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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