2011 Maryland CMOD Symposium (FDA Campus)

 September 12-13, 2011


SESSION ONE: Biomarkers and Imaging Technologies: Current Needs and Priorities (Chairs: P. Libby and N. Stockbridge)

Biomarkers 101Robert Temple, US FDA
Common Threads, Common Targets? - Peter Libby, Brigham and Women’s Hospital
That Status of PM Regulations in CanadaAgnes Klein, Health Canada
Biomarker Utility in Cellular, Tissue, and Gene Therapy Product DvptSteven Bauer, OCTGT/CBER, FDA
European Medicines Agency Biomarker Priorities - Pat O’Mahony, European Medicines Agency
Molecular Medicine in IrelandSuzanne Bracken, Molecular Medicine Ireland
Application of Advanced ImagingRobert Balaban, NHLBI, NIH

Roundtable Discussions - Faculty

SESSION TWO:  Developing Biomarkers for Generation X ,Y and Z (Chairs: S. Skarlatos and J-C Tardif)

Molecular Imaging at NIHSimhan Danthi, NHLBI, NIH
Biomarkers for Heart FailurePeter Liu, University of Toronto
Stem Cells, Genes and Devices in Cardiac RepairDoris Taylor, University of Minnesota
Protein-Based Technologies in Cancer ResearchLance Liotta, George Mason University
Integrating Blood-Based and Imaging Markers in Clinical TrialsJean-Claude Tardif, Montreal Heart Institute
Standardizing Imaging in Clinical TrialsAllen J. Taylor, Georgetown University

Roundtable Discussions - Faculty

SESSION THREE: Regulatory Innovation and Collaboration (Chairs: Doug Throckmorton and Agnes Klein)

Biomarker Qualification ProjectMarc Walton, US FDA
Renal BiomarkersMelanie Blank, US FDA
Cystatin C for Measuring GFRAndrew Levey, Tufts Med Center
Thorough BP ProjectRobert Fiorentino, US FDA
PharmacogenomicsIssam Zineh, US FDA
The Critical PathDouglas Throckmorton, US FDA

Roundtable Discussions - Faculty

SESSION FOUR: - Emerging Biomarker Challenges Case Study: HDL-Targeted Therapies (Chairs: Jean-Claude Tardif and Alan Remaley)

A Mechanistic Understanding of HDL PropertiesAlan Remaley, NHLBI, NIH
HDL-Targeted TherapiesBryan Brewer, Medstar Research
Completed and Ongoing Clinical Trials - CETP, HDL Infusion - Jean-Claude Tardif, Montreal Heart Institute
HDL as Marker of DiseaseRobert Rosenson, Mt. Sinai Medical Center
Regulatory Decision Making - Eric Colman, US FDA

Roundtable Discussions - Faculty