Drug Approval & Pharmacokinetics Consultant (1027)
Expertise
Supported the submission/approval of 6 NDAs and over 45 INDs/ERCs.
Championed the integration of drug metabolism and pharmacokinetics in drug discovery and include ADME parameters as part of the drug candidate selection criteria.
Instituted a system to provide 36-hour turnaround time for clinical samples to support concentration controlled phase I-III trials.
Designed and implemented a pre-clinical development process which routinely advanced development candidates from discovery to first dose in humans in six months or less.
Interfaced at every phase of drug discovery and development including the support of marketed products and ANDAs.
Chaired the Pre-Development Committee to coordinate and prioritize research activities with representation from Drug Metabolism and Pharmacokinetics, Safety Assessment, Pharmacy R&D, Analytical R&D, Discovery Chemistry and Pharmacology and Chemical Process R&D.
Experience
Consultant for the biotech and pharmaceutical industry in strategy and execution, pharmacokinetics, drug metabolism, and FDA submissions.
DuPont Pharmaceuticals Company, Newark, DE (acquired by Bristol-Myers Squibb in 10/01/01)
Executive Director, Drug Metabolism and Pharmacokinetics Senior Director, Drug Metabolism and Pharmacokinetics
Directed the activities of the Pre-clinical and Clinical Pharmacokinetics Groups, which consisted of 15 Ph.D. And 30 B.S./M.S. Scientists.
Conducted pre-clinical and clinical studies on the absorption, distribution, metabolism, and excretion of new and marketed drugs and drug candidates and their metabolites in the areas of cardiovascular, central nervous system, cancer, inflammatory, and infectious diseases.
Supported clinical development of new and marketed drugs and drug candidates, by designing clinical pharmacology and clinical pharmacokinetics studies. Activities included writing protocols, analysis of samples, data analyses and writing clinical study reports.
Validated analytical methods using state of the art instrumentation for the identification and quantification of new and marketed drugs and their metabolites in pre-clinical samples.
Partnered with Safety Assessment to conduct dose ranging and GLP studies during acute, subchronic, and chronic evaluation of drug candidates; determination of therapeutic index of drug candidates; preparation of risk benefit statements for regulatory submissions.
Member of Drug Candidate Review Committee and Product Development Board. These groups consisted of senior R&D management responsible for selecting drug candidates, approved pre-clinical and clinical development plans and make go/no go decisions on drug candidates at different stages of development.
Prepared regulatory documents for US (IND, NDA, PLA, etc.) and international (CTX, MAA, etc.) regulatory submissions, marketing pamphlets, clinical investigator's brochures, package inserts, summary basis of approvals, and annual reports to FDA and other regulatory agencies.
Interfaced with FDA and international regulatory agencies on drug metabolism, pharmacokinetics, clinical pharmacology and biopharmaceutics questions and issues.
DuPont Merck Pharmaceutical Company, Newark, DE
Senior Director, Drug Metabolism and Pharmacokinetics
Director, Drug Metabolism and Pharmacokinetics
E. I. DuPont de Nemours & Company, Inc. Newark, DE
Sr. Research Manager, Drug Metabolism and Pharmacokinetics
DuPont Critical Care, Waukegan, IL (acquired by E.I. DuPont in 9/86)
Section Head, Clinical Pharmacology and Drug Metabolism
University of Illinois, Rockford, IL
Guest Lecturer in Pharmacology
American Critical Care, Waukegan, IL
Section Head, Drug Metabolism
Group Leader, Drug Metabolism
Senior Research Investigator, Drug Metabolism
Research Investigator, Drug Metabolism
Honors & Publications
American Society for Pharmacology and Experimental Therapeutics
International Society for the Study of Xenobiotics
American Association of Pharmaceutical Scientists
American Chemical Society
Drug Metabolism Subsection of Pharmaceutical Research and Manufacturers of America
Member, Drug Metabolism Subsection Steering Committee of Pharmaceutical Research and Manufacturers of America (1992-1996)
REVIEWER FOR:
Drug Metabolism and Disposition
Pharmaceutical Research
J. Pharmaceutical Sciences
J. Clinical Pharmacology
J. Pharmaceutical and Biomedical Analysis
Education
University of Delaware, Newark, DE, 1998
Master in Business Administration
University of Wisconsin, Madison, WI, 1977 - 1979
Postdoctoral Study in Oncology, McArdle Laboratory for Cancer Research
University of California at Los Angeles, Los Angeles, CA, 1977
Ph.D. Pharmacology, School of Medicine
University of California at Los Angeles, Los Angeles, CA, 1972
B.S. Chemistry (Honors)