Office of Research on Women's Health

Pharmacology Conference

Speakers


DARRELL R. ABERNETHY, M.D., Ph.D.
Darrell R. Abernethy, M.D., Ph.D. has recently been appointed Clinical Director of the National Institute on Aging, where he serves as Chief, Laboratory for Clinical Investigation, Director of the NIA intramural Interventional Trials Unit, and has responsibility for the Baltimore Longitudinal Study on Aging. Within the Laboratory for Clinical Investigation, he directs the Section of Molecular and Clinical Pharmacology where ongoing studies to study the role of splice variants of the L-type Calcium Channel contribute to variability in drug response.

Prior to assuming his position at NIH, Dr. Abernethy was on the faculties of Tufts University School of Medicine, Baylor College of Medicine, Brown University School of Medicine, and most recently served as Francis Cabell Brown Professor of Medicine and Pharmacology, Director of the Division of Clinical Pharmacology, and Program Director of the Clinical Research Center at Georgetown University School of Medicine from 1994-1999.

Dr. Abernethy received the M.D. and Ph.D. (Pharmacology) from the University of Kansas School of Medicine, training in Internal Medicine from Jackson Memorial Hospital/University of Miami, and post-doctoral training in Clinical Pharmacology from the Massachusetts General Hospital.

To the present Dr. Abernethy has contributed to understanding of sources of variability in human drug distribution, to understanding strengths and limitations of in vivo pharmacokinetic/pharmacodynamic modeling, and to clinical pharmacodynamics of cardiovascular drugs. He has published 160 original scientific papers, and 50 reviews and book chapters.

 

GAIL D. ANDERSON, Ph.D.
Gail D. Anderson, Ph.D. is an Associate Professor in the School of Pharmacy at the University of Washington in Seattle, Washington. Dr. Anderson obtained her academic education from the University of Washington where she obtained a B.S. in Pharmacy, Master of Science in Pharmacy Practice and Ph.D. in Pharmaceutics. She completed a fellowship in Clinical Pharmacokinetics at the State University of New York at Buffalo, New York and an NIH training fellowship at the Regional Epilepsy center at Harborview Medical Center in Seattle.

Dr. Anderson's has been an investigator on numerous Federal and industry funded research grants. She is author of over 40 publications in the areas of drug metabolism, drug interactions, epilepsy, neurotrauma and women's' health issues.

Dr. Anderson is active in various Pharmacy and Epilepsy professional organizations; including a reviewer for over 10 journals. She serves on the editorial board of Epilepsy Research and currently is Chair of the Professional Advisory Board of Epilepsy Foundation of Washington.


LESLIE Z. BENET, Ph.D.
Dr. Benet, Professor and former Chairman (1978-1998), Department of Biopharmaceutical Sciences, University of California, San Francisco, and Chairman of the Board, AvMax, Inc., received his A.B. (English), B.S. (Pharmacy), M.S. from the University of Michigan and Ph.D. from the University of California. He has received four honorary doctorates: Uppsala University, Sweden (Pharm.D., 1987), Leiden University, The Netherlands (Ph.D., 1995) University of Illinois at Chicago (D.Sc., 1997), and the Philadelphia College of Pharmacy and Science (D.Sc., 1997). His research interests and more than 380 publications are in the areas of pharmacokinetics, biopharmaceutics, and pharmacodynamics.

His most recent work has addressed the cooperative effects of metabolic isozymes of cytochromes P-450 and antitransport proteins as related to immunosuppressive, anti-cancer, anti-AIDS and anti-parasitic drugs, as well as drugs of importance to women's health. He continues his studies to explain the immunotoxicity of NSAIDs as resulting from covalent adducts with proteins through acyl glucuronide and acyl CoA intermediates. Dr. Benet was a Founder and Editor of the JOURNAL OF PHARMACOKINETICS AND BIOPHARMACEUTICS (1973-98) and is presently an Associate Editor of PHARMACOLOGY AND THERAPEUTICS, and a member of the editorial boards of PHARMACOLOGY, PHARMACEUTICAL NEWS, and CLINICAL TRIALS ADVISOR. He is a Fellow of the Academy of Pharmaceutical Sciences, the American Association of Pharmaceutical Scientists (AAPS) and of the American Association for the Advancement of Science (AAAS).

In 1982, Dr. Benet received the APhA Academy of Pharmaceutical Sciences Research Achievement Award in Pharmaceutics and the University of Michigan, College of Pharmacy Distinguished Alumnus Award. In 1985, he served as President of the Academy of Pharmaceutical Sciences. During 1986, Dr. Benet was a Founder and first President of the AAPS. In 1987, Dr. Benet was elected to membership in the Institute of Medicine (IOM) of the National Academy of Sciences. In 1988, he received the Distinguished Service Award of the American College of Clinical Pharmacology and in 1989 he was chosen to receive the first AAPS Distinguished Pharmaceutical Scientist Award. In 1990, he was the recipient of the Rho Chi Lecture Award, and the UCSF School of Pharmacy Long Teaching Award, while in 1991, he received the Volwiler Research Achievement Award of the American Association of Colleges of Pharmacy (AACP). In 1993-94, he served as AACP President. In 1995, he received the Rawls-Palmer Progress in Medicine Award of the American Society for Clinical Pharmacology and Therapeutics and delivered the American College of Clinical Pharmacy ATherapeutic Frontiers Lecture. In 1996, he received the AAPS Distinguished Service Award. Dr. Benet formerly served as Chair for the Pharmacology Study Section and the Pharmacological Sciences Review Committee for the NIH, the FDA Center for Biologics Peer Review Committee and as a member of the FDA Generic Drugs Advisory Committee.

