2026 Conference Agenda
Check In (Breakfast not provided)
Chairperson’s Opening Remarks
Linking Drug Targets to the Optimal Patients: New Approach Methodologies (NAMs) to Improve Success in Pain R&D
Mark Field, Ph.D., CEO & Co-Founder, EptivA Therapeutics
Analgesic Metric Analysis to Determine Benefit and Harm in Early Drug Development in Humans
Albert Dahan, MD, Ph.D., Chief Executive Officer, MediD Consultancy
Novel Analogs of Hydroxynorketamine for the Treatment of Chronic Pain
The ketamine metabolite, (2R,6R)-hydroxynorketamine (RR-HNK) has been shown to be effective in animal models of chronic neuropathic pain and is currently in Phase 2 trials for this indication. Spirify Pharma is developing novel proprietary analogs of RR-HNK to identify candidates for optimized analgesic treatment. We will present key data that support RR-HNK analogs as a platform for non-opioid analgesics. We will report on the design, synthesis and initial testing of 36 proprietary HNK analogs, and focus on two HNK analogs and their testing in a mouse model of chronic neuropathic pain. The data demonstrate that the analogs provide rapid and profound analgesia and the potential for the development of new families of analgesics. (This work is supported by the NIH Grant 1R41NS145804-01, “HNK Analogs for the Treatment of Chronic Pain”.)
Irving Wainer, Ph.D., Chief Scientific Officer, Spirify Pharma
Refreshment Break
Stabilizing chronic opioid therapy: the promise of first-in-class QRFP receptor antagonists
The 26RFa neuropeptide and its QRFP receptor comprise a homeostatic anti-opioid neuroendocrine system that counter-balances both endogenous and xenobiotic opioids. QRFP receptor antagonists have no effect on sensory thresholds in naïve mice; but become powerfully anti-hyperalgesic after stressful or inflammatory (but not neuropathic) injury. We will present data from QRFPa-receptor knock-out mice and the profile of RF1755, a potent, selective, and orally-active QRFP receptor antagonist, in a model of latent pain sensitization, and show how it alters sensory, respiratory and discriminative stimulus response to sustained xenobiotic opioid use. We expect to demonstrate reduced opioid tolerance and hypersensitivity in healthy human subjects receiving repeated doses of an opioid; and a reduction in the frequency of breakthrough pain episodes in patients receiving chronic opioid treatment for moderate-to-severe pain. We believe QRFP receptor antagonists can stabilize chronic opioid therapy.
Michael Scherz, Ph.D., Co-founder, Chief Scientific Officer, Arphamid Therapeutics SAS
Assessing Nociceptor Excitability in Humans Including Sensory Tests to Identify Alterations of Nav 1.7 Function
In recent years preclinical techniques for assessing excitability and function of specific pain mediating channels such as Nav 1.7 or Nav 1.8 have been translated into humans. Nociceptive specific stimulation techniques such as laser and pin-electrode stimulations have been developed together with specific neurophysiological and psychophysical assessment techniques such as perception threshold tracking. This opens for new opportunities to study the contributions of peripheral small nerve fiber excitability in specific conditions (e.g., diabetic neuropathy, chemotherapy induced neuropathies) and in clinical drug trials.
Lars Arendt-Nielsen, Dr. Med, Ph.D., Professor, Head of Research Group, Center for Neuroplasticity & Pain, Aalborg University
Chemical Control, Clinical Confidence: Rethinking Opioids
Opioids remain the gold standard for severe acute pain. How can we do better to prevent undesirable outcomes when using them for treatment? One strategy is to modernize opioid therapy by embedding abuse and overdose protection directly into the drug’s chemistry. Beyond abuse deterrence, TAAP and MPAR provide overdose protection to these efficacious therapies. Clinical data to support this approach will be discussed.
Lynn Kirkpatrick, Ph.D., Chief Executive Officer, Ensysce Biosciences
Lunch
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.
Harold Minkowitz, MD, Co-President Acute & Chronic Pain, Evolution Research Group
David Leiman, MD, Co-President Acute & Chronic Pain, Evolution Research Group
The Role of AI in Making Clinical Trials Better, Faster and Cheaper
Clinical trials are expensive, operationally complex, and less reliable than anyone would like to admit. Even when a drug works, execution problems can obscure the treatment effect, delay development, increase cost, or weaken the evidence package needed for regulators, partners, and investors. AI may help—but only if it is applied by people who understand clinical trials, regulatory expectations, and real study-team workflows. In this presentation, Dr. Katz will describe what he has been learning while cofounding a company focused on AI-enabled clinical trial solutions. He will discuss both the promise and the landmines of AI, emphasizing the difference between software that merely “works” and software that demonstrably helps trial teams do critical work better, faster, or with fewer errors.
