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

Jeremy Adler

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PA Adler has practiced in the specialty of pain management for over 18 years and is a co-owner at Pacific Pain Medicine in Encinitas, CA. After receiving his undergraduate degree at UCSD, he earned his PA degree at SUNY, Stony Brook. He completed a specialty Masters’ Degree in Pain Management/Physical Medicine at the University of Nebraska Medical Center. He has been credentialed as a Fellow of the American Academy of Pain Management and is a Founder’s Society member of the American Academy of Pain Medicine Foundation. He has been recognized as a Distinguished Fellow of the American Academy of PAs.

PA Adler has been an active advocate for appropriate pain care for all patients. He is a published author and lectures nationally on a variety of pain topics. PA Adler is a co-author on evidence-based clinical practice guidelines jointly developed by the American Pain Society and American Academy of Pain Medicine on the use of opioids in non-cancer pain.

In addition to patient care and medical education, PA Adler has participated in healthcare leadership. He founded the San Diego Society of PAs and functioned as the President of the Society for 10 years. He has served as President for one of the largest state PA professional societies in the county, the California Academy of PAs. PA Adler was the inaugural President of the National Society of Pain Care Providers, is Vice-President of the Pain Medicine Special Interest Group at the American Academy of PAs and is a board member of the American Academy of Pain Medicine Foundation.

Charles Argoff
Professor of Neurology, ALBANY MEDICAL CENTER

David Baker

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David was appointed interim CEO of Alcobra in June 2017. He originally joined Alcobra as Chief Commercial Officer in 2014, responsible for all aspects of pre-launch marketing planning and business development.

Prior to joining Alcobra, he worked at Shire for 10 years, most recently as Vice President of Commercial Strategy and New Business in the Neuroscience Business Unit. He led the commercial assessment of neuroscience licensing opportunities, managed commercial efforts on pipeline CNS products, and led the long term strategic planning process. Previously, he served as Global General Manager for Vyvanse® where he led the launch of Vyvanse, led global expansion efforts including successful establishment of a partnership in Japan and launches in Canada and Brazil. Prior to that, Mr. Baker served as Vice President of Marketing for all of Shire’s ADHD products.

From 1990–2004, David worked at Merck where he held positions of increasing responsibility in marketing, sales, market research, and business development. In addition to his experience in neuropsychiatry, David’s therapeutic expertise includes osteoporosis, migraine, and hyperlipidemia. He has been directly involved with the marketing of five prescription drug brands with annual sales in excess of $1 billion each.

David graduated Magna Cum Laude with a bachelor’s degree in Economics and Computer Science from Duke University. He earned a Master of Business Administration in Marketing from Duke’s Fuqua School of Business.

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

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Colville Brown, M.D., is presently the Medical Director at Egalet U.S. Inc. He received his medical degree with honors from Howard University and was trained in Internal Medicine at the Hospital of the University of Pennsylvania. After leaving residency he served as Assistant Director at a long-term care facility for the intellectually disabled. In 2010, he joined AlphaBioCom where he served in roles of increasing responsibility to become Director of Clinical and Medical Affairs. Dr. Brown joined Egalet in 2016 where he plays a key role in the development and implementation of Medical Affairs activities.

John Burke

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Commander John J. Burke has been a law enforcement officer for over 49 years. He spent 32 years with the Cincinnati Police Department, the last nine years he formed and was in charge of the department’s Pharmaceutical Diversion Squad.

He commanded the Greater Warren County Drug Task Force in Lebanon, Ohio, a HIDTA initiative that employs local, state, and federal agencies working toward the disrupting of high-level drug trafficking, pharmaceutical diversion, and money laundering enterprises, for 16 years, retiring in October 2015.

He became the commander of the Brown County Drug & Major Crimes Task Force in Georgetown, Ohio in April 2016, and retired in May 2017.

Commander Burke is also the past national president of the National Association of Drug Diversion Investigators (NADDI) and is president and owner of Pharmaceutical Diversion Education Inc. He writes a monthly column on prescription drug abuse in Pharmacy Times magazine, and lectures nationally on the topics of pharmaceutical diversion to an audience that includes health professionals, law enforcement, health regulators, and others.

