Faculty – Pain Management Summit

Caroline Arout, Ph.D.

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Dr. Caroline Arout received her PhD in Neuropsychology from the Graduate Center of the City University of New York in 2014, after studying the paradoxical ability of opioids to increase pain sensitivity after repeated use in a rodent model. She completed her postdoctoral training at Yale University School of Medicine/VA Connecticut Healthcare System where she examined the role of the innate immune system in opioid effects.

Dr. Arout moved to the New York State Psychiatric Institute of Columbia University Irving Medical Center in July 2017, where she is currently an Assistant Professor of Clinical Neurobiology (in Psychiatry) and a Research Scientist. Her current interests continue to focus on the intersection of pain and substance use, and she is currently investigating cannabinoids for their potential therapeutic efficacy for pain in the context liability. Her current focus is on determining whether cannabinoids have opioid-sparing properties, where they can potentially be used alongside sub-therapeutic doses of opioids to produce synergistic and clinically effective analgesia. Her overarching goal is to identify a safer, more effective pharmacological treatment regime for chronic pain.

Scott L. Dax, Ph.D.
Chief Scientific Officer, CERSCI THERAPEUTICS

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Dr. Scott L. Dax has over 25 years of experience guiding research & development at both large
pharma houses and small biotechnology companies. His leadership roles span chemistry, drug
discovery, pharmacology, technology and intellectual property. Scott is Chief Scientific Officer at
CerSci Therapeutics (www.cersci.com) leading efforts to develop a new generation of non-opioids
to treat acute post-surgical pain and chronic painful diabetic neuropathy. CT-044, a Reactive
Species Decomposition Accelerant (RSDAx) has completed IND-enablement and will enter
clinical trials in 2Q2019.
Scott is also a Project Director at BioMotiv (www.biomotiv.com), a mission-driven development
company associated with The Harrington Project for Discovery & Development, a national
initiative centered at University Hospitals Cleveland Medical Center. The company focus is
accelerating breakthrough discoveries from research institutions into therapeutics for patients.
Previously, Scott served as Chief Technology Officer at Galleon Pharmaceuticals, where he
discovered and designed breathing control modulators to combat respiratory depression caused by
opioid therapy, without compromising analgesia. This work has also led to clinical candidates for
the treatment of narcotic-induced respiratory depression and sleep apnea. Scott’s contributions led
to venture capital investments totaling >$60M. Scott was also a Research Fellow & Analgesics
Research Team Leader at Johnson & Johnson. His team delivered multiple New Chemical Entities
into Early Development, working in the areas of delta-selective and mixed mu / delta opioid
agonists, (Transient Receptor Potential) TRPV1 and TRPM8 antagonists, mono-acylglycerol
lipase inhibitors, N-type calcium channel blockers, NSAIDs (non-steroidal anti-inflammatory
drugs), voltage-gated sodium channel blockers and differentiated tramadol and acetaminophen
analogs. Prior to J&J, Scott held positions at DuPont-Merck and Hoffmann-LaRoche working in
the area of infectious diseases.
Scott is inventor of over 100 issued patents worldwide and more than 100 publications /
presentations in peer-reviewed journal and professional societies. Scott earned his Masters and
Doctorate degrees in chemistry at the University of Michigan and was an NIH post-doctoral
awardee at the University of Wisconsin.

Nial DeMena
Chief Executive Officer, MANNA MOLECULAR SCIENCE

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Nial C. DeMena is a graduate of Colby College and has a MA from Virginia Tech. Starting in 2012, Nial founded several successful cannabis related enterprises, including but not limited to Temescal Wellness Massachusetts, which holds over seven medical and rec licenses, and, most notably, Manna Molecular Science, a biotechnology company formed in Massachusetts in 2015 that focuses on new delivery technologies in cannabis therapeutics, including sexual enhancement gel and transdermal lotion. Manna Molecular Science has sold over 1M transdermal patches in over 15 states. His applied leadership and vision has lead to breakthroughs in delivery of cannabinoids and his team continues to develop and test novel form factors for consumers and patients all over the US.