Nathaniel Katz, MD, MS, Chief Executive Officer, Analgesic Solutions
Detecting Analgesia Early: Translational Pain Models to Demonstrate Pharmacology in phase 1
Early-phase clinical studies increasingly need to do more than characterize safety and pharmacokinetics, they should also demonstrate target-related pharmacology and provide an early signal of analgesic potential. This presentation will highlight CHDR’s approach to establishing pharmacodynamic readouts in healthy-volunteer pain studies, using a standardized experimental pain battery to quantify modality-specific effects and dose/exposure relationships. Examples will illustrate how carefully selected evoked pain paradigms can differentiate mechanism classes and support early decision-making. In addition, we will discuss ongoing innovation in pain model development. We will explain how these strategies aim to strengthen confidence in mechanistic activity and optimize development paths for novel analgesics.
Geert Jan Groeneveld, MD, Ph.D., Neurologist | Clinical Pharmacologist | Professor of Clinical Neuropharmacology; CEO, Centre for Human Drug Research
Predictive Validity of Human Laser-EPs in Extended Phase-I Analgesic Research
This presentation will explore the predictive validity of human Laser Evoked Potentials (LEPs) as a translational tool in extended Phase I analgesic research. It will begin with a brief introduction to the LEP method in EEG and its application in evaluating pain-processing pathways in humans, followed by an example of a standard analgesia trial design incorporating this approach. The session will also highlight data generated with clinically relevant compounds, provide an overview of the broader analgesics database developed through LEP studies, and discuss how these findings can help strengthen decision-making during the transition from Phase I to Phase II development.
Klaus Schaffler, MD, Managing & Medical Director; Chief Executive Officer, Human Pharmacodynamic Research
Refreshment Break
Targeting Nav1.9: Mechanisms of Sensory Hyperexcitability and Emerging Therapeutic Opportunities
The voltage-gated sodium ion channel Nav1.9 plays a central role in setting the excitability threshold of peripheral sensory neurons and has emerged as a key determinant of inflammatory pain and itch. However, progress toward therapeutic targeting has been limited by the difficulty of studying this channel in heterologous systems and by an incomplete understanding of its regulatory mechanisms. In this talk, I will present recent advances from our laboratory that enable robust functional expression of Nav1.9 and reveal structural determinants controlling its gating and current density. I will also discuss how Nav1.9 integrates inflammatory and GPCR-mediated signaling pathways to amplify sensory neuron excitability, highlighting newly identified modulatory mechanisms and potential avenues for pharmacological intervention. These findings provide a mechanistic framework for considering Nav1.9 as a tractable therapeutic target for chronic pain and related sensory disorders.
Frank Bosmans, Ph.D., Professor, Experimental Pharmacology Research Group, Vrije Universiteit Brussel
Panel Session: Making Better Early Decisions in Pain Drug Development
Identifying meaningful early signals of efficacy and differentiation remains a central challenge in pain therapeutics. This panel brings together leaders across translational and clinical development to discuss how early-stage data can better inform decision-making and reduce downstream risk. Panelists will share perspectives on evaluating emerging therapies, interpreting early findings, and navigating the complexities of advancing new analgesics through development.
Geert Jan Groeneveld, MD, Ph.D., Neurologist | Clinical Pharmacologist | Professor of Clinical Neuropharmacology; CEO, Centre for Human Drug Research
Klaus Schaffler, MD, Managing & Medical Director; Chief Executive Officer, Human Pharmacodynamic Research
Nathaniel Katz, MD, Chief Scientific Officer, Vital Clinical Solutions
Cocktail Reception
Check In (Breakfast not provided)
Chairperson’s Opening Remarks
William Schmidt, Ph.D., President, NorthStar Consulting
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.
Cindy McReynolds, Ph.D., Co-founder & Chief Executive Officer, EicOsis
From Concept to Cure: The LEVI-04 Journey and the Next Frontier in Chronic Pain
LEVI-04 represents a first-in-class approach to chronic pain: a soluble p75 neurotrophin receptor fusion protein designed to restore physiological homeostasis of the neurotrophin system. By acting as a biomimetic of the endogenous receptor, LEVI-04 rebalances this system to deliver profound analgesia and a differentiated safety profile. Crucially, this mechanism also drives structural repair—specifically in osteoarthritic subchondral bone. This talk traces the journey from discovery to clinical validation, presenting Phase 2 data from over 500 patients that confirms LEVI-04's potential to safely treat both the symptoms and the underlying pathology of chronic disease.
