Dr. Abernathy

Dr. Alfaro

Dr. Balis

Dr. Calis

Dr. Collins

Dr. Dedrick

Dr. Figg

Dr. Flockhart

Dr. Foster

Dr. Frederiksen

Dr. Garzone

Dr. Gottesman

Dr. Grudzinskas

Dr. Markey

Dr. Miller

Dr. Morrison

Dr. Mould

Dr. Peck

Dr. Pohl

Dr. Preusch

Dr. Sausville

Dr. Susla

Dr. Takimoto

Faculty Biosketches

Dr. Abernethy received his M.D. (AOA) and Ph.D. (Pharmacology) degrees from the University of Kansas School of Medicine in 1976. Further clinical training was in internal medicine at Jackson Memorial Hospital/University of Miami through Board Certification in internal medicine. He then did post-doctoral fellowship training in clinical pharmacology at the Massachusetts General Hospital. Dr. Abernethy joined the faculty at Tufts University School of Medicine as Assistant Professor of Psychiatry and Medicine in 1981. He moved to Baylor College of Medicine in 1983 where he advanced to Associate Professor of Medicine in the Division of Hypertension and Clinical Pharmacology. In 1986 he moved to Brown University School of Medicine as Chief of the Division of Clinical Pharmacology. He was subsequently promoted to Professor of Medicine at Brown. In 1994 Dr. Abernethy became the Francis Cabell Brown Professor and Director of the Division of Clinical Pharmacology at Georgetown University School of Medicine, where he served until 1999, at which time he assumed his current post.

Dr. Abernethy has contributed to understanding of mechanisms of peripheral distribution of drugs and drug disposition and effect in obesity. He also has contributed to the knowledge base in pharmacokinetic/pharmacodynamic relationships of cardiovascular drugs in aging and has advanced the concept that the pathophysiology of aging must be considered when interpreting drug effects in the aged patient. Currently Dr. Abernethy is studying the role of genetic polymorphisms of drug effectors that effect responses to cardiovascular drugs. These studies include both phenotypic changes and genotypic changes which contribute to altered phenotype and nongenotypic splice variant transcriptional changes which result in phenotypic changes. Presently these studies are focussing on endothelial nitric oxide synthase and the L-type calcium channel.

Dr. Abernethy has participated in, and continues to participate actively in, service and organizational activities which promote the safe and effective use of medications in aged patients. As an extramural investigator, he served on the NIGMS Pharmacological Sciences study section (1988-1992), the FDA Generic Drugs (1990-1992) and Cardiorenal (1992-1996) Advisory Committees, and presently serves as chair of the VA Merit Review Geriatrics Subcommittee (1998-present). As an educator, he served on the National Board of Medical Examiners Pharmacology Test Committee (1992-1996) and currently is chair of the NBME (now called USMLE) Applied Pharmacology Committee (1997-present). Organizational and public service have included serving as President of the American Society of Clinical Pharmacology and Therapeutics (1991-1992) and on the Geriatrics Committee of the United States Pharmacopeia (1990-present) which he presently chairs (1999-present). Dr. Abernethy is the current editor of Pharmacological Reviews.

Dr. Alfaro received her B.S. degree in pharmacy from Purdue University in 1989 and her Pharm. D. degree from Ohio State University in 1991. She completed a one-year ASHP-accredited specialty residency in psychiatric pharmacy practice and a two-year fellowship with Dr. Larry Ereshefsky at the University of Texas Health Science Center at San Antonio. After completing her fellowship, Dr. Alfaro remained at the University of Texas as Clinical Assistant Professor where her main research interests included studying the effects of psychotropics on cytochrome P450 isozymes and translating these effects to the clinical environment. In 1998, Dr. Alfaro accepted a position as Clinical Pharmacy Specialist for the National Institute of Mental Health where she worked closely with clinicians and researchers in the areas of child and adult schizophrenia, Alzheimer's disease and mood disorders as well as being a member on the NIMH Institutional Review Board. In 2002, Dr. Alfaro accepted a position as a Clinical Reviewer of psychotropic drugs at the Food and Drug Administration. Dr. Alfaro is a Board Member for the College of Psychiatric and Neurologic Pharmacists, a member of the editorial board of the American Journal of Health-System Pharmacy and serves as a reviewer for a number of journals including The Journal of Clinical Psychopharmacology.

