The Resource 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

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

Label
Refining processes for the co-development of genome-based therapeutics and companion diagnostic tests : workshop summary
Title
Refining processes for the co-development of genome-based therapeutics and companion diagnostic tests
Title remainder
workshop summary
Statement of responsibility
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
Creator
Contributor
Author
Issuing body
Subject
Genre
Language
eng
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
Cataloging source
DNLM
Dewey number
615.19
Funding information
This project was supported by contracts between the National Academy of Sciences and the American Academy of Nursing (unnumbered contract); American College of Medical Genetics and Genomics (unnumbered contract); American Heart Association (unnumbered contract); American Medical Association (unnumbered contract); American Society of Human Genetics (unnumbered contract); Association for Molecular Pathology (unnumbered contract); Blue Cross and Blue Shield Association (unnumbered contract); College of American Pathologists (unnumbered contract); Department of the Air Force (Contract No. FA7014-0-P-0072); Department of Veterans Affairs (Contract No. VA248-P-1528); Eli Lilly and Company (unnumbered contract); Genetic Alliance (unnumbered contract); Health Resources and Services Administration (Contract No. HHSH250201100119P and Contract No. HHSH25034017T); International Society for Cardiovascular Translational Research (unnumbered contract); Johnson & Johnson (unnumbered contract); The Kaiser Permanente Program Offices Community Benefit II at the East Bay Community Foundation (Contract No. 20121257); Life Technologies (unnumbered contract); National Cancer Institute (Contract No. HHSN263201200074I, TO#5); National Coalition for Health Professional Education in Genetics (unnumbered contract); National Heart, Lung, and Blood Institute (Contract No. N01-OD-4-2139, TO#275); National Human Genome Research Institute (Contract No. N01-OD-4-2139, TO#264 and Contract No. HHSN263201200074I, TO#5); National Institute of Mental Health (Contract No. N01-OD-4-2139, TO#275 and Contract No. HHSN263201200074I, TO#5); National Institute of Nursing Research (Contract No. HHSN263201200074I, TO#5); National Institute on Aging (Contract No. N01-OD-4-2139, TO#275 and Contract No. HHSN263201200074I, TO#5); National Society of Genetic Counselors (unnumbered contract); Northrop Grumman Health IT (unnumbered contract); Office of Rare Diseases Research (Contract No. N01-OD-4-2139, TO#275); Pfizer Inc. (unnumbered contract); and PhRMA (unnumbered contract). The views presented in this publication do not necessarily reflect the views of the organizations or agencies that provided support for the activity
Illustrations
illustrations
Index
no index present
LC call number
RM301.25
Literary form
non fiction
Nature of contents
  • dictionaries
  • bibliography
Label
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
Publication
Note
Title from PDF title page
Bibliography note
Includes bibliographical references
http://library.link/vocab/branchCode
  • net
Carrier category
online resource
Carrier category code
cr
Carrier MARC source
rdacarrier
Color
black and white
Content category
text
Content type code
txt
Content type MARC source
rdacontent
Contents
Regulatory perspectives -- Perspectives from patients, providers, and laboratory representatives -- Perspectives of diagnostic test and pharmaceutical developers -- Perspectives of payers and regulators -- Concluding observations
Control code
ocn883365884
Dimensions
unknown
Extent
1 online resource (1 PDF file (xx, 82 pages))
Form of item
online
Isbn
9780309298223
Media category
computer
Media MARC source
rdamedia
Media type code
c
Other physical details
illustrations
http://library.link/vocab/recordID
.b35604505
Specific material designation
remote
System control number
  • (OCoLC)883365884
  • pebcs0309298210

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