He recently became the co-founder and President of the International Health Facility Diversion Association (IHFDA), www.ihfda.org a non-profit, 501C-3 organization dedicated toward the problems surrounding drug diversion within healthcare facilities.

Theresa Cassidy
Vice President, Health Analytics, INFLEXXION

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.

Angela DeVeaugh-Geiss
Director, Epidemiology, PURDUE PHARMA

Torben Elhauge
Senior Science Specialist, EGALET

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Torben Elhauge, M.Sc. Mr. Elhauge has been a part of the team initiating Cat 1 focus group, which purpose has been to make meetings for professionals in the abuse deterrence space with a particular interest in the field of in vitro abuse (Category 1) studies. The group is now part of the Cross Company Abuse Liability Council (CCALC), where Mr. Elhauge is a member. Mr. Elhauge has been responsible for running all Category 1 studies for Egalet during the last five years including the lead program ARYMO. Mr. Elhauge has been Senior Science Specialist since November 2015 and previously served as head of the analytical development since June 2011. Mr. Elhauge is one of the inventors of the recently approved product ARYMO has authored a number public presentations, patents, publications, and posters. Before Egalet Mr. Elhauge has served various positions at several Danish biotech companies and at the Danish Medicines Agency. Mr. Elhauge received an M.Sc. in Chemistry from the Technical University of Denmark, Copenhagen DK.

Aaron Graham
Director, Brand Safety and Security, BOEHRINGER INGELHEIM

Janetta Iwanicki

Ernest Kopecky
Vice President, Clinical Development, Head, Global Pain Medicine, TEVA

Gene Levinstein

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

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Dr. Lindhardt has been the initiator of a Cat 1 focus group, which purpose has been to make meetings for professionals in the abuse deterrence space with a particular interest in the field of in vitro abuse (Category 1) studies. The group is now part of the Cross Company Abuse Liability Council (CCALC), where Dr. Lindhardt serves as a Director of the board. Dr. Lindhardt has been heading the group responsible for running all Category 1 studies for Egalet since 2011 including the lead program ARYMO. Dr. Lindhardt is the Senior Vice President and Head of Research and Development since December 2013 and previously served as Vice President, Research and Development from April 2011. In these roles, Dr. Lindhardt has also been the Site Manager of the Danish branch of Egalet (Egalet Danmark). Dr. Lindhardt is Inventor of the Guardian™ Technology behind the recently approved product ARYMO and has authored a number public presentations, patents, publications, and posters. Before Egalet Dr. Lindhardt has served various management positions at Curalogic A/S, OSI Pharmaceuticals (Prosidion), Ferring Pharmaceuticals and Novo Nordisk A/S. Dr. Lindhardt has earned a Diploma of Business Excellence (DBE) at Columbia University, Copenhagen Business School. Dr. Lindhardt received an M.Sci. in Pharmaceutics and a Ph.D. in pharmaceutical development and pharmacology, each from the Royal Danish School of Pharmacy, Copenhagen DK.

Angela Moore
Analytical Scientist, ALCAMI

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 FDA’s Associate Commissioner for External Relations, serving as senior communications and policy adviser to the Commissioner. He supervised FDA’s Office of Public Affairs, Office of the Ombudsman, Office of Special Health Issues, Office of Executive Secretariat, and Advisory Committee Oversight and Management. He served on the agency’s obesity working group and counterfeit drug task force and as a Special Government Employee (SGE) consultant to the FDA’s Risk Communications Advisory Committee. His comments and commentaries on health care policy issues regularly appear in The Lancet, the British Medical Journal, The New York Times, The Los Angeles Times, The Washington Post, The Wall Street Journal, The Financial Times, Health Affairs, Time, Newsweek, The Boston Globe, The Washington Times, The Chicago Tribune, The San Francisco Examiner, Investor’s Business Daily, The Baltimore Sun, The Economist, The Lancet, Nature Biotechnology, The Journal of Life Sciences the BBC World Service, Fox News, CNBC, Bloomberg, The PBS NewsHour, NBC Dateline, The Daily Show with John Stewart, among others. He has given healthcare policy presentations throughout Europe, Canada, and the United States, as well as in Russia, China, India, the Philippines, Malaysia, Saudi Arabia, Lebanon, Oman, Israel, Turkey, The United Arab Emirates, Jordan, Kenya, South Africa, Egypt, Algeria, Ukraine, Taiwan, Thailand, Japan, Brazil, Mexico, Vietnam, Indonesia, Singapore, Panama, Costa Rica, Argentina, and Columbia. He is a Visiting Lecturer at the École Supérieure des SciencesÉconomiques et Commerciales (Paris and Singapore) and has served as an adjunct professor at Indiana University’s School of Public and Environmental Affairs and Butler University. A graduate of McGill University, he is married to Jane Mogel and has two sons.

