Preclinical and Clinical Models and Methods for Accelerating Analgesic Drug Discovery and Development


2nd Scientific Workshop
Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION)
an FDA Public-Private Partnership


Wednesday-Friday, October 24-26, 2012
7:00am - 5:00pm ET
FDA White Oak Campus
10903 New Hampshire Avenue
Silver Spring, MD 20993


AGENDA


Wednesday, October 24, 2012

7:00 am - 8:15 am: Registration and Continental Breakfast

8:15 am - 8:30 am: Welcome & Introduction to the Workshop

8:30 am - 9:15 am: Keynote Presentation

Disease Phenotype as the Target for Novel Analgesics

Clifford Woolf, MD, PhD
Director of the F.M. Kirby Neurobiology Center
Children's Hospital Boston
Professor of Neurobiology, Harvard Medical School

LEARNING WHERE TO GO BY UNDERSTANDING WHERE WE HAVE BEEN AND WHERE WE ARE

9:15 am - 9:40 am: Current Pharma Requirements for Consideration of New Targets

Richard Hargreaves, PhD

9:40 am - 10:05 am: Failed Analgesic Programs - Wrong Targets or Wrong Drugs?

Ian Chessell, PhD

10:05 am - 10:15 am: Audience Q & A

10:15 am - 10:45 am: Coffee Break

FROM THE LABORATORY TO THE CLINIC: REVISITING TRANSLATION

10:45 am - 11:10 am: Revisiting Predictive Value of Preclinical Studies

Tony Yaksh, PhD

11:10 am - 11:35 am: Targeting the CNS for Drug Discovery for Pain

Tony Dickenson, PhD

11:35 am - 12:00 pm: Targeting the CNS for Drug Discovery for Pain

Jeffrey Mogil, PhD

12:00 pm - 12:25 pm: Enhancing Translation in Preclinical Assessment of Pain

Frank Porreca, PhD

12:25 pm - 12:45 pm: Audience Q & A

12:45 pm - 1:45 pm: Lunch

FROM THE LABORATORY TO THE CLINIC: PRECLINICAL IMAGING AND TRANSLATION

1:45 pm - 2:10 pm: Impact of Chronic Pain and the Rodent Brain

M. Catherine Bushnell, PhD

2:10 pm - 2:35 pm: Imaging the Rodent Brain for Target Evaluation: A Language of Translation

David Borsook, MD, PhD

2:35 pm - 2:45 pm: Audience Q & A

2:45 pm - 3:15 pm: Coffee Break

FROM THE LABORATORY TO THE CLINIC: INFORMING MECHANISM FROM THE PATIENT

3:15 pm - 3:40 pm: Rodent to Human Studies with CCLX5

Steve McMahon, PhD

3:40 pm - 4:05 pm: Nav1.7 Channelopathies

Steve Waxman, MD, PhD

4:05 pm - 4:15 pm: Audience Q and A

4:15 pm - 5:00 pm: Panel Discussion of Presentations

Allan Basbaum, PhD; Frank Porreca, PhD; Clifford Woolf, MD, PhD

5:00 pm: Adjourn

Thursday, October 25, 2012

7:00 am - 8:15 am: Registration and Continental Breakfast

8:15 am - 8:45 am: Keynote Presentation

The Critical Need for a Permanent Clinical Trials Infrastructure in the United States

Janet Woodcock, MD
Director, Center for Drug Evaluation and Research
Food and Drug Administration

EMERGING BIOLOGICAL TECHNOLOGIES FOR PAIN

9:00 am - 9:25 am: New Technologies to Increase Translation for Pain

Allan Basbaum, PhD

9:25 am - 9:50 am: Directed Differentiation of Nociceptors from Human Pluripotent Stem Cells

