2011 Maryland CMOD Symposium (FDA Campus)

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

Biomarkers 101 - Robert Temple, US FDA
Common Threads, Common Targets? - Peter Libby, Brigham and Women’s Hospital
That Status of PM Regulations in Canada - Agnes Klein, Health Canada
Biomarker Utility in Cellular, Tissue, and Gene Therapy Product Dvpt - Steven Bauer, OCTGT/CBER, FDA
European Medicines Agency Biomarker Priorities - Pat O’Mahony, European Medicines Agency
Molecular Medicine in Ireland - Suzanne Bracken, Molecular Medicine Ireland
Application of Advanced Imaging - Robert 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 NIH - Simhan Danthi, NHLBI, NIH
Biomarkers for Heart Failure - Peter Liu, University of Toronto
Stem Cells, Genes and Devices in Cardiac Repair - Doris Taylor, University of Minnesota
Protein-Based Technologies in Cancer Research - Lance Liotta, George Mason University
Integrating Blood-Based and Imaging Markers in Clinical Trials - Jean-Claude Tardif, Montreal Heart Institute
Standardizing Imaging in Clinical Trials - Allen J. Taylor, Georgetown University

Roundtable Discussions - Faculty

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

Biomarker Qualification Project - Marc Walton, US FDA
Renal Biomarkers - Melanie Blank, US FDA
Cystatin C for Measuring GFR - Andrew Levey, Tufts Med Center
Thorough BP Project - Robert Fiorentino, US FDA
Pharmacogenomics - Issam Zineh, US FDA
The Critical Path - Douglas 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 Properties - Alan Remaley, NHLBI, NIH
HDL-Targeted Therapies - Bryan Brewer, Medstar Research
Completed and Ongoing Clinical Trials - CETP, HDL Infusion - Jean-Claude Tardif, Montreal Heart Institute
ACCORD and AIM-HIGH - Yves Rosenberg, NHLBI, NIH
HDL as Marker of Disease - Robert Rosenson, Mt. Sinai Medical Center
Regulatory Decision Making - Eric Colman, US FDA

Roundtable Discussions - Faculty