Scientific Advisors
David Alpers, M.D.
Dr. Alpers received his medical degree from Harvard Medical School and his house staff training in Internal Medicine at the Massachusetts General Hospital in Boston. After two years as a research associate at the National Institutes of Health, he completed a fellowship in Gastroenterology at the Massachusetts General Hospital and was a junior faculty member at Harvard Medical School for five years. He was the chief of the GI Division at Washington University School of Medicine from 1969-1996. Since 1998 Dr. Alpers has served part time as a senior consultant to R&D (gastrointestinal, pain, and anti-inflammatory drug development) for GlaxoSmithKline.
Dr. Alpers served the American Gastroenterological Association as chair of the Research Committee, director of the Undergraduate Teaching Project, and as President (1990-91). In 1997 he was awarded the Friedenwald medal by the AGA for a lifetime of contributions to the field of gastroenterology. He has served as editor for the American Journal of Physiology – Gastrointestinal and Liver Physiology (1991-1997), and for the Small Intestine and Nutrition sections of Current Opinion in Gastroenterology (1996-present). He was associate editor of the Journal of Clinical Investigation and of Annual Reviews of Nutrition, and is currently associate editor of the Textbook of Gastroenterology (Lippincott Williams & Wilkins, T. Yamada, editor-in-chief), now in its 4th edition. He is senior author of the Manual of Nutritional Therapeutics (Lippincott Williams & Wilkins, 4th edition). He served on the editorial board of the Journal of Biological Chemistry from 1998-2003.
Dr. Alpers' research activities include the structure/function relationships of the vitamin B12 binding proteins, and the biological role of intestinal alkaline phosphatase in intestinal physiology, especially fat absorption. His clinical research has focused on the psychiatric aspects of functional and inflammatory bowel disease.
Douglas Gourlay, M.D., FRCPC, FASAM
Dr. Gourlay received his medical degree from McMaster University in Hamilton, Ontario. He later completed his fellowship in anesthesiology, was certified in addiction medicine, and became a fellow of the American Society of Addiction Medicine. He is currently the director of the Pain and Chemical Dependency division of the Wasser Pain Management Centre at Mount Sinai Hospital in Toronto, as well as clinical director of laboratory services at the Centre for Addiction and Mental Health.
Dr. Gourlay's practice encompasses the assessment and treatment of patients suffering from pain and addiction, as well as general addiction medicine. He is certified by the American Society of Addiction Medicine, and was the past chair of the Agonist Committee for the American Society of Addiction Medicine. He is also a member of various organizations dedicated to the assessment and treatment of pain, including the American Academy of Pain Medicine and the American Society of Regional Anesthesia.
Dr. Gourlay's particular area of expertise is in chronic opioid therapy for the treatment of nonmalignant pain.
Charles Grudzinskas, Ph.D.
Dr. Grudzinskas is a founder and General Manager for NDA Partners LLC. He is a member of the Center for Drug Development Science at the UCSF-DC Center, and is active as a regulatory and drug development consultant to pharma and biotech companies, and to incubator and DOD organizations. Dr. Grudzinskas is a licensed U.S. Patent Agent. Dr. Grudzinskas previously held executive management positions at G.D. Searle & Company, Lederle Laboratories (both now Pfizer) and was the first director of the Medications Development Division at the National Institute on Drug Abuse at the/NIH. Dr. Grudzinskas chairs the Curriculum Committee of the American Course in Drug Development and Regulatory Science (ACDRS), which is offered through UCSF. Dr. Grudzinskas is a member of the Board of Directors for Immunomic Therapeutics, Inc.
Cynthia McCormick, M.D.
Dr. McCormick is a clinical and regulatory consultant to government and pharmaceutical companies developing products for central nervous system disorders. Dr. McCormick served as medical reviewer in the Division of Neuropharmacological Drug Products at the FDA for five years. During this time she was the lead reviewer for all antiepileptic drug product INDs and NDAs such as Neurontin®, Tiagabine®, and Topiramate®.
Dr. McCormick later assumed the position of Director of the Division of Anaesthetic, Critical Care and Addiction Drug Products where she oversaw the review and approval of anaesthetic agents, and drugs targeted for the treatment of pain and addiction, and supervised the Controlled Substances Review staff. During this time, she initiated strategies to ensure that a standardized approach to the development of drugs for pain was undertaken. She held positions sequentially on the FDA's pediatric drug development, labeling and pediatric (exclusivity) implementation team during her tenure at the FDA.
Prior to her FDA experience, Dr. McCormick served as a medical officer in the National Institute of Neurological Disorders (NINDS) Antiepileptic Drug Development Program, which led the development of new therapies for the treatment of epilepsy. Her last position in the federal government was that of Deputy Director of Extramural Research for the NINDS. She also played a key role in the implementation of the National Vaccine Injury Compensation Program as Chief Medical Officer and Deputy Director. Dr McCormick is a graduate of Bryn Mawr College and the Medical College of Pennsylvania. She received her postgraduate residency training at the University of Michigan, Department of Pediatrics and the University of Pennsylvania, Department of Neurology.