Dr. Atkinson received his A.B. degree in Chemistry from Harvard College in 1959 and his M.D. from Cornell University Medical College in 1963. Following medical internship and residency at the Massachusetts General Hospital, he was a Clinical Associate in the Laboratory of Clinical Investigation of the National Institute of Allergy and Infectious Diseases (NIAID) at the NIH. He subsequently received postdoctoral training in clinical pharmacology at the University of Cincinnati and was a Visiting Scientist in the Department of Toxicology at the Karolinska Institute before moving to Northwestern University Medical School in 1970 to start the program in Clinical Pharmacology. While at Northwestern, he and his colleagues set up the first U.S. laboratory devoted to general therapeutic drug monitoring, designed and conducted the first clinical investigations to develop the acetylated metabolite of procainamide as a new antiarrhythmic drug, carried out the first pharmacokinetic studies with stable isotope-labeled drugs, and completed basic research that elucidated the physiologic basis of some multicompartmental models of drug distribution. In 1994, Dr. Atkinson was appointed Corporate Vice President for Clinical Development and Medical Affairs at the Upjohn Company. Following the Upjohn-Pharmacia merger, he joined the Center for Drug Development science at Georgetown University as an Adjunct Professor of Pharmacology. In 1997, he returned to NIH as a Special Expert Consultant in Clinical Pharmacology for NIGMS, and was appointed in 1998 to the position of Senior Advisor in Clinical Pharmacology to the Director of the NIH Clinical Center. Dr. Atkinson has been President of the American Board of Clinical Pharmacology, President of the American Society for Clinical Pharmacology and Therapeutics, and is a Master of the American College of Physicians. He currently serves as an Associate Editor of Clinical Pharmacology and Therapeutics, and Pharmacological Reviews and is Vice Chair of the U.S. Pharmacopeia's Safe Medication Use Expert Committee.

Dr. Balis' primary research focus is the clinical pharmacology of anticancer drugs and new drug development for childhood cancers. Dr. Balis came to NCI in 1982 as a clinical associate in the Pediatric Oncology Branch. He became a senior investigator in 1988 and has developed an active preclinical and clinical research program focused on the study of the pharmacokinetics of anticancer drugs used to treat childhood cancers with an emphasis on the study of the central nervous system pharmacology of anticancer drugs, and the development of new treatment approaches for childhood cancers through the development of new drugs. Dr. Balis has also played a role in the NCI's Division of Clinical Sciences' clinical research program, as the founder and chair of the Pediatric Protocol Review Committee, and the former chair of both the NCI's Institutional Review Board and Protocol Review and Monitoring Committee. Dr. Balis received his B.S. in Zoology from the University of North Carolina and his M.D. from Vanderbilt University. He completed a pediatric residency at Vanderbilt Children's Hospital followed by four years of fellowship training in Pediatric Hematology/Oncology at the Children's Hospital in Seattle and the Fred Hutchinson Cancer Research Center.

