Adel H. Karara
Adel H. Karara, Ph.D., FCP is Professor of Pharmaceutical Sciences, teaches in the areas of pharmaceutics, biopharmaceutics and pharmacokinetics. Prior to joining UMES, he held senior positions in the pharmaceutical industry. His research had been primarily in the female health care area working on the pharmacokinetics/dynamics of combination hormone treatments. As Senior Clinical Pharmacologist at Roche, he had the responsibility for guiding the selection of early drug discovery compounds, due diligence projects and design of clinical pharmacology development programs for several metabolic drug candidates. Before joining Roche, he was Director at Berlex where he provided NDA support for Yasmin®, ClimaraPro® Menostar® and Angeliq®. At Novartis, he provided support for Starlix®, Lescol® and Neoral®. Dr. Karara was a tenured faculty at University of Louisiana where he mentored 3 PhD & 2 MS students and won the researcher of the year award. Dr. Karara is a Charter member of American Association of Pharmaceutical Scientists (AAPS), participated in teaching short courses and served on abstract screening committees. Dr. Karara was elected to serve as the Chair of the Clinical Pharmacology and Translational Medicine Section of AAPS. He has 39 peer reviewed publications and was invited speaker at several clinical pharmacology forums. He served on Pharmaceutical Research and Manufacturers of America, Clinical Pharmacology Technical Group where he led the exploratory Investigational New Drug (IND) survey initiative. Dr. Karara currently serves on the FDA Pharmaceutical Science and Clinical Pharmacology Advisory Committee for oncology drugs (ODAC). Dr. Karara is a fellow of American College of Clinical Pharmacology and serves on the editorial board of the Journal of Clinical Pharmacology.
Aaron S. Kesselheim
Aaron Kesselheim, M.D., J.D., M.P.H., is a Professor of Medicine at Harvard Medical School (HMS) and a faculty member in the Division of Pharmacoepidemiology and Pharmacoeconomics in the Department of Medicine at Brigham and Women’s Hospital (BWH). He is Board Certified in Internal Medicine, and serves as a primary care physician at the Phyllis Jen Center for Primary Care at BWH. Within the Division, Dr. Kesselheim created and leads the Program On Regulation, Therapeutics, And Law (PORTAL), an interdisciplinary research core focusing on intersections among prescription drugs and medical devices, patient health outcomes, and regulatory practices and the law. His research has concentrated on the interaction of law and public health related to drug discovery, testing, and regulatory approval, using a combination of quantitative and qualitative research tools and normative study. Author of over 350 publications in the peer-reviewed medical and health policy literatures, Dr. Kesselheim was recently recognized as the second most-cited health law scholar in Web of Science from 2013-2017. He has testified before Congress a half-dozen times on pharmaceutical policy, medical device regulation, generic drugs, and modernizing clinical trials, is a member of the FDA Peripheral and Central Nervous System Advisory Committee, and served on a National Academies of Science, Engineering and Medicine consensus committee on addressing the opioid epidemic. Aaron is a core faculty member at the HMS Center for Bioethics, where he co-teaches a course on health policy, law, and bioethics and organizes a popular monthly policy and ethics seminar series. Aaron also serves as the Irving S. Ribicoff Visiting Associate Professor of Law at Yale Law School, where he teaches a yearly course on Food and Drug Administration Law. He serves on the Perspectives Advisory Board of the New England Journal of Medicine and is the editor-in-chief of the Journal of Law, Medicine, and Ethics.
Robert MacArthur, Pharm.D., M.S., earned his Pharm.D. at St. John's University, in New York, and MS in Biostatistics at Columbia University, also in New York. For over 30 years he has been continuously engaged in the fields of commercial drug development, clinical research, and research pharmacy. His experience includes large pharma (Sandoz, Novartis), small/mid pharma (Systems Medicines, CTI, Aeson Therapeutics, Cancer Prevention Pharmaceuticals, multiple others), and academia, along with running his own companies. On behalf of these sponsors he has worked with and presented to FDA, EMA, NIH, NCI, patient groups, CROs, CDMOs, and others, always with the objective of moving a promising medication along the critical path towards regulatory approval. Over this time he has contributed to the development of many hundreds of human medicines, leading to multiple drug approvals. At AmPharmStatistics.com, (APS) Robert has the good fortune to work with highly experienced and talented statisticians. At APS, he is able to apply his knowledge and skills to pharmaceutical statistics and reporting for regulatory submissions, and to support clinical trial groups, for large and small pharma companies.
