2026 Conference Agenda
Monday, September 28, 2026
Registration & Breakfast
Chairperson's Opening Remarks
Challenges, Opportunities, and Innovation in Pain Medicine
This presentation will explore key challenges in pain research, including gaps in mechanistic understanding—particularly in the transition to chronic pain—and the limited translation of preclinical findings to humans. It will also address the complexity and heterogeneity of pain driven by genetic, psychological, and environmental factors.
The discussion will highlight emerging technologies enabling multi-level insights into pain biology, from molecular and cellular models to circuit-level analysis and real-world behavioral data. A focus will be placed on biomarker development for risk identification, prediction of therapeutic response, and personalized treatment, along with the growing role of artificial intelligence in objective pain assessment and target discovery.
Finally, the presentation will examine advances in therapeutics, including mechanism-based drugs and device-based interventions such as closed-loop neuromodulation and wearable biosensors, and how these innovations are contributing to the shift toward precision pain medicine.
Beyond Analgesic Effects: Using PKPD Modeling to Unlock the Full Potential of Experimental Pain Studies
At CHDR, the PainCart is used in early phase clinical research to characterize the pharmacodynamic effects of novel analgesic compounds. Experimental pain models can provide early evidence of analgesic activity, but their full potential is not always captured by conventional statistical analyses. This talk will explore how pharmacokinetic-pharmacodynamic (PKPD) modelling can be used to better characterize exposure–response relationships and extract more information from experimental pain data. Using examples from a Nav1.8 inhibitor and an S1P1 receptor modulator, we will illustrate how PKPD modelling can quantify the magnitude and time course of analgesic effects, account for variability and delays in drug effect, and support dose selection and predictions for further clinical development.
The Orphan Receptors GPR63 and GPR153 Promote Pathological Pain Relief by Suppressing Microglial Inflammatory Activation
Orphan receptors represent a rich and untapped source of therapeutic potential in pain and other diseases. Through our work, we've discovered that the novel orphan receptors GPR63 and GPR153 act as a previously-unknown feedback loop in microglia that restrains microglial pro-inflammatory activation. In this presentation we demonstrate their role in promoting pain relief in pathological pain states like post-surgical pain and chemotherapy-induced neuropathy, and evidence that these receptors modulate microglial activation state and the secretion of pro-inflammatory cytokines. We further demonstrate our screening efforts to discover the first known ligands for these receptors. Our studies thus promise to uncover a new receptor regulator of microglia and pathological pain which could provide new therapeutic targets for future exploitation.
VER-01: A First-In-Class Therapy for Chronic Low Back Pain – Presenting Data from Two Pivotal Phase III Trials
Chronic low back pain is the most prevalent chronic pain condition worldwide, yet effective long-term treatment remains elusive. For many people living with chronic pain, opioids remain the only pharmacological treatment option, however, they often fail to provide adequate relief and carry significant risks. Patients with a neuropathic pain component are among the hardest to treat and most underserved. VERTANICAL has developed VER-01, an innovative, first-in-class therapy for chronic pain. In two pivotal Phase 3 trials, VER-01 delivered highly significant pain reduction in chronic low back pain and demonstrated superior efficacy and safety compared to opioids, with no evidence of dependence or abuse. This presentation will review the clinical evidence for VER-01, with a focus on patients with a neuropathic pain component.
BupiZenge, a Bupivacaine Lozenge for Oral Mucositis Pain in Head and Neck Cancer: A Phase III Trial in Progress
Most patients receiving curative-intent radiotherapy for head and neck cancer develop oral mucositis, and approximately half experience severe (WHO Grade 3–4) disease. The resulting oral pain impairs swallowing and oral intake and can force interruptions in potentially curative treatment, yet current topical management with viscous lidocaine offers only short-lived relief, leaving many patients dependent on opioids. OncoZenge has developed BupiZenge, a locally acting bupivacaine lozenge designed to deliver extended analgesia directly at the site of injury. Across four completed Phase I and II studies with 122 exposed subjects, BupiZenge demonstrated a favorable safety profile with systemic exposure well below toxic thresholds, and in a randomized Phase II study it outperformed viscous lidocaine in pain reduction. This presentation will review the rationale for the program and the design of an ongoing randomized, open-label Phase III trial comparing BupiZenge with viscous lidocaine, including an update on patient enrollment.
