Agenda
DAY ONE - October 6th, 2008
7.30-8.30 Registration and Continental Breakfast
8.30-11.30 Pre-Conference Workshop: Pre-Clinical and Clinical Abuse Liability Evaluations
This workshop will provide a comprehensive review of the requirements for pre-clinical and clinical abuse liability evaluation within the regulatory frameworks of the FDA. The session will then focus in more detail on design, analysis and interpretation of abuse liability studies and data. Additional information, relating to content, is provided in the abstract that will follow.
The learning objectives include:
- Identifying regulatory expectations with respect to the abuse liability evaluation of central nervous system drugs.
- Outlining the principles and issues involved in the design, analysis, and interpretation of abuse liability studies and other relevant data in order to meet the regulatory requirements.
Workshop Leaders: Decision Line Clinical Research
11.45-12.45 Lunch for Workshop Participants
1.00-1.10 Chair’s Opening Remarks
Iain Chessell, Ph.D., CEO, NeuroDiscovery Group (formerly Worldwide Head of Pain Research at GlaxoSmithKline)
(BIOGRAPHY)
1.10-1.45 Overview of Chronic Pain: Emerging Implications for Pain Therapeutics
This presentation will cover the following key issues in the management of pain:
- Emerging ethical issues - such as racial/ethnic differences in pain management and opioid availability, and the continued undertreatment of pain
- Attitudes towards pharmacologic interventions: on the part of patients/families - fear of drugs and addiction and on the part of doctors - fear of DEA scrutiny, continued misunderstanding of addiction
- Interdisciplinary treatment of pain: Best model to implement pain therapeutics?
- The realities of addiction in patients with chronic pain
Alan Lebovits, Ph.D., Director, Psychological Services, Division of Neurology and Integrative Pain Medicine, ProHEALTH Care Associates, LLP and Associate Professor, Departments of Anesthesiology and Psychiatry, NYU School of Medicine
(BIOGRAPHY)
1.45-2.20 New Pain Therapies Based on Venom Peptide Analogs
Xenome has a discovery platform based upon peptide structures from venomous creatures, particularly cone shells. These short and compact peptides have been selected evolutionarily as potent and selective pharmacological agents and therefore represent a good starting point for drug discovery and development. Xenome has created proprietary libraries of venom peptides, analogs and structural motifs for drug discovery, either on its own or in partnership with other companies. The most advanced product to come from Xenome’s platform is Xen2174, a venom peptide analog that acts as an allosteric inhibitor of the norepinephrine transporter (NET). It is being developed for the treatment for severe pain, with a phase I/II study in cancer patients being completed earlier this year. A phase II study in acute post-operative pain will commence in the second half of 2008.
The presentation will provide details on the development of Xen2174 and Xenome’s commercialization plans for the drug, as well as describing the underpinning technology platform and Xenome’s drug discovery partnering program.
Ian Nisbet, Ph.D., CEO and Managing Director, Xenome
(BIOGRAPHY)
2.20-2.55 Wall Street’s View of the Pain Market from the New Tamper-Resistant Opioids to new Indications for Breath-Through Pain
Corey Davis, Ph.D., Senior Analyst Specialty Pharmaceuticals, Natixis Bleichroeder Inc.
(BIOGRAPHY)
2.55-3.15 Refreshment Break
3.15-3.50 Pain Drug Development: Minimising the Risks
Despite many decades of intensive investment and research, few if any genuinely novel therapies have made it to launch in recent years for the treatment of inflammatory or neuropathic pain. Progress is being made; projects are geared much more toward “failing early, failing cheaply”, but the fact remains that the success rate at proof of concept in the clinic for new pain drugs is less than 10%. Further investment in translational technologies, including biomarkers and volunteer studies in Phase I, may yet improve this situation, but there are other steps which must be employed now to understand and mitigate risk.
The presentation will focus on risk reduction, using recent examples, in late preclinical and early clinical development, and review progress of translational technologies.
