FDA '09

A Two-Part Seminar Focusing on the Key Issues Facing Life Sciences Companies in the Next Twelve Months

Thursday, January 29, 2009 • The Westin San Francisco Airport

8:00 AM - 1:45 PM PST

1 Old Bayshore Highway
Millbrae, California 94030

Sidley is co-hosting this event with Woodruff Sawyer & Company and Bay Bio.

Part I: Focus on FDA

What are the new Administration's priorities for FDA, health-care reform and innovation?
Will product review become more predictable, and FDA less risk-averse, in the new Administration?
How will Congressional oversight change with Congressman Waxman’s new leadership role?
Will the next Administration request, and will the Congress provide, additional resources for FDA to carry out its public health mission?

Speakers:

Scott Gottlieb, MD, Resident Fellow, American Enterprise Institute
A practicing physician, Dr. Gottlieb has been Senior Adviser for Medical Technology, Director of Medical Policy Development, and most recently Deputy Commissioner for Medical and Scientific Affairs at FDA. He has also served as a senior policy adviser at the Centers for Medicare and Medicaid Services.

John P. Ford, Counsel, Sidley’s Washington, D.C. office
John came to Sidley from the House Energy and Commerce Committee where he was a Senior Democratic Counsel. His practice focuses on food and drug and healthcare law and policy.

Part II: Litigation Risk Management

Update on FDA reviewers' referrals to the SEC under the 2004 MOU.
How can life sciences companies accurately disclose material information about the status of FDA review in the current environment of uncertainty in FDA review processes?
What factors have contributed to the recent securities cases against the biotech industry?
What disclosure issues should be of concern to life sciences companies?
How do the current SEC hot buttons, including the Foreign Corrupt Practices Act (FCPA), apply to life sciences companies?
What issues are of concern to D&O insurers?

Introduction:

Matthew J. Maletta, Vice President, Associate General Counsel and Assistant Secretary, Allergan, Inc.
Allergan, Inc. is a multi-specialty health care company focused on discovering, developing and commercializing innovative pharmaceuticals, biologics and medical devices.

Speakers:

Priya Cherian Huskins, Partner, Woodruff-Sawyer & Co.
Priya was selected in 2007 by Business Insurance as one of the industry’s “Women to Watch.” She is a recognized expert in D&O liability risk and its mitigation. Priya also counsels clients on how to reduce exposure to shareholder lawsuits and regulatory investigations as well as other corporate governance matters.

Sanjay Bhandari, Partner, Sidley’s Los Angeles office
A partner in Sidley's Los Angeles office, Sanjay is a former federal prosecutor and SEC enforcement lawyer. His practice focuses primarily on white collar defense matters including FCPA and complex civil litigation.

Sara B. Brody, Partner, Sidley’s San Francisco office
Sara has extensive experience defending shareholder class and derivative actions in state and federal courts throughout the United States. She regularly represents companies before the Securities and Exchange Commission and other regulatory organizations.

Mark C. Molumphy, Principal, Cotchett, Pitre & McCarthy
An accomplished plaintiffs' attorney, Mark has extensive experience in consumer and investor fraud class actions.

Agenda:

Registration (breakfast provided)	8:00 am
Part I: Focus on FDA	9:00 am – 11:00 am
Lunch (provided)	11:00 am – 11:30 am
Part II: Litigation Risk Management	11:30 am – 12:45 pm
Networking Coffee	12:45 pm – 1:45 pm

Applicable California MCLE credit will be provided.