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Tuesday, June 20 • 4:00pm - 5:15pm
#277: The Reauthorization of BsUFA and its Impact on Both the Regulator and Industry

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

FDA and industry have taken lessons learned from the first four years of the biosimilar user fee agreement (BsUFA) and applied them to this first reauthorization of the program. This session will focus on changes to the program and their affect on both industry and the agency.

Learning Objectives

Discuss what's new in BsUFA II and the impact on sponsors and regulators.

Chair

Juliana Marguerite Reed, MS

Speaker

Biosimilar User Fee Act (BsUFA II) Reauthorization: Proposed Agreements
Leah Christl, PhD

Panelist
Hillel Cohen, PhD

Panelist
Kimberly Greco

Panelist
John Pakulski, RPh


Moderators
avatar for Juliana Reed

Juliana Reed

Vice President, Government Affairs, Coherus BioSciences
Extensive experience in the development of biosimilars policy around the globe. Prior to joining Coherus Biosciences, Juliana was at Hospira Inc, for over 10 years working to advance biosimilars in multiple global regions. Juliana is one of the founders of the Biosimilars Forum, the... Read More →

Speakers
avatar for Leah Christl

Leah Christl

Associate Director for Therapeutic Biologics, TBBT, OND, CDER, FDA
Dr. Christl is the Director of the Therapeutic Biologics and Biosimilars Staff (TBBS) in the Office of New Drugs in the FDA's CDER. TBBS is responsible for ensuring consistency in the scientific and regulatory approach and advice to sponsors regarding development programs for biosimilar... Read More →
avatar for Hillel Cohen

Hillel Cohen

Executive Director, Scientific Affairs, Sandoz Inc., United States
Dr. Hillel P. Cohen PhD is Executive Director of Scientific Affairs at Sandoz, helping explain the principles of biosimilars and biosimilar policies to the healthcare community, patient advocacy groups, and health authorities. He has published and given presentations in the areas... Read More →
avatar for Kimberly Greco

Kimberly Greco

Director, Research and Development Policy, Amgen Inc.
JP

John Pakulski

Head, Regulatory Science, Biologics, Mylan Inc.

Tuesday June 20, 2017 4:00pm - 5:15pm CDT
N228 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  05: Regulatory, Forum