Dr. Calis earned his Bachelor of Science and Doctor of Pharmacy degrees from the University of Maryland School of Pharmacy and received a Master of Public Health degree from the Johns Hopkins University School of Hygiene and Public Health. Dr. Calis is a clinician, researcher, and educator. He has served as Clinical Pharmacy Coordinator, Assistant Director for Clinical Services, and director of a nutritional/metabolic support service which he established in 1987. He is a Fellow of the American Society of Health-System Pharmacists and is board certified in pharmacotherapy and nutritional support by the Board of Pharmaceutical Specialties. Dr. Calis is a Clinical Associate Professor at the University of Maryland and Associate Clinical Professor at the Medical College of Virginia, Virginia Commonwealth University. Dr. Calis is a clinical investigator in the NIH intramural research program with a primary focus in endocrinology, women's health, and clinical trial drug safety monitoring. Dr. Calis is a referee for several medical and pharmacy journals (including the New England Journal of Medicine and the Journal of the American Medical Association), reviewer for the American Hospital Formulary Service, assistant editor for the Micromedex DRUGDEX System, and contributor to the United States Pharmacopeia: Dispensing Information. Dr. Calis is a member of the United States Pharmacopeial Convention's Expert panel on Nutrition and Electrolytes and was formerly a member of the editorial board of the American Journal of Health-System Pharmacy. Dr. Calis received the Hospital Pharmacist of the Year Award in 1989 from the Washington Metropolitan Society of Hospital Pharmacists and later served as president of that organization. He is also the recipient of the McKesson and Squibb leadership awards.

Dr. Collins received his Ph.D. in 1976 from the University of Pennsylvania, and completed a postdoctoral fellowship in Clinical Pharmacology at Johns Hopkins University School of Medicine. He spent a total of 10 years at the NIH, including 5 years as Chief of the Pharmacokinetics Section at the National Cancer Institute (NCI). In 1988, he joined the FDA. He has authored or co-authored over 140 papers in the field of clinical pharmacology, primarily emphasizing the applications of PK/PD principles in the fields of cancer. His current work is focused upon extending these principles with positron emission tomography. In addition to research and administrative duties at the FDA, Dr. Collins holds adjunct faculty appointments at Johns Hopkins, Georgetown and the Uniformed Services University.

Dr. Daniels is presently responsible for comprehensive institution-wide pharmaceutical services, intramural drug development support programs, and pharmacy based research programs.

Dr. Daniels received his B.S. in Pharmacy from the University of Arizona then completed a Pharmacy Residency at the NIH. He earned his M.S. and Ph.D. degrees from the University of Minnesota as a fellow of the American Foundation for Pharmaceutical Education (AFPE). He served as a member of the faculty at the University of Minnesota College of Pharmacy for 15 years while holding pharmacy management positions at the University Hospital. As a member of the graduate faculty there, he has served as the Major Professor or Research Advisor for over two-dozen students who have completed the M.S. or Ph.D. He also served as the Director of Graduate Studies in Hospital Pharmacy. He has precepted more than 50 pharmacy residents in training.

Dr. Daniels has been elected to membership as a Fellow of the American Society of Health-Systems Pharmacists. His research interests include pharmacoeconomics, health related quality of life, and epidemiological evaluation of medication related events. He has published scientific and professional articles and book chapters on those topics.

Dr. Dedrick received his formal training in chemical engineering at Yale University (B.E. with highest honors), the University of Michigan (M.S.E.) and the University of Maryland (Ph.D.). Following a few years on the faculty of the George Washington University he was asked to develop a Chemical Engineering Section to provide support to the intramural program of the NIH. Most of the section staff and its portfolio of projects have been reorganized into the Drug Delivery and Kinetics Resource. Resource activities include physiological pharmacokinetics, pharmacokinetics of macromolecules, regional drug administration, spatially distributed models, kinetics, fluid mechanics, and related applications of engineering science and technology to biomedical research. His approximately 170 publications include discussions of the physiologic bases of pharmacokinetics and of numerous applications to pharmacology and toxicology such as in vitro-in vivo correlations, interspecies scaling and the design of Phase I clinical trials. He is recipient of the Scientific Achievement Award (Engineering Sciences) of the Washington Academy of Sciences, the Food, Pharmaceutical and Bioengineering Award of the American Institute of Chemical Engineers, the Founders' Award of the Chemical Industry Institute of Toxicology and is a Founding Fellow of the American Institute of Medical and Biological Engineering. Current research of his group includes microdialysis, the pharmacokinetics of macromolecules, intraperitoneal drug administration, pulmonary delivery of chemoprevention agents, and intra-arterial and intratissue drug infusion with particular emphasis on drug delivery to the brain.

