Darrell R. Abernethy, MD, PhD
Chief, Laboratory of Clinical Investigation, National Institute on Aging (NIA), NIH
Dr. Abernethy received his MD (AOA) and PhD (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 focusing 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 that 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.

Arthur J. Atkinson, Jr., MD
Adjunct Professor of Molecular Biochemistry and Pharmacology, Feinberg School of Medicine, Northwestern University
Dr. Atkinson received his AB degree in Chemistry from Harvard College in 1959 and his M.D. from Cornell University Medical College in 1963. Following his 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 US 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. He served in that position until October, 2005. While at the NIH, Dr. Atkinson initiated the “Principles of Clinical Pharmacology” course and served as the course Director until he left the NIH. Also, during that time at the NIH, he was the Program Director for the Clinical Pharmacology Research Associate Training (ClinPRAT) program, a postdoctoral fellowship training program in clinical pharmacology. Dr. Atkinson is currently Adjunct Professor of Molecular Biochemistry and Pharmacology at the Feinberg School of Medicine, Northwestern University.

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.

Frank M. Balis, MD
Clinical Director, National Cancer Institute (NCI), National Institutes of Health (NIH) and
Head, Pharmacology and Experimental Therapeutics Section, Pediatric Oncology Branch, NCI, NIH
Dr. Balis’ primary research focus is the clinical pharmacology of anticancer drugs and new drug development for childhood cancers. Dr. Balis came to the 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 BS in Zoology from the University of North Carolina and his MD from Vanderbilt University. He completed a pediatric residency at Vanderbilt Children’s Hospital followed by 4 years of fellowship training in Pediatric Hematology/Oncology at the Children’s Hospital in Seattle and the Fred Hutchinson Cancer Research Center.

Karim Anton Calis, PharmD, MPH
Director, Drug Information Service and
Clinical Specialist, Endocrinology and Women’s Health, Department of Pharmacy, NIH Clinical Center, NIH
Dr. Calis is a clinical specialist in endocrinology and women’s health for the National Institute of Child Health and Human Development (NICHD) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at the National Institutes of Health (NIH). He also is the Director of the NIH Drug Information Service.  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. Prior to joining the NIH in 1989, he held the positions of Clinical Pharmacy Coordinator and Assistant Director for Clinical Services and served as director of a nutritional and metabolic support service. Dr. Calis is a Fellow of the American College of Clinical Pharmacy and a Fellow of the American Society of Health-System Pharmacists.  He is board certified in pharmacotherapy and in nutritional support by the Board of Pharmaceutical Specialties. 

Dr. Calis is Clinical Professor at the University of Maryland and Shenandoah University and Professor at the Medical College of Virginia, Virginia Commonwealth University. He is a clinical investigator in the NIH intramural research program, with a primary focus on disorders of the hypothalamic-pituitary-adrenal axis, female reproductive endocrinology, physiologic sex-steroid replacement in women, and childhood growth and obesity. Dr. Calis is responsible for drug safety monitoring for a number of ongoing NIH studies and is a member of the NICHD Institutional Review Board. He also has served as a member and chair of several data and safety monitoring boards at the NIH. 

Dr. Calis completed a 5-year term on the Expert Panel on Nutrition and Electrolytes and another 5-year term as a member of the Expert Committee on Endocrinology of the United States Pharmacopeial (USP) Convention. Currently, Dr. Calis serves as Chair of the USP Endocrinology Expert Committee (an elected position) and Vice Chair of the Medicare Model Guidelines Expert Committee. He also is a member of the USP Council of Experts. 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 the recipient of the McKesson and Squibb leadership awards, the ASHP Research and Education Foundation’s Pharmacy Practice Research Award, and the Award for Excellence in Clinical Pharmacy Practice from the Association of Military Surgeons of the United States (AMSUS). In July of 2004, Dr. Calis was elected as a Distinguished Practitioner by the National Academies of Practice. In October of 2005, he was selected as the Honored Alumnus by the University of Maryland School of Pharmacy.

Jerry M. Collins, PhD
Associate Director, Developmental Therapeutics Program, Division of Cancer Treatment and Diagnosis, NCI, NIH
Dr. Collins received his PhD in 1976 from the University of Pennsylvania and completed a postdoctoral fellowship in Clinical Pharmacology at Johns Hopkins University School of Medicine.  In 2005, Dr. Collins returned to the National Institutes of Health (NIH) to lead the Developmental Therapeutics Program at the National Cancer Institute (NCI).  He has authored or co-authored over 170 papers in the field of clinical pharmacology, primarily emphasizing the applications of pharmacokinetic/pharmacodynamic (PK/PD) principles in the fields of cancer.  Prior to his current position, he spent 17 years at the Food and Drug Administration (FDA), where his work also included extending these principles with positron emission tomography (PET).  Before joining the FDA, Dr. Collins spent a total of 10 years at the NIH, including 5 years as Chief of the Pharmacokinetics Section at the NCI.  Dr. Collins retains an association at the FDA for joint NCI-FDA programs.