Iain Chessell, Ph.D., CEO, NeuroDiscovery Group (formerly Worldwide Head of Pain Research at GlaxoSmithKline)
(BIOGRAPHY)
3.50-4.25 Improving GI safety of NSAIDs with Phospholipids
Upendra Marathi, Ph.D., M.B.A, Senior Vice President, PLX Pharma and MediGen Group (private equity firm)
(BIOGRAPHY)
4.25-5.00 Topical Treatment of Neuropathic Pain: Targeting Pain at the Source
Though there have been substantial breakthroughs in the development of orally bioavailable treatments for neuropathic pain, each of these therapies is frought with substantial side effects. The patient may achieve pain relief but at the price of significant interference with normal cognitive function, for example. Much data indicate that in many neuropathic pain conditions the signal that triggers pain actually arises at the level of the skin. Thus a biological rationale exists for application of drugs to the skin involved in the neuropathic pain condition. The skin has been used extensively as an alternative means to deliver medications systemically, but there has been relatively little effort aimed at development of drugs to deliver to the affected/painful skin. Dr. Campbell will review the following topics:
- What have we learned from recent studies aimed at understanding peripheral pain signaling mechanisms and the pathophysiology of neuropathic pain and how might this increased understanding be used to advance treatment.
- What are some of the novel topical analgesics in development for neuropathic pain?
- a case study on the development of ARC-4558 a novel topical drug for the treatment of neuropathic pain currently in Phase IIB clinical trials.
James Campbell, MD, Professor of Neurosurgery and Director of the Blaustein Pain Treatment Center, School of Medicine, Johns Hopkins University; President and CEO, Arcion Therapeutics and Executive in Residence, Interwest Partners
(BIOGRAPHY)
5.00-5:35 Discovery of ABT-102, Potent and Selective TRPV1 Antagonist for the Treatment of Pain
This presentation will cover the following:
- Ion Channel TRPV1 (transient receptor potential vanilloid subtype 1) is considered to be a molecular integrator of pain signals
- TRPV1 antagonists block channel activation by vanilloids, heat and acid
- TRPV1 antagonists relieve pathophysiological pain in animal models
- Systematic optimization of pharmacological, pharmacokinetic and pharmaceutical properties of the high-throughput screening hit led to the clinical candidate ABT-102
Arthur Gomtsyan, Ph.D., Associate Research Fellow, Global Pharma R&D, Neuroscience Research, Abbott Labs
(BIOGRAPHY)
5.35-6.35 Wine and Cheese Reception
DAY TWO - October 7th, 2008
7.30-8.00 Registration and Continental Breakfast
8.00-8.10 Chair’s Opening Remarks
Daniel B. Carr, MD, President and Chief Medical Officer, Javelin Pharmaceuticals
(BIOGRAPHY)
8.10-8.45 p38 Inhibitors as New Therapies for Inflammatory Pain: The Case of ARRY-797
This session will cover the following:
- Background and rationale for p38 inhibition in inflammation and pain
- ARRY-797 preclinical data
- ARRY-797 14 day safety data
- Analgesic efficacy data from oral surgery model
Ann Remmers, Ph.D., Director, Pain and Supportive Care, Array Biopharma
(BIOGRAPHY)
8.45-9.20 An Investment View of the Pain Market
Angela Larson, Analyst, Specialty Pharmaceuticals, Susquehanna Financial Group
(BIOGRAPHY)
9.20-9.55 Ralfinamide: A Novel Treatment for Neuropathic Low Back Pain
Dr. Luca Benatti, CEO, Newron
(BIOGRAPHY)
9.55-10.10 Refreshment Break
10.10-10.45 NGX-4010: Peripheral Targeting of TRPV1 for the Treatment of Neuropathic Pain
Jeffrey Tobias, MD, Chief Medical Officer, Neurogesx
(BIOGRAPHY)
10.45-11.20 The Challenges of Clinical Development and Regulatory Approval of Rapid Onset Opioids for Treatment of Non Cancer Breakthrough Pain
Eric Floyd, Ph.D., MBA, VP Regulatory Affairs, Cephalon
11.20-11.55 Setbacks in the Clinical Development of TRPV1 Antagonists: What Next?
TRPV1 antagonists have been considered as potential treatments for pain associated with inflammatory diseases and cancer. During Phase I clinical trials with AMG 517, a highly selective TRPV1 antagonist, we found that TRPV1 blockade elicits marked, but reversible, and generally plasma concentration-dependent hyperthermia. Furthermore, in a Phase Ib study, AMG 517 administered after molar extraction (a surgical cause of acute pain) elicited long-lasting hyperthermia with maximal body temperature surpassing 40 ºC, suggesting that TRPV1 blockade elicits undesirable hyperthermia in susceptible individuals.