He presently serves as Chair of the FDA Expert Panel on Individual Bioequivalence and the Board of Pharmaceutical Sciences of the International Pharmaceutical Federation (FIP), as a member of the IOM Roundtable on Research and Development of Drugs, Biologics and Medical Devices, the FDA Science Board, and the Board of Directors of the American Foundation for Pharmaceutical Education. He is a Board member, Scientific Board Member and/or Consultant for more than 20 pharmaceutical and biotechnology companies, and Treasurer for the International Society for the Study of Xenobiotics. Dr. Benet was editor of the books, "The Effect of Disease States on Drug Pharmacokinetics," "The Pharmacokinetic Basis for Drug Treatment," "Pharmacokinetics C A Modern View," "Integration of Pharmacokinetics, Pharmacodynamics and Toxicokinetics in Rational Drug Development," and "Clinical Applications of Mifepristone (RU486) and Other Antiprogestins." He also chairs the Organizing Committee for the Millennial World Congress of Pharmaceutical Sciences, to be held April 16-20, 2000, in San Francisco.

 

ROBERT A. BRANCH, M.D.
Dr. Branch is a professor of medicine and pharmacology and a nationally and internationally recognized board certified clinical pharmacologist, whose main research has been on intersubject variability and mechanisms of regulation of drug metabolism in humans. He earned his doctor of medicine degree at the University of Bristol Medical School in Bristol, England. Dr. Branch is Director of the Center for Clinical Pharmacology, established in 1991 at the University of Pittsburgh Medical Center (UPMC) and also directs the General Clinical Research Center, an institution-wide research resource center funded by the NIH. Prior to coming to UPMC, Dr. Branch served as professor of medicine and pharmacology at Vanderbilt University in Nashville, Tennessee.

The multidisciplinary Center for Clinical Pharmacology brings together basic scientists and clinicians who are able to transfer advances in basic science research to clinical medicine. The primary areas of concentration are drug discovery, pharmacogenomics, cardiorenal and associated organ failure, and clinical outcome to drug therapy.

Dr. Branch has helped develop and promote a physiological and pathophysiological approach to understanding the determinants of drug disposition. Current work is exploring pharmacogenomic implications of new knowledge on human phase I and phase II drug metabolizing enzymes. This work extends to evaluation of the interaction between genetic constitution with environmental agents and disease processes, such as acute trauma and chronic liver disease, to influence drug disposition. Dr. Branch has also been applying pharmacogenomic principles and techniques to better understand determinants of inter-individual variation to retinoic acid therapy.

 

THOMAS J. COLATSKY, Ph.D.
Thomas J. Colatsky, Ph.D., is Vice President of Research and Development and CSO at Physiome Sciences, where he directs efforts to develop and validate physiologically detailed computer models of cells and organs for drug discovery and development.. Prior to joining Physiome Sciences in February 1999, Dr. Colatsky served as Vice President of Cardiovascular and Metabolic Diseases Drug Discovery, and Vice President, Scientific Evaluation, Clinical R&D at Wyeth-Ayerst Research. Dr. Colatsky has published extensively in the field of ion channel biophysics and cellular pharmacology. He currently serves as a member of the editorial boards of Circulation Research, Cardiovascular Research, Current Drugs, and Pharmaceutical News, and was recently elected a Fellow of the American Association for the Advancement of Science for his work on ion channels and drug action.

Dr. Colatsky received his Ph.D. in Medical Physiology from the State University of New York at Buffalo, with additional training as a postdoctoral fellow in physiology and membrane biophysics at the Yale University School of Medicine. Prior to joining Wyeth-Ayerst in 1982, Dr. Colatsky was a faculty member of the Department of Physiology and Biophysics at Cornell Medical College, with an adjunct appointment in the Laboratory of Cardiac Electrophysiology at the Rockefeller University. He has been the recipient of several national research grants, including an Established Investigator Award from the American Heart Association.

 

MAUREEN CRONIN, Ph.D.
Dr. Cronin is currently Director of DNA Array Product Applications for Protogene Laboratories, Inc. in Palo Alto, CA. She is currently working to establish, validate and advance functional genetic and genomic assay formats employing Protogene's proprietary surface tension DNA microarray technology. Her responsibilities include developing and managing outside collaborations focused on DNA array technology, including academic relationships supported by extramural funding. In addition, she is a key member of the team managing the basic technology platform development and optimization.

