D. BRUCE BURLINGTON, M.D.
Dr. Bruce Burlington is an Independent Consultant on regulatory affairs and drug development with special interests in helping companies prepare for key meetings with the U.S. Food and Drug Administration (FDA), conduct product due diligence evaluations, and set up processes, organizations, and staffing plans to achieve their regulatory obligations.
Dr. Burlington was Executive Vice President and worldwide head of Regulatory Affairs, Human Safety, and Quality at Wyeth. He led the company in the development and U.S. and global registration of many products as well as improving Wyeth's compliance posture. During these eight years, as a member of many Wyeth governance councils and committees, he participated broadly and in depth analyzing the complex forces driving the business side of the industry.
Before joining Wyeth, Dr. Burlington served at the FDA for 17 years. He was the first physician named as director at of the Center for Devices and Radiological Health (CDRH), where he led major changes, increased the rigor of clinical investigation for medical devices, and championed innovations in how the Center could work more productively with industry. Before that he was a research immunologist and then a manager in both the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER). In these centers he had responsibility for viral vaccines, investigational biologics, BLA review, NDA approvals, generic drugs and, as medical Deputy Director in CDER, policy and compliance decisions for pharmaceuticals.
He is a Member of the Boards of Directors for AzstraZeneca and Cangene. Dr. Burlington is board certified in Internal Medicine and Infectious Diseases.
Frederick Frank is Chairman of EVOLUTION Life Sciences Partners (ELSP). He is also co-founder and Managing Partner of Life Sciences Partners, LLC, a financial advisory firm. Before joining ELSP, Mr. Frank was Chairman of Burrill Securities and Vice Chairman of Burrill & Company.
He began his investment banking career at Smith, Barney & Co. Inc. in 1958, where he attained the positions of Co-Head of Research, Vice President and Director. Subsequently he joined Lehman Brothers, Inc., in 1969, as a partner. At Lehman, Mr. Frank provided investment banking services to an extensive number of companies in the pharmaceutical, biotechnology, healthcare services, medical device and nutraceutical industries, and was involved in hundreds of financings, strategic alliances, and merger and acquisition transactions in the global healthcare industry.
Mr. Frankís clients have included Marion Laboratories, from leading the companyís initial public offering to its acquisition of the pharmaceutical division of Dow Chemical, creating Marion Merrill Dow. Then, with Ms. Tanner, he represented Marion Merrill Dow in creating its merger with Hoescht to form Hoescht Marion Roussel, Inc. Mr. Frank also represented Synthelabo in France in its acquisition by Sanofi, which created the second largest French pharmaceutical company. Most recently, Mr. Frank advised CV Therapeutics Inc. in its $l.4B sale to Gilead Sciences Inc.; BioDuro LLC, a China-based company in its sale to PPD, Inc.; TargeGen, Inc., in its sale to sanofi-aventis; CGI Pharmaceuticals, Inc. in its sale to Gilead Sciences, Inc.; and OSI Pharmaceuticals Inc. in its sale to Astellas Pharma Inc.
ROBERT DE JAGER, M.D.
Dr. De Jagerís scientific, medical and broad-based expertise over the last 40 years in directing the development of new anti-cancer drugs, both domestically and internationally have contributed to the development and deployment of novel treatments for cancer. Most recently, Dr. De Jager led clinical research programs at the globally operating clinical research organization, ICON Clinical Research. Previously, Dr. De Jager served as Chief Medical Officer at Poniard Pharmaceuticals, Kosan Biosciences and Conforma Therapeutics (acquired by Biogen Idec). Prior to that, Dr. De Jager served as Head of Oncology Research and Development at Daiichi Pharmaceuticals, and as VP Clinical R&D at RGene Therapeutics. Earlier in his career, Dr. De Jager had served at AKZO-Nobel as Director of Medical Research, leading a significant cancer vaccine program for colorectal cancer. Before entering the industry, Dr. De Jager was Assistant Professor at Memorial Sloan Kettering Cancer Center, and was a founding member of the European Organization for Research and Treatment of Cancer (EORTC) Pharmacokinetics and Metabolism Group, and Member of the EORTC Early Clinical Trials Group. Dr. De Jager received his Doctorate of Medicine Degree at the Free University of Brussels, Belgium. Dr. De Jager contributed to over 200 publications, including research articles, book chapters and abstracts.
TOMMY G. THOMPSON
As former Health and Human Services Secretary, Tommy G. Thompson remains one of the nation's leading advocates for the health and welfare of all Americans. He was the 19th individual to serve as Secretary of the Department.
As Secretary, he launched major initiatives to strengthen the nation's preparedness for a bioterrorism attack, substantially increased funding for the National Institutes of Health, reorganized the Centers for Medicare and Medicaid Services to encourage greater responsiveness and efficiency, cleared the backlog of waivers and state plan amendments, approving 1,400 and thereby providing health insurance to 1.8 million lower-income Americans throughout the nation; urged all Americans to prevent disease by focusing on critical health areas, such as obesity, diabetes and health disparities; and continued making welfare a path to employment and opportunity.
Mr. Thompson has dedicated his professional life to public service, most recently serving as governor of Wisconsin since 1987. Mr. Thompson made state history when he was reelected to office for a third term in 1994 and a fourth term in 1998. During his 14 years as governor, he focused on revitalizing Wisconsin's economy. He also gained national attention for his leadership on welfare reform, expanded access to healthcare for low-income people, and education.
DAVID J. WILLIAMS
David J. Williams is the retired Chairman and CEO of Sanofi Pasteur, S.A., the vaccines business of sanofi-aventis Group. Over the course of his 30-year career, Mr. Williams played a vital role in growing Sanofi Pasteur into the world's largest vaccine company. During his tenure, the organization grew from 100 employees and sales of just over $5 million to 11,000 employees and more than $6 billion in revenue.
Mr. Williams' career with Sanofi Pasteur began when he joined the division as a finance manager in 1978. He held a series of increasingly senior positions, culminating in his appointment as President and CEO in 2002. He relinquished his role as CEO in August 2007, but continued to serve as Chairman of the Sanofi Pasteur board until his retirement in January 2008, when he marked his 30th anniversary of service.
In addition to Xcellerex, Mr. Williams presently sits on the Boards of Directors of Blue Cross of Northeastern Pennsylvania, the Hospital Service Association of Northeastern Pennsylvania, AllOne Health Group, and VaxInnate Corporation. Internationally respected, Mr. Williams served as the first liaison member of the Advisory Committee on Immunization Practices to the U.S. Centers for Disease Control and Prevention, on the boards of the International AIDS Trust and the Biotechnology Industry Organization, and as a leader of the Vaccine Policy Working Group of Pharmaceutical Research and Manufacturers Association.
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Page Updated: 05/23/2016 02:43:12 PM