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 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, including the necessity for control assurance in all aspects of research conduct, the need for regionally appropriate mechanisms, and the views of regulators.
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.
7:30 am breakfast and networking
8:00 am Mr. Daniel P. Cafaro, Vice President, Regulatory Affairs, XOMA;
Mr. Peter A. Carberry MD., VP Clinical Operations and Development Planning & Performance Analysis, Genentech Moderator;
Mr. Amor Esteban, Partner Shook, Hardy and Bacon LLP
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.
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.
Amor Esteban, Partner Shook, Hardy and Bacon LLP
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.