Faculty – 4th Human Abuse Liability & Abuse-Deterrent Formulations

Jeremy Adler

Charles Argoff
Professor of Neurology, ALBANY MEDICAL CENTER

David Baker

Michael Barnes

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Michael C. Barnes is executive director of the Center for Lawful Access and Abuse Deterrence (CLAAD), a national nonprofit working to reduce prescription drug abuse, and managing partner at DCBA Law & Policy in Washington, DC. He has served as a strategic advisor to executives at multinational corporations, primary legal counsel to national healthcare service providers, and compliance officer for multi-state providers of behavioral healthcare. Mr. Barnes has authored more than 10 scholarly articles; presents frequently at conferences nationwide; and performs legal analysis for radio and TV networks, including CNN, HLN and FOX News. He previously served as confidential counsel in the White House Office of National Drug Control Policy.

Colville Brown
Medical Director, EGALET

John Burke

Dan Cohen

Executive Vice President, Government Relations, KEMPHARM

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Mr. Cohen is the Executive Vice President, Government and Public Relations with KemPharm, Inc., a biopharmaceutical “Prodrug” company which develops and commercializes technology to create a diverse pipeline of therapeutics that target market opportunities in pain, attention deficit hyperactivity disorder and other central nervous system indications. He also serves as the Forum Chair of the U.S. Abuse Deterrent Coalition, a “talk group” of over 30 Abuse Deterrence Formulations (ADF) “innovator” manufacturers, patient advocates and related organizations seeking to expand access to ADF technologies.

He is the Vice Chairman of the Board of Directors for the MedStar National Rehabilitation Hospital Network, a 129-bed, $120m annual revenue specialty hospital and is a member of the Quality, Safety, and Patient Affairs subcommittee of the MedStar Hospital Network Board of Directors. He is a member of the Board of Trustees of the Keystone Policy Center, where his focus is healthcare public policy.

Previously, as the Senior Vice President for Government Relations and Health Policy with EnteroMedics, an early-stage medical device company, he was part of the senior management team that led the successful 2015 FDA approval of the first new obesity medical device for consumers since 2001.

As the Consulting Head of North American Government Relations, he was responsible for public policy and governmental regulatory relations in Washington, D.C., and Canada for Grünenthal USA, a biopharmaceutical company which develops and commercializes ADF for opioid analgesics.

Formerly, as Managing Director/Global Government Relations for The Depository Trust & Clearing Corporation, he was responsible for leading government relation functions, including formulating the overall strategy, representing the DTCC before the U.S. Congress, European Parliament, Asian governments and their respective regulatory bodies.

Cohen has served in Washington, D.C. since 1979 and has experience in various senior-level government relations positions. Prior to his current roles, Cohen served as a senior executive with several medical device and healthcare corporations, including US Oncology/McKesson, the largest U.S. national oncology physician provider network, and Inamed/Allergan, a medical device/aesthetics company. In those positions, he established Washington, D.C. and global government relations functions, led the companies’ legislative policy and governmental regulatory relations program and was also responsible for managing public policy, investor relations, and political functions at the state, national and global levels.

Cohen was a principal at Loeffler, Jonas & Tuggey, LLP, where he managed several clients in healthcare including Purdue Pharma and Inamed, as well as the financial services industry including Citibank and the Economic and Trade Office of Hong Kong. Earlier in his career, Cohen was the senior legislative liaison for the American Israel Public Affairs Committee (AIPAC), an Alternate Delegate of the United States to the United Nations, U.S. Chairman of an international NGO and earlier served as Legislative Director for two Congressmen on Capitol Hill and in various campaign positions at the Presidential, Congressional, State and local levels.

Additional Boards of Directors or Committees include recent tenures with the U.S. Congress chartered “Congressional Award Foundation,” the Business-Government Relations Council, the Ocean Reef Club and as Chair of the College of William & Mary Parent & Family Council.

Cohen earned a bachelor’s degree in Sociology from Willamette University and awarded a Master of Arts/Liberal Studies degree in International Affairs from Georgetown University.

Richard Dart
Executive Director, RADARS SYSTEM

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Dr. Dart is a physician specializing in emergency medicine and toxicology. He is certified by the American Board of Emergency Medicine and the American Board of Medical Toxicology. Since 1992 he has served as the Director of the Rocky Mountain Poison and Drug Center. He is the Executive Director of Researched Abuse, Diversion, and Addiction-Related Surveillance (RADARS) System. He has published more than 250 papers and chapters as well as served as editor for the book “The 5-Minute Toxicology Consult” and the 3rd edition of “Medical Toxicology”. In 2002 he was recognized with a special citation from the Commissioner of the FDA. He was the 2004 recipient of the American College of Medical Toxicology Matthew J. Ellenhorn Award for Excellence in Medical Toxicology. He also serves as a Deputy Editor of the medical journal Annals of Emergency Medicine and is immediate Past-President of the American Association of Poison Control Centers.

