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Join us June 7-8 at CHI's Fourth Annual Targeting Pain with Novel Therapeutics conference. Network with a unique mix of industry and academic thought leaders working on the discovery and development of analgesics. Hear updates on pre-clinical and clinical programs, including ion channels, endocannabinoid targets, and migraine. We will also explore biologics for pain, as the field moves beyond anti-NGF antibodies. Scientific presentations will provide in-depth coverage of the challenging transition of pain therapeutics from the lab to the clinic, with sessions dedicated to animal models and biomarkers for pain.
TUESDAY, JUNE 7
7:45 am Registration and Morning Coffee
8:45 Chairperson’s Opening Remarks
Jeffrey D. Kennedy, Ph.D., Senior Research Fellow, Neuroscience Discovery Research, Eli Lilly and Company
8:55 KEYNOTE PRESENTATION
Frank Porreca, Ph.D., Professor of Pharmacology and Anesthesiology, University of Arizona
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9:25 KEYNOTE PRESENTATION:
Pharmacokinetic Pharmacodynamic Correlations in the Translation of Efficacy from Animal Pain Models
Garth Whiteside, Ph.D., Director, Discovery, Purdue Pharma
Consideration of pharmacokinetics in translating efficacy across species is essential. If the PK does not translate, then the efficacy will also not translate. While clinical compounds are frequently used to validate pre-clinical models, as positive controls and to infer translatability from pre-clinical studies to clinical studies, consideration of the translatability of the pharmacokinetic parameters is all too often lacking. In addition, highly complex datasets, both clinical and pre-clinical, are frequently reduced to a one word summary – “worked”, “didn’t work”, “failed” etc. To more fully understand pre-clinical and clinical datasets, these one word summaries cannot reveal the full picture. In order to determine translatability and certainly to conclude a lack of translatability, one needs to more closely examine the data. This presentation focuses on the pharmacokinetic and pharmacodynamic relationship between a number of compounds that are active in both clinical and pre-clinical pain states. In addition, and to exemplify how continuous discourse between clinical and pre-clinical can inform a mechanistic understanding of drug action, the relationship between efficacy of a bisphosphonate, pain and extent of joint damage in an osteoarthritis model will be presented.
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9:55 Networking Coffee Break
10:25 Animal Models of Pain: Back Translating from Veterinary and Human Clinical Pain States
Edward Bilsky, Ph.D., Professor, Pharmacology & Director, Center of Excellence in the Neurosciences, University of New England
Prominent late stage failures of drug candidates have made the industry take a critical look at all aspects of the discovery and development process, including predictability of animal models. Several new approaches will be discussed that incorporate insights gained from pain practitioners, including assessing pain, rather than “nociception” in rodents. This includes measurement of affective and pain suppressed behaviors that may capture dimensions of pain with increased relevance to the clinical pain states versus evoked reflexive responses.
10:55 ED50s, Responder Rates and Number Needed to Treat: Can Animal Studies and Clinical Trials Speak the Same Language?
Jim Pomonis, Ph.D., Director, Technical Development, Algos Preclinical Services
Recent events have elevated the level of scrutiny placed upon animal models of pain. The subjective nature of pain clearly influences the difficulty translating efficacy testing in animals to self-reporting in humans, but gaps in how these data sets are analyzed still exist. This presentation focuses on two chronic pain models, examining what different analysis parameters reveal about the similarities and differences between preclinical and clinical research.
11:25 PANEL DISCUSSION: Animal Models of Pain
Moderator: Jeffrey D. Kennedy, Ph.D., Senior Research Fellow, Neuroscience Discovery Research, Eli Lilly and Company
Panelists to include:
Edward Bilsky, Ph.D., Professor, Pharmacology & Director, Center of Excellence in the Neurosciences, University of New England
Jeffrey S. Mogil, Ph.D., E.P. Taylor Professor, Pain Studies, McGill University
Jim Pomonis, Ph.D., Director, Technical Development, Algos Preclinical Services
Garth Whiteside, Ph.D., Director, Discovery, Purdue Pharma
11:55 pm Luncheon Presentations (Sponsorship Opportunities Available) or Lunch on Your Own
1:30 Chairperson’s Remarks
Mark R. Bowlby, Ph.D., Neurophysiology & Pain Lead, Merck Research Labs
1:35 Translational Models and Biomarkers for Pain Therapeutic Development
Mark R. Bowlby, Ph.D., Neurophysiology & Pain Lead, Merck Research Labs
Driven by drug failures and escalating costs of clinical trials, biomarkers have become an important component in the translation of pre-clinical results into the clinic. Biomarkers have traditionally been applied to patients to obtain an objective determination of disease outcome, but in the pain field biomarkers and translational models of pain are used to demonstrate target engagement and pharmacodynamic activity for new therapeutic agents. The importance of this approach will be demonstrated using examples from recent drug discovery efforts.
2:05 microRNA as Biomarkers in Pain
Seena K. Ajit, Ph.D., Assistant Professor, Pharmacology and Physiology, Drexel University College of Medicine
microRNAs (miRNAs) are small noncoding RNAs that regulate gene expression either by degradation or translational repression of target mRNAs. Correlations between altered expression patterns of miRNAs and disease states are now well established. A previous study showed that 63 miRNAs were significantly altered in dorsal root ganglion tissue from a rat model of neuropathic pain. We are now investigating miRNA changes in blood from patients with Complex Regional Pain Syndrome.
2:35 Imaging Pain and Analgesics: Going the Distance to the Clinic
David Borsook, M.D., Ph.D., Director, Center for Pain and the Brain, Harvard Medical School
3:05 NP2 Therapy for Severe Pain
Darren Wolfe, Ph.D., President, Diamyd, Inc.
HSV vectors have proved effective at treating a large number of nervous system disorders in pre-clinical models. Target diseases include pain, neuropathy, cancer, and central nervous system diseases such as Parkinson's. Diamyd Inc has developed replication defective HSV vectors for clinical use and have recently completed our first clinical trial with intractable pain as an indication. Results of the study will be presented that demonstrate the safety of the platform as well as substantial and sustained pain relief in subjects with terminal cancer pain.
3:35 Grand Opening Refreshment Break in the Exhibit Hall
4:35 The Promise of Biologic Drugs for the Treatment of Pain
Iain Chessell, Ph.D., Head, Neuroscience Centre of Excellence, MedImmune
There has been a recent upsurge of investment in the discovery and development of biologic drugs for the treatment of pain, with the anti- nerve growth factor (NGF) being the archetype. Currently, investment is being made to extend target classes from soluble mediators through to ion channels. In this presentation, the current state of the anti-NGF field will be reviewed, as well as recent developments in the anti-cytokine, ion channel and cellular receptor arena.
5:05 Roles for Innate Alarmins, Cytokines and Chemokines in Neuropathic Pain
Fletcher White, Ph.D., V.K. Stoelting Professor, Anesthesia, Indiana University School of Medicine
Chemokines are central to the innate immune response following tissue damage, injury and some diseases. There is also growing evidence that disease-associated or injury-induced functional expression of chemokines/receptors in the nervous system play crucial roles in the pathophysiology of chronic pain. Upregulation of chemokine/receptor signaling may be a mechanism that directly and/or indirectly contributes to the development and maintenance of chronic pain, and these molecules may represent novel targets for therapeutic intervention in sustained pain states.
5:35 Happy Hour in the Exhibit Hall
6:30 End of Day
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