November 14-15, 2022 | Washington, DC
Identifying and Advancing Novel Pain Drugs Through Clinical Development and Commercialization
Tim Warneke, MS, VP Clinical Operations, Propella Therapeutics, Inc.
W. Michael Hooten, MD, Professor, Division of Pain Medicine, Department of Anesthesiology and Perioperative Medicine, Mayo Clinic
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| Pain Drug Development Group |
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| @PainConference |
Chief Scientific Officer, Amorsa Therapeutics
Michael Palfreyman is a seasoned leader in the biotechnology and pharmaceutical industries with over 40 years experience in drug discovery, pre-clinical and early clinical development. He has directed research programs in Psychiatric, Neurological, Cardiovascular, Cancer, Infectious, Metabolic and Respiratory Disorders, Dr. Palfreyman’s own research includes discovery and development of a number of psychotherapeutic compounds including antipsychotics, antidepressants, anti-epileptics, analgesics, anti-Parkinson’s, anti-emetics, cognition enhancers and Alzheimer’s treatments. Many of these compounds have entered clinical development and a number have reached the market place.
He is a Fellow of the American College of NeuroPsychopharmacology and he is a qualified Pharmacist and Founding Member Royal Pharmaceutical Society of Great Britain. He is the co-inventor of 53 issued US and European patents, 4 pending patents and co-author of over 100 peer reviewed scientific articles, has edited books on glutamate antagonists and enzyme inhibitors and authored several book chapters on a number of different therapeutics. He is currently Chief Scientific Officer at Amorsa Therapeutics.
Chief Executive Officer, Analgesic Solutions
Dr. Nathaniel Katz is considered one of the leading experts of treatment and clinical study design in pain clinical trials. He is a neurologist and pain management specialist with a distinguished career at Harvard Medical School, Brigham & Women’s Hospital and Dana Farber Cancer Institute. From 2000-2004 he served as Chair of the Advisory Committee, Anesthesia, Critical Care, and Addiction Products Division, United States FDA, during which time he completed a Master of Science in Biostatistics at Columbia University.
Dr. Katz’s holds the position of Adjunct Assistant Professor of Anesthesia at Tufts School of Medicine. He has completed numerous clinical trials of treatments for pain, both industry-initiated and investigator-initiated, involving pharmaceuticals, non-pharmaceutical analgesics and devices, and has also conducted studies related to opioids, pain, addiction, and other issues related to opioid therapy. Dr. Katz was an Associate Editor at the Clinical Journal of Pain, and Associate Editor (Pain) for the Encyclopedia of Neurological Sciences.
Associate Professor, University of Montana, Co-Founder and Chief Scientific Officer, DermaXon
Dr. Diaz has more than 20 years of experience leading small and large teams of research scientists within both academics and industry. He started his career in Galderma R&D where he held senior leadership roles in the in the drug discovery department. He was senior scientist at Department of Anesthesiology and Pain Medicine at MD Anderson Cancer Center in Houston where he became interested by the complexity of cannabinoid pharmacology and the design of small molecules to treat Pain.
Philippe holds a Ph.D. in chemistry from the University of Aix-Marseille and an engineering degree in Chemistry from ENSSPICAM (now Ecole Centrale de Marseille). He has authored more than 30 peer-reviewed publications and is co-inventor of more than 24 patents.
Chief Scientific Officer, Lotus Clinical Research
Dr. Neil Singla, a board-certified anesthesiologist, is the founder and Chief Scientific Officer of Lotus Clinical Research. Since its inception in 2001, Dr. Singla has served in several roles within the organization including: Research Coordinator, Sub-Investigator, Principal Investigator, Coordinating Investigator, and Chief Scientific Officer.
In his capacity as CSO for Lotus Clinical Research, Dr. Singla has had the opportunity to interact frequently with the FDA’s Analgesics Division on behalf of clients and to play a significant role in guiding development strategies for dozens of putative analgesic agents. In the company’s 17-year history, Dr. Singla and Lotus Clinical Research have played a significant role in bringing several molecules to market.
Dr. Singla has published extensively and is a frequent lecturer for physicians, pharmaceutical companies, and medical research institutes throughout the country. He currently chairs the Analgesic Clinical Trials Shared/Special Interest Group at both the American Pain Society (APS) and the International Association for the Study of Pain (IASP). He chairs the annual APS Conference on Analgesic Clinical Trials (APS-CAT), which aims to help experts advance best practices in analgesic drug development.
The main focus of Dr. Singla’s academic endeavors has been to analyze and understand how the inherent variability in subjective endpoint analgesic clinical trials can be minimized. As a result, he has developed novel techniques for patient education designed to minimize variability, reduce placebo response, and increase effect size.
