October 28-29, 2024 | Boston, MA

Identifying and Advancing Novel Pain Drugs Through Preclinical, Clinical Development and Commercialization

2024 Conference Agenda

Monday, October 28, 2024

Registration/Continental Breakfast

Chairperson's Opening Remarks

William Schmidt, Ph.D., President, Northstar Consulting

Partnering with Patients in Clinical Pain Research: What's the Benefit?

Once considered merely "subjects" in clinical research, a paradigm shift is occurring to include patients as research partners, recognizing the value that their lived experience adds to the overall conceptualization, design and execution of clinical research. While this has long been standard practice in other research fields, such as cancer and HIV, this is not the case in pain research. In addition, major research funding agencies and regulatory bodies are increasingly mandating the inclusion of patient partners in grant applications, however, most clinical scientists report feeling inadequately educated and trained to do so. To begin to change this, ACTTION, a public-private partnership with the FDA, convened an international workshop to develop and publish the first consensus recommendations to aid the clinical pain research community in the authentic inclusion of patient partners. This session will provide an overview of patient engagement and best practices, as well as present key recommendations from the ACTTION workshop and publication on how clinical researchers can include patients as authentic partners on their research teams. Dr. Holzer (a clinical researcher) and Ms. Veasley (a patient partner) will also share their personal experience working on collaborative research teams that include patient and community engagement. Ms. Veasley will also discuss the new ENGAGE Initiative at the National Institutes of Health that she co-chairs, which will develop the first agency-wide guidance for the inclusion of patient and public engagement in all NIH-funded clinical research.

Christin Veasley, Co-Founder & Director, Chronic Pain Research Alliance

Katie Holzer, Ph.D., LCSW, Assistant Professor of Anesthesiology, Washington University School of Medicine

Christin Veasley
Christin Veasley
Katie Holzer, Ph.D., LCSW
Katie Holzer, Ph.D., LCSW

Targeting the Brain Mesolimbic Pathway to Prevent Pain-induced Anhedonia and Facilitated Opioid Intake

Our previous results highlight specific pharmacological actions of kappa opioid receptor (KOR) antagonists in discrete brain areas effective in preventing the emergence of pain-induced negative affect. However, oral administration of KOR antagonists, in both rodent models and clinical settings, faces a notable challenge due to their limited biodisponibility, necessitating high doses that may result in a significant occurrence of unwanted side effects, ultimately constraining their clinical efficacy. In this talk, we will discuss our current strategies to target KOR in the brain in order to improve their efficacy and safety profile of KOR antagonists.

Jose Moron-Concepcion, Ph.D., Henry E. Mallinckrodt Professor of Anesthesiology, Chief, Division of Basic Research in Anesthesiology, Washington University Pain Center, Washington University School of Medicine

Evaluating Drug Effects on Respiratory Drive

All CNS drugs have the potential of causing respiratory depression either alone or in combination with other CNS drugs. Common clinical biomarkers for assessing respiratory depression include oximetry, respiratory rate and end-tidal CO2. Unfortunately, these measures are late indicators of respiratory depression and do not provide an adequate pharmacodynamic profile of a drug’s effect, which is important for ensuring its safe use. In this presentation, Dr. Webster will discuss the optimal methodologies for evaluating a drug’s effect on respiratory drive aiming to provide useful data for the FDA package insert and to improve safety in clinical practice.

Lynn Webster, MD, Executive VP Scientific Affairs, Dr. Vince Clinical Research

Developing Novel Analgesics in the Era of the Platform Trial

In this presentation Dr. Markman will discuss Lilly’s systematic evaluation of novel analgesic mechanisms in its Chronic Pain Master Protocol. His presentation will consider recent trials of novel targets. Specific trial design and operational features of this master protocol approach will be reviewed.

John Markman, MD, Vice President, Global Pain, Eli Lilly

Morning Coffee & Tea Break/Poster & Exhibit Viewing

DLss: A Novel Mechanistic Biomarker for Assessment of Peripheral Neuropathic Pain and Analgesics Efficacy

Diode laser fiber selective stimulation distinguishes painful and painless neuropathy, revolutionizing pain assessment via selective C or Adelta nerve fiber activation. Demonstrating reproducibility, it provides mechanistic insights beyond traditional tests, assessing CMi fibers. It is already used in RTX therapy development and integrated into Merck's preclinical platform. As a translatable marker, it bridges preclinical and clinical studies. DLss, unfamiliar in the pain community due to a lack of dedicated reviews, will be comprehensively explored. Attendees gain insights into it advantages, drawbacks, status, and potential as a neuropathic pain biomarker, preparing them for preclinical and clinical studies.

Michael Nemenov, Ph.D., President, Chief Scientist, Lasmed

Michael Nemenov, Ph.D.
Michael Nemenov, Ph.D.