Prior to joining Protogene, Dr. Cronin spent seven years at Affymetrix, Inc. She was a member of the seminal team spun out of Affymax Company to conduct feasibility research demonstrating the utility of DNA microarray hybridization for nucleic acids analysis. Dr. Cronin actively participated in research teams integrating engineering, chemistry, spectroscopy, biology and software engineering to generate DNA arrays by means of a proprietary photolithographic process. Ultimately, Dr. Cronin designed and validated DNA Achip" microarrays useful for genotyping cystic fibrosis mutations, cytochrome P450 polymorphisms and scanning genomic sequences to discover novel polymorphisms and mutations. As the company's activities grew, Dr. Cronin managing contract research focused on applying hybridization array assays to specific genetic applications with corporate collaborators including Hewlett Packard Bioscience Products, Roche Molecular Systems and GlaxoWellcome. In parallel, Dr. Cronin initiated and managed an independent research program in pharmacogenetics supported by SBIR awards and established academic collaborations to support and expand the SBIR funded program.

Dr. Maureen Cronin completed her PhD in molecular pharmacology at the University of California, San Diego campus studying epidermal growth factor regulated genes in epidermoid carcinoma. As a Postgraduate Research Biochemist at UCSD School of Medicine in the Division of Hematology and Oncology, Dr. Cronin conducted research in retrovirology focused on understanding the regulation of human TGF_1, IL6 and TNF_ gene expression in lymphocytes in response to HIV and HTLV infection. The principle mechanism investigated was HIV-tat and HTLV-tax protein transcriptional transactivation of the host genes.

 

GILLIAN EINSTEIN, Ph.D.
Dr. Gillian Einstein is an Assistant Research Professor at Duke University in the Department of Neurobiology. She has a joint appointment in the Department of Zoology, is associated with the Joseph and Kathleen Bryan Alzheimer's Disease Research Center, and is a Senior Fellow in the Center for the Study of Aging and Development. Dr. Einstein obtained her undergraduate degree from Harvard College and her Ph.D. in neuroanatomy from the University of Pennsylvania. After a year's postdoctoral fellowship in physiology at Northwestern University, she moved to Duke University where she has been ever since.

Dr. Einstein's current research focuses on aging and Alzheimer's disease and the neuroprotective effects of estrogens. With her colleagues, she studies the effects of genotype on neuronal connections as animals age as well as the effects of estrogen deprivation and replacement on neuronal connectivity in regions of the brain that mediate learning and memory. Her most recent publication describes a sexual dimorphism in aging and response to estrogen replacement with females loosing neuronal connections as they age and responding with increased connectivity with estrogen replacement. These data may have significant consequences for the timing and administration of hormone replacement therapy in both females and males. Studies in progress include investigations into the combined effects of genotype and estrogen deprivation in accelerating the process of neuronal aging.

Dr. Einstein has authored over 23 peer-reviewed publications and numerous chapters and reviews of the literature. She currently serves on the Society for Neuroscience's Committee for the Development of Women's Careers in Neuroscience and is involved in interdisciplinary teaching and course development at Duke University.

 

DAVID A FLOCKHART M.D., Ph.D.
Dr. Flockhart was born and raised in Edinburgh, Scotland and then took Honors in Biochemistry at the University of Bristol, England from whence he graduated in 1973. He obtained a PhD from the Welsh National School of Medicine in 1976, and a MD from the University of Miami School of Medicine. He then did a residency in Internal medicine at Georgetown University Medical Center, and after a year as Chief Medical Resident at Fairfax Hospital, performed a fellowship in Clinical Pharmacology in the Division of Clinical Pharmacology at Georgetown. He has been an Assistant Professor of Medicine and Pharmacology in this Division since 1993, and has been the Director of the Pharmacogenetics Core Laboratory, and Associate Director of the Division of Clinical Pharmacology since 1995. Dr Flockhart has published more than 50 papers in the area of Clinical Pharmacology, in which he specializes in the study of drug interactions and the contribution of genetics to inter-individual variations in drug response. He is a member of the Executive Committee and Board of the American Society for Clinical Pharmacology and Experimental Therapeutics, and Co-Chair of the Annual Formulary Training Workshop of the ASCPT for Pharmacy and Therapeutics Committees.


MICHAEL M. GOTTESMAN, M.D.
Michael Marc Gottesman was born on October 7, 1946 in Jersey City, New Jersey, and grew up in Flushing, New York. He attended Harvard College where he graduated summa cum laude in biochemical sciences in 1966 and was married the same year to Susan Kemelhor. He graduated from Harvard Medical School with an M.D. degree magna cum laude in 1970 and completed a medical internship and residency at the Peter Bent Brigham Hospital in Boston. His research training began at Harvard in the laboratories of William Beck and Bert Vallee, and continued in the laboratory of Martin Gellert at the National Institutes of Health as a Research Associate from 1971 to 1974. Dr. Gottesman spent a year as an Assistant Professor at Harvard Medical School and then, together with his wife who is a bacterial geneticist, joined the permanent staff of the National Cancer Institute in 1976. He became Chief of the Molecular Cell Genetics Section of the Laboratory of Molecular Biology in 1980, Chief of the Laboratory of Cell Biology in 1990, Acting Director of the National Center for Human Genome Research (NCHGR) from 1992 to 1993, and also Acting Scientific Director of the NCHGR (April 1993 to October 1993). He became Deputy Director for Intramural Research, NIH in November 1993, and Assistant Surgeon General (Rear Admiral), Public Health Service in 1997.

