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E-book
Author Medicine, Institute of

Title Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests : Workshop Summary
Published Washington : National Academies Press, 2014

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Description 1 online resource (102 pages)
Contents FrontMatter -- Reviewers -- Acknowledgments -- Contents -- Boxes, Figures, and Tables -- Abbreviations and Acronyms -- 1 Introduction -- 2 Regulatory Perspectives -- 3 Perspectives from Patients, Providers, and Laboratory Representatives -- 4 Perspectives of Diagnostic Test and Pharmaceutical Developers -- 5 Perspectives of Payers and Regulators -- 6 Concluding Observations -- References -- Appendix A: Workshop Agenda -- Appendix B: Speaker Biographical Sketches -- Appendix C: Statement of Task -- Appendix D: Registered Attendees
Summary Annotation 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
Bibliography Includes bibliographical references
Notes English
Print version record
Subject Drug development -- Diagnosis -- Congresses
Gene therapy -- Congresses
Human chromosome abnormalities -- Congresses
Therapeutics -- Congresses
Genetics -- Technique.
Diagnostic services.
Pharmaceutical chemistry.
National health services.
Diagnosis.
Pharmacology.
Chemistry.
Medical care.
Physical sciences.
Life sciences.
Genetic screening.
Drugs -- Design.
Genetic Techniques
Genetic Services
Drug Discovery
Diagnostic Techniques and Procedures
Diagnostic Services
Evaluation Studies as Topic
Chemistry, Pharmaceutical
Investigative Techniques
Health Services
Preventive Health Services
Diagnosis
Analytical, Diagnostic and Therapeutic Techniques and Equipment
Health Care Facilities, Manpower, and Services
Pharmacology
Community Health Services
Chemistry
Delivery of Health Care
Natural Science Disciplines
Biological Science Disciplines
Disciplines and Occupations
Genetic Testing
Drug Design
Drug Evaluation
State Medicine
Patient Care
diagnosis.
pharmacology.
chemistry.
physical sciences.
biological sciences.
Physical sciences
Pharmacology
Pharmaceutical chemistry
National health services
Medical care
Life sciences
Genetics -- Technique
Genetic screening
Drugs -- Design
Diagnostic services
Diagnosis
Chemistry
Gene therapy
Human chromosome abnormalities
Therapeutics
Genre/Form Conference papers and proceedings
Form Electronic book
Author Policy, Board on Health Sciences
Health, Roundtable on Translating Genomic-Based Research for
ISBN 9780309298223
0309298229
0309298210
9780309298216