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This meeting took place in 2006
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Pain Mechanisms and the Development of Analgesics (E5)
Organizer(s) Tony L. Yaksh, Mitchell B. Max, James C. Eisenach, Patrick W. Mantyh and Frank Porreca
June 11—16, 2006
Keystone Resort • Keystone, CO USA
Abstract Deadline: Feb 9, 2006
Late Abstract Deadline: Apr 11, 2006
Scholarship Deadline: Feb 9, 2006
Early Registration Deadline: Apr 11, 2006
Supported by The Director's Fund
Summary of Meeting:
Pain and its control are appreciated to be a major medical problem. Over the past 20 years there have been major advances in our understanding of the mechanisms by which information leading to a pain state is processed. In spite of these substantial insights into the complex pharmacology, the translation of mechanistic data into clinically relevant drugs has been tedious. Several problems are recognized. First, an important problem relates to the interpretation of the preclinical behavioral models with respect to predicting human efficacy and whether specific models adequately predict outcomes in different pain states. Second, it is believed that the human experimental model would provide important insights into efficacy early in the drug development process, but validation of this model has been difficult. The meeting will first review the current thinking regarding the mechanisms whereby information generated by acute stimulation, tissue injury and nerve injury are encoded in a manner so as to present a pain state. Secondly, the preclinical surrogate models which present the behavioral expression of the noxious event will be reviewed and cross model consistency and reliability will be reviewed. Thirdly, we will review the experimental human models that provide a correlate in human volunteers of the preclinically defined pain mechanisms and consider their ability to predict drug activity in pathological states. Finally, presenters will review the implementation of human trials which define the analgesic efficacy of drug therapies. An important aspect of these 4 components is the frequent implementation of case-based parallels that reflect successes in prediction (e.g. COX2 inhibitors, GABApentin, ziconotide) and failures (NK1 antagonist).
View Scholarships/Awards
Pain and its control are appreciated to be a major medical problem. Over the past 20 years there have been major advances in our understanding of the mechanisms by which information leading to a pain state is processed. In spite of these substantial insights into the complex pharmacology, the translation of mechanistic data into clinically relevant drugs has been tedious. Several problems are recognized. First, an important problem relates to the interpretation of the preclinical behavioral models with respect to predicting human efficacy and whether specific models adequately predict outcomes in different pain states. Second, it is believed that the human experimental model would provide important insights into efficacy early in the drug development process, but validation of this model has been difficult. The meeting will first review the current thinking regarding the mechanisms whereby information generated by acute stimulation, tissue injury and nerve injury are encoded in a manner so as to present a pain state. Secondly, the preclinical surrogate models which present the behavioral expression of the noxious event will be reviewed and cross model consistency and reliability will be reviewed. Thirdly, we will review the experimental human models that provide a correlate in human volunteers of the preclinically defined pain mechanisms and consider their ability to predict drug activity in pathological states. Finally, presenters will review the implementation of human trials which define the analgesic efficacy of drug therapies. An important aspect of these 4 components is the frequent implementation of case-based parallels that reflect successes in prediction (e.g. COX2 inhibitors, GABApentin, ziconotide) and failures (NK1 antagonist).
View Scholarships/Awards
No registration fees are used to fund entertainment or alcohol at this conference
SUNDAY, JUNE 11
MONDAY, JUNE 12
TUESDAY, JUNE 13
WEDNESDAY, JUNE 14
THURSDAY, JUNE 15
FRIDAY, JUNE 16
Conference Program Print | View meeting in 12 hr (am/pm) time
SUNDAY, JUNE 11
19:30—20:30
Keynote Address
Mitchell B. Max,
University of Pittsburgh, Center for Pain Research, USA
Dissecting Chronic Pain Syndromes as Complex Genetic Disorders
Dissecting Chronic Pain Syndromes as Complex Genetic Disorders
08:00—11:00
Pharmacology of Pain Encoding I... Rational Targets of Analgesic Development
*
James C. Eisenach,
Wake Forest University School of Medicine, USA
Jon Levine,
University of California, San Francisco, USA
Pain Mechanisms and the Development of Analgesics: Target Practice
Pain Mechanisms and the Development of Analgesics: Target Practice
Clifford J. Woolf,
Children's Hospital, USA
Facilitatory Cascades in Post Injury States
Facilitatory Cascades in Post Injury States
Stephen B. McMahon,
King's College London, UK
CCL2 as a Mediator of Neuropathic Pain
CCL2 as a Mediator of Neuropathic Pain
14:30—16:30
Workshop 1
1) Cascades upon cascades.. does any one of them really matter? 2) Is neuropathic pain after peripheral nerve injury a question of persistent afferent traffic? 3) The sprouting axon, afferents to sympathetics in nerve injury induced pain states. 4) What makes a terminal discharge after local tissue inflammation? 5) Where is the convergence between tissue and nerve injury pain mechanisms? 6) The hottest target: left vs right brain choices?
