Impending legislation coupled with new FDA initiatives, leave many companies wondering what to expect as we head into 2010. Join the Biopharm Regulatory Reform Summit as
Steven Kozlowski, MD, Director, Office of Biotechnology Products, FDA discusses the challenges in establishing a regulatory pathway for biosimilars. Quality, patient safety, and efficacy are all primary issues the FDA must focus upon in the review and approvals for these complex biologics. Dr. Kozlowski addresses these issues in addition to comparative effectiveness and factors to consider for drug development plans for products in the pipeline. Bring home regulatory insights to challenges with defining “biosimilars” and their scope, biosimilars’ regulatory pathway, and the latest on comparative effectiveness.
Don’t miss the keynote presentations from
Mark McClellan, Senior Fellow, Director of the Engleberg Center for Healthcare Reform,
Carolyn Clancy, MD, Director, AHRQ, and Jim Greenwood, CEO, BIO.
Join the Meet and Greet session with
Jacquelyn White, Director, Office of Strategic Operations and Regulatory Affairs, CMS
In an era of personalized medicine, IIR’s
Biopharm Regulatory Reform Summit provides a unique opportunity to interact with industry thought leaders focusing exclusively on the true downstream effects of reform on how biopharm does business. Join senior leadership for two days to create actionable strategies to respond to reform, protect profitability, and deliver patient driven care for pharmaceutical, biotech and medical device executives.
2009 Faculty Highlights• Dr. Mark B. McClellan, Senior Fellow, Director of the
ENGELBERG CENTER FOR HEALTHCARE REFORM• Carolyn Clancy, MD, Director,
AGENCY FOR HEALTHCARE RESEARCH AND QUALITY (AHRQ)• Jim Greenwood, CEO,
BIOTECHNOLOGY INDUSTRY ORGANIZATION (BIO)• Joseph Antos, Health Adviser to the Congressional Budget Office,
AMERICAN ENTERPRISE INSTITUTE FOR PUBLIC POLICY RESEARCH• D. Bruce Burlington, MD, Pharmaceutical Product Development and Regulatory Affairs, Independent Consultant, former Executive Vice President Business Practices and Compliance,
WYETH• Jane Galvin, Managing Director, Regulatory Affairs,
BLUE CROSS BLUE SHIELD (BCBS)• Julie K. Letwat, JD, MPH, Government and External Affairs,
TAKEDA PHARMACEUTICALS AMERICA• Amy Miller, PhD, Director, Public Policy,
PERSONALIZED MEDICINE COALITION• Les Paul, MD, Vice President, Clinical and Scientific Affairs,
NATIONAL PHARMACEUTICAL COUNCIL (NPC)• Ian D. Spatz, Principal, ROCK CREEK POLICY GROUP and Senior Advisor, MANNATT HEALTH SOLUTIONS, formerly, Vice President, Global Health Policy,
MERCK • Dan Todd, Executive Director, Health Policy,
EMD SERONO• Myrl Weinberg, President,
NATIONAL HEALTH COUNCIL• Jacquelyn White, Director, OFFICE OF STRATEGIC OPERATIONS AND REGULATORY AFFAIRS,
CMS
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