RegLink Advisory Board

Harvey Bale

HARVEY BALE

Former Director-General, International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)

As head of IFPMA in Geneva, Switzerland from 1997 to 2008, Harvey coordinated the R&D-based pharmaceutical and vaccine industry’s work with international agencies including the World Health Organization (WHO), the World Trade Organization (WTO), and the World Intellectual Property Organization (WIPO), as well as public-private partnership initiatives. He played a lead role for industry in the development of the Global Alliance for Vaccines and Immunization (GAVI), and the Medicines for Malaria Venture. He was also a founder and served for eight years as the first president of the pharmaceutical industry's anti-countereiting organization, the Pharaceutical Security Institute (PSI). Earlier in his career, Harvey was Senior VP for International at the Pharmaceutical Research and Manufacturers of America (PhRMA); international trade manager at Hewlett-Packard; and Assistant US Trade Representative at USTR where he led negotiations on intellectual property protection that resulted in Trade-Related Intellectual Property Standards (TRIPS). In 1986, Harvey received the Distinguished Service Award from the President of the United States. He has a B.A. from Temple University and a Ph.D. in Economics from the University of Maryland, and taught a post-graduate level course at Georgetown University.

Contact Harvey: he.bale@gmail.com

Alan Bennett

ALAN BENNETT Esq.

Former Managing Partner, Ropes & Gray, Washington, D.C.

Alan is a recognized expert on issues that arise under the Hatch-Waxman Act, as well as on issues involving pharmaceutical marketing, promotion and education. Alan also has extensive experience in biological products, including the issue of follow-on biologics, in food additive approvals, and in over the counter drugs and procedures to switch them from prescription to non-prescription status. Upon graduating from law school, he served in the Office of the General Counsel of the Food and Drug Administration (FDA), where he was a trial and appellate lawyer and legal advisor to several FDA bureaus. Subsequently, Alan was legislative assistant to the late Senator Jacob Javits and Counsel to the Senate Governmental Affairs Committee, where he concentrated on a wide variety of health regulatory matters, including playing a major role in one of the first medical records privacy initiatives. He graduated with honors from the University of Connecticut and was a Harlan Fiske Stone Scholar at Columbia Law School.

Contact Alan: alan.bennett1@me.com

John Cohrssen

JOHN COHRSSEN Esq.

Member, U.S. Council on International Business (USCIB) and OECD Business, Industry, Advisory Council (BIAC)

John is an advisor to the OECD, U.S. government agencies, and international and domestic companies and organizations on matters relating to pharmaceutical development and marketing. He has a distinguished record of public service, including stints as counsel on FDA reform for the House Energy and Commerce Committee, staff director of the Congressional Biotechnology Caucus, and staff director of the Senate Subcommittee on Aging of the Health, Education, Labor and Pensions Committee during the Clinton Administration. During the Reagan Administration, John served as domestic policy advisor to Vice President Quayle, associate director of the President’s Council on Competitiveness, senior advisor in the White House Council on Environmental Quality, regulatory counsel for the White House Office of Science and Technology Policy, and legal counsel to the White House domestic policy working groups on biotechnology. He received a B.S. with Honors in psychology from the City College of New York, a M.Sc. in psychology from McGill University, and a J.D. from George Washington University.

Contact John: John.Cohrssen@health-law.info

Stuart Dombey

STUART DOMBEY, M.B., F.R.C.P.

Founder and former Chief Scientific and Regulatory Officer, QuatRx

Dr. Dombey co-founded QuatRx in November 2000 and served as its Chief Scientific and Regulatory Officer until August 2016. Dr. Dombey is a U.K.-trained physician with more than 40 years of experience in the pharmaceutical industry and 20 years in the international regulatory arena. His early career involved jobs with Hoechst as Medical Advisor in the U.K. and for Squibb, as U.K. Medical Director and then, as Vice President, Regulatory Liaison in the U.S. In 1990, he joined Parke-Davis in the U.S. as Vice President of International Regulatory Affairs, with responsibility for regulatory activities on Parke-Davis products outside the U.S. and for regulatory policy issues especially with the newly formed European Medicines Evaluation Agency. Prior to joining QuatRx, Dr. Dombey was Parke-Davis’ Vice President of R&D in Japan. Dr. Dombey received his M.B. and Ch.B. degrees from the University of Liverpool Medical School in 1971.

Contact Stuart: sdombey@comcast.net

Marie Dray

MARIE DRAY

Founder and President, International Regulatory Affairs Group, LLC

Marie is widely respected and recognized for her expertise in assisting clients in developing and implementing successful regulatory strategies for product development and marketing approval of pharmaceuticals. She advises on how to work effectively with regulators and whether or not to establish a presence in government policy circles.   Prior to founding the International Regulatory Affairs Group, Marie was with Merck & Co., Inc. in Washington, D.C. and in Brussels, Belgium, where she directed global regulatory policy development, office operations, and liaison with US and European policy makers. While at Merck, she also opened an FDA liaison office, a first for the company and for the industry. Before Merck, Marie was Director, Science and Technology, at PhRMA, directing device and diagnostic committees and high-tech groups, such as the Biotechnology Advisory Committee. She also served as industry’s representative on the U.S. Department of Commerce’s Industry Sector Advisory Group (ISAC) V and on the American National Standards Institute’s (ANSI) Medical Devices Standards Board. Marie began her career as a bacteriologist and hospital administrator (ICU/CCU) at Massachusetts General Hospital in Boston, MA. Marie is a former President of the Drug Information Association’s (DIA) Board of Directors (2008-2009). Marie received her MBA from the George Washington School of Public Administration and her BA from the University of Massachusetts.

