Skip to main content
Menu

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

Read Online

View Cover

Purchase Options
Purchase Options MyNAP members save 10% online. Login or Register
BuyPaperback: $35.00 BuyEbook: $27.99
EbookFormats:ePub, Kindle/MobiPocket
What is an Ebook?
Overview

Contributors

Description

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.

Topics

Suggested Citation

Institute of Medicine. 2014. Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests: Workshop Summary. Washington, DC: The National Academies Press.https://doi.org/10.17226/18617.

Import this citation to:

Publication Info

102 pages |6 x 9
ISBNs:
  • Paperback: 978-0-309-29821-6
  • Ebook: 978-0-309-29824-7
DOI: https://doi.org/10.17226/18617
Contents
Rights

Copyright Information

The National Academies Press and the Transportation Research Board have partnered with Copyright Clearance Center to offer a variety of options for reusing our content. You may request permission to:

  • Republish or display in another publication, presentation, or other media
  • Use in print or electronic course materials and dissertations
  • Share electronically via secure intranet or extranet
  • And more

For most Academic and Educational uses no royalties will be charged although you are required to obtain a license and comply with the license terms and conditions.

Click here to obtain permission forRefining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests: Workshop Summary.

Translation and Other Rights

For information on how to request permission to translate our work and for any other rights related query please click here.

Copyright.com Customer Service

For questions about using the Copyright.com service, please contact:

Copyright Clearance Center
22 Rosewood Drive
Danvers, MA 01923
Tel (toll free): 855/239-3415 (select option 1)
E-mail: info@copyright.com
Web: https://www.copyright.com
Stats

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