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

June 2010

Abstract

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.

Authors

Justin McCarthy

SVP Global Policy and International Public Affairs, Pfizer Inc., USA

Mr. McCarthy is the Senior Vice President of Global Policy and International Public Affairs at Pfizer Inc. In this role, Mr. McCarthy is responsible for defining Pfizer’s global policy positions, and driving the advocacy agenda internationally. He serves on the Boards of the Business Council for International Understanding and Acritas and on the harmonization subcommittee of the HHS Secretary’s Advisory Committee on Human Research Protections (SACHRP). He is the Secretary to the Pfizer Board’s Science and Technology Committee. Mr. McCarthy was the Chief Counsel for Pfizer’s Worldwide Research and Development division, advising on regulatory, policy and bioethics matters, and responsible for Pfizer's global Intellectual Property activities. He has extensive experience negotiating Pfizer’s research collaborations and has supported the company’s European Operations Prior to joining Pfizer in 1993, Mr. McCarthy was an associate in the Washington, D.C., law firm of Keller & Heckman, where he focused primarily on food and drug law. He holds a BS in Pharmacy from the University of Rhode Island and a JD from the Catholic University of America.

Marc Wilenzick

Chief Compliance Counsel, R&D, Pfizer Inc, USA

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.

Cara Cuenot

Lead counsel for the BioCorrection Research Unit, Pfizer Inc, USA

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.

Companies

Pfizer Inc.

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 www.pfizer.com.

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

Abstract

Authors

Companies

Pfizer Inc.

Pfizer Inc

Pfizer Inc

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