Contact Marie: madray@drayrai.com

Linda Horton

LINDA HORTON, Esq.

Linda has represented the U.S. government before international bodies and provided assistance on legislation in the EU, France, Russia, Ukraine, China, India, South and Central America, and the Caribbean. At FDA, she was Director of International Policy, Associate Chief Counsel for Medical Devices, and Deputy Chief Counsel for Regulations and Hearings, and director of the legislative branch. As a partner in Hogan & Hartson’s FDA group, she chaired the firm's international regulatory practice. Linda was on the board of directors of the American National Standards Institute (ANSI), the National Cooperation for Laboratory Accreditation (NACLA), and the Regulatory Affairs Professionals Society (RAPS). She chaired the Editorial Advisory Board of the Food and Drug Law Journal for the Food and Drug Law Institute (FDLI), which recognized her with its highest award for meritorious service. Linda has taught international food and drug law at the Georgetown University Law Center and FDA administrative law at the George Washington University Law School, in each case as an adjunct professor. She received her L.L.M. in international and comparative law in 1997 from Georgetown University Law School, her J.D. with honors in 1975 from the George Washington University Law School (where she was on law review and a member of the Order of the Coif), and her B.A. from the University of Kentucky.

Contact Linda: lrhorton@comcast.net

Bob Paarlberg

ROBERT PAARLBERG

Principal, Paarlberg and Associates, LLC

Bob specializes in corporate regulatory policy development and compliance with global clinical trial disclosure requirements. He is a founding member of the Drug Information Associations’ (DIA) Special Interest Area Community (SIAC) for Clinical Trial Disclosure. Prior to founding Paarlberg & Associates, Bob set up and directed UCB, Inc.’s first global regulatory policy and intelligence organization and chaired UCB’s multi-disciplinary team tasked with interpretation of and compliance with the FDA Amendments Act of 2007 (FDAAA). He also established UCB’s first in-house process for ensuring compliance with clinical trial disclosure requirements in the US and overseas. Prior to joining UCB, Bob was Senior Director at Pharmacia (Upjohn) where he created and directed the company’s first global regulatory policy and intelligence function. He also further enhanced Upjohn’s FDA liaison office in Washington DC and worked closely with the Government Affairs team on key federal legislative issues. Bob is a member of DIA’s Advisory Council of North America Executive Committee (2009-2011) and is the recipient of DIA’s Outstanding Service Award. He received a M.S. in Analytical Chemistry from Purdue University and is a lecturer on drug-related issues and policies.

Contact Bob: RPaarlberg@comcast.net

 

 

RegLink Expert Network

RegLink's Expert Network includes its Advisory Board as well as a number of other widely respected professionals recognized for their expertise*

 

John McManus

JOHN MCMANUS

President, McManus Group
Specializing in representation before the U.S. Congress and the U.S. Administration

John heads up the McManus Group, a consulting firm specializing in policy and political counsel for health care clients with issues before the U.S. Congress and the Administration. Prior to founding the McManus Group, John served as Staff Director of the House Ways and Means Subcommittee on Health where he was the chief staff architect of the Medicare Modernization Act of 2003. Before working in the House of Representatives, John was a Senior Associate at Eli Lilly & Company and Research Assistant for the Maryland House of Delegates Economic Matters Committee and its Health Subcommittee. He received his Master of Public Policy from Duke University and BA from Washington and Lee University.

Contact John: jmcmanus@mcmanusgroup.com

Dan Michels

DANIEL MICHELS

Former Director of FDA’s Office of Enforcement

Dan was a Senior Compliance Consultant with KMI, a division of PAREXEL International, LLC. He joined KMI after nearly 37 years of service with the U.S. Food and Drug Administration. At FDA, he was Director of the Office of Enforcement, Chairperson of the FDA Compliance Policy Council and Chairperson of FDA’s Consumer Safety Officer Peer Review Committee. Dan received his B.A. in Chemistry from the University of California at Berkeley.

Contact Dan: OldEnforcer@aol.com

Gillian Woollett

GILLIAN WOOLLETT

Vice President, Avalere Health
Specializing in evidence-based medicine

Gillian Woollett leads the FDA Practice within Avalere's Center on Evidence-Based Medicine. She provides the “prequel” of scientific and regulatory strategic policy expertise that supports medicinal products gaining approval at the FDA in a manner that allows them to be successful in the public and private reimbursement world. Immediately prior to joining Avalere, Gillian was Chief Scientist at the boutique food and drug law firm of Engel & Novitt, LLP. Prior to that, she was Vice President, Science and Regulatory Affairs at the Biotechnology Industry Organization (BIO), where she established and led a new Department to support BIO companies’ interactions with regulatory agencies in all aspects of the discovery, development, and manufacture of biotechnology-based medicines. She joined BIO after being Associate VP at PhRMA. Throughout, Gillian has represented the biopharma industry with the media, and she served as the industries’ voice on international, as well as domestic, regulatory and science issues. She has been an appointee on Federal Advisory Committees to CDC and the Department of Commerce, and provided a point of scientific interface with academic and professional organizations. Gillian earned her B.A., M.A. in the Natural Sciences Tripos (Biochemistry) from the University of Cambridge, and her D.Phil in Immunology from the University of Oxford in the United Kingdom.

Contact Gillian: gwoollett@avalerehealth.net

* Our Expert Network is a listing service of possible resources. We do not receive a commission from our Network members for referrals.

Follow us on Twitter
Follow RegLink News on Twitter