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

Off-label promotion continues to be a main focus of FDA enforcement action. Current trends point to industry executives also facing personal liability risks when found to be incompliant with FDA guidelines.

Today's life sciences companies are tasked with making sense of the gray areas concerning product promotion and other FDA enforcement priorities. But even before commercializing a product, understanding and identifying risks are key to any life science company. Whether these risks begin in the pre-clinical stage or while the product is commercialized, knowing the potential landminds is important in developing and implementing a risk management plan.

During this session panelists will discuss:

• Relevant compliance laws and FDA regulations
• Legal parameters Associated with off-label marketing
• Collateral consequences of off-label investigations
• Best practices for reducing the risks

Moderated by Emily Urban, Senior Vice President, Berkley Life Sciences

• Speaker: Anne Nevard, Life Sciences Risk Management CEO
• Speaker: Judy Waltz, Partner,  Foley & Lardner LLP
• Speaker: George M. Ward, Director of Risk Management, Corporate Compliance, Amylin Pharmaceuticals, Inc.

• Moderated by David Charapp, Foley & Lardner LLP
• Speaker: Sanjay Shukla,MD, Chief Executive Officer, RxMD
• Speaker: LenaA. Basile, Ph.D., J.D., President, Chief Executive Officer, Neumedicines
• Speaker: Randy Berholtz, Executive Vice President, General Counsel and Secretary, Apricus Bio

• Moderated by Richard Kaufman, Foley & Lardner LLP
• Speaker: James Chapman, Foley & Lardner LLP
• Speaker: David M. Sabow, Vice President, Investment Banking. Canaccord Genuity Inc.
• Speaker: Mark P. Stevenson, President and Chief Operating Officer, Life Technologies

• Moderated by Antoinette Konski, Foley & Lardner LLP
• Speaker: Ken Goldman, Global Head, Diagnostics Patents, Novartis Vaccines & Diagnostics, Inc.
• Speaker: Suneel Ratan, Founder and CEO of Care Architecture
• Speaker: Anita Chawla, Ph.D., Vice President, Analysis Group

• Moderated by Vanessa Herbert, Senior Manager, PricewaterhouseCoopers
• Speaker: Kevin O’Boyle, Senior Vice President and Chief Financial Officer, Advanced BioHealing, Inc.
• Speaker: Paul Broude, Foley & Lardner LLP
• Speaker: Bill Smith, Vice President Legal Affairs, General Counsel, Fluidigm Corporation