Dr. Figg received his doctoral degree in pharmacy from Auburn University. Following residency at the University of Alabama Hospital and a fellowship in Drug Development at the University of North Carolina, Dr. Figg joined the Clinical Pharmacology Branch of the NCI, NIH. In 1993, Dr. Figg became Head of the Clinical Pharmacokinetics Section within the Medicine Branch of the NCI. Dr. Figg is a Senior Staff member in the prostate cancer clinic and has focused his research on understanding the biology of metastic prostate cancer, as well as developing new therapeutic agents for this disease. His group has examined novel antitumor agents with particular emphasis on inhibitors of angiogenesis. Dr. Figg is a member of the American Society of Clinical Pharmacology and Therapeutics, American College of Clinical Pharmacy, American College of Clinical Pharmacology, American Association of Cancer Research, American Society of Clinical Oncology, and American Urological Association. He chairs the clinical pharmacology interest subgroup in oncology at NIH, as well as the NCI's angiogenesis working group.

In the summer of 2001, Dr Flockhart came to Indiana University from Georgetown University Medical Center, where he served as the Francis Cabell Brown Chair and Chief of the Division of Clinical Pharmacology and Director of the Pharmacogenetics Core laboratory. His research is focused on clinically-relevant applications of pharmacogenetics and drug interactions. He grew up in Edinburgh, Scotland and took Honors in Biochemistry at the University of Bristol, England. He subsequently obtained a Ph.D. from the Welsh National School of Medicine, and an M.D. from the University of Miami School of Medicine. He was an Internal Medicine resident at Georgetown University Medical Center, and after a year as Chief Medical Resident, completed a fellowship in Clinical Pharmacology in the Division of Clinical Pharmacology at Georgetown. He joined the faculty of the Georgetown Division of Clinical Pharmacology in 1993, and was appointed Director of the Pharmacogenetics Core Laboratory in1995.

Dr. Flockhart has been involved in the development of new pharmacogenetic tests using array, chip and other biotechnologies, and a focus of his research is to evaluate and communicate the value of pharmacogenetic tests to physicians and pharmacists involved in clinical practice. He is now the Principal Investigator of the Indiana University Medical Center site of the national Pharmacogenetics Research Network organized by NIGMS. Dr Flockhart has more than 100 publications in the area of pharmacology and 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 American Board of Clinical Pharmacology and has served on the Executive Committee and Board of the American Society for Clinical Pharmacology and Experimental Therapeutics, and as Chair of the Government Affairs Committee. He is currently the Vice-Chair of the Pharmacokinetics and Drug Metabolism Section of ASCPT. Dr. Flockhart is an active teacher, and teaches the Clinical Pharmacogenetics portion of the annual course in Clinical Pharmacology at the National Institutes of Health, in Bethesda, MD and the Pharmacogenetics section of the Annual Review in Clinical Pharmacology provided by the ASCPT. He also provided the "Clinical Pharmacology Update" module at the Annual Meeting of the American College of Physicians in Atlanta, GA in 2001.

Dr. Flockhart's website "drug-interactions.com", a tool to improve rational prescribing, has been cited by the Washington Manual of Medicine and Therapeutics, The Harriet Lane Handbook for Pediatrics and the Medical Letter, and receives approximately 2000 visits per month from physicians and scientists from around the world.

Dr. Foster received his undergraduate degree in mathematics from Northwestern University and his doctoral degree in mathematics from the University of British Columbia. After postdoctoral fellowships in mathematics at the University of Bristol and in physiology at the University of Michigan School of Medicine, Dr. Foster joined the Laboratory of Theoretical Biology of the National Cancer Institute as a Senior Staff Fellow. In this capacity, he worked from 1976 to 1980 with the late Mones Berman, who developed the SAAM computer program for pharmacokinetic analysis.

