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Identifying and Advancing Novel Pain Drugs Through Clinical Development and Commercialization

2021 Conference Agenda

November 1, 2021 (all times central US time)

9:30 am Chairperson's Opening Remarks
William Schmidt, Ph.D.
, President, Northstar Consulting

9:40 am A Look Back at Clinical Study Failures of Promising Targets in Pain: We Can’t Know Where We’re Going If We Don’t Know Where We’ve Been
In this presentation, Dr. Malamut will review clinical study results for targets in neuropathic pain including sodium channels, CCR2, NMDA blockers, TrPV1 and others. He will describe the potential reasons for negative results and will propose mitigations to increase the chances of success.
Richard Malamut, MD, Chief Medical Officer, Collegium Pharmaceuticals

10:15 am Psychedelics for Pain: Origins, Opportunity and Current Developments
We are amidst a resurgence in research on the psychedelic drug class, with numerous companies in Phase 2 and 3 clinical trials. Promising initial findings from this clinical research suggest that psychedelics may have the potential to treat a wide array of CNS disorders. Despite industry’s primary focus on treatments for psychiatric disorders, evidence for the potential analgesic effect of psychedelics dates back to the 1950s and has been further supported by modern studies. Mind Medicine, a leading biotech company developing psychedelic-inspired therapies, recently announced it will pursue a development program for psychedelics in the treatment of pain conditions. This discussion will address historical evidence from the literature, the opportunity for psychedelics as analgesics and an update on current developments.
Robert Barrow, Chief Executive Officer, MindMed

10:50 am Morning Break

11:15 am Unleashing the Full Potential of Psilocybin for Chronic Pain
While many companies are evaluating the use of psilocybin and other psychedelics for depression, anxiety, PTSD, and other mental health disorders, Tryp Therapeutics is leading the next wave of psychedelic drug development with its focus on chronic pain and other indications. Tryp will present information on its psilocybin-based drug development programs for various nociplastic pain indications including fibromyalgia, phantom limb pain, and complex regional pain syndrome (CRPS) that originate in the central nervous system. The discussion will include the biological and clinical rationale for pursuing nociplastic pain indications and the opportunity to treat the diseases rather than treating their symptoms.
Greg McKee, Chairman and Chief Executive Officer, Tryp Therapeutics

11:50 am What Could the Addition of Digital Endpoints or Biomarkers Into Pain Clinical Trials Enhance for Drug Discovery
Chronic pain is and remains a serious therapeutic challenge and a public health epidemic despite advancements in pain assessment. It is critically important that we make progress in the area of scalable, objective, pain assessment which will allow large population-based studies of the effects of a variety of pain treatments and treatment combinations. The objective of this presentation is to explore the emerging field of digital biomarkers and how they provide the opportunity to complement subjective data collections for the pain condition under study. This additional information has the potential to provide new insight into the pain condition and offer enhanced understanding of the physical, sleep and cognitive responses connected to the individual’s pain condition. The use of digital biomarkers will be the next evolution in pain research for understanding the pain experience for patients.
Dean J. Mariano, DO, FASA, Head of Neuroscience & Pain - Exploratory Medicine & Pharmacology, Eli Lilly

12:25 pm Lunch Break

1:10 pm Panel Session: The Potential Role for Psychedelic Drugs in the Treatment of Chronic Pain
Psychedelic drugs are currently being evaluated for their efficacy in treating several neuropsychiatric conditions and may have a potential role as treatments for chronic pain. This panel session will explore the potential role that psychedelic drugs may play in treating chronic pain and related symptoms. A panel Q&A session with speakers will follow the presentations.
Judy Ashworth, MD, Chief Medical Officer, Pinney Associates

Panel Presentation: Historical Evidence and Rationale for Developing Psychedelic Drugs as Analgesics
Dr. Lanier will review the historical evidence supporting the use of ketamine as an analgesic and reports of classic psychedelics used successfully to treat chronic pain. A scientific rationale, including mechanisms of action, will then be proposed to support why psychedelics might be effective treatments for chronic pain conditions providing long-term improvements in mood, cognitive function, and quality of life in addition to analgesia.
Ryan Lanier, Ph.D., Director, Clinical Development & Abuse Liability, Pinney Associates

Panel Presentation: Challenges Designing and Conducting Chronic Pain Trials with Psychedelics
Dr. Dworkin will highlight some of the design and operational challenges that are unique to clinical trials with psychedelics and discuss these in the context of typical trial designs for new chronic pain medications.
Robert H. Dworkin, Ph.D., Professor of Anesthesiology & Perioperative Medicine, Neurology & Psychiatry, University of Rochester School of Medicine & Dentistry