Angela DeVeaugh-Geiss
Director, Epidemiology, PURDUE PHARMA

Torben Elhauge
Director, Analytical Development, EGALET

Aaron Graham
Director, Brand Safety and Security, BOEHRINGER INGELHEIM

Gene Levinstein

Karsten Lindhardt
Senior Vice President, Head of R&D, EGALET

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Dr. Lindhardt has served as our Senior Vice President and Head of Research and Development since December 2013 and previously served as our Vice President, Research and Development from April 2011. In addition to Dr. Lindhardt’s roles over the last five years, he has served as the Site Manager of the Danish branch of Egalet (Egalet Danmark) and initiated a Cat 1 focus group in 2015 in the US, arranging open meetings with focus on in vitro abuse studies with representatives from the FDA, the pharmaceutical industry and academia. Dr. Lindhardt is a co-inventor of the Guardian™ Technology and the EG-001 product and has authored a number of public presentations, patents, publications and posters.

Peter J. Pitts

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Peter Pitts is President of the Center for Medicine in the Public Interest. A former member of the United States Senior Executive Service, Peter was the FDA’s Associate Commissioner for External Relations, serving as senior communications and policy adviser to the Commissioner. He supervised the FDA’s Office of Public Affairs, Office of the Ombudsman, Office of Special Health Issues, Office of Executive Secretariat, and the Advisory Committee Oversight and Management. He served on the agency’s obesity working group and counterfeit drug taskforce and as a Special Government Employee (SGE) consultant to the FDA’s Risk Communications Advisory Committee.

His comments and commentaries regularly appear in The New York Times, The Washington Post, The Wall Street Journal, Health Affairs, The Economist, Nature Biotechnology, the BBC World Service, CNBC The PBS NewsHour and the Daily Show with John Stewart, among others.

He is a Visiting Lecturer at the École Supérieure des Sciences Économiques et Commerciales in Paris and Singapore, and has served as an adjunct professor at Indiana University’s School of Public and Environmental Affairs and Butler University.

William Schmidt

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Dr. Schmidt is President of NorthStar Consulting, LLC, and simultaneously CMO for Ensysce Biosciences in San Diego, CA, and Vice President of Clinical Development for EicOsis, LLC in Davis, CA. Dr. Schmidt received his Ph.D. in pharmacology from the University of California, San Francisco. Following a postdoctoral fellowship at Boston University School of Medicine, Dr. Schmidt joined DuPont Pharmaceuticals (later the DuPont Merck Pharmaceutical Company), where he helped to develop nalbuphine (Nubain®), naltrexone (Trexan®, ReVia®) and the oxycodone-ibuprofen formulation used in Combunox™. At Adolor Corporation, Dr. Schmidt was a key member of the clinical team leading to the development of Entereg® (alvimopan), a peripherally-acting opioid antagonist. At CrystalGenomics, Dr. Schmidt designed Phase 1B through Phase 2B clinical trials leading to the approval of Acelex® (polmacoxib), a dual-acting COX-2 and carbonic anhydrase inhibitor, in South Korea. At NorthStar Consulting, Dr. Schmidt serves as an expert on pain medicine development with pharmaceutical and biotech companies throughout North America, Europe, Asia, Latin America and Australia.

Beatrice Setnik
Vice President, Clinical Pharmacology, INC RESEARCH

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Dr. Setnik has been working in the area of clinical drug development and abuse potential (AP) assessment since 2005. Dr. Setnik is currently the Vice President of Clinical Pharmacology at INC Early Phase and oversees the medical and scientific affairs groups. Dr. Setnik earned her doctorate degree in Pharmacology and the Collaborative Program in Neuroscience from the University of Toronto (Toronto, Canada) in 2005. In her previous role as Senior Director, Clinical Sciences (King Pharmaceuticals and Pfizer, Inc), Dr. Setnik led the clinical development and life cycle management — including the abuse potential evaluation — of several pain compounds, including abuse-deterrent opioid formulations. In her previous role as a Research Scientist (formerly Ventana/Decisionline Clinical Research, Toronto, Canada), Dr. Setnik was responsible for providing scientific input on various specialty phase I-II clinical trials including abuse potential studies for CNS drugs. Dr. Setnik has published numerous research articles in internationally recognized peer-reviewed journals and has presented at several scientific meetings and conferences. In addition, she chairs the clinical sub-team within the Cross Company Abuse Liability Consortium and has been an active member since 2008. Dr. Setnik is also an active member and participant in several congresses including the College on Problems of Drug Dependence. She has been actively engaged in many aspects of abuse potential assessment, including the development of patient-reported outcome instruments, and contributes to post-marketing surveillance studies.

