CEDRA Clinical Research conducts very specialized studies which require state-of-the art techniques, staffing, equipment and facilities. Such studies, often conducted early in the drug development process, require consummate expertise and precision in execution. At CEDRA, we have pioneered the development of many such novel studies, including:
- Maximum Tolerated Dose (MTD) (Bridging) studies in patient populations; these crucial studies define the tolerable dose range early in the development process, allowing confidence in knowing the common AE profile and highest tolerable dose that can be used in Phase II. We have conducted these studies in Alzheimer Disease, Anxiety, Depression, Schizophrenia, Parkinson's Disease, Diabetes, Migraine, and many other indications.
- Cerebrospinal Fluid (CSF) studies, employing discreet and continuous timepoint collections, can confirm brain penetration of psychotropic agents, their pK profile in the brain, and action on neurotransmitters and/or other strategic biomarkers. The Bioanalytical department at CEDRA is able to assay both concentrations of parent compound and metabolites as well as many potential biomarkers in CSF.
- QTc studies at any stage in the drug development process are conducted with state-of-art equipment and capability for data reading and transmission to your specifications.
- Special procedure studies, in healthy normals or patient populations, such as cognitive testing, challenge studies, imaging studies (PET and MRI), and surrogate marker studies.
We have developed and conducted these studies over the past several decades, and can assist you in designing and conducting your specialized trials in our new Special Studies Unit in San Antonio. Our staff, headed by CEDRA Medical Director, Mark Leibowitz MD, is comprised of experienced, board-certified physicians, nurses, psychologists, psychometricians, pharmacists, pharmacokineticists, paramedics and other dedicated staff who can provide 24-hour coverage for these demanding studies. Our expertise in these areas has been widely accepted, as evidenced by the following book references:
- Alzheimer's Disease: Optimizing the Development of the Next Generation of Therapeutic Compounds by Michael F. Murphy, John J. Sramek, Neil M. Kurtz, Angelico Carta, and Neal R. Cutler. Oxford University Press, 1998
- Anxiolytic Compounds: Perspectives in Drug Development by Neal R. Cutler, John J. Sramek, and Neil M. Kurtz. John Wiley & Sons, 1996
- Accelerating CNS Drug Development by Neal R. Cutler, John J. Sramek, Neil M. Kurtz, Michael F. Murphy, and Angelico Carta. John Wiley & Sons, 1998
- Optimizing the Development of Antipsychotic Drugs by John J. Sramek, Neal R. Cutler, Neil M. Kurtz, Michael F. Murphy, and Angelico Carta. John Wiley & Sons, 1997
- Accelerating CNS Drug Development: Critical Pathways to Success by Neal R. Cutler, John J. Sramek, Michael F. Murphy, Henry J. Riordan, Peter R. Bieck, and Angelico Carta. In preparation.
Drs. Cutler, Murphy, and Sramek will collaborate with you to develop and conduct state-of-the-art protocols which address and answer crucial questions about drug effects at an early stage in the development process. Brief biographies of these investigators are included directly below:
Neal R. Cutler, M.D.
President & Chief Executive Officer
Dr. Cutler, CEO of WCT, has a proven track record. He was Founder and Chairman of Worldwide Clinical Trials, Inc. (“Old WCT”), a global CRO providing a full range of product development services on a global basis to the pharmaceutical and biotechnology industries from 1986-1999, which was successfully merged into another CRO. In addition, he was founder and served as Director of California Clinical Trials, one of the largest Phase I-III clinical pharmacology and investigational sites in the U.S. From 2000 to 2006, he was the founder of and served as President and CEO of Alamo Pharmaceuticals, LLC. Dr. Cutler is a board-certified psychiatrist, and is also board-qualified in both neurology and clinical pharmacology. He was active at the National Institutes of Health for over nine years in a variety of positions such as Deputy Clinical Director of the National Institute on Aging, and Chief, Section on Brain Aging and Dementia. Currently, he is President of the American Foundation for Clinical Pharmacology, and serves on a special emphasis panel review committee for the National Institute on Aging for the National Institutes of Health. Dr. Cutler has been invited to give several hundred international and national presentations in the areas of aging, clinical pharmacology, and drug development, and has authored over 226 publications including nine books on the topics of clinical pharmacology, aging, Alzheimer’s disease, schizophrenia, anxiety disorders, and diabetes.
Dr. Cutler has also been instrumental in the design and clinical development of nearly 200 compounds in numerous therapeutic areas and has particular expertise in central nervous system disorders. His development of the revolutionary dynabridge study methodology has made feasible the study of both the presence and the dynamic activity of a compound in the brain, and has facilitated the rapid and effective development of a number of compounds. Dr. Cutler also developed and obtained an FDA approved registration as well as marketed a new drug product to treat schizophrenia, FazaClo®. In gaining approval for FazaClo®, the protocol designed by Dr. Cutler changed the approval process for generic formulations of similar CNS drugs requiring testing in patients consistent with the FazaClo® study. Dr. Cutler earned an M.D. from St. Louis University Medical School and a B.A. from St. Louis University.
Michael F. Murphy, M.D., Ph.D.
Chief Medical and Scientific Officer
Dr. Murphy’s professional career has spanned 25 years and his positions within pharmaceutical and contract research organizations have emphasized integration of medical and scientific acumen with operational excellence. Dr. Murphy worked with Dr. Cutler in articulating this vision for Worldwide Clinical Trials when the company was established as a global CRO in 1995 and was responsible for consulting services on protocol and program design, execution, analysis, and interpretation across multiple therapeutic areas. Prior to joining WCT, Dr. Murphy was Chief Medical Officer and Senior Vice President at TorreyPines Therapeutics Inc. with contributions emphasizing translational research activities in neurodegenerative conditions and analgesia. Dr. Murphy served as President of the Clinical Research Organization then Chief Medical and Scientific Officer for a large, global CRO, a division of UnitedHealth Group. He has been a consultant for the Duke Clinical Research Institute and is Research & Development Editor for American Health & Drug Benefits™. As a faculty member within the Center for Experimental Pharmacology and Therapeutics, Harvard-MIT Division of Health Sciences and Technology, he has been a lecturer for a decade within a competitive and credentialed Clinical Investigator Training Program. Dr. Murphy is board-certified in psychiatry and has a doctorate in pharmacology, with training at Tulane University, Stanford University, and the Mt. Sinai School of Medicine.
John J. Sramek, Pharm. D.
Director of Clinical Research
Dr. Sramek has served as the Director of Clinical Research for California Clinical Trials, Inc., Worldwide Clinical Trials, Inc., and Alamo Pharmaceuticals, LLC for over twenty years. Dr. Sramek has authored over 210 publications on psychopharmacology and various aspects of clinical pharmacology and drug development, including eleven books and numerous book chapters. Dr. Sramek has also worked on the design and clinical development of nearly 200 compounds over the full range of clinical drug development, from initial human pharmacology through pivotal efficacy trials. His co-development of the bridging study methodology has been instrumental in the rapid transition of a compound from Phase I to Phase II/III clinical efficacy trials by establishing the maximum tolerated dose early in patient populations. He has clinical pharmacology and clinical trial expertise in a wide range of indications including Alzheimer’s disease, schizophrenia, depression, anxiety disorders, migraine, and cardiovascular disorders. Dr. Sramek earned a Pharm.D. from the University of Southern California, and also holds undergraduate and graduate degrees in biology and psychology.