Ashley Elsner, J.D., MBA
Chief Executive Officer and Founder, ARTERY PAY

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Ashley Elsner is CEO and Founder of artery Pay. She is a FinTech expert with 14 years of global financial law, regulation and operations experience. Prior to artery, Ashley cofounded and was Vice President of Operations for Greenshoe Asset Management, an online hedge fund investment platform. She managed the investment process and financial regulatory compliance of $600M+ transactions for Bessemer Venture Partners in their legal and operations group, including interests and responsibilities for LinkedIn’s IPO and Amazon’s acquisition of Diapers.com, among many other exits, and developing the regulatory compliance strategies for India’s new Foreign Venture Capital Investors and Foreign Portfolio Investors laws. Ashley spent 4 years in the financial regulatory group of Sidley Austin LLP, where in addition to managing SEC and state regulatory compliance for its top-ranked fund services team for 800+ hedge funds and 6 publicly traded companies, she was instrumental in managing a year-long internal regulatory audit of an $850B+ international investment bank, clearing the firm’s regulatory record and saving the firm $40M+ in fines. Ashley holds a B.A. with majors in Political Science and Classics from Yale College and a J.D.M.B.A from Northwestern School of Law focused on the intersection of Law and Economics and Northwestern’s Kellogg School of Management with majors in Finance and Innovation and Entrepreneurship.

Danielle Friend, Ph.D.
Director, Science and Regulatory Affairs, BIOTECHNOLOGY INNOVATION ORGANIZATION

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Dr. Danielle Friend received her Ph.D. in neuroscience in 2013 from the University of Utah where her work focused on drug addiction and toxicity. After completing her graduate work, Danielle conducted postdoctoral research on the relationship between obesity and reward circuits in the brain at the National Institutes of Health. In 2016, Danielle was selected as a Science and Technology Policy Fellow with the American Association for the Advancement of Science. During her fellowship Danielle developed policies related to genomic and scientific data sharing within the Office of the Director, in the Office of Science Policy at the National Institutes of Health. In 2017, Danielle joined the Biotechnology Innovation Organization (BIO) as a Director of Science and Regulatory Affairs where she covers BIO’s work on rare diseases and orphan drugs, pediatric drug development, and PDUFA and 21st Century Cures Act implementation, including patient-focused drug development and co-leads BIO’s work related to the current opioid crisis.

Jeffrey Fudin, Pharm.D.
Chief Executive Officer and Chief Medical Officer, REMITIGATE, LLC.

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Dr. Fudin graduated from Albany College of Pharmacy & Health Sciences with his Bachelors Degree and Pharm.D. He is a Fellow to the American College of Clinical Pharmacy, American Society of Health-system Pharmacists, and the Federation of State Medical Boards.
He is managing editor of paindr.com Blog, Co-Editor-At-Large for Practical Pain Management, Senior Editor for Pain Medicine, and peer reviewer for several professional journals. He has over 30 years of direct patent care experience in pain management, and is a national expert in pharmacogenetics, forensic pharmacy and toxicology, and advanced pain therapeutics.
He has well over 300 publications and has participated in several educational films and community outreach forums.
He is Director of the Pharmacy Pain Residency at Stratton Veterans Administration Medical Center and Chief Executive Officer for Remitigate, both in Upstate NY where he also serves on the NY State Board of Medicine Office of Professional Conduct.
He holds several academic faculty positions and is a frequent invited speaker nationally and internationally.

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.

Tim Peara
President and Finance Director, BRIDGE THERAPEUTICS

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Mr. Peara has led businesses and arranged investments for over 30 years, much of it overseas. Tim’s career spans finance (Prudential, Lehman), industry (Koch, GE) and several technology start-ups. Throughout his career he has negotiated and structured investments, conducted due diligence and built financial models. Tim also has considerable international experience and foreign language skills. Tim is an avid learner, earning his MBA at night school (Chicago Booth) and is self-taught first in the energy and now in the pharmaceutical industry. Tim earned a BA from Wesleyan University, Connecticut and currently resides in Asheville, North Carolina.

Joseph V. Pergolizzi, M.D.