At the NIH his research interests have ranged from how DNA is replicated in bacteria to how cancer cells elude chemotherapy, and he has published extensively on these subjects. Using chloramphenicol resistance as a model, he was one of the first to show that drug resistance genes could move from one replicon to another in bacteria. Applying the tools of molecular and somatic cell genetics to the study of cAMP-resistance and anti-microtubule drug resistance in mammalian cells, he isolated and characterized cAMP-dependent protein kinase mutants and conditional - and -tubulin mutants. These mutants and novel techniques of DNA transfer, which he was among the first to exploit, were used as tools to demonstrate the role of cAMP-dependent kinase in growth regulation and to study the effect of microtubule defects on mitosis. The work on anti-microtubule drug resistance led to studies on multidrug resistance in human cancer cells. During the past 12 years, in close collaboration with Ira Pastan, he has identified the human gene responsible for resistance of cancer cells to many of the most common anti-cancer drugs and has shown that this gene encodes a protein which acts to pump anti-cancer drugs out of drug-resistant human cancers. In addition to the development of strategies to circumvent multidrug resistance in cancer, these studies have led to a new generation of selectable vectors for gene therapy.

Dr. Gottesman's professional activities include many active memberships in professional societies and editorial boards. He was elected a Fellow of the AAAS in 1988 and received the Milken Family Foundation Cancer Research Award in 1988, the Rosenthal Foundation Award in 1992, and the ASPET Award in 1997.

Dr. Gottesman has been actively involved in initiating several training and mentoring programs for high school students and teachers, college, and graduate students. As Deputy Director for Intramural Research at the NIH, he has initiated an NIH-wide lecture series, reformulated tenure and review processes in the intramural program, and he has instituted training programs for minority and disadvantaged students, loan repayment programs for clinical researchers at the NIH, and a clinical research training program for medical students.

 

WILLIAM J. JUSKO, Ph.D.
Dr. Jusko is Professor of Pharmaceutics and received his BS in Pharmacy (1965) and Ph.D. (1970) degrees from the State University of New York at Buffalo. He then joined the Clinical Pharmacology Section of the Boston Veterans Administration Hospital and was Assistant Professor of Pharmacology at Boston University School of Medicine. He returned to Buffalo in 1972 as Director of the Clinical Pharmacokinetics Laboratory and Assistant Professor. He was a Fulbright Scholar at The Mario Negri Institute for Pharmacology in Italy in 1978/79, received the Rawls-Palmer Award in 1987 from ASCPT, the Doctor Honoris Causae from the Jagellonian University of Cracow in 1987, the Russell R. Miller Award from ACCP in 1988, the Distinguished Service Award from the Am. College of Clinical Pharmacology in 1989, and the Research Achievement Award in PPDM from AAPS in 1998. He is a Fellow of AAPS, ACCP, and AAAS and serves on the Editorial Boards of six journals. His research involves clinical, basic, and theoretical pharmacokinetics and pharmacodynamics of diverse drugs, particularly corticosteroids and imunosuppressants. He has published over 380 research articles, book chapters, and reviews.

 

PATRICIA D. KROBOTH, Ph.D.
Patricia Kroboth is Professor and Chairman of Pharmaceutical Sciences at the University of Pittsburgh School of Pharmcy. She received a B.S. in Pharmacy from SUNY at Buffalo, and earned the M.S. and Ph.D. degrees in Pharmaceutical Sciences from the University of Pittsburgh School of Pharmacy, where she has been a faculty member since 1980.

Using benzodiazepines as GABA-agonist probe drugs, Dr. Kroboth's clinical research program has focused on discerning factors that alter GABA-mediated responses, including disease states, aging, and the development of acute tolerance. More recently, her research has been directed at the role of neurosteroids in modulating GABA-mediated responses. Steroids, including DHEA and DHEA-S, as well as metabolites of progesterone and cortisone have been shown to modulate GABA-receptor function in vitro. Concentrations of specific neurosteroids differ by gender and also change across the lifespan. This knowledge, along with gender- and age-related differences in drug sensitivity and response, provide the framework for the continuing investigations of her research group.

