Co-Sponsored by the U.S. Food and Drug Administration

PROGRAM

Workshop Speakers:
Speakers are confirmed from academia; pharmaceutical, instrument, and IT corporations; and regulatory authorities.

Program Topics:
   Drug Chemistry: Preclinical Disease Models
  Preclinical Safety Models: Translational Research
  Overview of Drug Development
  Phase II/III Regulatory Experiences
  Panel Discussion on Future Directions

Friday, 2 April
08:30 Welcome
David S. Lester, Ph.D., Pharmacia Corporation, Peapack, NJ, USA
08:40 Plenary Lecture:
Drug Discovery and Development: Applications for Aging
Richard Hargreaves, Ph.D., Merck & Co., Inc., Sumneytown Pike, PA, USA
09:30 Preclinical Safety/Efficacy:
NMR metabonomics for safety/efficacy
Marielle Delnomdedieu, Ph.D., Pfizer, DSE Emerging Technologies, Groton, CT, USA
10:30 Break
11:00 Translational research:
  • Cancer
    John C. Waterton, Ph.D., AstraZeneca, Cheshire, England, UK
  • Osteoarthritis
    Deborah Burstein, Ph.D., Beth Israel Deaconess Medical Center, Boston, MA, USA
  • Stroke and Experiences in MR Imaging
    Steven Warach, M.D., Ph.D., NINDS, NIH, Bethesda, MD, USA
12:00 Lunch - Supported by Perceptive Informatics and SNIDD
13:00 Proffered Paper Session I
  • Applications of functional MRI methods in neuropharmacology
    Shi-Jiang Li, Ph.D., Medical College of Wisconsin, Milwaukee, WI, USA
  • Identification of toxicodynamic metabolic markers in human blood after a single cyclosporine dose using 1H MRS
    Jost Klawitter, University of Colorado, Denver, CO, USA
  • Transplantation: Toxicodynamics of the novel immunosuppressive drugs using a MRS based metabonomics approach
    Nathalie Serkova, Ph.D., University of Colorado Health Services, Denver, CO, USA
  • Monitoring tumor response to inhibition of HIF-1a with PX-478, a thioredoxin reductase inhibitor: a pre-clinical study using diffusion weighted MRI and dynamic contrast enhanced MRI
    Benedicte F. Jordan, Ph.D., Arizona Cancer Center, Tucson, AZ, USA
15:00 Poster Session - Break
16:30 Other Imaging Modalities Impacting Drug Development:
This session presented with the cooperation of the Society for Nuclear Imaging in Drug Development.
  • Ultrasound
    Terry Matsunaga, PharmD., ImaRx, Tucson, AZ, USA
  • Contrast/Tracer Development
    Michael F. Tweedle, Ph.D., Bracco Research USA, Princeton, NJ, USA
  • PET
    Raymond E. Gibson, Ph.D., Merck and Co., West Point, PA, USA
18:00 Adjournment

Saturday, 3 April
08:40 Plenary Lecture:
Streamlining Clinical Trials with Electronic Data Management
David P. Vernon, Ph.D., IBM Life Sciences, Tucson, AZ, USA
09:30 Phase II/III research:
  • MS - Lessons Learned
    Joseph A. Frank, M.D., National Institutes of Health, Bethesda, MD, USA
  • Issues regarding use of MRI for atherosclerosis clinical therapeutic trials
    Chun Yuan, Ph.D., University of Washington, Seattle, WA, USA
10:30 Break
11:00-12:00 Future directions:
  • Nanoparticle technology
    Gregory M. Lanza, M.D., Ph.D., Washington University Medical School, St. Louis, MO, USA
  • New MRI contrast agents
    William Dow, Ph.D., Metaprobe, San Diego, CA, USA
12:00 Lunch - Supported by Beacon Bioscience, Inc., and VirtualScopics
13:00 Proffered Paper Session II
  • Quantitative phenotyping with MR histology
    G. Allen Johnson, Ph.D., Duke Medical Center, Durham, NC, USA
  • New methods and results in MR< computed tomography and MR for atherosclerotic plaque imaging in drug development
    Zahi A. Fayad, Ph.D., Mt. Sinai School of Medicine, New York, NY, USA
14:00 Regulatory Issues:
  • Product quality: The role of imaging in changing regulatory policy
    Ajaz Hussain, Ph.D.,     FDA, CDER, Pharmaceutical Science, Rockville, MD, USA
  • FDA view of in vivo imaging and drug registration
    Jerry M. Collins, M.D., Center for Drug Evaluation and Research, FDA, Bethesda, MD, USA
  • EC view of in vivo imaging in drug development and registration: The pharmacologic audit trail
    Paul Workman, Ph.D., UK Centre for Cancer Therapeutics, Sutton, Surrey, England, UK
15:30 Break
16:00 Panel Discussion:
Incorporation of MRI into Clinical Trials
Sandra Chica, M.D., Perceptive Informatics, Inc., Waltham, MA, USA
Ted Gastineau, Beacon Bioscience, Doylestown, PA, USA
MaryAnne Hinkson, Siemens Medical Solutions USA, Inc., Malvern, PA
Rolf M. Lamerichs, Philips Medical Systems, Best, Netherlands
Mikael Totterman, VirtualScopics, LLC, Rochester, NY, USA
18:00 Adjournment