James T. MacGregor
Toxicology Consulting Services
4811 Island Pond Court, #705
Bonita Springs, Florida 34134
EDUCATION AND PROFESSIONAL CERTIFICATION:
1980-present, Diplomate, American Board of Toxicology
1971 Ph.D., Toxicology, Department of Pharmacology and Toxicology, University of Rochester, School of Medicine and Dentistry, Rochester, New York
1970-72 Postdoctoral training, University of California, San Francisco
1965 B.S., Chemistry, Union College, Schenectady, New York
2004-Present Consultant and Principal, Toxicology Consulting Services, Bonita Springs, FL, and Arnold, MD, providing consulting services related to the development and regulation of pharmaceutical and other products.
2001-2004 Deputy to the Director (for Washington Operations), FDA National Center for Toxicological Research (NCTR), Rockville, MD. Deputy to the Director of the NCTR and Director of the NCTR Washington Office, serving as liaison between NCTR headquarters and FDA organizational units in the Washington, D.C., vicinity. Worked with Senior NCTR and FDA management staff in ensuring integration of NCTR activities with the needs and activities of other FDA organizational units, and with government and private organizations in the Northeast. Participated in setting NCTR program priorities, planning budgets, and identifying resources. Developed and facilitated cooperative research programs and oversaw NCTR and Agency planning and advisory activities in regulatory science.
1997-2001 Director, Office of Testing and Research, FDA Centerfor Drug Evaluation and Research, Rockville, MD.
Director of the Office of Testing and Research, consisting of five program groups and approximately 100 staff that provide scientific and laboratory support to the FDA regulatory programs in the areas of pharmacology, toxicology, product quality, chemical methods development and testing, clinical pharmacology, and regulatory database research and analysis. Implemented AAALAC-accreditation of CDER animal facility and assisted in design of FDA White Oak research facility. Provided interface between FDA policy and review groups and researchers with technical expertise.
1990- 1997 Director, Toxicology and Metabolism Laboratory, SRI International, Menlo Park, CA. Director of the SRI International (former Stanford Research Institute) Toxicology Program, an internationally-recognized research and testing program with approximately 40 staff. Program areas include mammalian toxicology, pharmacokinetics, metabolism, and cellular and genetic toxicology. Responsible for administrative management of the program group, including budget, staffing, facilities, and program development. Also served as Principal Investigator of toxicology research and testing contracts for private industry and Government, and as a consultant in toxicology and product development strategies. Direct manager of drug development contracts for government and industry.
1988 ‑ 1990 President, Toxicology Consulting Services, Inc., Danville, CA. Toxicology consultant to industry and government. During this period also held research appointment in the Division of Biochemistry, University of California, Berkeley.
1985 ‑ 1988 Research Leader, Food Safety Research Unit, U. S. Department of Agriculture, Western Regional Research Center, Berkeley, CA 94710. Manager of the Food Safety Research Unit, a multidisciplinary group with a staff of 35, including 11 professional and 24 support staff responsible for toxicological evaluation of natural products and chemicals related to the production and processing of agricultural commodities. Responsible for all aspects of staffing, budget and research planning. Designed new animal facility and implemented GLP/SOP procedures. Unit responsibilities included toxicological and microbiological evaluation of agricultural food products and research support of regulatory agencies.
1972 ‑ 1985 Toxicologist to Supervisory Toxicologist and Project Leader, Toxicology and Biological Evaluation Research Unit, U. S. Department of Agriculture, Western Regional Research Center, Berkeley, CA. Responsible for program development and toxicological investigations of natural products and chemicals related to the production and processing of agricultural commodities.
1970 ‑ 1972 Postdoctoral Fellow, Department of Pharmacology and Toxicology, Universityof California, San Francisco, CA. Conducted research on the mechanisms of bipyridinium herbicide toxicity, biliary methylmercury excretion, and metabolism and biliary transport of pyridine nucleotide metabolites. Lectured in toxicology and pharmacology courses for medical, pharmacy, and graduate students.