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Dr. Joseph Pergolizzi, M.D. is an internationally renowned perioperative and pain specialist, well-versed in the multiplicity of issues confronting patients and caregivers in acute and chronic pain. He is currently a senior partner at Naples Anesthesia and Pain Associates, Inc. In clinical practice, he combines the latest medical advances and scientific breakthroughs with his profound professional compassion for patients facing painful, life-altering conditions. As a physician, inventor, research scientist and advocate for pain patients, Dr. Pergolizzi has leveraged his significant medical, regulatory and business expertise to build a strong track record of success within the healthcare industry.

Previously, Dr. Pergolizzi served as an adjunct assistant professor in the Department of Medicine at Johns Hopkins University School of Medicine, a committee member of the Food and Drug Administration’s Safe Use Initiative and as a Special Government Employee for the Veterans Health Administration. He is a member of various advisory boards and medical societies, as well as institutional committees, including Medical Errors Committee and Pharmacy and Therapeutics Committee. Dr. Pergolizzi is the author of over 250 peer reviewed articles, abstracts, platform presentations and book chapters, and has been awarded the American Medical Association Physician Recognition Award with Commendation.

Robert Raffa, Ph.D.
Chief Scientific Officer, NEUMENTUM, INC.

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Dr. Raffa is Adjunct Professor at the University of Arizona College of Pharmacy and Professor Emeritus at Temple University School of Pharmacy. He earned bachelor’s degrees in Chemical Engineering and in Physiological Psychology (both from the University of Delaware), master’s degrees in Biomedical Engineering (from Drexel University) and Toxicology (Thomas Jefferson University), and a doctorate in Pharmacology (Temple University School of Medicine). He was a Research Fellow and a Team Co-Leader for analgesics drug discovery at Johnson & Johnson, where he was pivotal in the elucidation of the mechanism of action and development of the analgesic drug tramadol (Ultram™). He is a cofounder of CaRafe Drug Innovation and the CSO of Neumentum Inc, both companies directed to the discovery and development of non-opioid analgesics. He is the co-holder of several patents, including for the combination of tramadol plus acetaminophen (Ultracet™). He has published more than 300 papers in refereed journals, and co-authored or edited several books on pharmacology and thermodynamics, and is a Co-Editor of Journal of Clinical Pharmacy and Therapeutics. He is a past president of the Mid-Atlantic Pharmacology Society of ASPET and is the recipient of research and teaching awards. He lectures and consults worldwide on pain pathways and analgesics.