Refreshment Break — Exhibit Viewing & Poster Session
The NIH Pain Therapeutics Development Program (PTDP)
The NIH HEAL Initiative® is a trans-NIH effort to combat the opioid crisis through research on misuse, addiction, and pain management. Within it, the Pain Therapeutics Development Program (PTDP) accelerates the discovery of safe, effective, non-addictive pain treatments by de-risking innovative non-opioid therapies and advancing them toward the clinic. This introduction is followed by PTDP-supported presenters sharing updates on their projects.
Anesthetic Eluting Bandage Contact Lens for Corneal Pain
Corneal epithelial wounds cause severe ocular pain often treated with oral opioids. Anesthetic eye drops relieve pain but last only about 20 minutes and risk overuse and delayed healing, so they aren't prescribed for self-administration. We developed tetracaine-eluting contact lenses as a longer-acting alternative, and will describe their design, safety, and efficacy.
Development of MMP-9 Inhibitory Monoclonal Antibodies to Relieve Neuropathic Pain
Diabetic peripheral neuropathy (DPN) has no effective disease-modifying treatment. Because matrix metalloproteinase-9 (MMP-9) drives the neuroinflammation behind neuropathy, we developed selective, potent, stable monoclonal antibodies that inhibit it. In type I and type II diabetes mouse models, these antibodies reduced mechanical and cold pain, restored wound healing, and limited nerve fiber degeneration — offering strong translational evidence for a disease-modifying DPN therapy.
Development of Angiotensin AT2 Inhibitors for Neuropathic Pain Relief
Targeting pain in peripheral nerves enables effective analgesia while avoiding CNS-mediated side effects and addiction. AT2 receptor antagonists are thought to relieve pain by dampening immune activity near nerve injury. Using a structure-based discovery platform, we identified and optimized a novel series of potent, peripherally-targeted AT2R antagonists. We will describe our lead compound's safety and efficacy in rodent neuropathic pain models, along with PK/PD and toxicity studies, as it advances toward IND-enabling work.
Beyond the Pain Score: Understanding Rescue Use in Analgesic Trials
From Preclinical Translation to Clinical Strategy: Advancing a First-in-Class Non-Opioid Analgesic Across Multiple Indications
EicOsis is developing EC5026, a first-in-class oral inhibitor of soluble epoxide hydrolase (sEH), to stabilize endogenous epoxy fatty acids (EpFAs) that regulate inflammation, nociceptive signaling, and tissue homeostasis. We are initiating parallel clinical development programs in inflammatory and neuropathic pain that are informed by preclinical efficacy data, translatable PK/PD relationships, and lipidomic biomarkers of target engagement that guide dose selection and endpoint strategy.
Early clinical data with EC5026 demonstrate a favorable safety profile, pharmacokinetics supportive of once-daily oral dosing, and biomarker evidence of pathway modulation aligned with preclinical findings. This presentation will highlight our translational approach to clinical development, with a focus on a multi-indication strategy designed to enable cross-indication learning and support a more efficient path to regulatory approval.
Lunch
Innovating Trial Design in a Double-Masked, Randomized Trial of Psilocybin for Chronic Low Back Pain
In this presentation, we will give an overview of the trial design and preliminary findings from a 30-participant trial of psilocybin for the treatment of chronic low back pain. To improve upon previous attempts at masking the study arm allocation, we implemented participant-authorized incomplete disclosure of the trial design. Participants were informed of the potential dose-range for psilocybin (1-30mg) and that up to 2 other medications, zolpidem (10mg) and modafinil (200mg), would be co-administered with their dose of psilocybin. We will present preliminary outcomes including reductions in pain interference, as well as detailed masking assessments.
The State of Pain Therapeutics Investing: What's Changed and Where Capital is Flowing in 2026
Recent Challenges and Considerations in Assessing Abuse Potential of Novel Analgesics
New analgesics with novel mechanisms of action require a comprehensive abuse potential assessment to assist with scheduling and labeling decisions. Methods and approaches to more fully and accurately characterize the abuse potential of novel drugs have evolved since the 2017 FDA Guidance Assessment of the Abuse Potential of Drugs was issued. This talk will cover lessons learned since the guidance was published, including those identified by FDA's Controlled Substance Staff at scientific conferences and routine meetings with FDA. Specifically, the talk will detail areas such as dedicated animal studies, abuse-related adverse event collection in clinical studies, respiratory depression models, and assessing physical dependence. In addition, recommendations for emphasizing the public health benefits of a new drug in the Eight Factor Analysis (8FA) will be provided, and assessing the abuse potential of biologic analgesics will also be briefly covered.
