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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... Read More →

Speakers
avatar for Leah Christl

Leah Christl

Associate Director for Therapeutic Biologics, TBBS, OND, CDER, FDA
Dr. Christl is the Associate Director for Therapeutic Biologics in the Office of New Drugs at FDA, leading the Therapeutic Biologics and Biosimilars Staff (TBBS) in OND. TBBS ensures consistency in the scientific and regulatory approach regarding development programs for proposed... Read More →
avatar for Hillel Cohen

Hillel Cohen

Executive Director, Scientific Affairs, Sandoz Inc.
Hillel Cohen is Executive Director at Sandoz, helping explain biosimilar policies to the healthcare community, public, & health authorities. He led Sandoz efforts for the first biosimilar presentation (Zarxio®) to an FDA advisory committee. Recently he participated in BsUFA2 neg... Read More →
avatar for Kimberly Greco

Kimberly Greco

Director, Research and Development Policy, Amgen Inc.
JP

John Pakulski

Head, Regulatory Science, Biologics, Mylan Inc.
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... Read More →


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