Agenda
Day One - September 20, 2011
8:00 - 8:45 Registration/Continental Breakfast
Sponsored by 
8:45 Chair's Opening Remarks
William K. Schmidt, Ph.D.
Vice President
CrystalGenomics
8:50 New Approaches for Preclinical Assessment of Spontaneous (non-evoked) Pain
The disconnect between assessment of “pain” from evoked measures studied preclinically and the experience of pain in humans has impeded the development of new therapies. Understanding circuits that promote the aversive state that is associated with injury may offer an approach to increase translational relevance of preclinical studies. Dr. Porreca will present data on the mechanisms of spontaneous pain and “allodynia” in preclinical pain models and exploration of the circuits meeting these components of pain. The question of whether evoked hypersensitivity necessarily reflects the presence of an aversive state associated with “pain” and how these issues may impact drug discovery for pain medications will be addressed.
Frank Porreca, Ph.D.
Professor of Pharmacology and Anesthesiology
University of Arizona
9:25 Abuse-resistant Pro Drug Technologies in Pain Drug Development
Dr. Joseph Stauffer
Chief Medical Officer & VP, Corporate Strategy
PharmacoFore, Inc.
10:00 Morning Refreshment Break
10:20 Investing in Analgesics - Pain or Gain?
Mike Grey will provide an overview of investing in biotech companies developing pain therapeutics. He will address what VCs look for in pain therapeutic companies and the opportunities and challenges they face.
Venture Partner
Pappas Ventures
10:55 Synthesis and Pharmacological Evaluation of Conolidine, a Potent Antinociceptive Natural Product from the Crepe Jasmine
This presentation will provide an overall evaluation of the process of drug discovery starting with complete drug synthesis and combining both pharmacological and behavioral assessments to realize potential for clinical utility. The following will be covered:
- Introduction to the compound class- from the plant, Tabernaemontana divericata (crepe jasmine)
- Survey of the elegant 9-step enantioselective total synthesis route to generate conolidine
- Antinociceptive assays in mice: Each enantiomer and the racemate
- Evaluation of potential side effects in mice
- Search for the target of action: Results for the Psychoactive Drug Screening Program
Laura Bohn, Ph.D.
Associate Professor
Scripps Research Institute
11:30 Is This the New World? A Concept to Develop Analgesics Via External Discovery and Broad Collaborations Including Private-public Partnerships – Are There Limits?
Christine Rauschkolb, MD, Ph.D.
VP Pain Development
Johnson & Johnson
12:05 Luncheon
Sponsored by 
1:05 Panel Session: Moving Beyond Pain Intensity as the Unidimensional Endpoint for Assessing a Therapeutic
Sponsored by 
Panelists:
Bradley Galer, MD
President, Pain Group
Nuvo Research Inc.
Arnold Gammaitoni, Pharm.D.
Nuvo Research, Inc.
2:05 P2X3 Receptor Antagonists for the Treatment of Pain and Related Conditions: Rationale, Pharmacology and Clinical Progress
This presentation will include a background rationale of the role ATP plays in pain and sensitization, description of progress in understanding the relevance of P2X3 containing ion channels in mediating effects of ATP (based largely on gene-deletion and pharmacological studies performed at Roche and other companies), followed by progress in chemical targeting these receptors to advancement of medicinal candidates. The presenter will also provide an update on clinical progress to date with AF-219, which is the first such compound to enter human studies (in 2007, and only such compound). AF-219 is currently progressing into Phase 2 (patient) studies, and represents an exciting opportunity for a truly different class pain therapeutic.
Anthony P. Ford, Ph.D.
Chief Scientific Officer
Afferent Pharmaceuticals
2:40 Scoring a Therapeutic Bull's Eye with Targeted Drug Delivery to the Central Nervous System
Dr. Stewart will cover the following in his presentation:
- Advantages of targeted and/or controlled drug delivery
- Overview of drug pumps and infusion systems
- Treatment of chronic pain with intrathecal delivery
- Developmental and regulatory requirements for drug:device combination products
- Future treatment opportunities with targeted drug delivery to the brain
Greg Stewart, Ph.D.
Director, CNS Drug Therapy R&D
Medtronic
3:15 Afternoon Refreshment Break
3:45 An Examination of New and Upcoming Postsurgical Pain Therapies in Development
Dr. Patou will cover the following in this presentation:
- What causes postsurgical pain?
- A review of multimodal treatment of postsurgical pain
- A review and assessment of new and upcoming avenues to treat postsurgical pain
Gary Patou, MD
Interim Chief Medical Officer
Pacira Pharmaceuticals
4:20 Measurement and Control of Patterned Brain Activation Using Real Time Neuroimaging for Pain Diagnosis and Treatment
Christopher deCharms, Ph.D.
Chief Executive Officer
Omneuron, Inc.
