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Advisors & Consultants

Scientific/Clinical

Daniel J. Burch, MD, MBA – Dr. Burch serves as Pharmaceutical Product Development’s Vice President and Global Therapeutic Area Head for Neuroscience. In this position, he directs the neuroscience area strategic team and serves as a chief adviser to clients in developing and conducting clinical programs in this area. Dr. Burch has over 20 years of drug development experience. Prior to PPD, as Executive Vice President and Chief Medical Officer at CeNeRx BioPharma, he managed a portfolio of medicines focused on neuropsychiatric diseases. Prior to that, he led the Neuroscience Medicines Development Centre at GlaxoSmithKline (GSK) where he had global responsibility for phase II through life cycle management. Dr. Burch received his MD from the Vanderbilt University School of Medicine, where he also completed a residency in internal medicine. In addition, he earned his MBA from the Wharton School of Business at the University of Pennsylvania.

Anita H. Clayton, MD – Dr. Clayton is the David C. Wilson Professor as well as Chair of the Department of Psychiatry and Neurobehavioral Sciences. Her area of expertise is women’s mental health, which includes areas such as reproductive related mood and anxiety disorders. Dr. Clayton’s research interests concentrate on women’s mental health and sexual dysfunctions. Dr. Clayton earned her undergraduate and MD from the University of Virginia, where she also completed her internship and residency in behavioral medicine and psychiatry. She is board certified in psychiatry by the American Board of Psychiatry and Neurology.

Leonard R. Derogatis, Ph.D. – Dr. Derogatis is the Director of Maryland Center for Sexual Health. His research interest is in the area of sexual medicine, where he is doing sponsored research on screening diagnosis and treatment of sexual disorders. Dr. Derogatis served as an attending clinician at the John Hopkins Sexual Behaviors Consultation Unit, and he served 21 years on the faculty at John Hopkins. Dr. Derogatis founded and directed the Division of Medical Psychology as well as was the Chief Psychologist at the John Hopkins Hospital. Dr. Derogatis received his Ph.D. from Catholic University in Washington, D.C.

Stephen M. Stahl, MD, Ph.D. – Dr. Stahl is an Adjunct Professor of Psychiatry at the University of California at San Diego, Chairman of Neuroscience Education Institute, and serves as Editor-in-Chief of CNS Spectrums. He is also the Director of Psychopharmacology Services and Senior Academic Advisor for the California Department of State Hospitals. He is a globally recognized clinician, researcher, and teacher in psychiatry with subspecialty expertise in psychopharmacology. He was formerly Executive Director of Clinical Neurosciences at the Merck Neuroscience Research Center in the United Kingdom. Dr. Stahl earned his undergraduate degree as well as MD from Northwestern University in Chicago. At the University of Chicago, he received his Ph.D. in pharmacology and physiology. Dr. Stahl has trained in three specialties: internal medicine, neurology, and psychiatry.

Michael E. Thase, MD –Dr. Thase is Professor of Psychiatry for the Perelman School of Medicine at the University of Pennsylvania. He is a Founding Fellow of the Academy of Cognitive Therapy and a Distinguished Fellow of the American Psychiatric Association. In addition, Dr. Thase is a member of the Board of Directors of the American Society of Clinical Psychopharmacology as well as Vice Chairman of the Scientific Advisory Board of the National Depression and Bipolar Support Alliance. His research interest focuses on the assessment and treatment of mood disorders comprising studies of the differential therapeutics of bipolar affective disorder and depression. Prior to joining the faculty at Penn, Dr. Thase was professor at the University of Pittsburgh School of Medicine and the Western Psychiatric Institute and Clinic for more than 27 years. Dr. Thase obtained his undergraduate degree in psychology from Wright State University, and earned his MD from Ohio State University College of Medicine. Dr. Thase completed his internship and residency in psychiatry at Western Psychiatric Institute.

Regulatory

Thomas P. Laughren, MD – Dr. Laughren is the Director of Regulatory Affairs at Massachusetts General Hospital Clinical Trials Network and Institute, and he is an independent consultant in psychiatric drug development. As the Director of Regulatory Affairs, Dr. Laughren works with pharmaceutical companies to ensure the development of effective and safe psychiatric drugs. His key interests are the regulatory and methodological issues connected to the development of psychiatric drugs and he frequently speaks professionally on these matters. Dr. Laughren was the Division Director for the Division of Psychiatry Products at FDA from 2005 to 2012. In this role, he managed the review of all psychiatric drug development under INDs to the review of NDAs and supplements. Dr. Laughren earned his MD from the University of Wisconsin, where he also completed his residency in psychiatry.

Steven M. Weisman, Ph.D. – Dr. Weisman is Head of Clinical and Regulatory Support at Innovative Science Solutions, where he concentrates on the development of scientific and regulatory methods that increase market potential. Dr. Weisman has planned and presented FDA advisory committee meetings, many symposia, and numerous other regulatory venues, internationally. Dr. Weisman is a leading authority on the change of prescription-only products to over-the-counter status. He has more than 20 years of experience in clinical and regulatory affairs, marketing evaluation and communication, pharmacology, pharmaceutical product development, and toxicology. Dr. Weisman earned his Ph.D. in pharmacology from Cornell University Medical College. He then completed his postdoctoral training at Roche Institute of Molecular Biology in immunopharmacology.

Legal

Covington – Food, Drugs & Devices. Covington’s internationally leading Food, Drug, and Device Practice encompasses the full range of pharmaceutical, biotechnology, medical device, veterinary, food, beverage, dietary supplement, and cosmetic issues. Through their offices in the United States, Europe, and China and a network of local counsel, they advise trade associations, multinational corporations, and emerging companies on a global basis. They are the only firm ranked “Band 1” for Life Sciences across Chambers’ US, UK, Europe, China, and Global surveys.

Oblon – Life science companies require IP counsel with expertise that bridges science, law and business. Oblon’s Life Sciences Practice Group is designed to anticipate the needs of these companies and provide the necessary counsel for securing IP protections, in tandem with navigating regulatory hurdles of critical importance in the industry. Their patent agents and attorneys have a wide range of scientific, government and industry experience: as scientists, consultants, patent examiners and PTAB judges. All of Oblon’s Life Science members have a scientific background, and many hold doctorates in biological and chemical disciplines. These professionals are adept at small and large-scale IP portfolio management and will advise companies based on strategic competitor research findings as well as a full market analysis. Oblon’s Life Sciences team also offers experience in collaboration and licensing agreements, as well as counseling regarding freedom to operate in the marketplace.