1982 ‑ 1988 Adjunct Associate Professor of Toxicology, Department of Biomedical and Environmental Health Sciences, School of Public Health, University of California, Berkeley, CA. Taught three‑credit graduate genetic toxicology course. Lectured in graduate toxicology courses. Served as doctoral thesis advisor and thesis committee member.
1978 ‑ 1981 Lecturer, Department of Biomedical and Environmental Health Sciences, School of Public Health, University of California, Berkeley, CA. Taught genetic toxicology course. Lectured in general toxicology courses. Supervised graduate student research. Participated in MPH and Thesis examination committees.
1980 Adjunct Faculty, Department of Continuing Education, University of San Francisco, San Francisco, CA.
Lectured in general toxicology course.
1972 ‑ 1978 Lecturer in Food Science, Department of Nutritional Sciences, Universityof California, Berkeley, CA.
Lectured in graduate toxicology course. Supervised graduate student research.
OTHER TEACHING ACTIVITIES:
2003 Instructor, CFSAN Reviewer Training Course on Genetic Toxicology, U.S.Food and Drug Administration
2000 Instructor, CDER Staff College, U.S.Food and Drug Administration, Course on Genetic Toxicology
1970‑1983 University of California Medical Center, San Francisco: lectured each year on the subject of mutagenesis testing, 1972‑1983; taught one quarter graduate genetic toxicology seminar course, 1978; lectured, in toxicology, to medical, pharmacy, and toxicology graduate students, 1970‑72.
DISTINCTIONS & AWARDS
1980‑Present Diplomate, American Board of Toxicology
2018 Albert Nelson Marquis Lifetime Achievement Award, Marquis Who’s Who
2010 Excellence in Science Award, Genetic Toxicology Association
2004 FDA Distinguished Career Service Award
2001 CDER Distinguished Service Award
1998 CDER Award, for leadership of the Office of Testing and Research
1997-1998 CDER Directors Leadership Fellow
1995 Alexander Hollaender Award. Environmental Mutagen Society award in recognition of contributions to the field of environmental mutagenesis related to the protection of human health.
1980‑Present Biographee, Who's Who in the World (1994-pres.), Who's Who in Science and Engineering (1995-pres.), Who's Who in Medicine and Healthcare, (1996-pres.), Who's Who in America (1998-pres.) Who's Who in the West, Men of Achievement, Personalities of the West and Midwest, The Directory of Distinguished Americans, Two Thousand Notable Americans, Who's Who in California
1984 USDA Certificate of Merit (for contributions to the application of techniques of genetic toxicology to food safety evaluation).
1970‑1972 NIH Postdoctoral Fellowship
1965‑1970 NIH Predoctoral Fellowship
1965 Sigma Xi, Associate Membership
1961‑1965 New York State Regents Scholarship
1961‑1965 Cumulative Dean's List Academic Index, Union College
1961 Bausch and Lomb Science Award (Outstanding potential in science)
1961 Valedictorian, Carmel High School, Carmel, New York
1960-1961 President, Student Body, Carmel High School
1960-1961 National Honor Society
Society of Toxicology (Member 1978‑2017, Emeritus Member 2017-Present)
American College of Toxicology (1999-Present)
Environmental Mutagenesis and Genomics Society (1973‑Present)
Genetic Toxicology Association (1998-Present)
Society for Risk Analysis, Natl. Capital Area Chapter (2017-Present)
Society of Toxicology, National Capital Area Chapter (1997-Present)
American Association for the Advancement of Science (To Present)
American Association for Cancer Research (1990-2003)
Genetic and Environmental Toxicology Association of Northern California (1979‑2002)
Association of Government Toxicologists (1983‑1988; 1997-Present)
Society of Toxicology, Northern California Regional Chapter (1986‑1997)
The New York Academy of Sciences (Former)
The Toxicology Forum (2004-2015)
Recent Book: MacGregor, James T., A Natural Mistake: Why natural, organic, and botanical products are not as safe as you think, James MacGregor, Bonita Springs, FL, available as paperback and e-book through Amazon and Ingram distribution outlets, 234 pp, 2019.
Author of Numerous Scientific Journal Articles and Book Chapters