Panel Presentation: Abuse Potential Related Science and Regulatory Perspectives for Psychedelic Drug Product Development and Post-approval Challenges
Dr. Henningfield will discuss scientific and regulatory perspectives related to the abuse potential assessment, scheduling, labeling, and post-marketing requirements for psychedelic drug products in development.
Jack Henningfield, Ph.D., VP, Research, Health Policy & Liability, Pinney Associates

2:40 pm End of Day's Sessions

November 2, 2021 (all times central US time)

9:30 am Chairperson's Opening Remarks
William Schmidt, Ph.D.
, President, Northstar Consulting

9:35 am Development of the First Long Acting Immunomodulating Pain Nanomedicine Tailored for Military Medicine
The current non-opioid and local analgesia approaches lack molecular and cellular targeting specificity to effectively engage key cellular players in the neuronal injury milieu. Targeted pain nanomedicine offers significant safety and efficacy advantages to standard non-opioid treatments by directly engaging these targets and by doing so achieving >1000 fold increase in efficacy. Presented Long Acting Non-Opioid Analgesic (LANA) nanomedicine platform is a single-dose, intravenous (IV) injectable, injury-site specific, cell targeted, biocompatible, bi-specific nanomedicine analgesic therapeutic strategy administered at point of injury for acute pain, that can also provide extended pain relief (at least 72h), beyond Role 1-2 echelon care without the adverse effects seen with current treatments.
Jelena Janjic, Ph.D., Associate Professor, School of Pharmacy, Graduate School of Pharmaceutical Sciences, Duquesne University

10:10 am Taking a Leap Forward in Mitigating the Impact of the Placebo Response: Using Machine Learning to Predict Individual Patients’ Placebo Response
The placebo response has posed a significant challenge to demonstrating efficacy of novel pain therapies for decades – despite the best efforts of the industry. This has led to high clinical trial failure rates in this area and premature abandonment of potentially efficacious treatments. Better approaches to understand, quantify, and reduce the negative impacts of the placebo response in pain drug development are sorely needed. In this talk, we explore how machine learning can be used to predict individual clinical trial patient’s placebo responsiveness and how this approach can be implemented to de-risk drug development in pain and beyond.
Dominique Demolle, Ph.D., Chief Executive Officer, Tools4Patient

10:45 am Morning Break

11:05 am Gene-targeted Approaches to Pain
This presentation will discuss gene-targeted approaches to downregulation of molecular mediators of pain; upregulation of molecular mediators of pain suppression; and pain as a symptom of rare genetic disorders.
Nina Schor, MD, Ph.D., Deputy Director, NINDS, National Institutes of Health

11:35 am Identifying Common Data Elements for the NIH’s HEAL Initiative: Selecting Pain Domains and Patient Reported Outcome (PRO)s
In this presentation, Dr. Wandner will:
♦ Discuss the need for developing a core set of Common Data Elements (CDEs) in pain research.
♦ Discuss the scientific approach to identifying pain domains and patient reported outcome measures for the HEAL Initiative CDE program.
♦ Discuss international initiative to standardize the use of core pain domains when conducting pain research in both the United States and the European Union.
Laura Wandner, Ph.D., Program Director, Office of Pain Policy, NINDS, National Institutes of Health

12:05 pm Lunch Break

12:50 pm The NIH Back Pain Consortium (BACPAC) Research Program
Back pain is one of the most common forms of chronic pain among adults worldwide and chronic low back pain is the most common, non-cancer reason for opioid prescription in the U.S. The Back Pain Consortium (BACPAC) Research Program, part of the NIH Helping to End Addiction Long-termSM Initiative or NIH HEAL InitiativeSM ,is a patient-centric translational research initiative that is taking a biopsychosocial approach to address the need for more effective and personalized therapies for chronic low back pain (cLBP). This talk will describe the BACPAC Research Program, including the identification of cLBP sub-phenotypes, the design and implementation of a multisite precision medicine clinical trial, and the development of cutting-edge technologies.
Leslie Derr, Ph.D., Program Coordinator, Back Pain Consortium Research Program, NIAMS, National Institutes of Health

1:20 pm The NIH HEAL Initiative’s EPPIC-Net Program – An Overview and Update

This presentation will focus on NIH’s Early Phase Pain Investigation Clinical Network (EPPIC-Net) which is a part of the HEAL Initiative. This presentation will serve as an introduction to those unfamiliar with the program and provide important updates to those who are already aware. EPPIC-NET is a sophisticated clinical trial network created to design and execute innovative early phase trials of promising non-addictive pain therapies in well-characterized patient cohorts with pain conditions of high unmet need. EPPIC-Net funded and initiated its first clinical trial in 2021, and continues to seek out new assets via a recently revised preliminary application packet.
Rebecca Hommer, MD, Medical Officer, NINDS, National Institutes of Health