Director of Pain Research, Professor of Anesthesia, Stanford University School of Medicine
David Yeomans is the director of pain research and a professor of anesthesia at Stanford University School of Medicine. His research focuses on elaborating pain mechanisms and exploring novel approaches to the treatment of pain, including targeted transcranial magnetic stimulation and gene therapy. Dr. Yeomans has authored more than 100 articles and 11 book chapters in the field of pain, and has been the recipient of numerous grants and awards from the National Institutes of Health and other granting agencies. He has also been named Pfizer Professor of Pain Medicine and has received multiple visiting professorships.
Dr. Yeomans has authored numerous issued patents and co-founded two companies (Trigemina and SiteOne) devoted to the management of pain. He is the chair of the scientific advisory board of four companies and an advisor to numerous pharmaceutical and biotech companies, as well as venture capital firms and intellectual property law practices. Dr. Yeomans earned an AB degree from Dartmouth College, received his PhD in neuroscience from the University of Florida, and completed his research training as a NIH fellow at the University of Illinois.
Professor of Anesthesiology and Perioperative Medicine, Neurology, and Psychiatry, Director, Anesthesiology Research Center, Director, Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION), a public-private partnership with the FDA, University of Rochester School of Medicine and Dentistry
Robert H. Dworkin received his BA from the University of Pennsylvania and his PhD from Harvard University. He is Professor of Anesthesiology and Perioperative Medicine, Neurology, and Psychiatry, Professor in the Center for Health + Technology, and Director of the Anesthesiology Clinical Research Center at the University of Rochester School of Medicine and Dentistry.
Dr. Dworkin is Director of the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership with the U.S. Food and Drug Administration (FDA) and a Special Government Employee of the FDA Center for Drug Evaluation and Research; he previously served as a consultant to and member of the FDA Anesthetic and Life Support Drugs Advisory Committee and as a member of the U.S. Centers for Disease Control and Prevention Herpes Zoster Working Group. He is an Associate Editor of Pain, and a member of the Editorial Boards of Journal of Pain, Canadian Journal of Pain, and Current Pain and Headache Reports. Dr. Dworkin received the American Pain Society’s Wilbert E. Fordyce Clinical Investigator Award in 2005 and John and Emma Bonica Public Service Award in 2014, the Eastern Pain Association’s John J. Bonica Award in 2011 and Raymond Houde Lectureship Award in 2018, the American Academy of Neurology’s Mitchell B. Max Award for Neuropathic Pain in 2015, and the American Academy of Pain Medicine’s Founders Award in 2018.
Dr. Dworkin’s major research interests are (1) methodologic aspects of analgesic clinical trials and (2) treatment and prevention of chronic and acute neuropathic and musculoskeletal pain. The primary focus of his current research involves the identification of factors that increase the assay sensitivity of clinical trials to detect differences between an active and a control or comparison treatment. Dr. Dworkin has also been very interested in the identification of risk factors for the transition from acute to chronic pain. One of the major results of this program of research has been that patients with greater acute pain are more likely to develop chronic pain. This suggests that attenuating acute pain might prevent chronic pain, and an additional focus of his research has involved developing approaches to test this hypothesis.
Dr. Dworkin has authored over 300 journal articles and book chapters, which have been cited over 32,000 times (h index = 85). He has served as a consultant to over 150 pharmaceutical and device companies in the development and evaluation of analgesic and antiviral treatments, and as Director of the Anesthesiology Clinical Research Center, has been the principal investigator for a large number of clinical trials funded by government and industry. These studies have examined treatments for various types of chronic pain—including neuropathic pain conditions, low back pain, cancer pain, fibromyalgia, and osteoarthritis—as well as treatments for acute pain in herpes zoster and acute post-surgical pain.
CEO and Founder, Levicept
Dr. Westbrook a seasoned drug discoverer, the inventor of numerous patents who worked at Pfizer, Sandwich for c. 18 years in a variety of roles and departments including Urology, Cardiovascular/Metabolic Disease and Pain. Whilst in the Pain therapeutic area, Simon worked on the anti-NGF program with the role of identifying novel means of manipulating the neurotrophin pathway.
In September 2012 Simon founded Levicept, a Pfizer-spun out company, with the goal of developing a novel and safe neurotrophin modulator for the treatment of chronic pain.
Chief Medical Officer, Concentric Analgesics
Dr. Mike Royal is the Chief Medical Officer of Concentric Analgesics, Inc. (San Francisco). He has 17 years of pain drug development and medical affairs experience particularly in 505(b)(2) NDAs across several indications, but also with NCEs and generics. He has held senior clinical roles at Liquidia Technologies, Sorrento Therapeutics, AcelRx Pharmaceuticals, Cadence Pharmaceuticals, Solstice Neuroscience, Alpharma and Elan Biopharmaceuticals.
