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Growth Strategies for Bioscience Companies

Sponsored by

Wednesday, October 27, 2010
 
Session I:  9:00 a.m. - 10:15 a.m.

It’s All About the Exit: Strategies and Tactics

Your company has made significant developmental progress. You have an excellent management team; but, the costs to develop the technology to the next milestone are daunting.  You have less than one year’s worth of cash and your investors want an exit.  What should you do?
 
Our panel of experts will discuss:
  • Under what circumstances you should pursue a dual track (IPO and M&A simultaneously)? 
  • At what point should you officially engage a bank? 
  • What are the most important tactics for a successful IPO?
  • Does pursuing an IPO really provide leverage for an M&A?
  • What is the most effective way to pursue an M&A?
  • Will investors be less interested if you are also pursuing an M&A?
 
Attendees will learn the nuances of a successful diligence and will gain an appreciation for the importance of the diligence team, the timing of its assembly, and the potential internal and external components. 
 
Moderator:
 
Randall Sunberg
Partner
Morgan, Lewis, & Bockius, LLP
 
Panelists:

Leslie Browne, Ph.D.
President & CEO
Senesco Technologies, Inc.
 
Dennis Purcell
Senior Managing Director
Aisling Capital
 
H. Joseph Reiser, Ph.D.
President & CEO
CureDM, Inc.
 
Stephen Tullman
Executive Chairman
Vicept Therapeutics, Inc.

 
Session II:  10:30 a.m. - 11:45 a.m.

Regulatory Strategies for Growth

Recent proposed changes in the FDA approval processes have led to significant concerns on the part of bioscience companies. Some of the major issues that confound investors and corporate management alike include the length of time of new drug reviews, questions around clinical trials, uncertainty around regulatory reviews for devices, and the perception that regulatory processes are becoming unduly burdensome. 
 
The panelists will discuss approaches that mitigate regulatory risks as an impediment to growth, including: 
 
  • Strategies that can reduce regulatory uncertainty with clinical trials
  • Actions that should be taken to mitigate potential FDA concerns
  • Planning for REMS or if the program began before implementation of REMS, the best way to plan for this in real time
  • Approaches for dealing with foreign regulatory filings versus U.S. filings
  • Approaches for managing regulatory interactions if you are not satisfied with the pace / outcome of feedback

Moderator:

Timothy Whitten
President & CEO
Transave, Inc.

Panelists:

Roy J. Baranello, Jr.
Senior Director, Regulatory Affairs
ViroPharma Incorporated

Charles LaPree
Vice President, Global Regulatory Affairs
Shire Pharmaceuticals

John Maki
President & CEO
Vicus Therapeutics

Oye Olukotun, M.D., MPH, FACC
Chief Executive Officer
CardioVax
 
Session III:  1:45 p.m. - 3:00 p.m.

Alternative Business Models 

The bioscience industry is undergoing dramatic changes due to the economic downturn, the scarcity of capital, and contractions within various segments of the industry. These changes are forcing companies to re-examine their strategies for growth and to become much more creative and thoughtful about the way they nurture and grow their companies. 
 
The necessity of finding innovative ways to finance and grow bioscience companies, including medical devices and diagnostics, has led to transformational business models. Our panel of experts will explore some of the insightful approaches companies are taking to launch, grow, and hopefully find a way to capitalize on their entrepreneurial business endeavors, including: 
  • Single project company versus a portfolio approach
  • Strategic consolidation or roll up model
  • Hibernation or survival model
  • Put option model
  • Virtual model

Moderator:

Mel Billingsley, Ph.D.
President & CEO
Life Sciences Greenhouse of Central PA

Panelists:

Jim Lewis
Vice President, Business Development
Esperance Pharmaceuticals Inc.

Francois Nader, M.D. (Presentation)
President & CEO
NPS Pharmaceuticals

Andrew Reaume, Ph.D., MBA (Presentation)
President & CEO
Melior Discovery, Inc.

Darren Wolfe
President
Diamyd, Inc.

 

 
 
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