadership teams, and assists in the develop... Read More →
LV

Lucy Vereshchagina

Deputy Vice President, Science and Regulatory Advocacy, Pharmaceutical Research and Manufacturers of America (PhRMA)
Dr. Vereshchagina is a Deputy Vice President at the Pharmaceutical Research and Manufacturers of America or PhRMA. She leads the Regulatory Advocacy team with the focus on the Prescription Drug User Fee Act (PDUFA), the Biosimilar User Fee Act (BsUFA), as well as other regulatory... Read More →


Monday June 19, 2017 11:00am - 12:15pm
N228 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616