4:55 CRMP2: A Novel Biological Target in Pain Research
It is becoming increasingly clear that pain is sensed, in part, by proteins such as the voltage-gated calcium channels. Therapeutic strategies designed to block the function of these proteins have been developed for analgesic therapy. However, these inhibitors have broad and systemic effects, such as blood pressure changes and memory loss. Additionally, targeting calcium which is a ubiquitous cellular signaling molecule, involved in many cellular processes, may be detrimental. Therefore, alternative strategies that target proteins that assist with the signaling function of the channels may be a safer and more selective approach.
Dr. Khanna will present on the discovery of a novel synthetic peptide derived from a protein that alters the function of these channels. He will present data demonstrating that the signaling process for pain can be blocked by this novel therapeutic. Since this approach does not directly inhibit calcium entry through voltage-gated channels, it is expected that this molecule will be more specific and have fewer side effects. The question of whether this novel biological entity will serve as a new pharmacological therapeutic for the relief of chronic pain will be discussed.
Rajesh Khanna, Ph.D.
Assistant Professor
Department of Pharmacology and Toxicology
Stark Neurosciences Research Institute
Indiana University School of Medicine
5:30 Cocktail Reception
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Day Two - September 21, 2011
8:00 - 8:45 Continental Breakfast
8:45 Chair's Opening Remarks
Bradley Galer, MD
President, Pain Group
Nuvo Research Inc.
8:50 An Update on the Clinical Development of Cox-2 Inhibitors in the Post-Vioxx Era
The presenter will cover the following in this presentation:
- Use of “stealth” biodistribution technology to target drug action to inflamed joints and reduce effects on cardio-renal systems (advances in the development of CG100649 for treating osteoarthritis)
- Use of prostacyclin & thromboxane biomarkers to predict efficacy and safety of COX-2 inhibitors
- Potential uses of COX-2 inhibitors for preventing cancers or as an adjunct for treating solid tumors
- Potential uses of COX-2 inhibitors for treating psychiatric diseases
William K. Schmidt, Ph.D.
Vice President
CrystalGenomics
9:25 Panel Session: A Critical Review and Update on FDA's REMS (Risk Evaluation & Mitigation Strategies) Program
Panelists:
Deborah Leiderman, MD
Principal
CNS Drug Consulting LLC
(Former: Director, Controlled Substances, FDA Center for Drug Evaluation & Research)
John J. Coleman, Ph.D.
President
Prescription Drug Research Center
10:25 Morning Refreshment Break / Extended Poster Session Viewing
11:05 Clinical Update on NGF Inhibition for the Treatment of Knee OA and Other Musculoskeletal Conditions
Nancy Lane, MD
Endowed Professor of Medicine
University of California, Davis
11:40 Discovery of Differentiated TRPV1 Antagonists that Separate Efficacy from Hyperthermic Effects
One relatively new molecular target that has attracted significant attention in regards to the treatment of pain in the past decade is TRPV1 (transient receptor potential vanilloid type 1). The hypothesis that the TRPV1 receptor is a nexus in pain transmission, and that TRPV1 antagonists may deliver broad spectrum efficacy in nociceptive pain by silencing pain signaling pathways has made TRPV1 a seductive target for the pharmaceutical industry. Unfortunately, achieving clinical proof of concept for TRPV1 antagonists has remained elusive, in part due to the finding that first generation TRPV1 antagonists cause a mechanism-based increase in core body temperature in both preclinical species and in humans.
Recently, the discovery of stimulus-specific TRPV1 antagonists suggests the possibility of identifying a new generation of modality-specific TRPV1 antagonists that do not affect core body temperature. While the prospect of temperature neutral TRPV1 antagonists is enticing, there are still significant unanswered questions. This presentation will address the prospects for TRPV1 antagonists for pain.
Philip R. Kym, Ph.D.
Associate Director II
Pain Discovery Research
Abbott Laboratories
12:15 Luncheon
1:15 Efficient Proof of Concept Studies in Analgesic Drug Development: Utility of the Enriched Enrollment Randomized Withdrawal Design
Arnold Gammaitoni, Pharm.D.
Nuvo Research, Inc.
1:50 Advances in Post-Operative Patient-Controlled Analgesia
Current problems surrounding the use of the standard intravenous patient-controlled analgesia (IV PCA) method of post-operative pain control will be discussed. A novel sublingual PCA product candidate will be introduced, the Sufentanil NanoTab PCA System, and Phase 1 and Phase 2 data will be presented as well.
Pamela Palmer, MD
Chief Medical Officer
AcelRx Pharmaceuticals
2:25 Pain Therapeutics Development in the Age of Translational Medicine
Dr. Vornov's presentation will answer the following questions:
- What kind of efficacy signals should we look for on the path from animal studies to registration?
- What’s the best way to transition from animal studies to man?
- What is the role of adaptive trial design? Is it possible to establish dose prior to definitive clinical studies?
- Is there still a role for placebo controlled designs in pain trials? What are the alternatives?
James Vornov, MD, Ph.D.
CNS Therapeutic Area Leader
PAREXEL International
3:00 End of Conference