Winning Strategies: How to Create, Grow, and Sustain a Successful Life Sciences Company

The global push to reduce the costs of both R&D and clinical trials, coupled with the large Chinese population and relative ease of enrolling clinical trial participants in China, is causing many U.S. pharmaceutical and biotech companies to consider doing R&D work in China even for drugs destined for sale outside of China. Awareness of differences in regulatory and business practices between China and the U. S. can make the difference between a successful result and failure for these efforts.

• Potential pitfalls and obstacles in product development outside the US
  • Working with Chinese clinical research organization (CRO)
  • Effective use of clinical research data received from Chinese partners
  • Manufacturing issues
  • Legal issues related to export permits from China
  • Real-world case studies
• FDA enforcement priorities on Cross-Border R&D  
  • What happens when cross- border clinical trials go wrong?
• Understand contractual/culture differences when doing R&D in China

Moderated by:
Paul A. Stewart, Partner, Foley & Lardner LLP

Speakers:
David Rosen, Partner, Foley & Lardner LLP
Sofie Qiao, Ph.D, President, CEO and Co-Founder, LINQ Pharmaceuticals
Jimmy Z. Zhang, Ph.D., M.B.A, Vice President, Synergenics, LLC

The value of an innovative company’s intellectual property and how best to protect it globally is multifaceted.  In today’s environment of economic uncertainty, business leaders and IP counsel need an understanding of business transactions and the role IP plays in those transactions; the changing global landscape; and anticipated regulatory challenges. During this session, our speakers will discuss the following:

• Protecting intellectual capital in a time of uncertainty: strategies to protect IP in today’s changing economic landscape;
• Evaluating your IP value in a global economy - what to keep and what to shed; 
• Due diligence strategies in business transactions -  the role of IP and imperative steps to take to protect it  during and after the transaction; and
• Trends and tips from the experts:  what VCs value in IP portfolios.

Moderated by:
Antoinette F. Konski, Partner, Foley & Lardner LLP

Speakers:
Elin Hartrum, Director, Intellectual Property, Gilead Sciences, Inc.
Govind Gupta, Principal, Valuation & Business Modeling, Ernst & Young
Carol Cherkis, Ph.D., Life Sciences Consultant, NewCap Partners, Inc.

During the past several years, business development activity has a renewed focus on licensing and collaborations designed to continue to drive innovation, provide capital and further product portfolios.  Throughout the past years, these types of transactions have progressed and new models for deal structures have been developed in response to factors including financial and regulatory challenges.  There are benefits and disadvantages to deals as well as strategies for managing these complex strategic partnerships.  During this session panelists will review the following:

• How does big pharma identify new targets?Are companies investing in start-ups?
• How can you get noticed by big pharma? Getting a “yes” instead of a “no”
• What are the latest deal trends and are there new ways to structure deal terms?
• Real world examples – how to manage partnerships and keep the deal alive
• Cross boarder partnering deals - avoiding pitfalls and achieving a successful partnership

Moderated by:
Richard Kaufman , Partner, Foley & Lardner LLP

Speakers:
Linda Pullan, Pullan Consulting
Roy Wu, Senior Vice President for Business Development, NovaBay Pharmaceuticals
Remi Brouard, Vice President, External Innovation, Sanofi-Aventis
Ethan K. Knowlden, Vice President, Business Development & Licensing, Corporate Counsel, Novartis Diagnostics