Session Information
2008 BIO International Convention
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Getting Deals Done in a Regulated Industry
Track : Regulatory
Program Code: 53
Date: Wednesday, June 18, 2008
Time: 2:00 PM to 3:30 PM  EST
Location: 30DE
CHAIR :
Jill Alvarez, Senior Corporate Counsel, Vertex Pharmaceuticals Incorporated
SPEAKER (S):
Thomas Gunning, JD, VP & General Counsel , EMD Serono, Inc
Lawrence Miller, Assistant General Counsel Licensing and Mergers & Acquisitions, Pfizer Inc.
Kerry Reinertsen, PhD, Vice President, Corporate and Business Development , Vertex Pharmaceuticals, Inc.
Description
"This panel will address the intersection of business and regulatory issues that must be considered and reconciled in a merger, acquisition, joint venture or other transaction involving a biotech company. Doing a deal means not only
satisfying the business and financial objectives of the company, but also determining how the requirements imposed on a biotech company by the FDA and other regulators (both in the United States and internationally) affect and drive the business objectives. Understanding the interrelationship between the FDA and other regulators, including the SEC, is part of that."

Objective1:Outline how to conduct regulatory due diligence in all phases of a business transaction.

Objective2:Identify risks and risk-management strategies. For example, what are the implications to a buyer of acquiring a product line from a seller under government investigation?

Objective3:Explain how to evaluate a biotech company's IP, assets and products, including how to identify trends, marketing exclusivity and market competition.


Streaming Audio with
PowerPoint Slides
(Code: 53)
  
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