Dr. Kroboth's efforts in research and education, specifically in clinical pharmacokinetics and pharmacodynamics, fostered the development of the Clinical Pharmaceutical Scientist Ph.D. Program and the establishment of the Center for Pharmacodynamic Research at the University of Pittsburgh. In addition to her research publications, she has authored several papers regarding excellence in graduate education. Dr. Kroboth has been elected a Fellow of the American College of Clinical Pharmacy and a Fellow of the American Association of Pharmaceutical Scientists. She has held elected offices in the American Association of Colleges of Pharmacy and the American Association of Pharmaceutical Scientists.

 

GASTON LABRECQUE, Ph.D.
Gaston Labrecque, Ph.D. is presently Professor of Pharmacy and Pharmacology at the Faculty of Pharmacy, Université Laval and Senior Investigator at the Research Center on Infectious Diseases, Quebec University Medical Center in Sainte-Foy, Québec, Canada. He is also President and Scientific Director of Chronopharma Inc.

Dr. Labrecque obtained a B.Sc. degree in pharmacy from Université Laval in 1967 and a Ph.D. in pharmacology from the University of Michigan in 1973. Between 1973 and 1983, he was Assistant and Associate Professor of pharmacology at Laval's Medical School and he was Director of Laval's School of Pharmacy between 1983 and 1989. Dr. Labrecque was elected to the Canadian Foundation for Pharmacy and he served as President of the Fondation in 1998 -1989. He was also member of different Provincial Committees in pharmacy and he now served as an expert in pharmacy and pharmacology at the Office des Professions du Québec, Goverment of Quebec. He received also a visiting Medical Research Council (MRC) Scientist and a MRC-INSERM Exchange Scholarship Award to pursue research activities at the University of Montpellier-Nîmes in France.

In the last twenty years, Dr. Labrecque has been involved in research projects related to chronobiology and chronopharmacology. In collaboration with many colleagues, he studied time-dependent variations in pharmacokinetics and pharmacodynamics of anti-inflammatory agents in laboratory animals. He was also involved in clinical studies on biological rhythms in the effect of drugs in asthmatic children and as well as in the analgesic effectiveness of narcotic analgesic medications in post-surgical patients. Since 1991, he is working on the time-dependent nephrotoxicity of antibiotics and their underlying mechanisms at the Research Center on Infectious Diseases in the Quebec University Hospital.

Dr. Labrecque has been a member of the Organizing Committees of The International Conferences on Biological Rhythms and Medications (1984-1996) and he served in the Editorial Board of Chronobiology International since the foundation of this journal in 1984. He published 80 papers in peer reviewed journal and gave many scientific and professionnal conferences on chronobiology and chronopharmacology.

 

ALEXANDRA J. LANSKY, M.D
Dr. Lansky is the Director of the Angiographic Core Laboratory in the Cardiovascular Research Foundation located in the Washington Hospital Center. She is also Director of the Women's Cardiac Health Initiative at the Washington Hospital Center. Dr. Lansky is currently principal investigator on several studies that are being conducted in the Angiographic Core Lab. She has been published in several peer review journals and also has had numerous abstracts published as well.

 

DONALD P. McDONNELL, Ph.D.
Donald P. McDonnell, Ph.D., is Associate Professor of Pharmacology and Cancer Biology at Duke University Medical Center. He earned his Ph.D. in cell biologyfrom Baylor College of Medicine in 1987. Between 1991 and 1994 he served as Associate Director, then Director and Head of Molecular Biology at Ligand Pharmaceuticals. Dr. McDonnell has received numerous investigator awards, the most recent being ASPET's 1999 John J. Abel Award. He is an editor of the 60th Endocrine Reviews and The Journal of Steroid Biochemistry and Molecular Biology. His work has focused in recent years on the genetic and pharmacological dissection of the steroid hormone receptor signal transduction pathways. The insights from this work have led to the discovery and development of novel estrogen and progesterone modulators which are being evaluated clinically as treatments for cancer and osteoporosis.

Donald P. McDonnell, Ph.D., is Associate Professor of Pharmacology and Cancer Biology at Duke University Medical Center. He earned his Ph.D. in cell biologyfrom Baylor College of Medicine in 1987. Between 1991 and 1994 he served as Associate Director, then Director and Head of Molecular Biology at Ligand Pharmaceuticals. Dr. McDonnell has received numerous investigator awards, the most recent being ASPET's 1999 John J. Abel Award. He is an editor of the 60th Endocrine Reviews and The Journal of Steroid Biochemistry and Molecular Biology.

His work has focused in recent years on the genetic and pharmacological dissection of the steroid hormone receptor signal transduction pathways. The insights from this work have led to the discovery and development of novel estrogen and progesterone modulators which are being evaluated clinically as treatments for cancer and osteoporosis.