After leaving NIH in 1980, Dr. Foster joined the faculty of the Center for Bioengineering in the College of Engineering and School of Medicine at the University of Washington. In 1986, he founded the Resource Facility for Kinetic Analysis in the University's bioengineering department and developed a contemporary version of the SAAM program (SAAM II), and in 1995 became CEO of the SAAM Institute which distributes this program. Dr. Foster's group at the University of Washington is currently developing software for population kinetic analysis that will complement the SAAM II pharmacokinetic program. Dr. Foster is the recipient of numerous honors and has published over 98 papers and textbook chapters on both the theory and application of kinetic modeling techniques.

Dr. Frederiksen received her undergraduate degree from Cornell College in Mount Vernon, Iowa and her M.D. degree from Boston University School of Medicine. She had residency training in pediatrics at the University of Maryland School of Medicine and in obstetrics and gynecology at the Boston Hospital for Women of Harvard University. Following her residency, she had a clinical fellowship in maternal fetal medicine and a research fellowship in clinical pharmacology at Northwestern. Dr. Frederiksen is board certified in obstetrics and gynecology, maternal fetal medicine, and clinical pharmacology.

From 1989 through 1992 Dr. Frederiksen was a member of the NIH National Center for Research Resources (NCRR) General Clinical Research Center (GCRC) Committee, serving as Chair from 1992 through 1993, and she has served on a number of other NIH study sections and special review committees. Dr. Frederiksen's research work on drugs used for pregnant asthmatics led to her being asked to serve on the 1991-1992 NHLBI Task force on Asthma and Pregnancy. This task force developed guidelines for the care and treatment of pregnant patients with asthma. In 1992, Dr. Frederiksen was invited to speak on Clinical Trials in Pregnancy at an FDA symposium on Women in Clinical Trials and was an invited speaker at two workshops on pharmacokinetics in pregnancy that were held by NICHD and by the FDA last year.

Dr. Garzone has extensive product development experience in biotechnology and has held positions of increasing responsibility in four US biotechnology companies. She has been responsible for the preclinical and clinical development of proteins, peptides and small molecules, and the execution of those development plans, as well as several successful product license application submissions in the United States and in Europe. Her training and expertise is in the application of pharmacokinetic and pharmacodynamic principles for biologics and drugs in the drug development process. Prior to her industrial experience, Dr. Garzone was on faculty at the University of Pittsburgh School of Pharmacy, doing research in the CNS area and teaching undergraduate and graduate students. She also was a clinical pharmacy practitioner at a teaching hospital in Pittsburgh. Dr. Garzone received a Bachelor of Science in Pharmacy from Purdue University in 1977 and a Master of Science and Doctor of Philosophy degree from the University of Pittsburgh in 1981 and 1987, respectively.

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 NIH 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 (NCI) 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 a- and b-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.

Charles Grudzinskas is a consultant to the Center for Drug Development Science (CDDS) at Georgetown University and to MdBio (an organization that is dedicated to assisting bioscience companies become successful in Maryland). Dr. Grudzinskas consults on the strategy and tactics of drug development, regulatory strategies and project management, working across the full range of emerging and mature companies.

Dr. Grudzinskas' drug development career includes Vice President, Medications Development and Project Management, G.D. Searle and Company and Director, New Product Management at Lederle Laboratories. Prior to joining Searle, Dr. Grudzinskas was the first director of the Medications Development Division of the National Institute on Drug Abuse (NIDA) at the NIH. During his tenure at NIDA, Dr. Grudzinskas established state of the science anti-cocaine and anti-opiate discovery and clinical development programs. By working closely with the FDA review division and the FDA Drug Abuse Advisory Committee, Dr. Grudzinskas' NIDA division was able to achieve an 18-day approval of LAAM, an alternative to methadone. This remarkable partnership with the FDA included the piloting of a "Rolling NDA Process" which has now been incorporated as part of the FDA Modernization Act of 1997 (FDAMA).