Since TRPV1 blockade elicited hyperthermia is a major hurdle, we investigated the possibility of eliminating hyperthermia while maintaining antihyperalgesia by two approaches: i) peripheral restriction of TRPV1 antagonists, ii) characterization of TRPV1 modulators that exhibit differential pharmacology. Results from the preclinical studies of both approaches will be discussed.
Narender R. Gavva, Ph.D., Principal Scientist, Department of Neuroscience, Amgen, Inc.
(BIOGRAPHY)
11.55-1.00 Lunch
1.00-1.35 Dyloject (Injectable Diclofenac): A Specialty Pharma Strategy for Success
Daniel B. Carr, MD, President and Chief Medical Officer, Javelin Pharmaceuticals
(BIOGRAPHY)
1.35-2.10 Dermal and Transdermal Delivery of Pain Drugs
Fred Banti, B.S., M.S., Senior Vice President and Chief Business Officer, Phosphagenics
(BIOGRAPHY)
2.10-2.45 Kv7/KCNQ Ion Channels as Targets for Chronic and Neuropathic Pain
Gregory Rigdon, Ph.D., VP Product Development, Icagen
(BIOGRAPHY)
2.45-3.20 Challenges Facing the Development of New Pain Therapeutics
In one of the world’s largest pharmaceutical markets, it has been decades since we have produced truly new innovative effective pain drugs. Why are pain therapeutics so difficult to develop? What are the most promising mechanisms to explore? Are we any closer to making new discoveries for this multi-billion dollar market? What are the emerging clinical and regulatory challenges facing new pain therapeutics and how are they best approached? In this session, Dr. Christopher Gallen will speak about the challenges of developing pain drugs. Learn about:
- The underlying mechanistic complexity of pain
- The present state of pain medicines
- Next generation of pain medicines currently in development
- How to design the right clinical trials for pain therapeutics
Christopher Gallen, MD, Ph.D., President and CEO, Neuromed (formerly VP and Chief of Operations, Clinical Research and Development at Wyeth Research)
(BIOGRAPHY)
3.20-3.35 Refreshment Break
3.35-4.10 Cannabinoids and Cancer-related Pain: Development and Regulatory Challenges
Cannabinoids may offer a new therapeutic option in the treatment of cancer-related pain. Recent advances in understanding the pharmacology of non-psychoactive cannabinoids may enable a means of optimising the analgesic benefit of cannabinoids while reducing the dose-limiting CNS adverse effects. Sativex® is a botanical cannabinoid medicine which has recently been approved in Canada as a treatment for cancer-related pain in patients with advanced cancer who are not responding adequately to opioids. It is now under development in the US.
The development of botanical medicines containing cannabinoids presents unique challenges from several points of view. Firstly meeting the pharmaceutical requirements of a modern medicine; secondly overcomingclinical trial supply chain restrictions which apply to a Schedule 1 substance; and thirdly meeting the specific regulatory requirements that apply to the clinical assessment of trial results. This presentation reviews the development of Sativex and discusses how to meet these development and regulatory challenges.
Stephen Wright, MA MD FRCP (Edin) FFPM, Director of Research and Development, GW Pharma Ltd.
(BIOGRAPHY)
4.10-4.45 Targeting Voltage-gated Sodium Channels for Pain Therapy
This sesion will cover the following:
- Validation of NaV channels as targets for pain therapy
- Development and validation of automated functional assays for profiling compounds against the NaV channel family
- Generation and characterisation of NaV channels with mutations within the drug binding site
Jeff Clare, Ph.D., Director, R&D, Ion Channel Group, Millipore
(BIOGRAPHY)
4.45-5.20 Panel Session: Venture Financing and Creating Investor Enthusiasm in the Field of Pain Therapeutics
Moderator: Daniel B. Carr, MD, President and Chief Medical Officer, Javelin Pharmaceuticals
(BIOGRAPHY)
Upendra Marathi, Ph.D., M.B.A, Senior Vice President, PLX Pharma and MediGen Group (private equity firm)
(BIOGRAPHY)
James Campbell, MD, Professor of Neurosurgery and Director of the Blaustein Pain Treatment Center, School of Medicine, Johns Hopkins University; President and CEO, Arcion Therapeutics and Executive in Residence, Interwest Partners (tentative)
(BIOGRAPHY)
Angela Larson, Analyst, Specialty Pharmaceuticals, Susquehanna Financial Group
(BIOGRAPHY)