Dr. Royal holds Board certifications in Internal Medicine, Anesthesiology, Addiction Medicine and Pain Medicine with 12 years of medical practice experience in both academic and private practice settings. He has over 185 peer-reviewed publications, book chapters, and abstracts/posters. Dr. Royal received a BS in synthetic organic chemistry from MIT, MD from University of Massachusetts, JD from University of Maryland and MBA from TRIUM (NYU Stern School, London School of Economics, HEC-Paris).
Professor, Departments of Anesthesiology and Pharmacology, University of California, San Diego
Dr. Tony L. Yaksh obtained his Ph.D. degree from Purdue University (1971).He served in the U.S. Army in the Biomedical Laboratory at Edgewood Arsenal, MD (1971-73), was a research scientist in the School of Pharmacy, University of Wisconsin (1973-76) and an Associate Research Scientist in Anatomy at University College London with Pat Wall (1976-77). He worked at the Mayo Clinic with Dr. Frederick Kerr in Rochester, MN in Pharmacology and Neurosurgery (1977-1988), where he rose to the rank of Consultant and Professor.
Dr. Yaksh joined UCSD in 1988 as Professor in the Department of Anesthesiology, and Professor in the Department of Pharmacology and Vice Chairman for Research in Anesthesiology through 2014. His research has been on the biology of pain processing. His studies have provided a basis for understanding the pharmacology of the spinal gating of pain information.
He is an expert in spinal drug kinetics and evaluation of spinal drug safety. He has published 800+ papers and edited 6 texts. His work has garnered over 48,000 citations in over 27,000 papers. He has mentored more than 150 postdoctoral fellows and trainees. He has been funded consistently by NIH since 1977 and twice has been a Javitz Award recipient. He has received numerous awards, including from the American Pain Society (Kerr Award), the International Association for the Study of Pain (Bonica Award) and the Swedish Society of Medicine (Gordh Award).
Chair, Department of Anesthesiology, Professor, Department of Physiology and Pharmacology, Rutgers New Jersey Medical School
Dr. Alex Bekker is Professor and Chairman of Anesthesiology at Rutgers New Jersey Medical School. Dr. Bekker has been active in research and for many years. He is an author of 90+ peer-reviewed articles including publications in Anesthesiology, Pain, Nature Neuroscience, Molecular Pain, and Anesthesia & Analgesia, 6 US patents, 40 + educational reviews and more than 100 abstracts. His work has focused on the effects of anesthetics on CNS, neuroinflammation, neuropathic pain and postoperative analgesia. Dr. Bekker was a PI of numerous clinical trials, including studies sponsored by the National Institute of Health.
Director, Sports Neurology Program, Norton Healthcare, Head, NCAA Headache Task Force
Dr. Tad Seifert a graduate of the University of Oklahoma College of Medicine in Oklahoma City, Oklahoma. He completed his residency in neurology at the University of Texas-Houston and a subsequent fellowship in headache & facial pain at the renowned Houston Headache Clinic. Dr. Seifert currently serves as Director of Norton Healthcare’s Sports Neurology Program in Louisville, Kentucky.
Dr. Seifert is an Independent Neurotrauma Consultant for the NFL and serves as Head of the NCAA’s Headache Task Force. He is currently the Team Neurologist for a number of Kentucky and Indiana-based colleges and universities and is Chairman of the Kentucky Boxing & Wrestling Commission’s Medical Advisory Panel. His research interests include post-traumatic headache in athletes as well as combat sports medicine.
Associate Professor, Anesthesia and Pain Management, Harvard Medical School, Brigham and Women's Hospital
Dr. Nedeljkovic is anesthesiologist and pain medicine specialist based at Brigham and Women’s Hospital and an Associate Professor of Anaesthesia at Harvard Medical School in Boston, Massachusetts. He is also staff physician in the Spine Unit at Harvard Vanguard Medical Associates in Boston, a large multispecialty physician practice group. Dr. Nedeljkovic has had an extensive experience in pain medicine education, serving as Fellowship Director in Pain Medicine at BWH and as Vice Chair of the Pain Medicine examination committee at the American Board of Anesthesiology. Dr. Nedeljkovic is also a lecturer and course director in the Tufts University School of Public Health's PREP (pain research, education, and policy) program.
