Faculty – 5th Human Abuse Liability Testing & Market Access

Christopher Altomare
Director of Pharmaceutical Services, DRUGSCAN

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Chris Altomare is currently the Director of Clinical Development & Pharmaceutical services at Drugscan in Horsham, PA. During his time at DRUGSCAN he has led the development of numerous clinical toxicology screening and confirmation assays as well as a laboratory-based manipulation and extraction service offering to satisfy the FDA guidance for evaluating abuse-deterrent formulations. He has conducted over 50 category 1 studies on a variety of formulations and technologies ranging from physical/chemical barriers, agonist/antagonist, irritants, new molecular entities, opioids and non-opioids susceptible to abuse for Brand and Generic products. He possesses expertise in chromatographic method development and various detection techniques including mass spectrometry (LC-MS/MS), UV, LDTD, and CAD. He conducts internal research to evolve testing techniques which reflect the current drug abuse trends. Additionally, he oversees analytical method development for urine, blood and oral fluid matricies and laboratory automation development in DRUGSCAN’s clinical toxicology laboratory.

Andy Barrett
Vice President, Scientific Affairs, KEMPHARM

Dan Cohen

former Executive Vice President, Government and Public 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.

Karen DiDonato
Executive Director, Medical Affairs, ACELRX PHARMACEUTICALS

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Karen DiDonato, R.N., M.S.N., has over 20 years of clinical research and medical affairs experience. She began her career at the NIH in Bethesda, MD and spent several years at Stanford University before transitioning to industry. Karen’s risk management experience ranges from small biotech to large pharma companies and three of the last four products she helped develop and bring to market required Risk Evaluation and Mitigation Strategies (REMS). Karen currently serves as Executive Director, Medical Affairs at AcelRx Pharmaceuticals, a Silicon Valley firm specializing in the development of innovative therapies for acute pain management. She holds both a Bachelor’s (BSN) and Master’s (MSN) Degree in Nursing from the University of Virginia and guest lectures at both Duke University and University of North Carolina.

Eric Galia
International Project Leader, GRUNENTHAL

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Eric Galia, PhD is an International Project Leader (IPL) within the Innovation Unit Devices and Technologies at Grünenthal GmbH in Aachen, Germany. He is responsible for leading Grünenthal’s ADF platform projects.

Dr. Galia joined Grünenthal’s corporate headquarters in Aachen, Germany in 2005 as an International Technical Alliance Manager coordinating CMC development in technology driven projects. In 2013 he took over a position in business development coordinating licensing and M&A projects. As of late 2015 he returned to R&D in his current position as IPL.

Prior to Grünenthal he worked for Aventis (now Sanofi) as an analytical lab head as well as an application lab head for ERWEKA GmbH. Dr. Galia received his degree as a Pharmacist and a PhD in Pharmaceutical Technology and Biopharmaceutics from the University of Frankfurt, Germany.

Gary W. Jay, M.D., FAAPM
Clinical Professor, Dept. of Neurology, Division: Headache/Pain at UNC, UNIVERSITY OF NORTH CAROLINA, CHAPEL HILL

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Gary W. Jay, MD is currently Clinical Professor, Dept. of Neurology, Division: Headache/Pain at UNC, Chapel Hill, NC. He previously owned and ran an interdisciplinary Pain, Headache and mTBI NeuroRehabilitation Center for 26 years. He was a founder of the American Academy of Pain Medicine and the American Academy of Pain Management. He has been President of National, Regional and State Pain Medicine Groups. He then went into Pharma, became Chief Medical Officer of 2 Pharmas and a CRO. Dr. Jay then returned to Medicine at UNC. He has published 5 textbooks and over 170 peer reviewed journal articles and textbook chapters. He was also a part of the IMMPACT group while in Pharma. He continues to speak nationally on various topics (Pain, Headache and mTBI) and the issues dealing with the “opioid crisis” and the unanticipated or purposeful patient problems with this.

Bob Jones

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Bob Jones has worked in the pharmaceutical industry for over 30 years in such varied roles as vice president of market and sales to chief financial officer. His experience includes work in the brand, generic and OTC markets as well as NCE drug discovery. Bob has been President and Chief Executive Officer of Acura Pharmaceuticals since 2011. He holds a BS in engineering from Cornell University and an MBA from the University of North Carolina.

Shruti Kulkarni

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Shruti Kulkarni, J.D. is an attorney at DCBA Law & Policy. Ms. Kulkarni provides legal, regulatory, legislative, and policy counsel to pharmaceutical, biotechnology, and medical device companies. Additionally, in her capacity as a policy advisor, Ms. Kulkarni offers insight on the prevention of diversion, misuse, and abuse of controlled prescription medications and treatment of substance use disorders. In this capacity, she has analyzed existing and proposed legislation, regulation, and policies; drafted legislative and regulatory language, testimony, and white papers; and educated state and federal legislators and policy makers. Ms. Kulkarni is also serves on the board of non-for-profit organization Female Opioid Research and Clinical Experts (FORCE).

Ms. Kulkarni has over 10 years of experience in the health care industry. She previously completed a legal internship at the FDA’s Office of Policy in the Office of the Commissioner. Ms. Kulkarni obtained her Juris Doctor degree from George Mason University School of Law. She received her bachelor’s degree magna cum laude from Saint Joseph’s University.

