The French-American Chamber of Commerce of San Francisco
cordially invites you to join them to a:

Life Science Breakfast
Globalization of Clinical trials

Monday, April 23rd
7:30 am - 9:30 am at Swissnex

Swissnex connects the dots in science, education, art and innovation,
between Switzerland and Western North America
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"Clinical trials are essential to the successful launch of any drug. In today’s high FDA scrutiny environment, they represent an increasingly important - and therefore expensive - piece of the drug development process.

As a means to the lower costs of clinical research compared with the United States or Western Europe and to gain access large treatment-naive patient populations, middle-income countries in Asia, South America and Eastern Europe are rapidly emerging as significant areas of interest for pharmaceutical and biotech companies.

The increasing focus of clinical trials research in these regions posses several challenges, however, including the necessity for control assurance in all aspects of research conduct, the need for regionally appropriate mechanisms to support institutional approval and patient consent procedures, and the views of regulators, such as the FDA, about research conducted predominantly or exclusively outside the United States.

This session will consider the opportunities and challenges of conducting pivotal clinical trials outside the traditional research networks in high-income countries, the FDA’s stance regarding the globalization of clinical trials, and the impact that clinical trials have on the valuation of companies."

Peter A. Carberry M.D., VP Clinical Operations and Development Planning & Performance Analysis, Genentech

Peter Carberry attended medical school and residency in Surgeryat the University of Nairobi, Kenya. He completed a postdoctoral fellowship in clinical pharmacology at the University of Texas, Health Science Center in San Antonio in 1991. and graduated with an MBA from Western Michigan University in August 2000. Peter has 14 years of experience in the industry having worked in clinical development, corporate pharmacovigilance and clinical operations at Pharmacia for 10 years, moving to J&J PRD as VP of Clinical Operations in 2003, followed by his promotion to SVP Global Clinical Operations for J&J Pharma. Peter joined Genentech in March 2005 and is VP Clinical Operations and Development Planning & Performance Analysis. He is based in San Francisco, California.

Daniel P. Cafaro, Vice President, Regulatory Affairs, XOMA

Daniel P. Cafaro is XOMA's Vice President, Regulatory Affairs. He joined the Company in 1996 as Director of Regulatory Affairs. In addition to directing worldwide regulatory activities for the Company, he has had primary responsibility for leadership of ophthalmic product development applications. From 1981 to 1996, Mr. Cafaro held several managerial positions at Allergan, Inc., directing worldwide regulatory affairs and product development. He belongs to several professional societies including the Regulatory Affairs Professional Society, the British Institute of Regulatory Affairs, and the Drug Information Association. Mr. Cafaro holds a B.S. in Chemistry from the University of California Los Angeles.

As a partner of Shook, Hardy & Bacon L.L.P., Amor specializes in the representation of pharmaceutical, biotech and medical device manufacturers in mass torts and class actions, with an emphasis in clinical trials and electronic discovery. His practice includes the defense of commercial litigation involving claims of unfair business practices and commercial disputes. Amor consults with industry on subjects ranging from clinical trials and clinical trial agreements, the development of electronic records management systems, crisis management, avoiding litigation and risk management. Amor was the co-chair of the life science department at his former firm and the managing partner of its San Francisco office. Amor’s expertise in e-discovery and data management is widely known. In 2003, he served on the ABA task force that was responsible for the 2004 e-discovery amendments to the 1999 Discovery Standards promulgated by the Section of Litigation. Having served on various working groups for The Sedona Conference, an e-discovery think-tank, Amor currently sits on Sedona’s editorial board for the working group that focuses on electronic discovery internationally. Amor is also recognized for his legal work on behalf of the sponsors of clinical trials and has written and lectured extensively on the subject. His experiences include the transactional aspects of the representation, for example the drafting of clinical trial agreements and participant consent protocols, as well as the defense of personal injury claims arising from clinical trials.

Ms. Caroline Puiggali is a Vice President with the San Francisco Office of Cogent Valuation. Ms. Puiggali joined the firm in 2000 after she graduated from the University of Paris Dauphine, France, where she earned a Master’s Degree in Finance. Her experience at Cogent Valuation includes the valuation of various companies involved in the high technology and life science sectors and the service industry, as well as interests in venture capital funds. She has also worked on a range of valuation assignments for transaction, tax, solvency, recapitalization, and litigation support purposes. Ms. Puiggali is a Chartered Financial Analyst charter holder and an Accredited Senior Appraiser of the American Society of Appraisers.

REGISTRATION

Registration price valid until 5-days Prior to the event date
Cancellations must be made 5-days prior to the event date
Any cancellation within a 5-day period of the scheduled date will not be refunded
Name of guest will be kept at the door