Joe Stauffer, DO, MBA, FAPCR
Chief Medical Officer, INHERIS BIOPHARMA

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Dr. Stauffer is an executive biotech physician and currently the Chief Medical Officer (CMO) of Inheris Biopharma, a subsidiary of Nektar Therapeutics. He was most recently CMO of CARA Therapeutics. He is the Founder of Alta Life Sciences, LLC., a boutique pharmaceutical/investment consulting firm based in Princeton, NJ. Since 2004 he has served as CMO in both public and private specialty pharma/biotech companies. From 2004-2009 he was CMO at Alpharma Pharmaceuticals; and the architect of the clinical development program for EMBEDA, the first abusedeterrent long-acting opioid analgesic approved by the FDA. His medical practice and clinical research experience spans over 25 years; having built teams of clinicians, scientists, Medical Science Liasons, regulators and safety experts in support of clinical development projects, marketed brand drugs and devices. Areas of expertise include acute and chronic pain, oncology supportive care, peri-operative medicine, neuroanesthesia and neonatal-adult critical care. He was instrumental in raising CARA’s secondary offerings on the heels of positive phase 2/3 clinical data resulting in $80M, $92M and $98M of new equity financing in 2015, 2017 and 2018 respectively. 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 maintained an appointment as part-time Assistant Professor in the Department of Anesthesiology & Critical Care Medicine at the Johns Hopkins University School of Medicine through 2016. He received his medical degree from the Philadelphia College of Osteopathic Medicine and 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. Dr. Stauffer is a veteran of the US Navy; honorably discharged as a Lieutenant Commander after serving 10 years as a Naval Medical Officer. He maintains an active Pennsylvania physician medical license. Joe began his industry career as Global Medical Director at Abbott Laboratories. In that role he was responsible for Phase I-III trials and medical affiars support of hospital and retail marketed products. 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. He led clinical, operations, regulatory and medical affairs teams at Alpharma and Ikaria; both of which were acquired in $1.6B cash deals in 2009 and 2014 respectively. He is a 2002 founding member of the Initiative on Methods, Measurement and Pain Assessment in Clinical Trials (IMMPACT). In 2011, under the FDA’s Critical Path Initiative, this collaboration became an official public-private partnership between pharma, FDA, NIH, academia and patient advocacy associations. The new group, Analgesic Clinical Trial Translations, Innovations, Opportunities and Networks (ACTTION) is an ongoing multi-year effort designed to address the major gaps in scientific information which confound analgesic clinical trials and analgesic drug development. He has lectured internationally on topics ranging from clinical drug development, medical affairs, investor relations and the FDA regulatory process. In 2005, at the invitation of the MD Anderson Cancer Center, he served as an expert member of the FDA/Mayo Clinic Working group on Patient Reported Outcomes and co-authored the supportive paper (Value in Health, Nov/Dec 2007) on validation of self-reported outcome measures. This consortium presented their consensus to the FDA at an open meeting in February 2006 as part of the rollout of the FDA Guidance for Industry, PatientReported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. He has served as an expert manuscript reviewer for Mayo Clinic Proceedings (2006) , Pain Medicine (2014-present), and Therapeutic Advances in Drug Therapy (2014) In 2007 he was named one of the “100 Most Inspiring People” by PharmaVOICE magazine. From 2014-2015 he served on the Board of Directors of TrialScope, a provider of technology enhanced clinical trial solutions and services. In 2015 he joined the Director Network of Edison Partners, a growth equity firm based in Princeton, NJ. In 2012 the European Commission appointed him as an expert clinical research reviewer; part of the EU Health Initiative for Research & Innovation. He was invited back in 2014 and 2018 to continue this work.

Penny Toren, MS
SVP Regulatory Affairs & Program Management, VALLON PHARMACEUTICALS

Alex Wasyl
Chief Executive Officer, NEXIEN BIOPHARMA

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Alex has acquired a decade+ of experience in several industry verticals including pharmaceutical, biotechnology, drug delivery systems, food, beverage, nutritional supplements, nutraceuticals, consumer products, industrial chemicals, and green cleaning technology.

Alex possesses an exceptional background in business, marketing, nutritional sciences, biology, biochemistry, and related life sciences.

Debra R. Wilson, Ph.D.

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Dr. Debra Rose Wilson is a nurse and a health psychologist. She has worked gaining expertise in public health, obstetrics, complementary and alternative therapies, and epidemiology. Seeking to view health from outside the western model, Debra completed a Master of Science in Holistic Nursing. Then, with a focus on Psycho-neuro-immunology, completed a PhD in Health Psychology. With over 100 publications, her research experience includes autoimmune disease, breastfeeding, and women’s health. She has been the managing editor of the International Journal of Childbirth Education since 2011. Debra has taught graduate courses in psychoneuroimmunology, holistic nursing, biopsychology, stress & coping, complementary & alternative therapies. Dr. Wilson was the 2017 – 2018 American Holistic Nurse of the Year. She is a life-long learner seeking graduate education in physics, and teaches at Austin Peay University and Walden University. Dr. Wilson is an internationally known speaker on stress and self-care, holistic nursing, and complementary therapies.

John A. Zebala M.D., Ph.D.
Chief Executive Officer and President, SYNTRIX PHARMACEUTICALS

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Dr. Zebala is the founder, CEO and President of Syntrix Pharmaceuticals. In the company’s 18-year history, Dr. Zebala has guided the company in developing a pipeline of investigational drug assets from early discovery through clinical testing and across a broad range of indications. He is an inventor on over 120 issued patents worldwide, author to more than 25 peer reviewed scientific articles, and principal investigator on numerous grants to the company from the National Institutes of Health (NIH). Dr. Zebala has served as an invited reviewer on numerous NIH study sections and review groups concerning drug development and therapeutics. Dr. Zebala received his MD and Ph.D. from Cornell Medical College in 1993.