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WEDNESDAY, JUNE 16
7:30 am Continental Breakfast Break-Out Discussions
Breakout Discussion Topics:
Animal Models in Pain
Moderator: Ed Bilsky, Ph.D., Professor, Pharmacology, COM; Director, Center of Excellence in the Neurosciences, University of New England
Ion Channels as Pain Targets
Moderator: Michael F. Jarvis, Ph.D., Vowiler Research Fellow, Associate Director, Neuroscience, Global Pharmaceutical Research & Development, Abbott
Pain Clinical Trials
Moderator: Linda Jett, MSN, Clinical Director, Drug Development, DARA BioSciences
What have you found to be the biggest challenge in pain trials?
How have you dealt with site and patient recruitment challenges?
The patient diary is often an important component of data collection for pain studies
What are some methods used to assure the best quality diary data possible?
Which collection system has worked best for you, paper or electronic diaries?
How have you dealt with the placebo response rate, which can be particularly high in pain studies?
8:30 Chairperson's Remarks
Lindsay H. Burns, Director, Pre-Clinical Research, Pain Therapeutics, Inc.
8:40 Antibodies for Pain
Richard Torres, Ph.D., Senior Staff Scientist, Pain Therapeutics, Regeneron Pharmaceuticals, Inc.
Pain affects hundreds of millions of people worldwide and is a major challenge for physicians. Current medications have adverse effects on the gastrointestinal, neurological and respiratory systems. Using our Velocimmune technology, Regeneron is developing fully human blocking monoclonal antibody therapeutics for the treatment of pain. By combining superior specificity, affinity, stability, and pharmacokinetics, antibodies are uniquely suited as pain targets.
9:10 Cellular Basis of Itch Sensation
Zhou-Feng Chen, Ph.D., Associate Professor, Washington University Pain Center, Departments of Anesthesiology, Psychiatry & Developmental Biology, Washington University School of Medicine
Chronic itch or pruritus represents a major unmet health problem, because little is known about the molecular and cellular basis of itch sensation in the nervous system. I will discuss our identification of the first itch-specific receptor and neuronal pathway in the spinal cord. Therapeutic implications of our findings for treating chronic pruritus will also be discussed.
9:40 Filamin A: A Novel Target in Treating Pain
Lindsay H. Burns, Director, Pre-Clinical Research, Pain Therapeutics, Inc.
Initially associated with chronic opioid administration as well as analgesic tolerance and dependence, Gs coupling by mu opioid receptors also occurs acutely and transiently, resulting in CREB activation. High affinity binding to a pentapeptide region in the scaffolding protein filamin A prevents Gs coupling by mu opioid receptors, thereby mitigating many of the problems of current opioid therapy.
10:10 Networking Coffee Break, Poster and Exhibit Viewing
10:50 EXPERT PANEL: Novel Approaches to Drug Development and Study Design in Pain Programs
- Challenges in pain clinical development including predictive value of in vivo pre-clinical studies and failed trials
- Perspectives on conduct of smaller and more efficient proof-of-concept studies in pain
- Evaluating full potential of compounds across pain indications
Panelists:
Ramana Sonty, Ph.D., MBBS, Vice President, Prescient Life Sciences
Hong Wan, Ph.D., Director, Translational Medicine, Pfizer, Inc.
Mark R. Bowlby, Ph.D., Director, Pain & Migraine, Merck Research Laboratories
John T. Farrar, M.D., M.S.C.E., Ph.D., Assistant Professor & Senior Scholar, Biostatistics and Epidemiology, Neurology and Anesthesiology, University of Pennsylvania
11:20 Xen2174: Discovery, Binding Mode and Development of a Novel Conopeptide Norepinephrine Transporter Inhibitor for Moderate to Severe Pain
Richard Lewis, Ph.D., CSO, Research & Development, Xenome Ltd.
Xen2174 is a synthetic 13-amino acid peptide developed from the χ-conopeptide MrIA that non-competitively inhibits the norepinephrine transporter (NET) and reverses neuropathic pain behaviors in rats. SAR studies have revealed critical binding determinants for binding to NET and docking and mutational studies reveal the structural basis for non-competitive inhibition at hNET. A single bolus IT injection in a cohort of mixed oncology patients (N=37) with chronic pain demonstrated that Xen2174 was safe and tolerated and support the continued clinical investigation of the usefulness of Xen2174 in pain management.
11:50 KRN5500 Demonstrates Significant Reduction in Neuropathic Pain in Patients with Cancer
Linda Jett, MSN, Clinical Director, Drug Development, DARA BioSciences
KRN5500, a novel spicamycin-derived, analgesic agent was provided to 19 patients in a Phase 2a clinical trial for patients with end-stage cancer and neuropathic pain. In this multicenter, randomized study, the KRN5500 group demonstrated a statistically significant median decrease of 23.6 % from baseline Numeric Rating Scale scores compared to a median change of zero in the Placebo arm (p=0.03).
12:20 pm End of Conference
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