Topical Nanoparticle Cream/Patch Formulations of Resiniferatoxin to Treat Painful Peripheral Neuropathies

Resiniferatoxin (RTX), an ultra-potent TRPV1 agonist, at very low doses (picomolar ranges) causes depolarization block of nerve terminals preventing action potential generation and transmission of pain. Development of polymer coated RTX nanoparticle cream formulation trade marked as ResinizinTM (Patent # (US-11707437-B2) is effective in suppressing pain associated with peripheral neuropathies. The oral agents to treat chronic pain conditions are associated with adverse effects. Addiction and over-dose have become serious problems with opioids. Topical RTX nanoparticle cream/patch will be useful to treat painful peripheral neuropathies.

Louis Premkumar, Ph.D., Professor of Pharmacology, Southern Illinois University Medicine

Louis Premkumar, Ph.D.
Louis Premkumar, Ph.D.

Development of a Topical System with Local Anesthetic: Relieving Neuropathic Pain and Beyond

Topical system containing Lidocaine was first approved by FDA in 1999 for treatment of Post-Herpetic Neuralgia. Recent advancements in technology have led to the development of a system with much improved adhesion characteristics and 3-times stronger dose delivered per area of skin, which enables drug penetration to the muscle, opening opportunities for other indications and clinical uses. Participants will explore advancements in topical delivery of lidocaine to improve adhesion, therapeutic effect, and patient compliance. And will learn about development of a higher dose strength product with deeper penetrance through the skin.

Elaine Chan, PharmD, Executive Director, Medical Affairs, Scilex Pharmaceuticals

Elaine Chan, PharmD
Elaine Chan, PharmD

Presentation to be Announced

Todd Bertoch, MD, Chief Medical Officer, Cenexel JBR

Luncheon

When All You Have is a Hammer...A New Approach to Soften the Blow

Many new analgesic entrants have promised opioid like efficacy but to date none have delivered. This has caused opioid mistrust and a reduction in access for those who actually depend on opioid pain relief for a decent quality of life. Instead of giving up on these effective analgesics, a new class of opioids is in development, that may provide a novel option for high-risk patients. Introducing TAAP and MPAR, delivering effective pain relief with advantages over currently used ADF opioid products. TAAP modified opioids are only activated to release the opioid if taken orally and exposed to trypsin in the gut, reducing multiple forms of abuse. MPAR applies another layer of protection, adding a trypsin inhibitor, resulting in oral overdose protection for each of the TAAP products. Clinical data for PF614 and PF614-MPAR will be presented demonstrating these unique qualities which don’t diminish the effective pain relief provided by each product.

D. Lynn Kirkpatrick, Ph.D., Chief Executive Officer, Ensysce Biosciences

Presentation to be Announced

Robert Dworkin, Ph.D., Professor of Anesthesiology & Perioperative Medicine, Professor of Neurology, University of Rochester School of Dentistry

Long-Acting Local Analgesics: Progress Endured, Promises Envisioned

A brief review of Long-Acting Local Analgesics, focusing on the options available in the US and ROW. Options available now and progress over the past decade will be discussed, along with how these medicines fit into a multi-modal analgesic regimen to ensure optimal pain control with minimal opioid usage.

Erol Onel, MD, Chief Medical Officer, Cali Biosciences

Discovery of a Novel Inflammatory Bio-signature Capable of Predicting Extent of Post-operative Pain

Post-operative pain is a major contributor of the opioid crisis. In a recent study funded through the NIH HEAL Initiative, we discovered a novel bio-signature composed of various serum inflammatory proteins. The bio-signature predicts acute experimental pain, underlying brain endorphin release, and subsequently, acute post-operative pain following elective abdominal surgery (e.g. herniorrhaphy, etc.) in the same individuals. Current efforts are already underway to validate these findings in a larger, more clinically heterogeneous sample. We believe this bio-signature is well poised to facilitate development of personalized, opioid sparing interventions in the peri-operative period.

Alan Prossin, MD., Associate Professor, Psychiatry & Behavioral Sciences, McGovern Medical School at UT Health

Presentation to be Announced

Gregory Scherrer, PharmD, Ph.D., Associate Professor – Department of Cell Biology and Physiology, University of North Carolina at Chapel Hill

Afternoon Coffee & Tea Break/Poster & Exhibit Viewing

Panel Session: Pain Biomarkers: Advancing Pain Therapeutics Development, Clinical Trials, and Patient Care

Chair: Ram Arudchandran, Ph.D., Program Director, NINDS, National Institutes of Health

Panelists to be Announced

Ram Arudchandran, Ph.D.
Ram Arudchandran, Ph.D.

Evening Reception

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