Expert Details
Pharmacoepidemiology, Pharmacoeconomics, Epidemiology, FDA, Drugs, Education
ID: 722003
Missouri, USA
As Director of Global Pharmacoepidemiology and Health Economics Research for a major pharmaceutical company, he initiated a program to integrate epidemiologic and health economic considerations in to the entire drug development cycle.
He has experience addressing FDA and other regulatory agency regulations for reporting potential adverse reactions to marketed drugs and for reporting possible safety issues during the drug development process.
He founded the major international society in pharamcoepidemiology and served as its Executive Director for 15 years. He has traveled extensively to many of the 53 countries represented in the society and currently works with collaborators in Europe, Australia, Africa, and Asia. He has particular interests in projects in China and holds an Adjunct Professorship at the Medical School in Tianjin.
He Chairs the Quality Improvement Committee for a major community hospital and partners with a physician who specializes in industry quality management.
Expert spent a year directing the development of a pharmacoeconomics outcomes research business for a major CRO. He commuted monthly for onsite interactions and client visits.
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 1974 | Degree: Ph.D. | Subject: Epidemiology | Institution: University of California - Berkeley |
| Year: 1968 | Degree: M.A. | Subject: Mathematical Statistics | Institution: University of Missouri |
| Year: 1966 | Degree: M.S. | Subject: Public Health | Institution: University of Missouri |
| Year: 1962 | Degree: B.S. | Subject: Mathematics | Institution: University of Maryland |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 1991 to Present | Employer: Undisclosed | Title: Professor | Department: Preventive Medicine |
Responsibilities:Responsibility includes teaching epidemiology and pharmacoepidemiology, advising and supervising graduate students, and research.Semi-retired from Univ. as of September 1, 2009. Continue with funded research projects, community health planning, suicide prevention, and collaborations. |
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| Years | Employer | Title | Department |
| Years: 1987 to 1991 | Employer: Hoechst Marion Roussel | Title: Director | Department: Global Pharmacoepidemiology and Health Economics Research |
Responsibilities:He established and directed the global postmarketing safety department responsible for providing epidemiologic and health economic support to company products. |
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| Years | Employer | Title | Department |
| Years: 1981 to 1983 | Employer: Bureau of Drugs, FDA | Title: Director | Department: Epidemiology Development Branch |
Responsibilities:He directed the program which developed epidemiologic approaches to studying postmarketing drug safety. |
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| Years | Employer | Title | Department |
| Years: 1968 to 1981 | Employer: United States Public Health Service - SF | Title: Associate Chief Research Coord. Br, Chief Clinical Research | Department: Division of Hospital and Clinics |
Responsibilities:He managed the peer review system of clinics and IRBs which distributed $6-$8 million/year in intramural funding. He also directed the coordinating center for two large multi-center clinical trials. |
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Career Accomplishments
| Associations / Societies |
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| Expert is a member of ISPE, ACE, SER, APHA, and the American Society of Suicidology. |
| Professional Appointments |
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| He is a Lifetime Board Member of ISPE and is the Chair of the Global Devleopment Committee of ISPE. He serves on the Board of Governors for the Truman Medical Center. He is also the Chair of the Joint Quality Committee for Truman Medical Center. |
| Awards / Recognition |
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| Expert is the Founder and Incorporator of the International Society for Pharmacoepidemiology. |
| Publications and Patents Summary |
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| He has over 40 publications in peer reviewed journals, has edited one book and has written several book chapters. |
Additional Experience
| Expert Witness Experience |
|---|
| Expert has served as an expert for legal firms in several states and as a "friend of the court." |
| Training / Seminars |
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| He developed and managed over 30 international meetings and conferences, with from 50 to 650 participants. |
| Marketing Experience |
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| He has extensive international experience and contacts in the pharmaceutical industry, regulatory agencies and academia. |
| Other Relevant Experience |
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| He has conducted extensive travel and collaboration in Europe, and has had several lecture visits to Japan and China. |
Language Skills
| Language | Proficiency |
|---|---|
| German | He currently has low levels of German fluency, but at one time spoke fluently. |
Fields of Expertise
drug, drug development, drug regulation, globalization, health care industry quality management, economic research, medical causation, suicidology, pharmacoepidemiology, adverse effect, bioethics, Food and Drug Administration National Drug Code, prescription drug, disinfectant Food and Drug Administration regulation, telecommunications strategic planning, corporate strategic planning, strategic quality planning, pharmaceutics, strategic planning, Federal Food, Drug, and Cosmetic Act, Food and Drug Administration regulation, strategic research planning