Ryan Lanier
Senior Consultant, Drug Development, ANALGESIC SOLUTIONS

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Ryan K. Lanier, PhD is Associate Director, Consulting at Analgesic Solutions, where he has been since June 2016. Prior to joining Analgesic Solutions, Dr. Lanier most recently acted as an independent consultant providing consulting services related to all aspects of pharmaceutical drug development, including preclinical and clinical research, abuse liability assessments, medical writing and communications, and regulatory affairs. He previously held the position of Chief Scientific Officer at Rock Creek Pharmaceuticals, Inc., located in Gloucester, MA and Sarasota, FL where he oversaw the preclinical (toxicological, pharmacological, and behavioral) and clinical drug development of anatabine citrate, a nicotinic acetylcholine receptor agonist with wide-ranging anti-inflammatory effects. Prior to joining Rock Creek, Dr. Lanier worked as a Clinical Research Scientist at Javelin Pharmaceuticals, located in Cambridge, MA, where he assisted in the development of novel analgesic drug formulations intended to treat acute pain syndromes, including novel formulations of morphine (intranasal), ketamine (intranasal), and diclofenac (intravenous).

Dr. Lanier has special interests in clinical trial design and evaluating the behavioral and physiological effects of CNS active drugs, including pain relievers, investigating the impact that drugs of abuse have on personal and public health, and developing drugs with reduced abuse liability. He received his PhD in Biological Psychology from the University of North Carolina at Chapel Hill, where he investigated the effects of opioids and behavioral processes on immune status in preclinical models. Dr. Lanier subsequently completed a three-year postdoctoral fellowship within the Behavioral Pharmacology Research Unit (BPRU) at Johns Hopkins University School of Medicine. While at the BPRU, Dr. Lanier performed human behavioral pharmacology research, with a focus on the development and evaluation of new medications for treatment of substance use disorders, and evaluation of the abuse potential of new medications (opioid-based pain relievers) developed by the pharmaceutical industry.

Dr. Lanier has authored or co-authored numerous manuscripts and book chapters, and has presented his research findings at a variety of prestigious scientific meetings such as those held by the College on Problems of Drug Dependence, American Pain Society, the International Association for the Study of Pain, Drug Information Association, Psychoneuroimmunology Research Society, the Society on Neuroimmune Pharmacology, the Society for Neuroscience, the American Psychological Association, the Society for Research on Nicotine and Tobacco, and the Annual Duke Nicotine Research Conference.

Richard Mannion

former Executive Director, Pharmaceutical and Analytical Development, PURDUE PHARMA

Andrea Maresca

Senior Vice President for Health Policy, THORN RUN PARTNERS

Denise Milovan
Research Scientist, Neuropsychologist, SYNEOS HEALTH

Elizabeth Nugent
Director, Clinical Research and Pharmacovigilance, RADARS SYSTEM

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Elizabeth Nugent MSPH is a graduate of the Colorado School of Public Health at the University of Colorado. Ms. Nugent has worked in the area of clinical research and data analysis for the past 30 years including bench research, epidemiologic surveillance and clinical trials focusing in the areas of improving the efficacy and speed of clinical research through the use of healthcare networks and development of new approaches to post-marketing surveillance. She was instrumental in building a network for the study of rare cancers partnering Kaiser Permanente with the National Cancer Institute and industry sponsors. She has also worked extensively with state and federal legislators on topics related to appropriate access to medications and clinical trials. She is currently the Director of Clinical Research and Pharmacovigilance at RMPDC/RADARS-a mosaic surveillance system to research non-medical use, abuse and diversion of prescription medications in the US, Canada and the European Union.

Steven D. Passik, Ph.D.
Vice President, Scientific Affairs, Education, and Policy, COLLEGIUM PHARMACEUTICALS

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After a 25-year academic and clinical career at Memorial Sloan Kettering Cancer Center, University of Kentucky and Vanderbilt University, Dr. Passik spent the past five and one-half years in the toxicology and most recently the pharmaceutical industry. He is presently the Vice President of Scientific Affairs, Education and Policy at Collegium Pharmaceuticals. His research has focused on the interface of pain management and addiction and psychiatric aspects of cancer and non-cancer pain and symptom management. He has served as editor and reviewer for multiple journals in pain and psycho-oncology. He has authored over 200 scholarly publications.

Sebastian Schwier, Ph.D.
Director, Transfer and Integration Management, GRUNENTHAL

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Sebastian Schwier, PhD is Project Director within Global Operations at Grünenthal GmbH in Aachen, Germany, and serves as Transfer and Integration Manager. In this function, he leads internal and external cross functional teams for project transfers and product integrations into the Grünenthal network. Before taking over this role Dr. Schwier was part of the Innovation Unit Devices and Technologies at Grunenthal. Further, he is part of the Cross Company Abuse Liability Council (CCALC) and is heading the Category One Focus Group for abuse deterrent formulations.

Dr. Schwier joined Grunenthal’s corporate headquarters in Aachen, Germany in 2008 as a laboratory head in the Pharmaceutical Development department developing abuse deterrent formulations (ADFs). From 2012 to 2019 he was responsible as CMC project leader for the development of ADFs internally as well as in collaboration with partners. In addition, he steered collaborations with partners on developing, manufacturing and testing ADFs.

Dr. Schwier received his degree as Pharmacist and later achieved a PhD in Pharmaceutical Technology and Biopharmaceutics from the University of Munster, Germany.

Graham Wood

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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.