Limited Offer
The Path from Biomarker Discovery to Regulatory Qualification
- 1st Edition - July 16, 2013
- Editors: Federico Goodsaid, William B. Mattes
- Language: English
- Paperback ISBN:9 7 8 - 0 - 1 2 - 3 9 1 4 9 6 - 5
- eBook ISBN:9 7 8 - 0 - 1 2 - 3 9 4 4 0 8 - 5
The Path from Biomarker Discovery to Regulatory Qualification is a unique guide that focuses on biomarker qualification, its history and current regulatory settings in both… Read more
Purchase options
Institutional subscription on ScienceDirect
Request a sales quoteThe Path from Biomarker Discovery to Regulatory Qualification is a unique guide that focuses on biomarker qualification, its history and current regulatory settings in both the US and abroad. This multi-contributed book provides a detailed look at the next step to developing biomarkers for clinical use and covers overall concepts, challenges, strategies and solutions based on the experiences of regulatory authorities and scientists. Members of the regulatory, pharmaceutical and biomarker development communities will benefit the most from using this book—it is a complete and practical guide to biomarker qualification, providing valuable insight to an ever-evolving and important area of regulatory science.
For complimentary access to chapter 13, 'Classic' Biomarkers of Liver Injury, by John R. Senior, Associate Director for Science, Food and Drug Administration, Silver Spring, Maryland, USA, please visit the following site: http://tinyurl.com/ClassicBiomarkers
- Contains a collection of experiences of different groups taking different types of biomarkers to different levels of qualification and provides insightful case studies of an important area of regulatory science
- Focuses on practical advice, concepts, strategies and overall outcomes to support those working toward biomarker qualification for clinical use
- Offers a valuable resource for members of the regulatory, pharmaceutical and biomarker development communities
The primary audience includes pharmaceutical scientists and pharmacologists, clinicians and drug development managers and executives involved in pharmaceutical development.
Section 1: Introduction
1. Biomarker Applications in the Pharmaceutical Industry
Diagnostic Applications
Prognostic Applications
Intervention Management/Monitoring
Concluding Remarks
References
2. Impact of Biomarker Qualification Regulatory Processes on the Critical Path for Drug Development
Introduction
Has the Process at the FDA (CDER) Achieved the Goals Originally Proposed by the Pharmacogenomics Guidance in 2005 and the Critical Path Opportunities List and Report in 2006?
What are the Strengths and Weaknesses of the Different Versions of a Biomarker Qualification Process Developed in Each ICH Region?
How Well Have the Different Versions of This Process Been Harmonized across These Regions?
What are the Opportunities and Challenges for a Single, Universal, Biomarker Qualification Process?
How Can We Develop Metrics with Which to Measure the Impact of These Processes on Drug Development and Their Acceptance by the Pharmaceutical Industry?
Summary
References
3. Regulatory Experience of Biomarker Qualification in the EMA
Other Informal Interactions with the EMA
Examples of Qualification Opinions
4. Regulatory Experience at the FDA, EMA, and PMDA: Regulatory Experience at the PMDA
Acknowledgment
References
Section 2: Biomarker Development and Qualification in the Pharmaceutical Industry
5. The Impact of Changing Context of Use on Weight of Evidence for Qualification of Biomarkers: A Case Study in Ischemic Stroke
6. Safety Biomarker Development and Qualification in the Pharmaceutical Industry
7. First-Ever Regulatory Biomarker Qualification – Review and Insights by a Participant
References
8. Metabolomics-Derived Biomarkers of Drug-Induced Skeletal Muscle Injury and Urinary Bladder Transitional Cell Carcinoma in Rats
Metabolomic Biomarker for Drug-Induced Skeletal Muscle Injury in Rats
Metabolomic Biomarker for Causation of Bladder Tumorigenesis in Rats
Summary
References
9. Molecular Biomarkers for Patients with Castration-Resistant Prostate Cancer: Validating Assays Predictive of Tumor Response
Unmet Needs to be Addressed with Biomarkers
FDA-Approved Method and Demonstrated Use
Emerging Molecular Biomarkers
Validating Genomic Biomarkers in CTCs
Molecular Biomarkers in a CLIA-Certified Laboratory
Changing the Paradigm for Assessment of Recurrent Prostate Cancer: a Liquid Biopsy
References
Section 3: Toxicogenomic Biomarkers
10. Gene Logic and Toxicogenomics Biomarkers
References
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
Acknowledgments
Introduction and Background
Toxicogenomic Applications in Drug Discovery and Development
The Case Examples
A Hypothetical Submission in Support of the Safety Claims for a Hypolipidemic Drug
Highlights from the Discussions
Conclusions
References
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
HESI’s Contributions to the Emerging Field of Toxicogenomics
Use of Toxicogenomics to Biological Assess Mechanisms – Case Studies
Current Focus and Activities of the HESI Genomics Committee
Summary and Future Horizons
References
Section 4: Biomarkers of Drug Safety
13. ‘Classic’ Biomarkers of Liver Injury
Bilirubin
Alternative and Discarded Biomarkers
Aminotransferases (Transaminases)
Combined ALT and TBL Measurements
Conclusions and Recommendations
References
14. Qualification of Urinary Biomarkers for Kidney Toxicity
Regulatory Framework: Advancing the Science of Biomarkers
Kidney Injury Molecule-1: Characteristics
Collaborations in Consortia
Interactions with the FDA and EMA
Translation to Clinical Use
Conclusions
References
Section 5: Consortia
15. Renal Biomarker Qualification: An ILSI Health and Environmental Sciences Institute Perspective
Safety Biomarker Research – the Origin of this Activity in HESI
Creation of Biomarker Working Groups
Biomarkers of Nephrotoxicity Committee (BNC)
Biomarker Qualification: the Changing Landscape
References
16. Vignette Regarding Consortia: C-Path Institute
17. The Telemetric and Holter ECG Warehouse to Enable the Validation and Development of Novel Electrocardiographic Markers
Introduction
QT Interval as a Safety Marker in Drug Development
QT Interval: from a Biomarker to a Surrogate Marker
The Thorough QT Studies (TQT)
Improving the QT Marker
QT, Heart Rate and Autonomic Regulation
Inception of the Telemetric and Holter ECG Warehouse (THEW): a Model to Develop Academia-Regulators-Industries Partnerships
Involving the FDA and Industry
Participation by the National Institutes of Health
Facilitating the Submission of New ECG Markers to the FDA
Conclusions and Perspectives
References
Section VI: Path to Regulatory Qualification Process Development
18. Path to Regulatory Qualification Program Development: A US FDA Perspective
Acknowledgments
The Biomarker Qualification Process at US FDA
Current Status of Biomarker Qualification Submissions
Future Perspectives
References
19. Path to Regulatory Qualification Process Development
Acknowledgment
References
20. The Tortuous Path From Development to Qualification of Biomarkers
- No. of pages: 206
- Language: English
- Edition: 1
- Published: July 16, 2013
- Imprint: Academic Press
- Paperback ISBN: 9780123914965
- eBook ISBN: 9780123944085
FG
Federico Goodsaid
WM