Steven Passik, Ph.D.
Dr. Passik is a clinical psychologist whose areas of expertise include the general psychological aspects of cancer including palliative care, and symptom management with an emphasis on pain, depression, nausea and fatigue.
In addition to Dr. Passik's work as a clinical psychologist, he also leads the symptom studies and pharmacotherapy laboratory. The lab conducts and examines symptom assessment studies, which are aimed at enhancing quality of life and relieving suffering of patients. His research interests include examining pain medication usage among cancer patients; assessing abnormal drug usage among cancer and HIV+ patients; and developing psychosocial interventions for cancer patients.
Dr. Passik is a Professor of Psychiatry and Anesthesiology, Vanderbilt University Medical Center. He is also a member of many scientific and medical societies including the American Psychological Association, International Psycho-Oncology Society and American Society of Psychiatric Oncology/AIDS, all organizations of specialists in his field. He has also written extensively on the interface of pain management and addiction.
Frank L. Sapienza
Mr. Sapienza has been a Partner with The Drug & Chemical Advisory Group, LLC for six years. He provides consulting services to industry and government. Previously, Mr. Sapienza worked for the Drug Enforcement Administration (DEA) for thirty-one years. He held various positions, including Chief, Drug and Chemical Evaluation Section, DEA Office of Diversion Control, and forensic scientist, DEA Laboratory.
Mr. Sapienza’s areas of expertise include domestic and international scheduling, assessment of abuse potential, U.S. and international narcotic raw material issues, international treaty requirements, reports and policies, drug diversion, trafficking and abuse data collection and analysis, DEA/FDA interactions for drug development, and domestic and international chemical control issues.
He has served on expert panels with the U.S. Government and with the World Health Organization, the International Narcotics Control Board, and the United Nations Office of Drug Control Policy, as well as on expert advisory panels for the pharmaceutical industry. He has lectured internationally, written and co-authored scientific and other articles on drug regulation, conducted numerous training sessions, prepared portions of national legislation, and testified as an expert witness in criminal, administrative and legislative hearings.
Mr. Sapienza earned a B.S. and M.S. in Chemistry from the University of Pittsburgh.
Steven L. Shafer, M.D.
Dr. Shafer is a co-founder of PharmacoFore. Dr. Shafer was recruited to Columbia University's College of Physicians and Surgeons from Stanford University in 2007, joining the faculty as professor of anesthesiology. He continues to hold an adjunct academic position at Stanford, where he received his medical degree and did a clinical fellowship in pharmacology, as well as a similar appointment in biopharmaceutical sciences at the University of California at San Francisco. Dr. Shafer is a graduate of Princeton University and completed his anesthesia residency at the University of Pennsylvania. He is editor-in-chief of the peer-reviewed journal Anesthesia & Analgesia and former chair of the Anesthesia and Life Support Drug Advisory Committee at the FDA, with which he continues to work as a special government employee. An expert in mathematical modeling of drug behavior, Dr. Shafer has conducted and led numerous clinical studies on the intravenous opioid drugs and hypnotics used in anesthetic practice.
Lynn Webster, M.D., FACPM, FASAM
Dr. Lynn Webster is board certified in anesthesiology and pain medicine and is also certified in addiction medicine. In his private practice, he treats chronic pain patients, many of whom have complex diagnoses. He also detoxes opioid-addicted patients. This dual role lends Dr. Webster a valuable perspective. He is dedicated to treating patients in pain while simultaneously working to minimize the potential for abuse and addiction.
Dr. Webster is co-founder and medical director of Lifetree Clinical Research. His research interests are diverse and he has been keenly interested in developing safer and more effective therapies for chronic pain and addiction.
Dr. Webster earned his doctorate of medicine from the University of Nebraska Medical Center and completed his residency in the University of Utah Medical Center's Department of Anesthesiology. He lectures extensively on the subject of preventing opioid abuse and criminal diversion in chronic pain patients, and he has authored over 100 scientific abstracts, journal articles and the recently published book Avoiding Opioid Abuse While Managing Pain: A Guide for Practitioners. This book was written for clinicians who prescribe opioid drugs as a guide to sort out the clinical, regulatory and ethical issues associated with the prescribing of opioid analgesics. It includes step-by-step protocols for assessing patients for the risk of opioid abuse as well as for legally protecting the opioid prescriber.
He is the co-founder of LifeSource, a non-profit foundation established in 2006 to educate physicians, patients and communities on health issues (with an emphasis on pain-related, scientific and social issues), as well as fund and conduct research that will discover new solutions and hope for improved life. LifeSource's first project was entitled Zero Unintentional Deaths. The campaign was developed to educate physicians, chronic pain sufferers and all communities about the increasingly serious issue of unintentional overdose deaths related to methadone and other prescription medications. It aims to eliminate unintentional overdoses from prescription medication. He also leads American Pain Foundation's PainSAFE program which focuses on ensuring all pain therapies are safe.
Dr. Webster is currently on the Board of Directors for the American Academy of Pain Medicine and the American Board of Pain Medicine.