 

M. A. RUDA, Ph.D.
Dr. Ruda received her Ph. D. from the Department of Anatomy of the University of Pennsylvania in Philadelphia, PA where she studied the role of descending control on pain pathways. She went on to a post-doc in the Neurobiology and Anesthesiology Branch at the National Institute of Dental Research, NIH and is currently Chief of the Cellular Neuroscience Section of the Pain and Neurosensory Mechanisms Branch of the National Institute of Dental and Craniofascial Research at NIH. Dr. Ruda's main area of research interest is the cellular and molecular analysis of neurochemically defined circuits in somatosensory systems with a special emphasis on nociception and nerve injury. As part of her numerous professional activities, Dr. Ruda was Chair of the IASP Task Force on Special Pain Problems Related to Women from 1990-1996. In April of 1998, Dr. Ruda organized and Chaired the NIH Pain Research Consortium conference on AGender and Pain: A Focus on how Pain Impacts Women Differently than Men". She is also the founder and head of the NIH Pain Interest Group.
JANICE B. SCHWARTZ, M.D.

Janice B. Schwartz, is currently Professor of Medicine and Chief of Geriatric Medicine and Clinical Pharmacology and Professor, and Molecular Pharmacology, at Northwestern University Medical School. She got her M.D. from Tulane Medical School, has completed clinical training in internal medicine, cardiology and geriatric medicine and served on the faculties of Stanford, Baylor, and the University of California, San Francisco before joining Northwestern in 1995. She has long-standing interests in studying phamacokinetics and pharmacodynamics of cardiovascular drugs. Her research has focused on changes in drug elimination kinetics and the role of altered physiology and cardiovascular reflex responses in modulating drug effects with aging. Her work was among the first to demonstrate both age and gender-related changes in drug kinetics and responses.

 

HAROLD C. SLAVKIN, D.D.S.
Dr. Harold C. Slavkin is the director of the National Institute of Dental and Craniofacial Research. He assumed the leadership position in July 1995.

As director of NIDCR, Dr. Slavkin oversees a staff of about 450 scientists and administrators and an annual budget of more than $234 million. NIDCR supported investigators and grantees are recognized as leaders in cell and molecular biology studies of disfiguring birth defects, chronic pain conditions, oral cancer, oral infections and immunity, bone and joint diseases, and in the development and testing of new diagnostics, therapeutics and biomaterials. The Institute directs the NIH Pain Research Clinic, located on the NIH campus.

In addition, Dr. Slavkin continues his interests in craniofacial development and molecular genetics with his research team in the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).

As head of the USC Center for Craniofacial Molecular Biology, Dr. Slavkin directed a team of scientists investigating the genetics of normal and abnormal craniofacial, oral, and dental development. In addition, he taught molecular biology at the graduate level and biochemistry and nutrition at the USC School of Dentistry. Dr. Slavkin was responsible for creating the first Ph.D. program in the nation in craniofacial biology, a program he chaired for 10 years. He has published more than 200 scientific papers in peer-reviewed journals. Dr. Slavkin has long been active in programs to support and strengthen pre-college science education in Los Angeles. He helped initiate a program sponsored by the National Science Foundation that gives high school students an opportunity to work on a research project at a university.

Dr. Slavkin is a member of the Institute of Medicine, National Academy of Sciences; past president of the American Association for Dental Research; he belongs to numerous professional organizations including the International Society of Developmental Biology, the American Dental Association, International Association for Dental Research, the American Cleft Palate Association, and the American as well as International Colleges of Dentistry.

Dr. Slavkin received his undergraduate degree from the University of Southern California in 1961, and his D.D.S. from USC in 1965. He pursued postdoc training in Anatomy at UCLA and Biochemistry at USC. He received honorary doctorates in science degrees from Georgetown University (1990), the University Paris (1996), and the University of Maryland (1997).


MICHAEL H. SMOLENSKY, Ph.D.
Dr. Smolensky attended the University of Illinois in Champaign-Urbana, Illinois from 1960-1970 earning his bachelor's, master's and doctoral degrees in human physiology. Since 1971, he has been employed by the School of Public Health, University of Texas-Houston, Health Science Center as Professor of Environmental Physiology. Dr. Smolensky is founder and Director of the Hermann Center for Chronobiology and Chronotherapeutics--the first clinic in the world to utilize biological rhythm methods to diagnose and treat patient disorders. He is the founder and current co-editor-in-chief of Chronobiology International (Marcel Dekker, Inc.), the official journal of the International Society for Chronobiology (ISC).

Dr. Smolensky is a board member of the ISC, co-founder and Vice-President of the American Association of Medical Chronobiology and Chronotherapeutics and co-organizer since 1984 of the International Conferences of Chronopharmacology and Chronotherapeutics. Dr. Smolensky is the author or co-author of more than 200 scientific and clinical articles on medical chronobiology, two books and several continuing education monographs for physicians, pharmacists and academic scientists. He recently served as co-editor of Time-Dependent Structure and Control of Arterial Blood Pressure, Volume 783 of the Annals of the New York Academy of Sciences (1996). More recently he had collaborated with the American Medical Association (AMA) to develop educational materials for doctors and patients about medical chronobiology and chronotherapeutics, Taking Your Medication: A Question of Timing--A Patient Guide to Chronotherapy. Dr. Smolensky is a consultant to pharmaceutical companies in the USA and overseas regarding rhythm-dependencies of medications and chronotherapeutics plus federal agencies such as the Food and Drug Administration (Cardio-Renal Division) and National Aeronautical Space Administration regarding circadian rhythm-related matters.

