Actions for Refining Processes for the Co-Development of Genome-based Therapeutics and Companion Diagnostic Tests : workshop summary

Email RIS file
Bookmark
Report an Issue

Refining Processes for the Co-Development of Genome-based Therapeutics and Companion Diagnostic Tests : workshop summary / Sarah H. Beachy, Samuel G. Johnson, Steve Olson, and Adam C. Berger, rapporteurs ; Roundtable on Translating Genomic-Based Research for Health, Board on Health Sciences Policy, Institute of Medicine of the National Academies

Conference Author
Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests (Workshop) (2013 : Washington, D.C.), author
Published
Washington, D.C. : The National Academies Press, [2014]
Physical Description
xx, 82 pages : illustrations ; 23 cm
Additional Creators
Beachy, Sarah H., Johnson, Samuel G., Olsen, Steve, and Berger, Adam C.
Online Version
  • National Academies Press: www.nap.edu
  • www.nap.edu , Connect to this title online: http://www.nap.edu/openbook.php?isbn=0309298210

Availability

RM301.25.R44 2014 RM301.25.R44 2014 EBOOK
I Want It
I Want It

Finding items...

Contents
Regulatory Perspectives -- Perspectives from Patients, Providers, and Laboratory Representatives -- Perspectives of Diagnostic Test and Pharmaceutical Developers -- Perspectives of Payers and Regulators -- Concluding Observations -- References -- Appendix A: Workshop Agenda -- Appendix B: Speaker Biographical Sketches -- Appendix C: Statement of Task -- Appendix D: Registered Attendees.
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."-- Publisher's description.
Subject(s)
ISBN
9780309298216
0309298210
Note
"Roundtable on Translating Genomic-Based Research for Health"--Cover.
Bibliography Note
Includes bibliographic references (pages 55-56)
Other Forms
Also available via the World Wide Web.
View MARC record | catkey: 12554234