Dr. Nedeljkovic has had extensive experience as a leader in clinical pain research, serving as the site Principal Investigator of the BOLD (Back Pain Longitudinal Data) project as well as the LESS (Lumbar Epidural Steroid Injections for Spinal Stenosis) study. Over the past several years, he has led a number of innovative clinical research protocols, including a study of VVZ-149, a novel glycine T2 inhibitor and 5HT2A receptor antagonist. In addition, Dr. Nedeljkovic has served as principal investigator in studies using Exparel, a long-acting liposomal bupivacaine local anesthetic, and a study using RTX (resiniferitoxin), a TRPV1 receptor agonist that causes selective neurolysis of primary sensory neurons responsible for pain perception. Dr. Nedeljkovic is currently in the process of initiating studies on the clinical efficacy of pharmacogenomic testing in the perioperative period and in a pain management center environment.
Research Fellow, University College London
Dr Shafaq Sikandar has more than 10 years of research experience and extensive expertise in using electrophysiology, behaviour, molecular biology and pharmacological assays to study pain in rodents and humans. During her Ph.D. in Pharmacology in University College London, she established new electrophysiological assays for evaluating visceral pain and descending modulation in rodents. In her following first postdoctoral post at University College London, she employed translational approaches to assess pain in rodents and humans in parallel. Her findings showed strong correlations between both species for measures of nociception, thereby substantiating the use of preclinical tests to predict clinical outcomes. These were novel reports of the correlation between evoked neuronal activity in rodent preparations and human perceptual responses to pain.
She was awarded a fellowship to work at UC San Diego, where she studied analgesic mechanisms of botulinum toxin. Her next postdoc was in a molecular genetics lab at the Wolfson Institute of Biomedical Research in University College London, where she has been working on hyperalgesic priming models to study pain plasticity in the nervous system. She is currently an Arthritis Research UK fellow as part of the Centre for Adolescent Rheumatology in London, and continues to use rodent models to identify which subpopulations of sensory neurons mediate the transition of acute to chronic pain.
Founder, Neurotherapia
Dr. Foss received his undergraduate and medical degrees from Brown University, and his training in clinical pharmacology at the University of Chicago. There he led the development of methylnaltrexone, a peripherally active opioid antagonist. This involved the proof of principle trials in pre-clinical models, the first-in-man studies, and subsequent proof of concept trials and studies of the pharmacokinetics and pharmacodynamics in man. Methylnaltrexone was licensed out and approved for clinical use (as Relistor®) in the management of opioid side effects in patients with advanced medical illness.
Subsequently Dr. Foss worked for Adolor, a small biotech company, which was developing alvimopan, another peripherally acting opioid antagonist, which also has been approved for clinical use. Dr. Foss was also responsible for the translational program there that was developing novel analgesics. Dr. Foss was recruited to the Cleveland Clinic to assist in developing the research program in anesthesiology. Dr. Foss began to work with Dr. Mohamed Naguib recently to provide direct support to the development program for the CB2 agonists. They have done extensive research on the mechanisms by which microglial mediated neuroinflammation plays a role in disease and are currently advancing NTRX-07 into human trials for the treatment of neuropathic pain and Alzheimer’s disease. He is a founder of NeuroTherapia Inc.
Chief, Division of Pain Medicine, Director, Stanford Systems Neuroscience and Pain Lab, Stanford University School of Medicine
Sean Mackey, MD, PhD, is Redlich Professor and Chief of the Stanford Division of Pain Medicine. He uses research tools such as big data, psychophysical, neurobehavioral and neuroimaging tools to investigate chronic pain and opioids. Dr. Mackey is author of over 200 journal articles and book chapters. He is developer of an open-source learning health system—CHOIR (http://choir.stanford.edu)—to transform the care of people with pain, and serve as a platform for research in real-world clinic patients. Recently, he was Co-Chair of the HHS/NIH National Pain Strategy (NPS) to establish a national health strategy for pain care, education and research.
Under Dr. Mackey’s leadership, the Stanford Pain Management Center has been twice designated a Center of Excellence by the American Pain Society for the Center’s innovative approach in comprehensive, interdisciplinary, and outcomes-based care. He has served as principle investigator on multiple NIH awards where he has overseen efforts to map the specific regions of the brain and spinal cord that perceive and process pain.
Clinical Professor, Neurology and Neurological Sciences, Stanford University School of Medicine
Dr. Robert Cowan is Professor of Neurology and Director of the Headache and Facial Pain Program at Stanford University. He is board certified in neurology and pain medicine with a subspecialty certification in headache medicine. Dr. Cowan holds several nationally elected positions, including chair of the section on chronic daily headache for the American Headache Society.
He is President of the Headache Cooperative of the Pacific, a fellow of the American Academy of Neurology and the American Headache Society. He sits on the board of the Alliance for Headache Diseases Advocacy and the American Headache and Migraine Association. He has published over 50 articles and is the author of The Keeler Migraine Method.