Placebo Responses in Pain Research: Evolving Perspectives and Clinical Implications
This panel session will explore the evolving understanding of placebo responses in pain research and clinical development. Panelists will discuss how perceptions of the “placebo problem” have changed over time, the biological and psychological mechanisms underlying placebo effects, and the growing recognition of placebo responses as an important component of patient outcomes rather than simply a barrier to drug development. The discussion will also examine the implications for clinical trial design, endpoint selection, patient engagement, and the interpretation of efficacy data in pain therapeutics research.
Development of Novel Injectable Steroid Formulation with Extended Local Effect for Treatment of Lumbosacral Radicular Pain
This presentation will discuss the development of a novel injectable steroid formulation designed to provide an extended local therapeutic effect for the treatment of lumbosacral radicular pain. Topics will include the formulation’s pharmacokinetic and pharmacodynamic profile, clinical trial design challenges in subacute pain, experience from a Phase 3 registrational trial, key safety and efficacy findings, and an update on the ongoing second Phase 3 study with investigative sites in India and the United States.
Refreshment Break — Exhibit Viewing & Poster Session
Engineering Intranasal Kappa Opioid Receptor Antagonist Nanotherapeutics to Prevent Pain-Induced Negative Affect
Although opioid analgesics remain effective for pain management, their long-term use is associated with significant adverse effects, including tolerance, hyperalgesia, opioid misuse, and opioid use disorder, limiting their utility in chronic pain treatment. Endogenous opioid peptide systems regulate not only pain signaling but also reward, motivation, and affect, making them promising targets for safer analgesic development. Dr. Jose Morón-Concepción will present preclinical research identifying the dynorphin/kappa opioid receptor (KOR) system as a key driver of pain-induced negative affect and increased opioid vulnerability. The presentation will highlight innovative brain-targeted therapeutic approaches, including intranasal and nanoliposome-based delivery systems carrying KOR antagonists, designed to selectively modulate KOR signaling while minimizing systemic exposure and adverse effects. Together, these findings provide a translational framework for developing next-generation, non-addictive therapies that address chronic pain, negative affect, and opioid misuse risk.
Pain Biomarkers: Advancing Pain Therapeutics Development, Clinical Trials, and Patient Care
The field of pain biomarkers continues to evolve rapidly, offering new opportunities to improve the understanding, assessment, and treatment of pain across a wide range of conditions. This session will provide a picture of emerging research and translational advances related to biomarkers in pain therapeutics development, clinical trial design, patient stratification, treatment response, and real-world patient care. Discussions may include molecular, imaging, digital, physiological, and other biomarker approaches that have the potential to enhance precision medicine strategies, support therapeutic development, and improve outcomes for patients living with acute and chronic pain.
From Signals to Signatures: Mechanistic Science and Digital Monitoring in Pain Care
Digital Measures of Pain and Mobility Impairments in Knee Osteoarthritis
Longitudinal Multi-omics Analyses of Chemotherapy-induced Peripheral Neuropathy in Response to Taxanes
Networking Reception
Tuesday, September 29, 2026
Breakfast
Chairperson's Opening Remarks
Without a Report Card, How do We Improve? A Look at Site Metrics
One of the “hot topics” at recent Arrowhead Pain Therapeutic Summit meetings has been the placebo response at individual sites, and more broadly how sites can see their own results in order to improve with their next trial. In this presentation, we will review several different site metrics, covering efficacy, safety, and compliance, and wrapping up in a discussion of ways that sites can improve over time and build on the experience of conducting multiple trials. We will also discuss the Sponsor’s obligation to the sites, and hopefully may start a new necessary step in the cycle of clinical trials.
Placebo Response, Mitigation and Procedural Integrity
This talk focuses on practical strategies investigators can use to mitigate placebo responses and ensure high procedural integrity in clinical trial execution. It highlights how study conduct, patient interactions, and site workflows can significantly influence placebo effects and trial outcomes. Ensuring procedural integrity is critical when study outcomes depend upon accurate placement of the investigational product. Together, these best practices are designed to improve data quality, strengthen treatment signal detection, and support the generation of reliable, regulatory-grade clinical evidence.
Development of BTB-101, a Novel α2B Adrenergic Receptor Antagonist for the Treatment of Pain
BTB-101 is a selective presynaptic α2B adrenergic receptor antagonist that specifically promotes norepinephrine release in the spinal dorsal horn to produce its analgesic effects by stimulating the α2A adrenergic receptor-dependent descending pain inhibitory pathway. The characterization of BTB-101's mechanism of action, it's analgesic effects in a broad range of animal models, and the results of safety assessments both nonclinically and clinically will be discussed in this presentation.
