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Monday, June 27 • 8:30am - 9:45am
#110: Updates and Pending Issues in the US Biosimilar Environment

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Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-544-L01-P; CME 1.25; IACET 1.25; RN 1.25

The US biosimilars market is maturing rapidly. In the past year, we’ve seen the first biosimilar launch in the US market, multiple draft guidances on biosimilars and biologics emerge from the FDA, and several biosimilar applications that focus on diverse range of complex reference products. The debate and discussion in the US around biosimilars highlights the importance of the biosimilars market to the US drug industry, and the continued impact of the 2010 Biologics Price Competition and Innovation Act. This panel will discuss recent developments in US biosimilars regulation from a manufacturer’s perspective, lessons learned, and areas that would benefit from further global policy discussion.

Learning Objectives

Discuss recent developments in US biosimilar regulation: Identify areas that would benefit from further global policy discussion.

Chair

Andrew S. Robertson, JD, PhD

Speaker

Panelist
Karen M Hauda

Panelist
Mark McCamish

Panelist
Kimberly Greco



Chair
AR

Andrew Robertson

Director, Global Regulatory Policy, Merck & Co., Inc.
Andrew S. Robertson works in Global Regulatory Affairs at Merck & Co., focusing on regulatory policies concerning vaccines, biologics, biosimilars, in vitro diagnostics, mobile medical apps and software medical devices. He has over 13 years of experience spanning academia, industry and government. Andrew holds a JD from the University of California, Berkeley, and a Ph.D. in structural biology from Cambridge University.

Speakers
KG

Kimberly Greco

Director, Research and Development Policy, Amgen Inc.
avatar for Karen Hauda

Karen Hauda

Senior Director, Regulatory Policy, Novo Nordisk Inc.
Karen Hauda is the Senior Director for Regulatory Policy in the Clinical Development, Medical and Regulatory Affairs Division at Novo Nordisk. In this role, she supervises regulatory advocacy and develops filing strategies to positively influence the regulatory environment in the United States and globally. Karen also teaches in the Department of Global Health at George Washington University, in Washington, D.C. She holds a M.S. in Veterinary... Read More →
avatar for Mark McCamish

Mark McCamish

Global Head Biopharm and Oncology Injectables Development, Sandoz, Inc
Dr. McCamish is a physician scientist with a long history of drug, biologic, and biosimilar development in large and small organizations. He is currently Global Head of Biopharmaceutical Development for Novartis biosimilar development housed in Sandoz International.


Monday June 27, 2016 8:30am - 9:45am
201B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA