International Conference on Accelerating the Development of Enhanced Pain Treatments


Conducted under the auspices of Analgesic Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION), a public-private partnership with the US Food and Drug Administration


Sponsored by the University of Rochester Center for Human Experimental Therapeutics and Department of Anesthesiology


The Fairmont Southampton
Bermuda
March 24-26, 2011


Steering Committee:

Robert H. Dworkin, PhD, Chair
Ralf Baron, Dr med
Laurie B. Burke, RPh, MPH
Sharon Hertz, MD
Nathaniel P. Katz, MD
Srinivasa N. Raja, MD
Bob A. Rappaport, MD
Michael C. Rowbotham, MD
Dennis C. Turk, PhD

Thursday, March 24, 2011

7:00-9:00: WELCOME RECEPTION

Friday, March 25, 2011

8:00-8:15: Welcome

Robert H. Dworkin, PhD

8:15-8:45: Ethical aspects of analgesic clinical trials

Michael C. Rowbotham, MD

WORKSHOP: Proof-of-concept trials

Moderator: Nathaniel P. Katz, MD

8:45-9:10: Proof-of-concept trials in osteoarthritis

Nathaniel P. Katz, MD

9:10-9:35: Proof-of-concept trials in neuropathic pain

Srinivasa N. Raja, MD

9:35-10:00: Proof-of-concept trials in chronic low back pain

John D. Markman, MD

10:00-10:15: Discussant

Ian Gilron, MD

10:15-10:45: COFFEE BREAK

10:45-12:15: Questions, panel discussion, and specific recommendations

I. Gilron, MD; N. Katz, MD; J. Markman, MD; M. Rowbotham, MD; S. Raja, MD

12:15-1:30: LUNCH

WORKSHOP: Can imaging contribute to analgesic drug development?

Moderator: Michael C. Rowbotham, MD

1:30-1:55: Imaging the placebo response

M. Catherine Bushnell, PhD

1:55-2:20: Can imaging dissect analgesic vs. placebo responses?

Irene M. Tracey, PhD

2:20-2:45: Imaging and analgesic drug development

David Borsook, MD, PhD

2:45-3:00: Discussant

Michael C. Rowbotham, MD

3:00-3:30: COFFEE BREAK

3:30-5:00: Questions, panel discussion, and specific recommendations

D. Borsook, MD; C. Bushnell, PhD; M. Rowbotham, MD; I. Tracey, PhD

DINNER WORKSHOP: Academic, government, and industry collaborative initiatives

Moderator: Robert H. Dworkin, PhD

7:00: Dinner

7:15-7:30: Analgesic Clinical Trial Innovations, Opportunities, and Networks (ACTION)

Bob A. Rappaport, MD

7:30-7:45: The Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT)

Dennis C. Turk, PhD

7:45-8:00: EuroPain

Andrew SC Rice, MB, BS, MD

8:00-8:15: An industry perspective on public-private partnerships

Christine Rauschkolb, MD, PhD

8:15-9:00: Audience discussion with the panel

R. Dworkin, PhD; B. Rappaport, MD; C. Rauschkolb, MD, PhD; A. Rice, MD; D. Turk, PhD

Saturday, March 26, 2011

WORKSHOP: Phenotyping chronic pain patients

Moderator: Ralf Baron, Dr med

8:00-8:25: Sensory profiles and their causes, correlates, and consequences

Ralf Baron, Dr med

8:25-8:50: Symptoms, signs, and underlying mechanisms

Clifford J. Woolf, MB, BCh, PhD

8:50-9:15: Is there a chronic pain-prone phenotype?

Daniel J. Clauw, MD

9:00-9:15: Discussant

Srinivasa N. Raja, MD

9:30-10:00: COFFEE BREAK

10:00-11:30: Questions, panel discussion, and specific recommendations

Robert Allen, MD; R. Baron, Dr med; D. Clauw, MD; S. Raja, MD; C. Woolf, MD, PhD

11:30-1:00: LUNCH

WORKSHOP: Can assay sensitivity be increased in analgesic trials?

Moderator: Robert H. Dworkin, PhD

1:00-1:20: The impact of patient and site factors on assay sensitivity

Robert H. Dworkin, PhD

1:20-1:40: Maximizing the reliability and validity of outcome measures

Laurie B. Burke, RPh, MPH

1:40-2:00: What can be done to reduce placebo group responses?

John T. Farrar, MD, PhD

2:00-2:20: Negative trials and assay sensitivity: a regulatory perspective

Sharon Hertz, MD

2:20-2:40: Negative trials and assay sensitivity: an industry perspective

R. Michael Poole, MD

2:40-3:10: COFFEE BREAK

3:10-4:30: Questions, panel discussion, and specific recommendations

L. Burke, RPh, MPH; R. Dworkin, PhD; J. Farrar, MD, PhD; S. Hertz, MD; N. Katz, MD; M. Poole, MD