Pre-Conference Interactive Workshop, Tuesday 2nd March 2010, Boston, USA
Creating confidence in a new wave of biologics therapy - Overcoming barriers to entry
Led by: Gil Bashe, Executive Vice President, Makovsky + Co
Brian E. Harvey, MD, PhD, Vice President, Regulatory Policy, sanofi-aventis
Kristie Kuhl, JD, Senior Vice President, Makovsky + Company
Francis B. Palumbo, PhD, JD, Professor and Executive Director, University of Maryland School of Pharmacy Center on Drugs and Public Policy
Timings: 09:30 - 10:00 Coffee & Registration
10:00 - 15:00 Workshop
Timing includes lunch and refreshment breaks
Agenda:
Legislative pathways for biosimilar regulatory approval may provide significant implementation confusion. The wrong path to biosimilar approval may jeopardize ability to develop future advancements and place obstacles in the path to reducing healthcare costs. The debate on whether legislation is pro-innovator or biogenerics entrepreneur may overshadow addressing key concerns for future success. This workshop will summarize the key concerns and enable participants to tackle these issues. Discussions include:
• How much authority will FDA have to make case-by-case approval decisions?
• What should the clinical data requirements be for approval, immunogenicity and subsequent interchangeability?
• Class and product-specific naming
• How should market exclusivity address ever greening?
• How does patent law affect FOBs entry into the market?
• What should the nomenclature system be to reduce confusion and promote patient safety?
About your workshop leaders:
Gil Bashe, Executive Vice President, Makovsky + Co
Workshop Leader
Mr. Bashe is counselor to pharmaceutical, biotechnology, medical-device manufacturers and patient advocacy groups. He has advised clients on follow-on-biologic (FOB) policies and reimbursement, first in Europe and now in the United States. Mr. Bashe is a limited partner with GTCR Golder Rauner, one of the nation’s leading private-equity firms and was CEO of CommonHealth, a WPP Group company, having served as at sister-company Hill and Knowlton as Worldwide Health Practice director overseeing policy, provider and product communications.
Brian E. Harvey, MD, PhD, Vice President, Regulatory Policy, sanofi-aventis
Dr. Harvey leads the sanofi-aventis Corporate Regulatory Affairs (CRA) office in Bethesda, Maryland and interacts with the Food and Drug Administration (FDA), C-Path Institute and key industry representatives on behalf of sanofi-aventis. He represents sanofi on PhRMA, Regulatory Affairs Coordination Committee, and BIO’s Regulatory Affairs Committee. Prior to joining sanofi, Dr. Harvey worked at the FDA in CDRH, CBER and CDER centers for more than 11 years and worked on health issues in the U.S. Senate. Dr. Harvey completed his Ph.D. in biochemistry and his M.D. degree at the University of Connecticut.
Kristie Kuhl, JD, Senior Vice President, Makovsky + Company
Kristie Kuhl provides counsel on issues that impact biotechnology, specialty pharma, dietary supplements and medical devices. Her legal and communication skills provide keen insight in bringing together communities with diverse interests especially important in the FOB arena. She has provided counsel on the issues surrounding biosimilar approvals in Europe including communicating the differences between biosimilars and generic drugs.
Francis B. Palumbo, PhD, JD, Professor and Executive Director, University of Maryland School of Pharmacy Center on Drugs and Public Policy
Dr. Francis Palumbo is both a lawyer and registered pharmacist and approaches biosimilars with a unique perspective. He has a strong interest in pharmacy and food and drug law, pharmacoeconomics, pharmacoepidemiology and health services research. As an adjunct professor at the Maryland School of Law, he teaches a course in food and drug law, including content on foods, dietary supplements, drugs and other products regulated by the FDA and its sister agencies. Dr. Palumbo received his B.S. in Pharmacy from the Medical University of South Carolina, M.S. and Ph.D. in Health Care Administration from the University of Mississippi and J.D. from the University of Baltimore Law Center.
About: Makovsky + Co
Founded in 1979, Makovsky + Company is today one of the nation’s leading independent global public relations consultancies. The firm attributes its success to its original vision: that the Power of Specialized ThinkingTM is the best way to build reputation, sales and fair valuation for a client. Celebrating its 30th year in 2009, Makovsky has received numerous industry accolades including; the American Business Awards 2009 PR Agency of the Year and Holmes Report 2009 Multispecialist Agency of the Year. Based in New York City, the firm has agency partners in more than 26 countries and in 35 U.S. cities through IPREX, the third largest worldwide public relations agency partnership, of which Makovsky is a founder.
For further information, please visit: www.makovsky.com