Simon Westbrook, Ph.D., Founder & CEO, Levicept
AP-325: A Dual-Acting Non-Opioid Therapy Demonstrating Sustained Analgesia Beyond Treatment in Post-Surgical Neuropathic Pain
In this presentaiton Dr. Koopmans will present results from their randomized, double-blind, placebo-controlled Phase 2a trial evaluating AP-325 in 99 patients with post-surgical neuropathic pain. The talk will cover key aspects of the study design (patient population, dosing and treatment duration, endpoints, and statistical approach) and summarize efficacy outcomes across pain intensity and neuropathic pain.
Guido Koopmans, Ph.D., Chief Scientific Officer, Algiax Pharmaceuticals
Refreshment Break
Pivotal Data Demonstrates First-in-Class Dual NMR Agonist Cebranopadol Can Provide Opioid-Level Analgesia With Significantly Reduced Risks
Opioids are the only effective option for treating many acute and chronic pain patients, especially those with more severe pain, however their use is tempered by serious risks including dependence, abuse liability and respiratory depression. Preliminary data suggested that dual NOP/MOP (dual NMR) agonists could potentially provide comparably effective analgesia with significantly improved safety. With the recent completion of phase 3 acute pain and human abuse potential studies, the profile of cebranopadol has now been very well characterized and seems to confirm this hypothesis. Dr. Hackworth will discuss this data and where the drug could fit into clinical practice.
James Hackworth, Ph.D., President, Brand Division, Tris Pharma
Designing a Better Analgesic: Clinical and Regulatory Lessons from a Dual Mechanism Novel Tetrapeptide, Lumekefamide
Can opioid effectiveness be preserved while materially reducing central risk? This talk presents the pharmacologic rationale and clinical experience behind lumekefamide, a novel subcutaneous tetrapeptide analgesic approved ex-US, and currently in development in the US and beyond. We will review mechanism, PK compartmentalization, naloxone reversibility data, and implications for Human Abuse Liability trial design. Emphasis will be placed on how distribution-driven pharmacology can reshape acute/chronic pain development strategy.
Joe Stauffer, DO, Chief Medical Officer, PVP Labs
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase IIa Clinical Trial Evaluating the Safety, Efficacy and Pharmacokinetics of an AT2R Antagonist in Treating Post-surgical Acute pain
TRD205 is a novel, highly selective AT2R antagonist. In a completed multicenter, randomized, double-blind, placebo-controlled Phase IIa trial, TRD205 demonstrated effective analgesia with a favorable safety and tolerability profile in post-surgical patients. The primary efficacy endpoints were total postoperative morphine consumption over 0–48 hours and patient-controlled intravenous analgesia (PCIA) button presses over 0-12, 0-24, 0-36, and 0-48 hours. Safety endpoints included treatment-emergent adverse events (TEAEs).
Hao Shang, Ph.D., Senior Director, Sino Biopharmaceutical
Lunch
How Pain Is Gated in the Periphery: Emerging Concepts
Accumulating evidence suggests that peripheral somatosensory ganglia may regulate nociceptive transmission. One mechanism for such regulation is ‘gating’ or ‘filtering’ of nociceptive action potentials as these travel through the dorsal root ganglia (DRG) by the intrinsic GABAergic inhibitory system within the DRG. I will outline the key principles of DRG gating and discuss our recent findings for the role of satellite glial cells (SGCs) in the DRG gating. Specifically, I will highlight the emerging role of glial endozepines – endogenous benzodiazepine-mimicking peptides - in peripheral control of nociception. Emerging evidence for a ‘peripheral gate’ in the somatosensory system highlights potential new routes for pain relief that bypass central nervous system side effects.
Nikita Gamper, Ph.D., Professor of Neuroscience, School of Biomedical Sciences, University of Leeds
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.
Sebastian Hach, Chief Executive Officer, VERTANICAL
Panel Session: Can We Build Safer Analgesics Without Losing Efficacy?
As the need for effective pain management continues to grow, so does the demand for therapies with improved safety and tolerability profiles. This panel brings together experts across the field to explore the evolving landscape of analgesic development and the challenges of balancing efficacy with risk. Panelists will share perspectives on current approaches, key considerations in development, and where the field may be heading next.
Simon Westbrook, Ph.D., Founder & CEO, Levicept
James Hackworth, Ph.D., President, Brand Division, Tris Pharma
Hao Shang, Ph.D., Senior Director, Sino Biopharmaceutical
Lynn Kirkpatrick, Ph.D., Chief Executive Officer, Ensysce Biosciences
Joe Stauffer, DO, Chief Medical Officer, PVP Labs