Stuart Chambers, PhD

9:50 am - 10:15 am: Audience Q & A

10:15 am - 10:45 am: Coffee Break

EXPANDING THE CHEMICAL SPACE FOR DRUG DISCOVERY

10:45 am - 11:10 am: Bifunctional and Multi-Target Strategies

Ed Roberts, PhD

THE PATH FORWARD

11:10 am - 11:35 am: Structural Changes in Discovery Research: Public-Private Partnerships

Chas Bountra, PhD

11:35 am - 12:00 pm: Synthesis and Recommendations

Howard Fields, MD, PhD

12:00 pm - 12:30 pm: Audience Q & A

12:30 pm - 1:30 pm: Lunch

Human Experimental Models of Pain Mechanisms and Analgesia

Roy Freeman, MD - Chair and Moderator

1:30 pm - 1:55 pm: Evaluating Pain Mechanisms and Targets with Human Experimental Models

Gary Bennett, PhD

1:55 pm - 2:20 pm: Translating Preclinical Targets to Human Experimental Models of Analgesic Efficacy in Healthy Volunteers

Martin Schmelz, MD

2:20 pm - 2:45 pm: Human Experimental Models of Analgesic Efficacy in Patients With Inflammatory and Neuropathic Pain

Michael Rowbotham, MD

2:45 pm - 3:15 pm: Coffee Break

3:15 pm - 3:30 pm: Discussant

Roy Freeman, MD

3:30 pm - 4:30 pm: Panel Discussion and Audience Q & A

Roy Freeman, MD - Moderator
Gary Bennett, PhD; Christopher Breder, MD, PhD; Michael Rowbotham, MD; Martin Schmelz, MD

4:30 pm: Adjourn

Friday, October 25, 2012

7:00 am - 8:30 am: Registration and Continental Breakfast

8:30 am - 9:30 am: Keynote Presentation

The Next 10 Years of Analgesic Drug Development: A Regulatory Crystal Ball

Bob A. Rappaport, MD
Director, Division of Anesthesia, Analgesia, and Addiction Products, Center for Drug Evaluation and Research
Food and Drug Administration

Novel Clinical Trial Designs

Srinivasa Raja, MD - Chair and Moderator

9:30 am - 9:55 am: Enriched Designs in Analgesic Drug Development

Nathaniel Katz, MD

9:55 am - 10:20 am: Sequential Parallel Comparison Designs in CNS Clinical Trials

Maurizio Fava, MD

10:20 am - 10:45 am: Interim Analyses: Promises and Pitfalls

Michael McDermott, PhD

10:45 am - 11:15 am: Coffee Break

11:15 am - 11:30 am: Discussant

Srinivasa Raja, MD

11:30 am - 12:30 pm: Panel Discussion and Audience Q & A

Srinivasa Raja, MD - Moderator
Maurizio Fava, MD; Sharon Hertz, MD; Nathaniel Katz, MD; Michael McDermott, PhD

12:30 pm - 1:30 pm: Lunch

Biomarkers and Clinical Trial Methods

Dennis Turk, PhD - Chair and Moderator

1:30 pm - 1:55 pm: An FDA Perspective on Biomarkers, Surrogate Endpoints, and Related Measures

Laurie Burke, RPh, MPH

1:55 pm - 2:20 pm: The Role of Imaging in Accelerating Analgesic Drug Development: IMMPACT Considerations

Irene Tracey, PhD

2:20 pm - 2:45 pm: The Role of QST and Punch Skin Biopsy in Accelerating Analgesic Drug Development: IMMPACT Considerations

Ralf Baron, MD

2:45 pm - 3:10 pm: Update on ACTTION Activities and Working Groups

Robert Dworkin, PhD

3:10 pm - 3:40 pm: Coffee Break

3:40 am - 4:40 pm: Panel Discussion and Audience Q & A

Dennis Turk, PhD - Moderator
Ralf Baron, MD; Laurie Burke, RPh, MPH, Robert Dworkin, PhD, Bob Rappaport, MD, Irene Tracey, PhD

4:40 am - 5:00 pm: Workshop Overview

Dennis Turk, PhD

5:00 pm: Adjourn