FDA Regulatory Changes and Impacts on Biomedical Product Approval and Company Valuations
How Vioxx and the 2008 Election Results are Affecting Your Business
How do changes in the Food and Drug Amendments Act of 2007, heightened scrutiny of safety by the FDA, and pending biosimilars legislation impact product development and intellectual property strategies for life sciences companies?
This interactive session will address FDA and legislative trends and best practices for bringing products to market in the current regulatory and legislative environment. Leading FDA experts and attorneys will share strategies on how to minimize the impact of these trends, optimize company valuation, and develop winning IP strategies.
DATE: Thursday, October 1, 2009
TIME: 7:30 – 8:00am registration and networking breakfast
8:00 – 11:30am program
PLACE: UMass Club, 225 Franklin Street, Boston
TO REGISTER: Contact Kirsten Lovett at klovett@lahive.com or 617.994.0851
Agenda
8:00 – 8:30 FDA Interpretation of the Food and Drug Act Amendments of 2007: Impact on Product Development and on Company Valuation
Allan M. Green, MD, PhD, JD
Attorney-at-Law
amgreen@sdgltd.com
8:30 – 9:00 FDA’s Heightened Scrutiny of Safety Post-Vioxx: Current Agency Policy and Company Best-Practices Response
Lee S. Simon, MD
Former Division Director, CDER, FDA
lsimon@sdgltd.com
9:00 – 9:30 Biosimilars and Generic Biologics: The Development of New Food and Drug Law
William D. Schwieterman, MD
Former Chief of the Medicine Branch, Division of Clinical Trials, CBER, FDA
schweiterman@sdgltd.com
9:30 – 9:45 Break
9:45 – 10:30 Going to Market: Freedom to Operate and Intellectual Property Strategies
Amy E. Mandragouras, Esq.
Partner, Lahive & Cockfield LLP
amandragouras@lahive.com
10:30 – 11:00 Statistical Concepts for Management and Program Analysts: What You Need to Know to Understand the Impact of Clinical Trial Data
Robert W. Makuch, PhD
Former Head, Biostatistics, Yale University School of Medicine
Member, FDA Committee on Setting Guidelines for Examining Large and Computerized Databases for Safety
11:00 – 11:30 Discussion, Questions and Answers
About the Sponsors
SDG, LLC
SDG helps FDA-regulated organizations, their investors and their Boards to accurately assess FDA regulatory risks and opportunities and to take decisive action to achieve their scientific and commercial goals.
One Mifflin Place, Suite 400
Cambridge, MA 02138
Tel: 617.520.6676
Fax: 617.547.1413
E-mail: amgreen@sdgltd.com
www.sdgltd.com
LAHIVE & COCKFIELD LLP
Lahive & Cockfield is one of New England's largest intellectual property law firms and has been a leader in the Life Sciences field for more than 25 years. The Life Sciences group includes 20 professionals, many with Ph.D. degrees, who specialize in biotechnology, pharmaceuticals, and chemistry. Our team is known for developing and implementing effective IP strategies and building strong patent portfolios that protect and facilitate commercialization of products for companies ranging from biotechnology start-ups to leading pharmaceutical companies.
One Post Office Square
Boston, MA 02109
Tel: 617.227.7400
Fax: 617.742.4214
E-mail: amandragouras@lahive.com
www.lahive.com
