The Path from Biomarker Discovery to Regulatory Qualification

Content: 
Front Matter, Page iii
Copyright, Page iv
Contributors, Pages xi-xii, Shashi Amur, Jiri Aubrecht, Joseph V. Bonventre, Bruce D. Car, Jean-Philippe Couderc, Daniel C. Danila, Frank Dieterle, Stephen T. Furlong, Federico Goodsaid, Ernie Harpur, Akihiro Ishiguro, Jeffrey Jacob, Peter G. Lord, William B. Mattes, Raegan O’Lone, Yasuto Otsubo, Syril Pettit, Donald G. Robertson, Denise Robinson-Gravatt, Howard I. Scher,  et al.
Preface, Page xiii, Federico Goodsaid, William B. Mattes
1 - Biomarker Applications in the Pharmaceutical Industry, Pages 3-20, William B. Mattes
2 - Impact of Biomarker Qualification Regulatory Processes on the Critical Path for Drug Development, Pages 21-34, Federico Goodsaid
3 - Regulatory Experience of Biomarker Qualification in the EMA, Pages 35-40, Spiros Vamvakas
4 - Regulatory Experience at the FDA, EMA, and PMDA: Regulatory Experience at the PMDA, Pages 41-44, Akihiro Ishiguro, Yasuto Otsubo, Yoshiaki Uyama
5 - The Impact of Changing Context of Use on Weight of Evidence for Qualification of Biomarkers: A Case Study in Ischemic Stroke, Pages 47-51, Stephen A. Williams
6 - Safety Biomarker Development and Qualification in the Pharmaceutical Industry, Pages 53-58, Stephen T. Furlong
7 - First-Ever Regulatory Biomarker Qualification – Review and Insights by a Participant, Pages 59-66, Frank Dieterle
8 - Metabolomics-Derived Biomarkers of Drug-Induced Skeletal Muscle Injury and Urinary Bladder Transitional Cell Carcinoma in Rats, Pages 67-70, Bruce D. Car, Donald G. Robertson
9 - Molecular Biomarkers for Patients with Castration-Resistant Prostate Cancer: Validating Assays Predictive of Tumor Response, Pages 71-80, Daniel C. Danila, Howard I. Scher
10 - Gene Logic and Toxicogenomics Biomarkers, Pages 83-89, William B. Mattes
11 - The When, Where and How of Toxicogenomic Submissions to Regulatory Agencies: The Deliberations of the HL7/CDISC/I3C Pharmacogenomics Data Standards Track 1 Toxicogenomics Working Group, Pages 91-100, Peter G. Lord
12 - Biomarker Qualification – Past, Present and Future: Initiating a Cross-Sector Toxicogenomics Biomarker Initiative – Health and Environmental Sciences Institute (HESI) Committee on Application of Genomics to Mechanism-Based Risk Assessment, Pages 101-108, Denise Robinson-Gravatt, Jiri Aubrecht, Raegan O’Lone, Syril Pettit
13 - ‘Classic’ Biomarkers of Liver Injury, Pages 111-128, John R. Senior
14 - Qualification of Urinary Biomarkers for Kidney Toxicity, Pages 129-137, Joseph V. Bonventre, Vishal S. Vaidya
15 - Renal Biomarker Qualification: An ILSI Health and Environmental Sciences Institute Perspective, Pages 141-148, Syril Pettit, Ernie Harpur
16 - Vignette Regarding Consortia: C-Path Institute, Pages 149-151, Jeffrey Jacob
17 - The Telemetric and Holter ECG Warehouse to Enable the Validation and Development of Novel Electrocardiographic Markers, Pages 153-166, Jean-Philippe Couderc
18 - Path to Regulatory Qualification Program Development: A US FDA Perspective, Pages 169-173, Shashi Amur
19 - Path to Regulatory Qualification Process Development, Pages 175-177, Yasuto Otsubo, Akihiro Ishiguro, Yoshiaki Uyama
20 - The Tortuous Path From Development to Qualification of Biomarkers, Pages 179-180, Federico Goodsaid
Index, Pages 181-192