ENA-001 for Safer and More Effective Postoperative Pain Management
Postoperative patients frequently experience respiratory complications related to opioid-based pain management, with studies suggesting that up to 50% develop episodes of opioid-induced respiratory instability. These events can increase morbidity, prolong hospitalization, and complicate pain management.
ENA-001 is a first-in-class ventilatory modulator that stimulates the carotid bodies and has shown promise in preventing and reversing respiratory depression without reducing analgesic efficacy. This presentation will highlight preclinical research and early clinical data demonstrating ENA-001's safety and effectiveness against opioid- and anesthetic-induced respiratory depression. Emerging data also suggest potential applications in reversing mixed-drug overdose states, supporting its development as a novel respiratory rescue therapy.
Refreshment Break — Exhibit Viewing & Poster Session
Advancing Small-molecule ALOX15 Pathway Inhibitors for the Treatment of Chronic Pain
Kinoxis is advancing KNX101, a longer-acting inhibitor selected as its primary clinical candidate for chronic pain. Preclinical studies in established neuropathic pain demonstrate robust efficacy following acute and chronic dosing, with no evidence of tolerance after repeated treatment or abuse liability in testing conducted to date. Dr. Bowen will discuss how the company is integrating lipidomic measures of biochemical pathway engagement with fMRI and EEG markers of circuit engagement to guide dose selection, demonstrate biological activity in early clinical studies, and de-risk KNX101 ahead of clinical proof-of-concept testing.
New Pain Therapeutics Through NewCo Creation
Translating novel pain targets into funded drug development programs remains a significant challenge. This presentation will provide an overview of the approach to NewCo creation at Blackbird Laboratories from target selection through early incubation, company creation, preclinical development, and syndication. Blackbird Laboratories is a nonprofit life sciences incubator dedicated to transforming research breakthroughs into scalable, venture-ready biotech companies based in Baltimore, MD.
Advancing the Science of Analgesic Assessment in Chronic Musculoskeletal Disease
This presentation will examine how osteoarthritis analgesic trial methods have evolved over the past 25 years in response to advances in analgesic mechanisms, clinical endpoints, patient population definition, imaging criteria, and changing regulatory expectations. Using COX-2 inhibitors, anti-NGF therapies, and incretin analogues as recurring examples, the session will explore how study duration, population selection, imaging strategy, endpoint interpretation, placebo response, and assessment of clinical meaningfulness must be aligned with the biology of the intervention. Participants will gain an understanding of the methodological considerations associated with each therapeutic approach, including differences in treatment duration, onset of clinical benefit, and responder characterization. The presentation will also examine the strengths and limitations of clinical endpoints, imaging biomarkers, metabolic measures, and joint replacement outcomes for evaluating analgesic efficacy and assessing the potential for disease-modifying effects in osteoarthritis.
Reshaping the Way we Think and Conduct Clinical Trials in Chronic Pain
What will be presented here are a specific set of new hypothesis and critically important questions directed to the chronic pain community at large. Substantial evidence in the form of published research and collected clinical trial experiences over the past 3 decades, involving the Core Domains (Pain, Sleep, Mood, and Function) will be shared; This evidence is being offered up as a starting point for further debate and discussion, seeking a full revision of the manner in which we conduct clinical trials in chronic pain. The impact of this work, ie the irrefutable evidence which will be presented, is expected to lead to a resetting of consensus positions across, academics, industry, regulatory and special interest groups, all on behalf of our studies of chronic pain patients.
Lunch
The Cold Pressor Test: Insights, Applications, and Translational Limitations
The Cold Pressor Test (CPT) has become a staple in early-phase analgesic drug development. In this presentation, Dr. Christian Brett will review the physiological basis of the CPT, share practical site-level insights from early-phase clinical trials, and evaluate the translational limitations of the CPT in predicting clinical analgesic efficacy.
Cold Pressor as a Pharmacodynamic Biomarker for NAV 1.8 Development
Advancing Therapeutic Strategies for Trigeminal Neuralgia
Trigeminal neuralgia remains one of the most challenging and debilitating neuropathic pain conditions, with significant unmet need for safe and effective long-term treatments. This panel brings together leading experts to discuss emerging therapeutic approaches, including novel pharmacologic agents and targeted interventions. Panelists will share insights from their latest research, explore mechanisms underlying treatment response, and consider how new developments may shape the future of care for patients living with this condition.
End of Conference
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.