 

BERT SPILKER, Ph.D., M.D.
Bert Spilker, PhD, MD, FCP, FFPM, is the Senior Vice President of Scientific and Regulatory Affairs for PhRMA (Pharmaceutical Research and Manufacturers of America) based in Washington, D.C. He was President and cofounder (in 1993) of Orphan Medical, Inc., a public pharmaceutical company that develops and markets important medical products for patients with uncommon diseases. He is Clinical Professor of Pharmacy Practice at the University of Minnesota and Adjunct Professor of Medicine and Pharmacy at the University of North Carolina in Chapel Hill. He is well known as the author of 15 books on clinical trial methods and the processes of drug discovery and development. These books are considered by many as the standard references on clinical trials and drug development. He has worked at four major pharmaceutical companies for over 20 years (Pfizer, Philips-Duphar, Sterling-Winthrop, and Burroughs Wellcome) in medicine discovery, development, and management. He serves on three Boards of Directors and is on the Steering Committee for the International Conference on Harmonization, or ICH. He has received numerous honors including the FDA Commissioner's Special Citation for work in the orphan medicine area. His medical training in pharmacology and internal medicine was at Cornell Medical College, State University of New York (Downstate Medical Center), University of California at San Francisco, University of Miami Medical School (Ph.D. to M.D. Program) and Brown University Medical School.


RICHARD M. WEINSHILBOUM, M.D.
Dr. Weinshilboum received B.A. and M.D. degrees at the University of Kansas, followed by residency training in Internal Medicine at the Masschusetts General Hospital in Boston. He was also a Pharmacology Research Associate at the National Institutes of Health in Bethesda, Maryland, in the laboratory of Nobel laureate Dr. Julius Axelrod. Dr. Weinshilboum began his affiliation with the Mayo Medical School and Mayo Clinic in 1972 where he is presently Professor Pharmacology and Internal Medicine. He has been an active investigator in the area of pharmacogenetics and pharmacogenomics and he has authored over 200 scientific manuscripts. His major areas of research have focussed on the pharmacogenetics of methylation and sulfation. Dr. Weinshilboum has been the recipient of many awards and honors including an Established AInvestigatorship of the American Heart Association, a Burroughs Wellcome Scholar Award in Clinical Pharmacology Award and, recently, the Oscar B. Hunter Award of the American Society for Clinical Pharmacology and Therapeutics.

 

KATHARINE D. WENSTROM, M.D.
Dr. Wenstrom is currently a Professor, Director of the Division of Reproductive Genetics, and member of the Division of Maternal-Fetal Medicine in the Department of Obstetrics and Gynecology at the University of Alabama Hospital. She is also Director of the Genetics Residency, and has a graduate faculty appointment in Medical Genetics at the University of Alabama at Birmingham. Dr. Wenstrom is a Diplomate of the American Board of Medical Genetics, the American Board of Obstetrics and Gynecology, and the American Board of Obstetrics/Gynecology Subspecialty Maternal-Fetal Medicine.

A member of various organizations including the American Society of Human Genetics , the Society of Maternal-Fetal Medicine, the Society of Gynecologic Investigation, and the Teratology Society, Dr. Wenstrom is a Fellow of the American College of Obstetrics and Gynecology. She serves on the S.P.O. Board of Directors, several ACOG committees, and the Editorial Board of the American Journal of Perinatology. She is a peer journal reviewer for several publications including the American Journal of Obstetrics and Gynecology and Obstetrics and Gynecology.

Dr. Wenstrom is widely published in her field, and has presented at many national meetings. She received her B.A. in Biology Cum Laude from Case Western Reserve University, her M.A. in Pathology from Columbia University Graduate School of Arts and Sciences, and her M.D. from Case Western Reserve University School of Medicine.

 

CATHERINE A. WHITE, Ph.D.
Catherine A. White is an Associate Professor in the Department of Pharmaceutical and Biomedical Sciences at the University of Georgia College of Pharmacy. She earned her B.S. in Pharmacy from the St. Louis College of Pharmacy and a Ph.D. in Pharmaceutics from the University of Washington in Seattle, WA in 1986 under the direction of Dr. John Slattery. Dr. White was an NIH research fellow in the Department of Pharmacology and Toxicology at the University of Kansas Medical Center with Dr. C. D. Klaassen. Upon completion of her postdoctoral fellowship, she joined the faculty of the Department of Pharmaceutics at the University of Houston College of Pharmacy. In 1993, Dr. White moved to her current position at the University of Georgia.