*
James C. Eisenach,
Wake Forest University School of Medicine, USA
Short Talk(s) Chosen from Abstracts
17:00—19:00
Preclinical Behavioral Models: Models of Mechanisms and Predictive Surrogates for the Human Experience? I
*
James C. Eisenach,
Wake Forest University School of Medicine, USA
Timothy Brennan,
University of Iowa, USA
Acute-Postoperative Pain
Acute-Postoperative Pain
Frank Porreca,
University of Arizona, USA
Peripheral and Central Sensitization in Chronic Pain of Osteoarthritis and Rheumatoid Arthritis
Peripheral and Central Sensitization in Chronic Pain of Osteoarthritis and Rheumatoid Arthritis
Theo F. Meert,
Johnson & Johnson Pharmaceutical Research & Development, LLC, Belgium
Nerve Injury Models
Nerve Injury Models
08:00—11:00
Preclinical Behavioral Models: Models of Mechanisms and Predictive Surrogates for the Human Experience? II
*
Tony L. Yaksh,
University of California, San Diego, USA
Patrick W. Mantyh,
University of Arizona, USA
Mechanisms that Drive Cancer Pain
Mechanisms that Drive Cancer Pain
Jerry F. Gebhart,
University of Pittsburgh, USA
Preclinical Models: Visceral Pain States
Preclinical Models: Visceral Pain States
Nigel A. Calcutt,
University of California, San Diego, USA
Painful Diabetic Neuropathy: Peripheral vs Central Mechanisms and Therapies
Painful Diabetic Neuropathy: Peripheral vs Central Mechanisms and Therapies
Robert P. Yezierski,
University of Florida, USA
The Injured Spinal Cord: At-Level Versus Below-Level Pain
The Injured Spinal Cord: At-Level Versus Below-Level Pain
14:30—16:30
Workshop 2
1) Pharmacological Convergence between animal models…whither internal consistency. or are differences meaningful? 2) Model Potency; how good does the response have to be to be meaningful in humans, or does the preclinical profile mean anything in predicting human target? 3) When does the pain surrogate fail in predicting human analgesic efficacy? 4) Do side effects count in predicting efficacy?
*
Tony L. Yaksh,
University of California, San Diego, USA
Victor J. Hruby,
University of Arizona, USA
Addressing the Mechanism of Prolonged and Neuropathic Pain with Novel Ligands that are Agonists at Opioid Receptors and Antagonists at NK-1 or CCK Receoptors
Addressing the Mechanism of Prolonged and Neuropathic Pain with Novel Ligands that are Agonists at Opioid Receptors and Antagonists at NK-1 or CCK Receoptors
Short Talk(s) Chosen from Abstracts
17:00—19:00
Human Experimental Pain Model
*
Tony L. Yaksh,
University of California, San Diego, USA
Lars Arendt-Nielsen,
Aalborg University, Denmark
Experimental Models of Pain in Human
Experimental Models of Pain in Human
Irene Tracey,
University of Oxford, UK
Developing Human FMRI and EEG as Surrogate Markers of Pain Processing and Pharmacological Analgesia
Developing Human FMRI and EEG as Surrogate Markers of Pain Processing and Pharmacological Analgesia
08:00—11:00
Organization of Clinical Analgesic Studies
*
Mitchell B. Max,
University of Pittsburgh, Center for Pain Research, USA
Paul J. Desjardins,
Pfizer Consumer Healthcare, USA
Acute Postoperative Pain Models and Their Predictive Validity
Acute Postoperative Pain Models and Their Predictive Validity
Jennifer A. Haythornthwaite,
Johns Hopkins University, USA
Psychological Variables in Trial Design and Efficacy Assessment
Psychological Variables in Trial Design and Efficacy Assessment
Dan Clauw,
University of Michigan Medical School, USA
Studies of Complex Pain Syndromes: Fibromyalgia and Related Regional Pain Syndromes
Studies of Complex Pain Syndromes: Fibromyalgia and Related Regional Pain Syndromes
John T. Farrar,
University of Pennsylvania School of Medicine, USA
The Design of Clinical Trials and Analgesic Drug Research
The Design of Clinical Trials and Analgesic Drug Research
14:30—16:30
Workshop 3
1) Is there a value of experimental pain drug assessment in drug development, in achieving drug approval? 2) What end points matter?
*
Mitchell B. Max,
University of Pittsburgh, Center for Pain Research, USA
*
Lars Arendt-Nielsen,
Aalborg University, Denmark
17:00—19:00
Panel Discussion: Approval of Analgesic Drugs
Bob A. Rappaport,
U.S. Food and Drug Administration, USA
A Common Sense Approach to Analgesic Drug Development and Approval
A Common Sense Approach to Analgesic Drug Development and Approval
Mitchell B. Max,
University of Pittsburgh, Center for Pain Research, USA
Dan Clauw,
University of Michigan Medical School, USA
John T. Farrar,
University of Pennsylvania School of Medicine, USA
Paul J. Desjardins,
Pfizer Consumer Healthcare, USA
Lars Arendt-Nielsen,
Aalborg University, Denmark
08:00—11:00
Case Studies in Analgesic Development I
Charles P. Taylor,
Pfizer Global Research & Development, USA
Case Review of Gabapentin and Pregabalin
Case Review of Gabapentin and Pregabalin
Ray G. Hill,
Merck & Co., Inc., UK
The Development of Substance P (NK1 Receptor) Antagonists as Putative Analgesics
The Development of Substance P (NK1 Receptor) Antagonists as Putative Analgesics
Stuart Apfel,
Dov Pharmaceutical Inc., USA
Bicifadine, A Novel Reuptake Inhibitor, In the Treatment of Chronic and Acute Pain
Bicifadine, A Novel Reuptake Inhibitor, In the Treatment of Chronic and Acute Pain
02:30—04:30
Workshop 4
1) What constitutes preclinical evidence for efficacy
2) Go/ No-go decision points
17:00—19:00
Case Studies in Analgesic Drug development II
Jonathan Moss,
University Of Chicago, USA
Development of Methylnaltrexone: Pain Relief Without Side Effects
Development of Methylnaltrexone: Pain Relief Without Side Effects
Smriti Iyengar,
Eli Lilly and Company, USA
Case Review of Duloxetine
Case Review of Duloxetine
*Session Chair †Invited, not yet responded.
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