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Industry Regulatory Issues to be Highlighted at 2012 BIO International Convention

May 9, 2012
In the words of BIO’s Andrew Emmett, Managing Director, Science & Regulatory Affairs, ‘2012 is shaping up to be a momentous year for FDA reform.’ From the reauthorization of the Prescription Drug User Fee Act (PDUFA V) to modernizing and expediting the approval of new drugs and biologics, implementing the new biosimilars pathways and addressing the growing global drug shortage crisis, all eyes are on the current regulatory environment and its role in supporting innovation.

The 2012 BIO International Convention will return to Boston, MA and the Boston Convention and Exhibition Center, June 18-21, 2012 and will feature a breakout session track on regulatory issues.

Attendees can expect the Achieving Regulatory Approval and Compliance educational track to feature leading Food & Drug Administration (FDA) leaders who will share their prospective priorities, senior European medical agency executives discussing international and harmonization issues as well as major biotechnology and pharmaceutical companies exploring best practices and addressing questions.

With drug development a long and costly process, speakers will also address how companies can continue to innovate and attract investor capital.

Highlights include:

FDA Town Hall

Tuesday, June 19, 2:00 p.m. – 3:30 p.m.

Speakers: Karen Midthun, MD, Director, Center for Biologics Evaluation and Research, Food and Drug Administration (FDA) and Janet Woodcock, Center for Drug Evaluation and Research, Food and Drug Administration (FDA)

PDUFA V: Impact on Innovation, Patients, and Modern Medicines – Super Session

Wednesday, June 20, 3:30 p.m. - 5:15 p.m.

Moderator: Steve Usdin, Washington Editor, BioCentury, Co-host, BioCentury This Week

Speakers: Marc Boutin, JD, Executive Vice President and Chief Operating Officer, National Health Council, Peter Greenleaf, President, MedImmune, and Margaret Hamburg, M.D., Commissioner of Food and Drug Administration (FDA)

Analysis and Impact of PDUFA V: What Regulatory Affairs Professionals Need to Know

Tuesday, June 19, 8:30 a.m. - 9:45 a.m.

Moderator:  Janet Jenkins-Showalter, Senior Regulatory Group Director, Genzyme, A Member of the Roche Group

Speakers:  Andrew Emmett, Managing Director, Science and Regulatory Affairs, Biotechnology Industry Organization, Kay Holcombe, Senior Policy Advisor, Genzyme, a Sanofi Company, and Patrick Frey, Director, Office of Planning and Analysis, Center for Drug Evaluation and Research (CDER), Food and Drug Administration

Interchangeable Biosimilars: Distinguishing between Aspiration and Achievement

Thursday, June 21, 8:30 a.m. – 9:45 a.m.

Moderator:  Ramsey Baghdadi, Senior Editor, The RPM Report

Speakers: Erika Lietzan, Special Counsel, Covington & Burling LLP, Joseph Miletich, Senior Vice President, Research and Development, Amgen, Gregory Schimizzi, Co-Founder, Carolina Arthritis, Coalition of State Rheumatology Organizations and Jan Wyatt, Patient Advocate, Arthritis Foundation

Biological Product Pediatric Development in the US: Implementation of PREA and BPCIA

Monday, June 18, 3:45 p.m. – 5:00 p.m.

Moderator: Chin Koerner, Executive Director, Novartis Pharmaceuticals

Speakers: Barbara Buch, MD, Supervisory Medical Officer, Center for Biologics and Evaluation Research, Food and Drug Administration (FDA), Sharon Olmstead, Vice President, Novartis Pharmaceuticals and Karen Weiss, Vice President, Janssen Research and Development

To learn more about the Achieving Regulatory Approval and Compliance educational track and get the most up-to-date program and speaker information, visit