As a member of the 1986-89 FDA/PMA Project Management Working Group, Dr. Grudzinskas recommended to the FDA that to ensure higher quality NDAs, CDER should make better use of their Refuse to File authority. More rigorous enforcement of Refuse to File has played a role in ensuring higher quality NDAs, resulting in shortening NDA review times. Dr. Grudzinskas played a major role in the creation of role of Project Managers within CDER prior to PDUFA. Dr. Grudzinskas has been the course director for the PERI Drug Development Course and is a faculty member of PERI Courses in Project Management, R&D; Finance, Clinical Trials, Primer for New Physicians and Scientists, and the NDA Game. Dr. Grudzinskas is a registered U.S. Patent Agent. He received his Ph.D. from the University of Minnesota.

Dr. Markey received his Ph.D. degree in chemistry from M.I.T., then joined the Departments of Pediatrics and Pharmacology at the University of Colorado. In 1974, Dr. Markey came to the Laboratory of Clinical Science in the National Institute of Mental Health, NIH. Since 1996, Dr. Markey has been Chief of the NIMH Laboratory of Neurotoxicology.

Dr. Markey has authored over 160 scientific papers and two books and has received numerous awards. He has been an Associate Editor of Organic Mass Spectrometry and has served on the Editorial Advisory Boards of Biological Mass Spectrometry and the Journal of the American Society for Mass Spectrometry.

Dr. Miller received his B.Sc. degree in Pharmacy in 1968, his M.Sc. (Pharmacology) in 1971 and his D.Sc. (Pharmacology) in 1974 from Potchefstroom University, South Africa. During that time he served as a research scientist for the Medical Research Council. He received postdoctoral training in clinical pharmacology at the University of California, School of Medicine, San Francisco from 1977 to 1979. In 1984 he was appointed Professor and Chairman of the Department of Pharmacology, University of Durban-Westville (UDW), Durban, South Africa. Dr. Miller implemented therapeutic drug monitoring clinics in Durban and extended the discipline nationally. In 1987 he established the Drug Studies Unit at UDW in the department of Pharmacology and served as the Director. The unit provided research support for the University and implemented pharmacokinetic/pharmacodynamic (PK/PD) techniques in data analysis. During that time Dr. Miller carried out annual workshops on PK/PD modeling to extend the science nationally. Nonlinear mixed effect modeling was implemented by him at UDW and subsequently introduced at key academic institutions throughout the country. In 1994 he joined the Food and Drug Administration as a Senior Staff Fellow in the Division of Pharmacometrics. He implemented novel PK/PD modeling approaches in the agency and applied modeling approaches to answer key regulatory questions. He served as Acting Director of Pharmacometrics at the FDA from 1997-1999. Currently he is Director of Pharmacometrics, Parke-Davis Pharmaceutical Research, Ann Arbor, Michigan.

After obtaining his bachelor's degree at the University of Michigan, Dr. Morrison attended the California Institute of Technology where he received his Ph.D. from the Department of Chemistry and Chemical Engineering in 1972. His research there was focused on the statistical mechanics and x-ray scattering behavior of molecular fluids.

From 1972 until 1983, Dr. Morrison worked at the Rand Corporation in Santa Monica, California. There he completed studies in the risk assessment of environmental toxins and, under NIH funding, pharmacokinetic and cell kinetic studies of anti-cancer agents and the dynamics of drug resistance to these agents by gene amplification. In 1984 Dr. Morrison moved to the NIH and joined what is now the Drug Delivery and Kinetics Resource in the Bioengineering and Physical Science Program. His research specialties have been the kinetic modeling of biochemical networks, physiological pharmacokinetics, and the transport processes associated with microdialysis and the direct interstitial infusion of substances.

