Pain Therapeutics Summit 2007- Agenda (Day Two)

8:00-8:30 Breakfast

8:30 Chair’s Opening Remarks

Najib Babul, PharmD., CEO, TheraQuest Biosciences

8:40 Bridging the Gap Between R&D and Commercialization Efforts in Pain Therapeutics Development

Early commercial input in R&D – more important than before
What’s the best way for commercial input to be provided to early stage candidates?
Commercial need and unmet medical need: how can the two meet?
Models of commercial and R&D interaction
Types and approaches of commercial valuation
Looking to the future – emerging changes in commercial interaction with R&D

Tariq Arshad, Sr. Marketing Manager, Worldwide Commercial Development, Pfizer

9:20 Progress in Delta Opioid Receptor Targeted Analgesics

The delta opioid receptor (DOR) is an attractive target for the development of new drugs to control pain, offering potential clinical benefits compared with mu opioid receptor agonists
(reduced respiratory depression, constipation, physical dependence, and abuse liability) and non-steroidal anti-inflammatory drugs (reduced cardiovascular and GI effects). DOR agonists also have potential application in several other therapeutic indications, including affective disorders, organ protection, and neurodegenerative diseases. Development of DOR agonists has been hindered by the propensity to produce convulsions in rodents and primates, but literature suggests that not all DOR agonists are proconvulsive. Recent progress in DOR research and DOR agonist development at Adolor will be discussed.

Rolf T.Windh, Ph.D., Principal Research Investigator, Adolor Corporation

10:00-10:30 Break

10:30 Imaging Pain and Analgesia - Defining a Model in Drug Development

The presentation will cover new developments in the use of imaging in pain and analgesia. Specifically, a knowledge of functional and structural changes in the CNS have radically altered the nature of how we understand pain. As such, imaging also offers the potential for both translational and clinical science to provide a better understanding of disease state and drug effects on neural circuits. The potential benefits of these will be discussed.

David Borsook, MD, Ph.D., Director, Pain and Analgesia Imaging and Neuroscience (P.A.I.N.) Group, McLean Hospital, a Harvard Medical School affiliate

11:10 Abuse Resistant Opioids: Scientific, Regulatory and Commercialization Issues

A number of classes of analgesics, most notably opioids have the potential to be abused and diverted into the illicit market. This presentation will review:

Various technologies currently in development to deter the abuse and diversion of opioids;
Regulatory challenges in developing abuse deterrent drugs; and
Post-approval barriers to effective commercialization of abuse resistant opioids.

Najib Babul, PharmD., CEO, TheraQuest Biosciences

11:50 Peripheral Nervous System Targets for Pain Management: Advances on Multiple Fronts

This presentation will cover the following areas:

Benefits of peripheral versus central targets
Novel approaches under development
Overview of Acid-Sensing Ion Channels (ASICs) and Neurotrophin receptors
Importance of ASICs and NGF receptors in pain pathways
ASIC and NGF blockers in pain management
Overview of PainCeptor’s drug development pipeline

Kazimierz Babinski, Vice-President, Research, PainCeptor Pharma Corp.

12:30-1:30 Lunch

1:30 Can We Model the Affective Component of Pain in Animals?

The development of novel analgesics for the treatment of pain is dependent on the use of clinically relevant animal models. Several animal models that reliably mimic both acute and chronic human pain conditions have been validated; these assays model the sensory component of pain via application of a graded stimulus and measurement of a nocifensive reflex response. However, pain is a complex pathophysiological disorder and in addition to sensory processing, pain states include a negative affective component that traditional animal screening methods do not include. This talk will discuss the following:

The comorbidity of pain and depression (i.e. negative affect)
The common biological pathways associated with each
How we can potentially address this issue of comorbidity from a preclinical perspective with the establishment of novel animal models in our search for new pain compounds

Michele Hummel, Ph.D., RPh, Post-Doctoral Fellow, Wyeth, Neuroscience Discovery Research

2:10 NGF-TRPV1 Interaction in Inflammatory and Neuropathic Pain

As chronic pain (inflammatory and neuropathic) remains a poorly addressed condition, novel targets such as the TRP channels, as well as antagonists to NGF are attractive possibilities for drug and biologicals research. Specifically, antagonists of TRPV1 have shown promising results in models of neuropathic and inflammatory pain. Also, as new compounds become available, it is possible to study the biology of this channel, and associated pathways that mediate various states of pain are being discovered. The current talk will discuss the following issues:

Inflammatory and neuopathic pain: are there common mechanisms and is there an overlap?
Mechanisms that mediate NGF-TRPV1 interactions
The interaction of TRPV1 and NGF and its consequence in chronic pain
Modulation of opiate receptors by TRPV1 receptor

Uri Herzberg, Ph.D., Principal Scientist, Johnson & Johnson

2:50 Pain and the Pain of Clinical Development

James L. Perhach, Ph.D.,FCP, Executive Director, Clinical Development, Forest Research Institute

3:30-4:00 Afternoon break / Networking session

4:00 The Application of Drug Delivery in Analgesics: Conversion from Immediate-release (IR) to Extended-release (ER) Formulations as a Life Cycle Management Strategy in Rx and OTC Analgesics

This presentation will cover the following:

Discussion on how companies are able to maintain and in some cases increase market share by converting IR products to ER products.
Discussion on how ER conversion can improve the therapeutic responses of analgesics for certain indications.
Why there is a place for both IR and ER products in the Rx and OTC analgesic category.
Case study on a novel ER OTC ibuprofen tablet and how it compares to previous attempts and current ibuprofen products found outside the US market.

Stephen J. Turner, Vice President, Chief Technical Officer, SCOLR Pharma

4:40 Close of conference

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