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HD Consulting works with leading companies in the pharmaceutical, biotechnology and medical device industries, offering clients high level strategic advice:
- Domestic and global development programs for product approvals,
- Strategies for moving new technologies and therapies through the complex regulatory approval process,
- Protocol design, including collateral study materials,
- Clinical trial management,
- Analysis and presentation of results, and
- Preparation for FDA meetings, particularly FDA Advisory Panels.
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Staff
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Frank L. Hurley, Ph.D.
Chief Scientific Officer |
Dr. Frank Hurley co-founded Biometric Research Institute (later BRI International) in 1971. He established the company's mission to contribute to society by helping to bring safe and effective healthcare products to people around the world. As Chairman and Chief Scientific Officer of BRI, Dr. Hurley had overall responsibility for direction and growth of the company until BRI's 1996 merger with Quintiles Transnational Corporation. Dr. Hurley served as Quintiles Chief Scientific Officer from 1996 to 2000.
Currently, Dr. Hurley serves as Chief Scientific Officer for HD Consulting, LLC. In this capacity, Dr. Hurley works with clients to develop strategic plans for regulatory approval and evaluates regulatory and clinical research projects for new product development.
Dr. Hurley has played a major role in moving significant new technologies and therapies through the complex regulatory approval process, involving presentations and filings to nearly every new product review division of the FDA. He has been involved in over 200 successful clinical studies of pharmaceuticals, biologics, medical devices, and diagnostic products, as well as a number of epidemiologic studies of the long-term effects of drugs and medical devices. He is widely respected by government, industry, and academia for his knowledge and expertise in all phases of the regulatory approval process, including multinational clinical studies, clinical trials management, and post-marketing surveillance.
A nationally recognized and published educator and authority on research strategy and study design, Dr. Hurley has presented over 100 papers to congressional committees, FDA advisory panels, and other bodies. He is Adjunct Professor of Biostatistics and Epidemiology at Georgetown University and received its Vicennial Medal, recognizing 20 years of service to the University. He received his B.S. in Mathematics from Georgetown University in 1966 and his Ph.D. in Biostatistics from Johns Hopkins University in 1970. He is a member of the American Statistical Association, the Drug Information Association, the Food and Drug Law Institute, the Regulatory Affairs Professionals Society (Past Vice President, International Section), and the Society for Clinical Trials.
Since 2000, Dr Hurley has served as Chairman of the Board of Directors of Anvil Informatics, a bioinformatics company serving the biotechnology and pharmaceutical industries.
In 1996, Dr. Hurley was appointed by Governor Allen to the Board of Directors, Virginia Biotechnology Research Park Authority. Dr. Hurley also serves on the following Boards: The Johns Hopkins University Health Advisory Board of the Bloomberg School of Public Health, The Johns Hopkins University Bloomberg School of Public Health Dean's Alumni Council, Coagulation Diagnostics, Inc. Board of Directors, and The BRI Foundation Board of Directors.
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Catharine C. Dorrier, M.S
Senior Technical Advisor |
Catharine Dorrier has over 30 years of experience in the field of clinical trial design, conduct of clinical trials, and analysis and reporting of clinical trial results. She has provided senior oversight to domestic and global development programs for product approval.
Her focus is the effective design, management, and evaluation of trials to conform to regulatory requirements and support approvable regulatory submissions. She serves in a senior advisory capacity in the development of study materials (protocols, CRFs, instruction manuals), in trial management (oversight of clinical sites, monitoring, and audits), in database management (system setup, ongoing management), and in analysis and reporting of results.
Ms. Dorrier has experience in a wide range of therapeutic areas for pharmaceutical products and medical devices, including cardiovascular, CNS, dermatology, rheumatology, hematologic, orthopedic and ophthalmic. She has been involved in the development of many regulatory submissions, including INDs, NDAs, IDEs, PMAs, and 510(k)s.
Ms. Dorrier received her Masters Degree in Biostatistics and Epidemiology from Georgetown University and a Bachelor of Arts degree from the University of North Carolina.
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Contacting Us
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Frank L. Hurley, Ph.D.
Chief Scientific Officer
Ph: (302)541-0980, Ext. 14
Fhurley@hdconsulting.com
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Catharine C. Dorrier, M.S.
Senior Technical Advisor
Ph: (302) 541-0980, Ext. 13
Kdorrier@hdconsulting.com
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Melissa D. Atkinson
Business Manager
Ph: (302) 541-0980, Ext. 19
Matkinson@hdconsulting.com
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Mailing Address:
HD Consulting, LLC
P.O. Box 1467
Bethany Beach, DE 19930
Courier/FedEx Address:
HD Consulting, LLC
98 Oakwood Street
Bethany Beach, DE 19930
Ph: (302) 541-0980
Fx: (302) 541-9275 |
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Places on the Web
U.S. Government Sites Food and Drug Administration
European Sites
International Conference on Harmonisation (ICH) Related Sites
Regulatory Affairs and Resource Sites
Related Industrial and Professional Medical Societies
Other Government Sites
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