Charles E. Daniels, PhD
Professor and Associate Dean, and
Pharmacist-In-Chief, School of Pharmacy and Pharmaceutical Sciences, University of California at San Diego
Dr. Daniels received his BS in Pharmacy from the University of Arizona and then completed a Pharmacy Residency at the National Institutes of Health (NIH). He earned his MS and PhD 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 served as the Major Professor or Research Advisor for over two-dozen students who completed the MS or PhD. 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 epidemiologic evaluation of medication-related events.  He has published scientific and professional articles and book chapters on those topics.

Dr. Daniels is currently Professor and Associate Dean, and Pharmacist-In-Chief, School of Pharmacy and Pharmaceutical Sciences at the University of California at San Diego (UCSD).

Before joining UCSD Dr. Daniels was Chief of the Pharmacy Department at the NIH Clinical Center, where he was responsible for comprehensive pharmaceutical services, new drug development support programs, and pharmacy-based research programs.

Robert L. Dedrick, MSE, PhD
Special Volunteer and former Director, Drug Delivery and Kinetics Resource, Bioengineering and Physical Science Program, National Institutes of Health (NIH)
Dr. Dedrick received his formal training in chemical engineering at Yale University (BE with highest honors), the University of Michigan (MSE), and the University of Maryland (PhD). 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 physiologic pharmacokinetics, pharmacokinetics of macromolecules, regional drug administration, spatially distributed models, kinetics, fluid mechanics, and applications of engineering science and technology related 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; and the Founders’ Award of the Chemical Industry Institute of Toxicology. He 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.

David A. Flockhart, MD, PhD
Professor of Medicine, Genetics and Pharmacology
Chief, Division of Clinical Pharmacology
Indiana University School of Medicine
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 PhD from the Welsh National School of Medicine and an MD 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 the National Institute of General Medical Sciences (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 interindividual 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 2,000 visits per month from physicians and scientists from around the world.

Marilynn C. Frederiksen, MD
Associate Professor of Obstetrics and Gynecology, Department of Obstetrics and Gynecology, Northwestern University Medical School
Dr. Frederiksen received her undergraduate degree from Cornell College in Mount Vernon, Iowa and her MD 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 National Institutes of Health (NIH) National Center for Research Resources (NCRR) General Clinical Research Center (GCRC) Committee, serving as Chair from 1992 through 1993. Also, 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 National Heart, Lung, and Blood Institute (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 a Food and Drug Administration (FDA) symposium on Women in Clinical Trials and was an invited speaker at two workshops on pharmacokinetics in pregnancy that were held in 2000 by the National Institute of Child Health and Human Development (NICHD) and by the FDA.

Pamela D. Garzone, PhD
Director of Clinical Pharmacology, ChemoCentryx, Inc.
Dr. Garzone has extensive product development experience in biotechnology and has held positions of increasing responsibility in a number of United States (US) biotechnology companies. Currently, she is the Director of Clinical Pharmacology at ChemoCentryx, Inc., a clinical-stage biopharmaceutical company focused on discovering and developing orally administered medicines that target the chemokine system.

Dr. Garzone 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 US 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 central nervous system (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.

William Gillespie, PhD
Vice President, Strategic Consulting Services, East Coast Operations, Pharsight Corporation
Dr. Gillespie joined Pharsight in April 1999 as a Senior Consultant, Scientific Affairs. From 1997 to April 1999, he was Vice President for Pharmacokinetic Research and Development at GloboMax LLC. From 1993 to 1997, he was with the Center for Drug Evaluation and Research, United States (US) Food and Drug Administration, serving as Associate Director for Scientific Affairs and heading the Pharmacometrics staff in the Office of Clinical Pharmacology and Biopharmaceutics. From 1987 to 1993, he was Assistant Professor of Pharmaceutics at the University of Texas at Austin, College of Pharmacy. He received his PhD in Pharmacy from the University of Iowa in 1987. Dr. Gillespie's recent research efforts have concentrated on novel applications of pharmacokinetic (PK) and pharmacokinetic/pharmacodynamic (PK/PD) modeling, including clinical trial simulations, Bayesian approaches to population PK/PD modeling, in vivo/in vitro correlation, and bioequivalence assessment based on pharmacodynamic measurements. He has published over 50 research articles pertaining to pharmacokinetics and biopharmaceutics.

Michael M. Gottesman, MD
Deputy Director for Intramural Research, National Institutes of Health (NIH)
Dr. Gottesman attended Harvard College, where he graduated summa cum laude in biochemical sciences in 1966. He graduated from Harvard Medical School with an MD 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 M