PRECLINICAL AND CLINICAL MODELS AND METHODS FOR ACCELERATING ANALGESIC DRUG DISCOVERY AND DEVELOPMENT

Size: px

Start display at page:

Download "PRECLINICAL AND CLINICAL MODELS AND METHODS FOR ACCELERATING ANALGESIC DRUG DISCOVERY AND DEVELOPMENT"

Sarah Wilkins
6 years ago
Views:

Food and Drug Administration and the University of Rochester School of Medicine and Dentistry present PRECLINICAL AND CLINICAL MODELS AND METHODS FOR ACCELERATING ANALGESIC DRUG DISCOVERY AND

October 24-26, 2012 7:00am 4:30pm ET FDA White Oak Campus 10903 New Hampshire Avenue Silver Spring, MD 20993 7:00 am 8:15 am Registration and Continental Breakfast 8:15 am 8:30 am Welcome and

1 Food and Drug Administration and the University of Rochester School of Medicine and Dentistry present PRECLINICAL AND CLINICAL MODELS AND METHODS FOR ACCELERATING ANALGESIC DRUG DISCOVERY AND DEVELOPMENT 2 nd Scientific Workshop Analgesic Clinical Trial Translations, Innovations, Opportunities, and Networks an FDA Public-Private Partnership Wednesday, October 24, 2012 Wednesday-Friday, October 24-26, :00am 4:30pm ET FDA White Oak Campus New Hampshire Avenue Silver Spring, MD :00 am 8:15 am Registration and Continental Breakfast 8:15 am 8:30 am Welcome and introduction to the workshop Robert Dworkin, PhD, University of Rochester 8:30 am 9:15 am KEYNOTE PRESENTATION Disease phenotype as the target for novel analgesics Clifford Woolf, MD, PhD, Harvard University Learning where to go by understanding where we have been and where we are 9:15 am 9:40 am Richard Hargreaves, PhD: Current pharma requirements for consideration of new targets 9:40 am 10:05 am Iain Chessell, PhD: Failed analgesic programs wrong targets or wrong drugs? 10:05 am 10:15 am Audience Q & A 10:15 am 10:45 am Coffee break Page 1

2 From the laboratory to the clinic: revisiting translation 10:45 am 11:10 am Tony Yaksh, PhD: Revisiting predictive value of preclinical studies 11:10 am 11:35 am Tony Dickenson, PhD: Targeting the CNS for drug discovery for 11:35 am 12:00 pm Jeffrey Mogil, PhD: Translational value of mouse genetics 12:00 pm 12:25 pm Frank Porreca, PhD: Enhancing translation in preclinical assessment of 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 M. Catherine Bushnell, PhD: Impact of chronic and the rodent brain 2:10 pm 2:35 pm David Borsook, MD, PhD: Imaging the rodent brain for target evaluation: a language of translation 2:35 pm 2:45 pm Audience Q & A 2:45 pm 3:15 pm Coffee Break From the clinic back to the laboratory: informing mechanism from the patient 3:15 pm 3:40 pm Steve McMahon, PhD: Rodent to human studies with CCLX5 3:40 pm 4:05 pm Steve Waxman, MD, PhD: Nav1.7 channelopathies 4:05 pm 4:15 pm Audience Q & 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 Page 2

3 Thursday, October 25, :00 am 8:30 am Registration and Continental Breakfast 8:30 am 9:15 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 9:15 am 9:40 am Allan Basbaum, PhD: New technologies to increase translation for 9:40 am 10:05 am Stuart Chambers, PhD: Directed differentiation of nociceptors from human pluripotent stem cells 10:05 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 Ed Roberts, PhD: Bifunctional and multi-target strategies The path forward 11:10 am 11:35 pm Chas Bountra, PhD: Structural changes in discovery research: public-private partnerships 11:35 am 12:00 pm Howard Fields, MD, PhD: Synthesis and recommendations 12:00 pm 12:30 pm Audience Q & A 12:30 pm 1:30 pm Lunch Human experimental models of mechanisms and analgesia Chair and moderator: Justin McArthur, MD 1:30 pm 1:55 pm Gary Bennett, PhD: Evaluating mechanisms and targets with human experimental models 1:55 pm 2:20 pm Martin Schmelz, MD: Translating preclinical targets to human Page 3

4 experimental models of analgesic efficacy in healthy volunteers 2:20 pm 2:45 pm Michael Rowbotham, MD: Human experimental models of analgesic efficacy in patients with inflammatory and neuropathic 2:45 pm 3:15 pm Coffee Break 3:15 pm 3:30 pm Justin McArthur, MD: Discussant 3:30 pm 4:30 pm Panel discussion and audience Q & A moderator: Justin McArthur, MD Gary Bennett, PhD; Christopher Breder, MD, PhD; Michael Rowbotham, MD; Martin Schmelz, MD 4:30 pm Adjourn Friday, October 26, :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 chair and moderator: Srinivasa Raja, MD 9:30 am 9:55 am Nathaniel Katz, MD: Enriched designs in analgesic drug development 9:55 am 10:20 am Maurizio Fava, MD: Sequential parallel comparison designs in CNS clinical trials 10:20 am 10:45 am Michael McDermott, PhD: Interim analyses: promises and pitfalls 10:45 am 11:15 am Coffee Break 11:15 am 11:30 am Srinivasa Raja, MD: Discussant 11:30 am 12:30 pm Panel discussion and audience Q & A Page 4

5 12:30 am 1:30 pm Lunch moderator: Srinivasa Raja, MD Maurizio Fava, MD; Sharon Hertz, MD; Nathaniel Katz, MD; Michael McDermott, PhD Biomarkers and clinical trial methods chair and moderator: Dennis Turk, PhD 1:30 pm 1:55 pm Laurie Burke, RPh, MPH: An FDA perspective on biomarkers, surrogate endpoints, and related measures 1:55 pm 2:20 pm Irene Tracey, PhD: The role of imaging in accelerating analgesic drug development: IMMPACT considerations 2:20 pm 2:45 pm Ralf Baron, MD: The role of QST and punch skin biopsy in accelerating analgesic drug development: IMMPACT considerations 2:45 pm 3:10 pm Robert Dworkin, PhD: Update on ACTTION activities and working groups 3:10 pm 3:40 pm Coffee Break 3:40 pm 4:40 pm Panel Discussion and Q & A moderator: Dennis Turk, PhD Ralf Baron, MD; Laurie Burke, RPh, MPH; Robert Dworkin, PhD; Bob Rappaport, MD; Irene Tracey, PhD 4:40 pm 5:00 pm Dennis Turk, PhD: Workshop overview 5:00 pm Adjourn Page 5

SESSION I: DATA STANDARDS AND CLINICAL TRIAL DATABASES AS TOOLS

SESSION I: DATA STANDARDS AND CLINICAL TRIAL DATABASES AS TOOLS November 30 - December 1, 2011 Crowne Plaza Hotel 8777 Georgia Avenue Silver Spring, MD Collaborations between industry, regulatory agencies, and academia are generating consensus on the value of innovative