Explore the Agenda
7:30 am Check In, Coffee & Light Breakfast
8:55 am Chair’s Opening Remarks
Accelerating Pain Breakthroughs: Translational Models & Placebo Insights for Clinical & Regulatory Success
9:00 am Translational Models Driving Clinical Development of Novel Analgesics
Session details to be announced
9:30 am Discovering the Power of Dual NMR Receptor Agonist: Unique Biology, Proven Safety & Clinical Breakthroughs
- Overview of biology of the dual NMR agonist mechanism and how the interaction between these receptors creates a unique therapeutic profile
- Evaluate the strategies behind demonstrating that this complex mechanism delivers potent pain relief while showing evidence of minimal addiction risk or abuse potential
- Examine findings from phase III acute pain trials and the learnings that guide the translation of design elements into future chronic pain studies
10:00 am Morning Break & Refreshments
Redefining Gold Standards: Human-Centric Models & Smarter Trial Design in Pain Research
11:00 am Fireside Chat: Setting The New Gold Standard: Human-Centric Pain Models Using DRG Neurons, Tissue Models & IPSCs
- Discuss the technological, regulatory, and organizational shifts required to embed human-centric pain models as the new industry standard
- What are the current barriers to adoption? How can biopharma, CROs, and regulators collaborate to accelerate validation and scale-up of these models across the pipeline
11:30 am Pilavapadin: A Novel Non-Opioid Mechanism of Action for Neuropathic Pain – Translational Insights from Preclinical to Clinical Studies
- Pilavapadin, a first-in-class AAK1 inhibitor, offers a differentiated non-opioid mechanism for treating neuropathic pain, addressing limitations of current therapies
- Robust efficacy in multiple preclinical pain models supported advancement into clinical studies, which demonstrated target engagement, favourable PK, and a tolerable safety profile
- Clinical trials in neuropathic pain revealed analgesic activity and provided critical insights on dose optimization, patient variability, and trial design challenges in neuropathic pain
12:00 pm Networking Lunch
Aligning Pharma Priorities & Trial Design: Ensuring Translational Impact in Pain Therapies
1:00 pm Panel Discussion: Pharma’s Perspective on Search & Discovery in Pain Therapeutics
- What is the industry looking for in terms of novel pain therapies?
- Target prioritization for pharma between NaV channels and emerging novel targets
- The importance of having pre-clinical data beyond animal studies to validate novel pain targets
- Utilizing human biology data sets to help determine the translational potential
Optimizing Safety Frameworks, Innovative Trial Designs & Precision Pain Therapeutics for Accurate Data & Streamlined Regulatory Success
2:00 pm Discussing the Recently Approved Tonmya, a Centrally Acting Non- Opioid Analgesic for the Treatment of Fibromyalgia
- Key learnings from Phase III trials include study design, patient selection, endpoint development, and regulatory engagement to streamline approval
- Pharmacologically targeting non-refreshing sleep can improve pain and address other core symptoms of fibromyalgia
- Evaluating selectivity in pain drug development requires balancing toxicology risk with efficacy to maximize therapeutic potential
2:30 pm Translational Science in Pain Research: Linking Patient Phenotypes to Molecular Mechanisms
- Evaluating patients comprehensively using multiple measures, including pain assessments and somatosensory testing, to capture responses to diverse stimuli
- Discovering associations between clinical characteristics and molecular findings from patient tissue to identify potential therapeutic targets
- Investigating how specific pain phenotypes relate to underlying pain mechanisms, advancing understanding for more precise interventions