The Globalization of Clinical Trials - Challenges, Opportunities and a Path Forward

Cara Cuenot, Lead counsel for the BioCorrection Research Unit, Pfizer Inc
Marc Wilenzick, Assistant General Counsel, Regulation and Compliance Section, Pfizer Inc
Justin McCarthy, Senior Vice President and Associate General Counsel, Pfizer Inc

In recent years, pharmaceutical companies have expanded clinical research in emerging markets around the world and increasingly involving populations that traditionally have had limited or no access to clinical trials (other than experimental treatments for communicable diseases). Trial sponsors can increasingly find well qualified investigators from Latin America, Eastern Europe, Asia and other non-European and non-North American regions. By identifying and including them in their trials, industry can build a strong presence in formerly under-served areas, accelerate trial enrollment, and maintain or improve data quality and scientific standards.

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USA Regulation Pharmaceutical June 2010 Vol. 3, No. 11, Spring 2010

Cara Cuenot


Cara Cuenot is lead counsel for the BioCorrection Research Unit at Pfizer. She also helps to support R&D policy related matters. She holds a BS from the University of Vermont, a JD / MS from Syracuse University and her MBE from the School of Medicine at the University of Pennsylvania.

Marc Wilenzick


Marc Wilenzick is the Chief Compliance Counsel for R&D & Clinical Trials at Pfizer. He also serves as the lead regulatory and policy counsel for R&D. Prior to joining Pfizer, Marc was an attorney at the U.S. Food and Drug Administration. He holds a BA and a JD degree from the University of Texas at Austin.

Justin McCarthy


Justin McCarthy is a Senior Vice President and Associate General Counsel at Pfizer Inc and is the Chief Counsel for Pfizer’s Worldwide Research & Development division. He is responsible for coordinating legal support for the company’s research activities and external collaborations across R&D and leads a clinical trial platform that supports Pfizer’s clinical trial activities across all of Pfizer’s business units. As part of this role, Justin is leading an industry-wide initiative focusing on improving public trust in industry-sponsored clinical trials and is a member of the SACHRP Subcommittee on Harmonization. Justin also has responsibility for Pfizer's global Privacy function. In addition to counselling Pfizer on research policy and bioethics, Justin has led the design and implementation of a novel outside counsel program that attempts to fundamentally alter the relationship between inside and outside counsel by doing away with the billable hour and using a smaller alliance of firms with whom the company can form stronger relationships to provide more effective and efficient legal support to Pfizer. Justin joined Pfizer in 1993 based at corporate headquarters in New York, where he provided regulatory law support for all Pfizer businesses. In 1998, he relocated to Brussels where he provided legal support to Pfizer’s European Operations. He returned to the US in 2001 to support Pfizer’s expanded research and development operations after the merger with Warner-Lambert. Prior to joining Pfizer in 1993, Justin was an associate in the Washington, D.C., law firm of Keller & Heckman, where he focused primarily on food and drug law. Justin holds a BS in Pharmacy from the University of Rhode Island and a JD from the Catholic University of America.

Pfizer Inc


Pfizer is the world's leading biopharmaceutical company. We apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world s best-known consumer products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world s leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more about our commitments, please visit us at

USA Regulation Pharmaceutical June 2010 Vol. 3, No. 11, Spring 2010

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