1:50 pm Enhancing Therapy Development Within the HEAL Initiative
Smriti Iyengar, Ph.D., Program Director, Division of Translational Research, NINDS, National Institutes of Health

2:20 pm PANEL SESSION: How is the NIH Advancing Pain Research and Drug Development: A Discussion with Leaders from NINDS/NIH
Smriti Iyengar, Ph.D., Program Director, Division of Translational Research, NINDS, National Institutes of Health
Rebecca Hommer, MD, Medical Officer, NINDS, National Institutes of Health
Leslie Derr, Ph.D., Program Coordinator, Back Pain Consortium Research Program, NIAMS, National Institutes of Health
Laura Wandner, Ph.D., Program Director, Office of Pain Policy, NINDS, National Institutes of Health
Nina Schor, MD, Ph.D., Deputy Director, NINDS, National Institutes of Health

2:50 pm End of Day's Sessions

November 3, 2021
(all times central US time)

9:30 am Chairperson's Opening Remarks
William Schmidt, Ph.D.
, President, Northstar Consulting

9:35 am Opening Pandora’s Box: Central Statistical Surveillance, Scary Observations, and Attempted Remediation
Arturo Morales, Ph.D., Vice President, Data & Technology Solutions, Analgesic Solutions (WCG)

10:10 am Non-paralyzing Botulinum Neurotoxin for the Management of Neuropathic Pain.
Botulinum neurotoxins (BoNTs) are widely used for local treatments of muscular and some secretory conditions due to their ability to potently block neuronal secretion at very low doses. While peripheral injection of BoNT type A has also been shown as a promising approach to alleviate chronic pain, the paralytic activity of the toxin remains a major obstacle. Here, we describe a novel engineered BoNT with markedly reduced paralytic properties which exerts long-lasting analgesia with minimal adverse effects on the muscle function. This modified BoNT can efficiently target sensory neurons, making it an attractive biopharmaceutical for treatment of neuropathic pain.
Bazbek Davletov, Ph.D., Chair in Biomedical Science, Department of Biomedical Science, University of Sheffield

10:45 am Refreshment Break

11:00 am Long-lasting Analgesia Via Epigenetic Repression of NAV 1.7 Using CRISPR-DCAS9 and Zinc-Finger Proteins

In this presentation Dr. Moreno will discuss the following:
• DNA-level repression of key genes responsible for pain transmission holds great therapeutic potential
• Discussing future applications of epigenome regulation to treat pain using CRISPR-dCas9 and Zinc-Finger proteins.
• Demonstrate the efficacy of this approach to prevent and treat neuropathic preclinical pain models
• Demonstrate preliminary safety results of this approach.
Ana Moreno, Ph.D., CEO, Navega Tx

11:35 am Subcutaneous Delivery of Low-Dose Ketamine by a Wearable Patch Pump: A New Approach for Non-Opioid Pain Management

Clinicians need more options for non-opioid pain management that patients can use in-clinic or at home. BB106 is a low dose ketamine therapy designed for subcutaneous delivery via a self-contained, wearable patch pump. This presentation will review the key innovations, clinical use case, and regulatory approach for this therapy.
Gregg Peterson, Chief Executive Officer, Bexson Biomedical

12:10 pm Discovering Non-opioid-based Pain Therapies Using All-optical Electrophysiology
Voltage-gated sodium channels are promising drug targets for chronic pain treatment. Q-State has developed an integrated platform combining engineered optogenetic cell lines (spiking HEK cells) and dorsal root ganglion (DRG) neuronal models with high throughput all-optical electrophysiology (Optopatch) characterization and machine learning-based analytics. Q-State Biosciences has demonstrated Optopatch measurements in Nav1.7 spiking HEK cells with a throughput of 10,000 wells/day using our proprietary next generation optogenetic kinetic plate reader (SWARM). They have executed a 200,000-compound small molecule screen using the SWARM instrument and identified novel Nav1.7 inhibitors with sub-micromolar potency and more than 100-fold selectivity against Nav1.5. The Optopatch DRG excitability assay can achieve single cell and single action potential resolution in a high throughput manner. Q-State has also leveraged these optogenetic tools to develop Nav1.7 and Nav1.8 targeting ASO therapeutics for chronic pain.
Hongkang Zhang, Ph.D., Director, Pain Therapeutic Lead, Q-State Biosciences

12:40 pm End of Conference

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