A tentative schedule of events for the M-CERSI symposium on Evidentiary Considerations for Integration of Biomarkers in Drug Development is provided below for your convenience.
This one-day symposium scheduled for August 21, 2015, will be held at the University of Maryland School of Pharmacy in Baltimore, Md. It is open to the public. For a printable version of this schedule, please download the agenda.
Session 1: General Introduction and Overview
| Time | Activity |
|---|---|
| 9:00-9:10 a.m. | Welcome James Polli, PhD Shangraw/Noxell Endowed Chair in Industrial Pharmacy and Pharmaceutics Department of Pharmaceutical Sciences University of Maryland School of Pharmacy Natalie D. Eddington, PhD, FCP, FAAPS Dean and Professor University of Maryland School of Pharmacy |
| 9:10-9:30 a.m. | Opening Remarks/Charge to Participants Janet Woodcock, MD Director, Center for Drug Evaluation and Research Food and Drug Administration |
| 9:30-9:55 a.m. | FDA’s Efforts to Encourage Biomarker Development and Qualification Shashi Amur, PhD Biomarker Qualification Scientific Coordinator Office of Translational Sciences Center for Drug Evaluation and Research Food and Drug Administration |
| 9:55-10:15 a.m. | Statistical Considerations in Biomarker Development and Qualification Aloka Chakravarty, PhD Director, Division of Biometrics Office of Biostatistics Center for Drug Evaluation and Research Food and Drug Administration |
| 10:15-10:35 a.m. | Assay Validation and Reproducibility Considerations for Biomarkers Used in Drug Development Lisa McShane, PhD Mathematical Statistician Division of Cancer Treatment and Diagnosis National Cancer Institute |
| 10:35-10:55 a.m. | Q&A and/or Panel Discussion |
| 10:55-11:05 a.m. | Coffee Break |
Session 2: Evidentiary Considerations for Clinical Safety Biomarkers
| Time | Activity |
|---|---|
| 11:05-11:20 a.m. | Mechanisms of Drug Toxicity and Relevance to Pharmaceutical Development F. Peter Guengerich, PhD Tadashi Inagami Professor of Biochemistry Vanderbilt University |
| 11:20-11:40 a.m. | A Case Study: Clinical Safety Biomarkers Including Methodological Considerations John-Michael Sauer, PhD Executive Directory, Predictive Safety Testing Consortium Critical Path Institute |
| 11:40-12:00 p.m. | Statistical Considerations for Clinical Safety Biomarkers Robin Mogg, PhD Scientific Director, Statistical Modeling The Janssen Pharmaceutical Companies of Johnson & Johnson |
| 12:00-1:00 p.m. | Panel Discussion Michael Lawton Research Fellow Pfizer Paul Watkins, MD Director, Hamner Institutes for Health Sciences University of North Carolina Sue Jane Wang, PhD Associate Director (Pharmacogenomics) Office of Biostatistics Organization Center for Drug Evaluation and Research Food and Drug Administration Christopher Leptak, MD, PhD Medical Officer Office of New Drugs Food and Drug Administration Norman Stockbridge, MD, PhD Director, Division of Cardiovascular and Renal Products Office of Drug Evaluation I Food and Drug Administration |
| 1:00-2:00 p.m. | Lunch |
Session 3: Evidentiary Considerations for Biomarker-Based Enrichment of Clinical Study Populations to Increase Efficacy or Safety of Drugs
| Time | Activity |
|---|---|
| 2:00-2:15 p.m. | Biomarker-Based Enrichment of Clinical Study Populations Scott Patterson, PhD Vice President, Biomarker Sciences Gilead Sciences, Inc. |
| 2:15-2:30 p.m. | Neuroimaging Enrichment Biomarkers for CNS Diseases Adam Schwarz, PhD Head of Imaging Eli Lilly and Company |
| 2:30-2:45 p.m. | Case Study: Polycystic Kidney Disease – From Bench to Bedside Arlene Chapman, MD Chief of Nephrology Professor of Medicine University of Chicago |
| 2:45-3:00 p.m. | Statistical Considerations for BQ for Biomarker-Based Enrichment in Clinical Studies Suzanne Hendrix, PhD President Pentara Corporation |
| 3:00-3:40 p.m. |
Panel Discussion |
| 3:40-4:00 p.m. | Coffee Break |
Session 4: Facilitated Discussion (FDA/C-Path)
| Time | Activity |
|---|---|
| 4:00-5:00 p.m. | Evidentiary Considerations for Safety Biomarkers and Enrichment Biomarkers ShaAvhrée Buckman-Garner, MD, PhD, FAAP Director, Office of Translational Sciences Center for Drug Evaluation and Research Food and Drug Administration Martha Brumfield, PhD President and Chief Executive Officer Critical Path Institute |