Monday, October 4th, 2010

12:00 - 12:45 Registration

12:45 Chair's Opening Remarks

Daniel Carr, MD, Consultant, Hospira, Inc.; Saltonstall Professor of Pain Research, Departments of Anesthesia and Medicine, Tufts Medical Center

12:55 A Whole Genome Approach in Research for Pain and Analgesia

Current status and future directions of whole genome approaches in genetics of pain will be discussed along with the introduction of recently developed and applied technologies. The ultimate goal of this line of research is to realize individualized pain medicine based on genomic information and its derivatives such as RNA, protein and its metabolites.

Hyungsuk Kim, DDS, Ph.D, Staff Scientist, NINR, National Institutes of Health

1:30 The Drug Development Landscape for Opioid-Induced Constipation

Lynn R. Webster, MD, FACPM, FASAM, Medical Director and Co-Founder, Lifetree Clinical Research & Pain Clinic, Director-At-Large, American Academy of Pain Medicine

2:05 Abuse and Diversion of Controlled Substances: Are FDA Mandated REMS the Remedy?

Theodore Cicero, Ph.D., Professor of Psychiatry, Anatomy & Neurobiology, Washington University in St. Louis

2:40 Refreshment Break

3:05 Na+ Channels in Primary Afferent Neurons from Physiology to Pathophysiology

This presentation will cover the following:

• A general overview of the diverse properties of Na+ channels in primary afferent neurons and how the distribution and biophysical properties influence afferent function
• The role of Na+ channels in inflammatory pain states
• The role of Na+ channels in neuropathic pain states

Michael Gold, Ph.D., Associate Professor, Anesthesiology, University of Pittsburgh

3:40 Critical Compliance and Risk Management Issues for Pain Practitioners: Stepping Stones to Success

Discussion points:

• Legal/Regulatory update – key case opinions and administrative/licensing board changes impacting compliance and risk management boundaries for pain practitioners
• Integrating clinical guidelines with regulatory boundaries to establish a solid working outline for compliance and risk management
• Documentation tips and how to avoid common errors in demonstrating medical necessity for decisions relating to prescribing of controlled medications and use of common risk management tools, such as drug testing

Jennifer Bolen, JD, Founder, The Legal Side of Pain (A division of the J. Bolen Group, LLC)

4:15 Challenges to Analgesic Drug Development and the Role of Efficient Proof of Concept Studies

David Hewitt, MD, Senior Director, Clinical Neuroscience, Merck & Co.

4:50 Phase III Clinical Success for a Dual Opioid: the Story of MoxDuo, a Morphine/Oxycodone Combination Product

QRx's recently completed phase 3 studies will be discussed along with new data on the therapeutic differences between this combination product and single entity opioids.

Patricia Richards, MD, Ph.D., Chief Medical Officer, QRx Pharma

5:25 Cocktail/Wine & Cheese Reception

Brought to you by: Lifetree Clinical Research

6:30 Dinner & Panel Session

Meeting the Challenges Facing Developers of Pain Therapeutics: Safety, REMS and Abuse Liability

Jennifer Bolen, JD, Founder, The Legal Side of Pain (A division of the J. Bolen Group, LLC)
Lynn R. Webster, MD, FACPM, FASAM, Medical Director and Co-Founder, Lifetree Clinical Research & Pain Clinic, Director-At-Large, American Academy of Pain Medicine
Theodore Cicero, Ph.D., Professor of Psychiatry, Anatomy & Neurobiology, Washington University in St. Louis
Chair: Daniel Carr, MD, Chief Medical Officer and President, Hospira, Inc.; Saltonstall Professor of Pain Research, Departments of Anesthesia and Medicine, Tufts Medical Center

Tuesday, October 5th, 2010

7:45 - 8:15 Registration / Breakfast

8:15 Chair's Opening Remarks

William K. Schmidt, Ph.D., Vice President, CG Pharmaceuticals

8:25 TrpV1 Antagonists for Pain: “Hot” Target or Not?

Results with TrpV1 antagonists in the clinic to date have been mixed, with reports of efficacy in experimental human pain models but also effects on body temperature and on normal heat pain sensation. So is there a viable way forward for TrpV1 antagonists as analgesics? This presentation will address this question by reviewing the current state of the field, including AstraZeneca’s preclinical and clinical results with TrpV1 antagonists for pain.

Jennifer Laird, Ph.D., Senior Principal Scientist, AstraZeneca R&D

9:00 Development of CG100649, a Tissue-specific Dual Inhibitor of COX-2 and Carbonic Anhydrase, for Treatment of Hip and Knee Osteoarthritis

Discussion points:

• Progress in mitigating cardiovascular and GI risk with COX-1 and COX-2 inhibitor drugs
• Effect of carbonic anhydrase binding on the biodistribution and safety profile of CG100649
• Evaluation of other compounds, including naproxcinod and Vimovo (naproxen + esomeprazole)
• Regulatory hurdles in the US and Europe

William K. Schmidt, Ph.D., Vice President, CG Pharmaceuticals

9:35 Discovery and Characterization of a Novel P2X7 Antagonist

Charles G. Garlisi, Ph.D., Fellow, Biological Research – Respiratory and Immunology, Merck Research Laboratories

10:10 Refreshment Break

10:35 Clinical Status of Kappa Agonists for Post-Operative Pain

Frédérique Menzaghi, Ph.D., Vice President Research & Development, Cara Therapeutics

11:10 Nose to Brain Drug Transmission: Is it Real?

Gary W. Jay, MD, DAAPM, FAAPM, Chief Medical Officer, Archimedes Pharma

11:45 Lunch / Networking

1:15 What’s Wrong with Animal Models of Pain?

Recent decades have seen an explosion in our understanding of the molecular and cellular underpinnings of pain, but virtually none of this knowledge has resulted in new clinical therapies. The problem may lie in the existing animal models of pain, which are reliable but much more complex and subtle than is commonly realized, and of questionable clinical relevance. Most basic science studies of pain continue to rely on the measurement of reflexive, evoked hypersensitivity responses after artificial neuropathic or inflammatory injuries, whereas clinical pain in humans features much spontaneous pain and an important cognitive and emotional overlay.

In addition to the disconnect between clinical symptoms and animal measures, there is a disconnect between the clinical epidemiology of pain and the types of pain being modeled in animals. Dr. Mogil's lab has recently attempted to develop an “ethological” approach to animal models of pain, involving systematic and rigorous analysis of videotaped spontaneous mouse behaviors. His talk will cover recent successes in their laboratory, involving migraine, vestibulodynia, and the development of a facial expression-based pain scale for the mouse (recently published in Nature Methods).

Jeffrey S. Mogil, Ph.D., E.P. Taylor Chair in Pain Studies, Canada Research Chair in Genetics of Pain, McGill University

1:50 Novel Indications for TNF Inhibitors in Pain Management

James R. Gorman, MD, Ph.D., CEO and Chief Medical Officer, BioAssets Development Corporation

2:25 End of Conference