Jose E. Manautou
José Manautou, Ph.D., is a Professor of Toxicology and Interim Head of the Department of Pharmaceutical Sciences at the University of Connecticut. He was selected to serve on the National Advisory Environmental Health Sciences Council (NAEHSC), part of the National Institute of Environmental Health Sciences (NIEHS) in 2017. He has also served on the Board of Scientific Counselors within NIEHS. He is a world-renowned expert in acetaminophen hepatoxicity. Dr. Manautou received his undergraduate degree in pharmacy from the University of Puerto Rico and his Ph.D. in pharmacology and toxicology from Purdue University. He came to UConn as a post-doctoral researcher in 1992, working with pioneering toxicologist Professor Emeritus Steven Cohen. He was named a tenure track assistant professor in Toxicology in 1995, and received tenure and promotion to associate professor in 2001.
Nancy K. Reame
Nancy King Reame, Ph.D., MSN is the Mary Lindsay Professor Emerita of Health Promotion and Risk Reduction in the School of Nursing at Columbia University in New York City. From 2005-2015, she directed the Pilot Studies Resource of the Irving Institute for Clinical and Translational Research in the College of Physicians and Surgeons and was the Director of the PhD program in Nursing. From 1980-2005, she held faculty posts at the University of Michigan in the School of Nursing and the Department of Obstetrics-Gynecology in the School of Medicine. Dr. Reame’s research is focused on the impact of reproductive neuroendocrinology on women’s health across the lifespan. Current studies include the role of menopause on cognition and HIV symptoms, and the impact of endometriosis on menstrual cycle phenotypes. A member of the Institute of Medicine, Dr. Reame is a women's health advocate, having served on the advisory committee to the NIH Women's Health Initiative, and as advisor for many years to the Boston Women's Health Book Collective for the iconic book, “Our Bodies, Ourselves.” A past member of the Board of Trustees for the North American Menopause Society, she is certified as a menopause clinician. Nancy received her undergraduate degree in nursing from Michigan State University, a Master’s degree as a clinical nurse specialist from Wayne State University College of Nursing, and a PhD in physiology from Wayne State University School of Medicine, with postdoctoral training in reproductive endocrinology at the University Of Michigan School Of Medicine.
David R. Rubinow
David R. Rubinow, M.D., is the Meymandi Professor and Chair, Department of Psychiatry, at the University of North Carolina-Chapel Hill, School of Medicine; prior to being recruited to the University of North Carolina, he was Clinical Director of the National Institute of Mental Health (NIMH) and Chief of the Behavioral Endocrinology Branch of NIMH. His research interests focus on neurobehavioral effects of gonadal steroids and how genetic variation contributes to differential behavioral response to changes in steroid signaling. Research methods used include administration of hormone super agonists and receptor blockers to manipulate the menstrual cycle and identify the central effects of gonadal steroids in isolation. These studies have demonstrated that, unlike mood disorders accompanying endocrinopathies, reproductive endocrine-related mood disorders represent abnormal responses to normal hormonal signals. Current NIH funded studies include investigations of continuous oral contraceptive administration in menstrual cycle-related mood disorders, estradiol effects on cardiovascular risk and mood dysregulation during the perimenopause, and biomarkers of postpartum depression. Additionally, the UNC Women’s Mood Disorders Program, which he directs, has the first and only NIH training fellowship in Women’s Mood Disorders. On the basis of his research, he was inducted into the Institute of Medicine of the National Academies in 2012.
Rulla Tamimi, Sc.D., aims to better understand breast cancer risk by incorporating biospecimens and molecular tools in epidemiologic studies. She is an Associate Professor of Medicine at Harvard Medical School. She and her team have led research on breast cancer, including work on lifestyle risk factors, biomarkers, genetics and gene expression. She studies intermediate markers of breast cancer risk including benign breast disease and mammographic density as an approach to better understand early life influences on breast cancer risk. Working with computer scientists, she and her group are identifying additional mammographic imaging features that predict risk of breast cancer. By leveraging molecular tools and intermediate markers of risk, Dr. Tamimi hopes to shed new light on our understanding of risk factors of breast cancer with the goal of identifying strategies for breast cancer prevention and improved risk assessment. She received her M.S. and ScD.D. from the Harvard School of Public Health.