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

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor principal: Medicine, Institute of
Otros Autores: Policy, Board on Health Sciences, Health, Roundtable on Translating Genomic-Based Research for
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Washington : National Academies Press, 2014.
Temas:
Acceso en línea:Texto completo

MARC

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100 1 |a Medicine, Institute of. 
245 1 0 |a Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests :  |b Workshop Summary. 
260 |a Washington :  |b National Academies Press,  |c 2014. 
300 |a 1 online resource (102 pages) 
336 |a text  |b txt  |2 rdacontent 
337 |a computer  |b c  |2 rdamedia 
338 |a online resource  |b cr  |2 rdacarrier 
588 0 |a Print version record. 
505 0 |a 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 
546 |a English. 
504 |a Includes bibliographical references. 
520 8 |a Annotation  |b 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. 
590 |a ProQuest Ebook Central  |b Ebook Central Academic Complete 
650 0 |a Drug development  |x Diagnosis  |v Congresses. 
650 0 |a Gene therapy  |v Congresses. 
650 0 |a Human chromosome abnormalities  |v Congresses. 
650 0 |a Therapeutics  |v Congresses. 
650 0 |a Genetics  |x Technique. 
650 0 |a Diagnostic services. 
650 0 |a Pharmaceutical chemistry. 
650 0 |a National health services. 
650 0 |a Diagnosis. 
650 0 |a Pharmacology. 
650 0 |a Chemistry. 
650 0 |a Medical care. 
650 0 |a Physical sciences. 
650 0 |a Life sciences. 
650 0 |a Genetic screening. 
650 0 |a Drugs  |x Design. 
650 2 |a Genetic Techniques 
650 2 |a Genetic Services 
650 2 |a Drug Discovery 
650 2 |a Diagnostic Techniques and Procedures 
650 2 |a Diagnostic Services 
650 2 |a Evaluation Studies as Topic 
650 2 |a Chemistry, Pharmaceutical 
650 2 |a Investigative Techniques 
650 2 |a Health Services 
650 2 |a Preventive Health Services 
650 2 |a Diagnosis 
650 2 |a Analytical, Diagnostic and Therapeutic Techniques and Equipment 
650 2 |a Health Care Facilities, Manpower, and Services 
650 2 |a Pharmacology 
650 2 |a Community Health Services 
650 2 |a Chemistry 
650 2 |a Delivery of Health Care 
650 2 |a Natural Science Disciplines 
650 2 |a Biological Science Disciplines 
650 2 |a Disciplines and Occupations 
650 2 |a Genetic Testing 
650 2 |a Drug Design 
650 2 |a Drug Evaluation 
650 2 |a State Medicine 
650 2 |a Patient Care 
650 6 |a Thérapie génique  |v Congrès. 
650 6 |a Chromosomes humains  |x Anomalies  |v Congrès. 
650 6 |a Thérapeutique  |v Congrès. 
650 6 |a Génétique  |x Technique. 
650 6 |a Diagnostics  |x Méthodologie. 
650 6 |a Services de diagnostics. 
650 6 |a Chimie pharmaceutique. 
650 6 |a Services de santé. 
650 6 |a Diagnostics. 
650 6 |a Pharmacologie. 
650 6 |a Chimie. 
650 6 |a Prestation de soins. 
650 6 |a Sciences physiques. 
650 6 |a Sciences de la vie. 
650 6 |a Dépistage génétique. 
650 6 |a Médicaments  |x Conception. 
650 6 |a Soins médicaux. 
650 7 |a diagnosis.  |2 aat 
650 7 |a pharmacology.  |2 aat 
650 7 |a chemistry.  |2 aat 
650 7 |a physical sciences.  |2 aat 
650 7 |a biological sciences.  |2 aat 
650 7 |a Physical sciences  |2 fast 
650 7 |a Pharmacology  |2 fast 
650 7 |a Pharmaceutical chemistry  |2 fast 
650 7 |a National health services  |2 fast 
650 7 |a Medical care  |2 fast 
650 7 |a Life sciences  |2 fast 
650 7 |a Genetics  |x Technique  |2 fast 
650 7 |a Genetic screening  |2 fast 
650 7 |a Drugs  |x Design  |2 fast 
650 7 |a Diagnostic services  |2 fast 
650 7 |a Diagnosis  |2 fast 
650 7 |a Chemistry  |2 fast 
650 7 |a Gene therapy  |2 fast 
650 7 |a Human chromosome abnormalities  |2 fast 
650 7 |a Therapeutics  |2 fast 
655 7 |a Conference papers and proceedings  |2 fast 
700 1 |a Policy, Board on Health Sciences. 
700 1 |a Health, Roundtable on Translating Genomic-Based Research for. 
758 |i has work:  |a Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests (Text)  |1 https://id.oclc.org/worldcat/entity/E39PCYX7DFKVqKMMbcpkJRY3wC  |4 https://id.oclc.org/worldcat/ontology/hasWork 
776 0 8 |i Print version:  |a Medicine, Institute of.  |t Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests : Workshop Summary.  |d Washington : National Academies Press, ©1900  |z 9780309298216 
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