William Schmidt

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Dr. Schmidt is head of NorthStar Consulting, LLC, which specializes in providing advice on preclinical and clinical studies of novel analgesic drugs. He is simultaneously part-time VP of Clinical Development for EicOsis, LLC, in Davis, CA, and Chief Medical Officer for Ensysce Biosciences in San Diego, CA. Dr. Schmidt has also held VP-level clinical positions with Centrexion (Baltimore, MD), CapGenesis LLC (Fairfax, VA); CrystalGenomics (Seoul, South Korea) and its U.S. subsidiary, CG Pharmaceuticals (Emeryville, CA); Limerick BioPharma (South San Francisco, CA); Renovis, Inc. (South San Francisco, CA); and Adolor Corporation (Exton, PA). At Adolor, Dr. Schmidt was a key member of the team leading to the clinical development, NDA filing, and FDA approval of Entereg® (alvimopan), a peripherally-acting opioid antagonist. At CrystalGenomics, Dr. Schmidt lead Phase 1b through Phase 2b clinical trials that lead to the approval of Acelex® (polmacoxib) in South Korea. At NorthStar Consulting, Dr. Schmidt now serves as an expert on pain medicine pharmaceutical development with pharmaceutical and biotech companies throughout North America, Europe, Asia, Latin America, and Australia. Dr. Schmidt currently sits on the Scientific or Medical Advisory Boards of one academic laboratory, 5 biotech companies, and one internet medical publishing company.

Dr. Schmidt is the Parliamentarian and a Past-President of the Eastern Pain Association, the largest regional affiliate of the American Pain Society. He received the John J. Bonica award for the development of new analgesics and his sustained contributions to the educational efforts of the Eastern Pain Association in 2014. He is the co-editor of “Pain: Current Understanding, Emerging, Therapies, and Novel Approaches to Drug Discovery” (Marcel Dekker, 2003). Dr. Schmidt received his Ph.D. in Pharmacology from the University of California, San Francisco. Following his 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™.

Dr. Schmidt continues to chair the annual Arrowhead Pain Summit (2010-2017) and the Pharmaceutical Roundtable / Innovations in Pain Research for the Eastern Pain Association (2003-2017).

Beatrice Setnik
VP, Scientific and Medical Affairs, INC RESEARCH / INVENTIV HEALTH

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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 Scientific & Medical Affairs at INC Research/ inVentiv Health, Early Phase and an Adjunct Professor with the Department of Pharmacology and Toxicology at the University of Toronto. Dr. Setnik earned her doctorate degree in Pharmacology and the Collaborative Program in Neuroscience from the University of Toronto in 2005. In her previous role as Senior Director, Clinical Sciences (King Pharmaceuticals and Pfizer, Inc), Dr. Setnik led the clinical development and lifecycle 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 is a recognized expert in the area of abuse and dependence evaluation. In addition, she is a Managing Director of 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 in 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 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, postoperative, 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 received an honorable discharge as a Lieutenant Commander from the US Navy after serving 8 years as a medical officer. He completed his Anesthesiology residency at Johns Hopkins and maintained an appointment as part-time Assistant Professor in the Department of Anesthesiology and Critical Care Medicine at the Johns Hopkins University School of Medicine through 2016. 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.