Marta Sokolowska
Vice President, Medical and External Affairs, DEPOMED

Joseph Stauffer

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Dr. Stauffer is an executive physician and the Chief Medical Officer at Cara Therapeutics. Prior to joining CARA, he served as CMO at both public and private biopharma and specialty pharma companies. From 2004 to 2009, he was CMO at Alpharma Pharmaceuticals and the architect of the clinical development program for EMBEDA, the first abuse-deterrent long-acting opioid analgesic approved by the FDA.

Joe began his industry career as Global Medical Director at Abbott Laboratories. Prior to Abbott he worked at the FDA as a Medical Review Officer in the Anti-Inflammatory & Analgesic Division of the Center for Drug Evaluation and Research. While there, he reviewed Investigational New Drug (IND) Applications and New Drug Applications (NDA) for opiate, non-opiate, anti-inflammatory, topical and novel analgesic compounds. Disease areas included: rheumatoid/osteo/psoriatic arthritis, AS, PHN, DPN, post-operative, acute/chronic pain, Multiple Sclerosis and other rare diseases. He serves as an expert clinical research reviewer for the European Commission, and has spoken internationally on topics ranging from clinical development and medical affairs to investor relations and the FDA regulatory process.

Dr. Stauffer has more than 20 years of medical practice and clinical research experience. He practiced clinically for eight years, first as a Navy general medicine physician and then as an Anesthesiologist. He completed residency training in Anesthesiology & Critical Care Medicine at the Johns Hopkins University Hospital and maintains an appointment as part-time Assistant Professor in the Department of Anesthesiology and Critical Care Medicine at the Johns Hopkins University School of Medicine. He received his MBA from a joint program (TRIUM) between New York University, Stern School of Business, London School of Economics (LSE) and HEC (Hautes Etudes Commerciales) School of Management in Paris.

Lynn Webster
Vice President, Scientific Affairs, PRA HEALTH SCIENCES

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Lynn R. Webster, M.D., is a leading pain physician and researcher with a focus on the management of complex pain problems. Dr. Webster has long been an advocate for patients suffering from chronic pain and has fought for better education and safer therapies to address the twin crises of chronic pain and addiction in America.

For 25 years he treated patients with chronic pain, many of whom were at high risk for substance abuse. For 15 of those years, he also treated individuals with opioid addiction. The dual role lends Dr. Webster a valuable perspective: He is dedicated to treating patients in pain while simultaneously working to minimize the potential for harm from pain medications.

As developer of the Opioid Risk Tool (ORT), he is considered a world expert on how to assess patients for abuse risk with opioid medications. The ORT is currently used in multiple countries and thousands of clinics worldwide. He spends most of his time now developing safer and more effective therapies for chronic pain and campaigning for safer use of medications.

Dr. Webster earned his doctorate of medicine from the University of Nebraska and completed his residency in the University of Utah’s Department of Anesthesiology. He is board certified in anesthesiology and pain medicine, and is also certified in addiction medicine. Dr. Webster has given more than 250 presentations across the United States and internationally. He lectures extensively and has authored more than 300 scientific publications and a book entitled Avoiding Opioid Abuse While Managing Pain: A Guide for Practitioners. Dr. Webster is a senior editor to Pain Medicine and former editor of the sections on Neuromodulation and Opioids, Substance Abuse and Addiction.

Dr. Webster is vice president of Scientific Affairs for PRA Health Sciences, a leading clinical research organization that operates in more than 80 countries. Dr. Webster also serves on the National Institutes of Health National Pain Strategy Working Group and is a past president of the American Academy of Pain Medicine (AAPM). He lives in Salt Lake City, Utah.

Graham Wood
Executive Vice President, Phase I Clinical Development, ALTASCIENCES CLINICAL RESEARCH

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Dr. Graham Wood joined Altasciences Clinical Research as Executive Vice President, Phase I Clinical Development, in 2015. In his role, Dr. Wood works directly with sponsors on their clinical development programs, and provides strategies to further enhance the array of specialty Phase I study areas offered by Altasciences. Dr. Wood also leads the global Project Management team to ensure the successful completion of studies and efficient management of multi-site Phase I to Phase IIA programs.

Dr. Wood started his career at Phoenix International Life Sciences in 1999 as a Project Manager focused on Phase I studies. In 2006, Graham accepted a position at Allied Research to help build their innovator Phase I business. After the acquisition Allied Research by Cetero Research, Dr. Wood became President of the Toronto and Miami operations (Phase I to Phase IV studies). In this role, he successfully led six FDA audits and a Health Canada audit.

In 2012, he became the CEO of Manna Research, a late stage investigator site. Under his leadership, Manna became the largest network of primary care sites in Canada and sold to LMC Research in 2015.

Dr. Wood has a Ph.D. in neurology and neurosurgery from McGill University. Through his career, Dr. Wood has helped sponsors bring more than 30 compounds from Phase I to IIA, as well as worked on more than 400 Phase I studies.