Name: Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests. Workshop Summary
SKU: 64811412
Price: 641.00 ZAR
Availability: InStock
Author: Board on Health Sciences Policy;Steve Olson;Sarah H. Beachy;Samuel G. Johnson;Adam C. Berger;Roundtable on Translating Genomic-Based Research for Health;Institute of Medicine
ISBN: 9780309298216

portada Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests. Workshop Summary

Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests. Workshop Summary

Type

Physical Book

Publisher

National Academies Press

Author

Board on Health Sciences Policy;Steve Olson;Sarah H. Beachy;Samuel G. Johnson;Adam C. Berger;Roundtable on Translating Genomic-Based Research for Health;Institute of Medicine

Year

2014

Pages

102

Format

Paperback

Dimensions

22.9x15.2x2.5 cm

ISBN13

9780309298216

Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests. Workshop Summary

Board On Health Sciences Policy;Steve Olson;Sarah H. Beachy;Samuel G. Johnson;Adam C. Berger;Roundtable On Translating Genomic-Based Research For Health;Institute Of Medicine (Author) · National Academies Press · Paperback

New Book Imported to South Africa

Delivery: 29 Sep - 07 Oct

R 641

R 641

Add to Wishlist

Synopsis "Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests. Workshop Summary"

Many drug developers have examined new strategies for creating efficiencies in their development processes, including the adoption of genomics-based approaches. Genomic data can identify new drug targets for both common and rare diseases, can predict which patients are likely to respond to a specific treatment, and has the potential to significantly reduce the cost of clinical trials by reducing the number of patients that must be enrolled in order to demonstrate safety and efficacy. A key component of the approval of targeted therapeutics is the ability to identify the population of patients who will benefit from treatment, and this has largely hinged on the co-development and co-submission to the FDA of a companion diagnostic test.The co-development process, or the development of the test and drug for the simultaneous submission to FDA, has led to a major alteration in the way that drugs are being developed, with traditionally separate entities—pharmaceutical and diagnostic companies—now working in close collaboration. Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests is the summary of a workshop held by the Roundtable on Translating Genomic-Based Research for Health on February 27, 2013 to examine and discuss challenges and potential solutions for the codevelopment of targeted therapeutics and companion molecular tests for the prediction of drug response. Prior to the workshop, key stakeholders, including laboratory and medical professional societies, were individually asked to provide possible solutions to resolve the concerns raised about co-development of companion diagnostic tests and therapies. Workshop speakers were charged with addressing these solutions in their presentations by providing insight on (1) whether the proposed solutions address the problems described, (2) whether there are other solutions to propose, and (3) what steps could be taken to effectively implement the proposed solutions.Table of ContentsFront Matter1 Introduction2 Regulatory Perspectives3 Perspectives from Patients, Providers, and Laboratory Representatives4 Perspectives of Diagnostic Test and Pharmaceutical Developers5 Perspectives of Payers and Regulators6 Concluding ObservationsReferencesAppendix A: Workshop AgendaAppendix B: Speaker Biographical SketchesAppendix C: Statement of TaskAppendix D: Registered Attendees