CBI Generic Drugs Forum

15 November 2007 Arlington, VA Past Event

Location

Doubletree Hotel Crystal City
Arlington, VA

Agenda

November 15-16, 2007

The Center for Business Intelligence (CBI) Annual Forum on Generic Drugs will take place in Arlington, VA, on November 15-16, 2007, with the focus “Concrete Strategies for Confronting Regulatory Challenges, Sustaining Growth and Enhancing Pipelines.”

Chairing the conference this year is David Rosen, partner and co-chair of the Life Sciences Industry Team at Foley & Lardner LLP. As well, Mr. Rosen will present the following two sessions:

Forces Shaping the Generic Drug Regulatory Legislative Landscape
Thursday, November 15, 2007
1:30 – 2:30 p.m.

Examine the current regulatory and legislative environment for the international and domestic generic drug industry, biogenerics and FTC investigations into authorized generics. This panel discussion provides insights into the current state of affairs, the market drivers influencing regulatory and legal rulings and addresses critical issues pertaining to recent legislative decisions. Topics for discussion include:

  • Recent high-impact court cases and how they have impacted pipeline decisions
  • The current climate of FDA, Congress and the courts and the implications on the industry
  • The current status and possible future of biogenerics in the EU & US
  • Results of the FTC's investigation into authorized generics and reverse payments
  • Industry-shaping transactions related to patent disputes, industry consolidation and the emerging presence of foreign companies

Moderator

  • Keeto Saabhawal, Parnter, Blank Rome LLP

Panelists

  • Vincent Andolina, VP Regulatory Affairs, GeneralMedix Pharmacueticals Inc.
  • David Rosen, Partner, Foley & Lardner LLP

Examine the Past, Present and Possible Future of Proving Equivalency for Topical Generics
Friday, November 16, 2007
2:50-3:40 p.m.

Gain an understanding as to the FDA's methods and practices for determining bioequivalency for topical generics. Historically, these products have created more of a challenge than would be expected given the scientific methods employed by the agency. Two former FDA employees investigate how the regulatory approval procedure has evolved and provide insight regarding how the process may progress moving forward. Topics for discussion include:

  • Examine how the agency has handled the approval of topicals over the years
  • Predictions for changes and the evolution of the process for the future
  • Understand why this has been such a challenge

Panelists

  • David Rosen, Partner, Foley & Lardner LLP
  • Nicholas Fleisher, VP Clinical Pharmacology & Biopharmaceutics, The Weinberg Group

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CBI Generic Drugs Forum

Location

Doubletree Hotel Crystal City
Arlington, VA

Agenda

November 15-16, 2007