Dr. Mould received a Ph.D. in Pharmaceutics and Pharmaceutical Chemistry from the Ohio State University College of Pharmacy and then held the position of Associate Director in the Department of Drug Metabolism and Pharmacokinetics at Smith-Kline Beecham. Following that she joined the Center for Drug Development Science at Georgetown University Medical Center as Research Associate Professor in the Department of Pharmacology. During that time, she specialized in population modeling and conducted population PK/PD analyses of hematopoietic, anti-cancer and anti-viral agents, and sedative/hypnotic drugs. She recently left Georgetown University Medical Center to form her own company, Projections Research, Inc.

Dr. Mould has been involved in trial simulation and the design of numerous drug development studies, and she has made numerous national and international presentations on advanced PK/PD modeling and simulation of clinical trials.

Dr. Mould joined the Georgetown faculty in 2000 and has been involved in clinical trial simulation and the design of drug development studies. Dr. Mould is a member of the Scientific Advisory Board of the Pharsight company, where she consults on the development of their trial simulation package, and she has made numerous national and international presentations of advanced modeling and simulation work.

Dr. Peck obtained a B.A. in mathematics and chemistry from the University of Kansas in 1963 and his M.D. from the same institution in 1968. During 1963-1964, he studied physical chemistry in Tubingen and Stuttgart, Germany under a Fulbright Scholarship. Following internship and residency in internal medicine, he undertook a research fellowship in clinical pharmacology at the University of California, San Francisco (1972-1974), at the completion of which he joined the UCSF clinical faculty in medicine and clinical pharmacology. From 1974-1980, Dr. Peck was employed at the Letterman Army Institute of Research, San Francisco, CA, first as staff scientist and later as Chief of the Army blood Preservation Research Program. In 1980 Dr. Peck became Director of the Division of Clinical Pharmacology and in 1982, Professor, Departments of Medicine and Pharmacology, Uniformed Services University, Bethesda, Maryland. Dr. Peck joined the Food and Drug Administration as Director, Center for Drug Evaluation and Research in October 1987. He was promoted to Assistant Surgeon General in the Public Health Service in October 1990. In 1993, Dr. Peck ended 26 ½ years of public service to become "Boerhaave" Professor of Clinical Drug Research at Leiden University in the Netherlands. In September 1994, Professor Peck joined the faculty of the Georgetown University Medical Center, where he is the founding Director of the new Center for Drug Development Science. His research interests center on pharmacokinetics, pharmacodynamics, transdermal drug delivery and dosimetry, experimental design, data analysis, and drug development and regulation. He is an author of more than 100 original research papers, chapters, and books dealing with those subjects.

Dr. Pohl received both his Pharm.D. and Ph.D. in Medicinal Chemistry from the University of California Medical Center, San Francisco (UCSF). He joined the Laboratory of Chemical Pharmacology NHLBI at NIH as a Postdoctoral Fellow. He has progressed through the ranks at NIH and is presently Chief of the Section on Molecular and Cellular Toxicology of the Laboratory of Molecular Immunology of the NHLBI.

Dr. Pohl's primary research interests are in the study of the molecular and cellular basis of toxicities caused by reactive metabolites of endogenous molecules and drugs, and he has published over 120 papers, most of which are focused on this area. Dr. Pohl has received numerous awards and honors and is currently an Editorial Board Member for both Drug Metabolism and Disposition and Drug Metabolism Reviews.

In 1974 Dr. Preusch received his B.S. Degree in Biochemistry from Pennsylvania State University, and in 1979 his Ph.D. Degree (Major: Biochemistry, Minor: Chemical Engineering) from Cornell University. After Postdoctoral Training in Biochemistry from 1979 to 1983 at the University of Wisconsin-Madison he held the position of Assistant Professor of Chemistry at the University of Akron from 1983 to 1990. In 1990, Dr. Preusch came to NIH as a Scientific Review Administrator in the Special Review Section at the Center for Scientific Review. In 1992, he moved to NIGMS as Program Administrator in the Pharmacology, Physiology, and Biological Chemistry Division, National Institute of General Medical Sciences, NIH. In 1999, he became the Program Director for the Pharmacological Sciences Training Grant Program at NIGMS.