Dr. White has published over 70 research abstracts and papers. She has served as principal investigator/Co-Investigator on over 20 federally and privately funded grants and currently holds grants from National Institute for Allergy and Infectious Diseases (Synthesis and Biotransformation of Anti-HIV Prodrugs, Co-Investigator) and NASA (Effect of Microgravity on the Disposition of Therapeutic Agents Used in Space Flight: Clenbuterol, Cefazolin, and Cefoperzaone as Model Compounds, Co-Principal Investigator). Her research interests include pharmacokinetic/ pharmacodynamics of antibacterial-antiviral agents with emphasis on the mechanisms of drug action, toxicology and resistance, influence of liposomal encapsulation on efficacy, pharmacokinetics and cellular pharmacology/distribution of drugs, influence of factors such as gender, food intake, chronobiology on the disposition of drugs, and placental transport of xenobiotics. Dr. White is a member of the American Association of Pharmaceutical Scientists, American Society of Microbiology, American Association for the Advancement of Science, International Society for Chronobiology, and American Association of Colleges of Pharmacy. She has chaired several symposium sessions at the annual meetings of the American Association of Pharmaceutical Scientists and International Society for Chronobiology as well as serving as an abstract reviewer.

 

RAYMOND L. WOOSLEY, M.D., Ph.D.
Raymond L. Woosley earned a Ph.D. in Pharmacology from the University of Louisville (1967) and an M.D. degree from the University of Miami (1971). Dr. Woosley has completed Post-doctoral training at the University of Louisville in Pharmacology and at Vanderbilt University in Clinical Pharmacology. Following graduate school, he worked in the pharmaceutical industry as the first scientist employee of Meyer Laboratories (now Glaxo-Wellcome, Inc.). After returning to study medicine, he specialized in Internal Medicine and Clinical Pharmacology at Vanderbilt University. He remained on the faculty and rose to the rank of Professor of Medicine and Pharmacology. In 1988, he assumed the position of Chairman of the Department of Pharmacology at Georgetown University. He has served on many national advisory committees for the NIH, Veterans Administration, the US Pharmacopeial Convention, the Cardiorenal Advisory Committee of the Food and Drug Administration, the Institute of Medicine (National Academy of Sciences) and chairman of the Joint Advisory Committee on Cardiovascular Drugs for the American Heart Association and the American College of Cardiology. He has served as ad hoc consultant for numerous FDA advisory committees and is currently a Special Consultant for the FDA and a member of the Clinical Trials Review Committee for the National Heart Lung and Blood Institute.

Dr. Woosley's research has investigated the basic and clinical pharmacology of antiarrhythmic drugs and he is considered an international authority on the drug treatment of arrhythmias. He has demonstrated the importance of active drug metabolites, stereoisomerism and pharmacogenetic differences in drug metabolism as factors influencing the pharmacologic and clinical response to antiarrhythmic drugs, beta adrenergic antagonists, antimalarials and, more recently, antihistamines such as terfenadine. This research has been reported in over 200 publications including 122 original articles. In March of 1990, he received the Rawls-Palmer Award for his contributions to medicine by the American Society of Clinical Pharmacology and Therapeutics. He was selected by practicing physicians to be listed in The Best Doctors in America. In 1995, he was appointed Director of the Institute for Cardiovascular Sciences at Georgetown University. In addition, Dr. Woosley is Past-president of the Association for Medical School Pharmacology which is a society of chairs of pharmacology and the President-elect of The American Society for Clinical Pharmacology and Therapeutics (ASCPT).

 

ROGER L. WILLIAMS, M.D.
Roger L. Williams, M.D., completed his medicine and internal medicine training at the University of Chicago. He served in the United States Army, both in Korea and at Walter Reed Army Institute of Research, where he conducted antimalarial drug research. In 1977, he completed a clinical pharmacology training program at the University of California, San Francisco, and became a faculty member at the University, a position he retains. In 1989, Dr. Williams worked briefly in the pharmaceutical industry where he directed clinical studies of an anti-HIV drug. In 1990, Dr. Williams became the Director of FDA's Office of Generic Drugs in the Center for Drug Evaluation and Research. In 1993, he became Associate Director for Science and Medical Affairs in the Center and in 1995 the Deputy Center Director for Pharmaceutical Science. In this capacity he directs the Office of Pharmaceutical Science, with oversight responsibility for the Office of New Drug Chemistry, the Office of Generic Drugs, the Office of Clinical Pharmacology and Biopharmaceutics, and the Office of Research and Testing. With this responsibility, he is directly responsible for the Center's regulation of product quality. He is responsible for the Center's international activities and is the FDA's lead representative to the International Conference on Harmonization. He is also the lead delegate for FDA in Trilateral meetings with Canada, US, and Mexico regulators and in Bilateral meetings with the European Commission/Union and FDA. He has worked with FDA and PAHO to create a regulatory steering committee of the Americas. Dr. Williams is a fellow of AAPS, and expert member of the FIP Board of Pharmaceutical Sciences, and a member of the WHO Expert Committee on Pharmaceutical Preparations. In 1995, he was the FDA's representative to the U.S.P. Quinquennial. He has authored or co-authored numerous reports in the areas of clinical pharmacology and biopharmaceutics. Dr. Williams is board certified in internal medicine and in clinical pharmacology.

 

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