Dr. Preusch's training and research experience are in the areas of biochemistry, enzyme mechanism and inhibition, vitamin K metabolism, coumarin anticoagulant action, and reductive activation of anticancer quinones. His responsibilities as a Scientific Review Administrator included reviews of projects on all phases of drug discovery, drug development, and drug delivery, plus reviews of research on protein biophysics and biophysical instrumentation. His responsibilities as a Program Administrator have included research grants and fellowships in biochemistry and bio-related chemistry. Dr. Preusch has led the NIGMS program initiative to elucidate the structures of membrane proteins, and in 1999 co-chaired the AAPS-NIGMS Frontier Symposium on transport proteins as a class of membrane proteins of particular interest in drug delivery.

The program that Dr. Sausville directs is charged with the preclinical evaluation of agents potentially suitable for entry into clinical trial for cancer. This includes initial demonstration of antiproliferative activity in vitro, validation of activity in preclinical in vivo models, selection of compounds for further development, and formulation and toxicology experiments to support the preparation of an Investigational New Drug Application (IND). In addition, since 1988 this program has also had an extensive effort to determine novel agents for the treatment of AIDS and AIDS-related malignancies. The NCI is unique among the categorical Institutes of the National Institutes of Health in having in-house capacity to develop a compound from laboratory bench to clinically used product, as well as to conduct and monitor clinical trials intramurally and at extramural sites pertinent to those products, as well as to others which may be presented to it from outside sources.

Dr. Susla received his B.S. in Pharmacy from the University of Connecticut School of Pharmacy in Storrs, Connecticut and his Doctor of Pharmacy degree from the University of Florida College of Pharmacy in Gainesville, Florida. Dr. Susla completed a Specialty Residency in Critical Care Pharmacy at the Ohio State University Hospitals and Clinics in Columbus, Ohio. He is currently a Pharmacy Manager with VHA Consulting Services, VHA, Inc. Previously, Dr. Susla was a Clinical Pharmacy Specialist, Critical Care Medicine, and Program Director, Pharmacy Practice Residency Program, Pharmacy Department, Warren Grant Magnuson Clinical Center, NIH.

Dr. Susla also is a Consultant to the Critical Care Medicine Department, National Naval Medical Center. He is the past Chairman of the Clinical Pharmacology and Pharmacy Section of the Society of Critical Care Medicine, is a Fellow in the American College of Critical Care Medicine and President of the Washington D.C. Area Critical Care Society. Dr. Susla received the 1996 United States Public Health Service Clinical Pharmacist of the year Award. Dr. Susla is a co-author of the Handbook of Critical Care Drug Therapy.

Dr. Takimoto earned his M.D. at Yale University School of Medicine in New Haven, Connecticut and his Ph.D. in pharmacology from the Yale University Graduate School, both in 1986. He completed his internship and residency in internal medicine at the University of California in San Francisco. Dr. Takimoto completed fellowships in medical oncology at the NCI and in clinical pharmacology at the Uniformed Services University of the Health Sciences in Bethesda, Maryland. Until the spring of 1999, Dr. Takimoto was Senior Investigator, Developmental Therapeutics Department, Medicine Branch, Division of Clinical Sciences, National Cancer Institute (NCI), NIH and Assistant Professor of Medicine, Division of Clinical Pharmacology, Uniformed Services University of the Health Sciences.

Dr. Takimoto is a fellow of the American College of Physicians and a member of the American Association for Cancer Research, the American Society for Clinical Pharmacology and Therapeutics and the American Society for Clinical Pharmacology and Therapeutics and the American Society of Clinical Oncology. He is also an Associate Editor of Clinical Cancer Research. His research interests include the pharmacology of novel new anticancer agents, chemotherapy for advanced gastrointestinal tumors and Phase I drug development.