National Academies Press: OpenBook
« Previous: 6 Concluding Observations
Suggested Citation:"References." 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. doi: 10.17226/18617.
×

References

ACOG (American College of Obstetricians and Gynecologists Committee on Genetics). 2011. ACOG committee opinion no. 486: Update on carrier screening for cystic fibrosis. Obstetrics & Gynecology 117(4):1028–1031.

Anderson, S., K. J. Bloom, D. U. Vallera, J. Rueschoff, C. Meldrum, R. Schilling, B. Kovach, J. R. Lee, P. Ochoa, R. Langland, H. Halait, H. J. Lawrence, and M. C. Dugan. 2012. Multisite analytic performance studies of a real-time polymerase chain reaction assay for the detection of BRAF V600E mutations in formalin-fixed, paraffin-embedded tissue specimens of malignant melanoma. Archives of Pathology & Laboratory Medicine 136(11):1385–1391.

Beau-Faller, M., A. Degeorges, E. Rolland, M. Mounawar, M. Antoine, V. Poulot, A. Mauguen, V. Barbu, F. Coulet, J. L. Pretet, I. Bieche, H. Blons, J. C. Boyer, M. P. Buisine, F. de Fraipont, S. Lizard, S. Olschwang, P. Saulnier, D. Prunier-Mirebeau, N. Richard, C. Danel, E. Brambilla, C. Chouaid, G. Zalcman, P. Hainaut, S. Michiels, and J. Cadranel. 2011. Cross-validation study for epidermal growth factor receptor and KRAS mutation detection in 74 blinded non-small cell lung carcinoma samples: A total of 5550 exons sequenced by 15 molecular French laboratories (evaluation of the EGFR mutation status for the administration of EGFR-TKIs in non-small cell lung carcinoma [ERMETIC] project—part 1). Journal of Thoracic Oncology 6(6):1006–1015.

Bellon, E., M. J. Ligtenberg, S. Tejpar, K. Cox, G. de Hertogh, K. de Stricker, A. Edsjo, V. Gorgoulis, G. Hofler, A. Jung, A. Kotsinas, P. Laurent-Puig, F. Lopez-Rios, T. P. Hansen, E. Rouleau, P. Vandenberghe, J. J. van Krieken, and E. Dequeker. 2011. External quality assessment for KRAS testing is needed: Setup of a European program and report of the first joined regional quality assessment rounds. Oncologist 16(4):467–478.

Brawley, O. W., and P. Goldberg. 2012. How we do harm: A doctor breaks ranks about being sick in America. 1st ed. New York: St. Martin’s Press.

Cheng, S., W. H. Koch, and L. Wu. 2012. Co-development of a companion diagnostic for targeted cancer therapy. New Biotechnology 29(6):682–688.

Chiang, A., and R. P. Million. 2011. Personalized medicine in oncology: Next generation. Nature Reviews Drug Discovery 10(12):895–896.

Suggested Citation:"References." 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. doi: 10.17226/18617.
×

CMS (Centers for Medicare & Medicaid Services). 2013. Forecast summary. Major findings for national health expenditures: 2012–2022. http://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData/Downloads/Proj2012.pdf (accessed September 20, 2013).

Davis, P. B., U. Yasothan, and P. Kirkpatrick. 2012. Ivacaftor. Nature Reviews Drug Discovery 11(5):349–350.

Dequeker, E., M. J. Ligtenberg, S. Vander Borght, and J. H. van Krieken. 2011. Mutation analysis of KRAS prior to targeted therapy in colorectal cancer: Development and evaluation of quality by a European external quality assessment scheme. Virchows Archiv 459(2):155–160.

DiMasi, J. A., R. W. Hansen, and H. G. Grabowski. 2003. The price of innovation: New estimates of drug development costs. Journal of Health Economics 22(2):151–185.

Eichler, H. G., B. Bloechl-Daum, E. Abadie, D. Barnett, F. Konig, and S. Pearson. 2010. Relative efficacy of drugs: An emerging issue between regulatory agencies and third-party payers. Nature Reviews Drug Discovery 9(4):277–291.

FDA (U.S. Food and Drug Administration). 2011. Guidance for industry and Food and Drug Administration Staff—in vitro companion diagnostic devices. http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm262292.htm (accessed October 24, 2013).

Gonzalez de Castro, D., B. Angulo, B. Gomez, D. Mair, R. Martinez, A. Suarez-Gauthier, F. Shieh, M. Velez, V. H. Brophy, H. J. Lawrence, and F. Lopez-Rios. 2012. A comparison of three methods for detecting kras mutations in formalin-fixed colorectal cancer specimens. British Journal of Cancer 107(2):345–351.

Halait, H., K. Demartin, S. Shah, S. Soviero, R. Langland, S. Cheng, G. Hillman, L. Wu, and H. J. Lawrence. 2012. Analytical performance of a real-time PCR-based assay for V600 mutations in the BRAF gene, used as the companion diagnostic test for the novel BRAF inhibitor vemurafenib in metastatic melanoma. Diagnostic Molecular Pathology 21(1):1–8.

Longshore, J. W., H. Amidon, H. N. Todd, J. Fu, M. Christensen, J. Tsai, G. Hillman, H. Halait, F. Shieh, J. Lawrence, E. Lipford. 2012. A methods comparison analysis of the Roche cobas 4800 BRAF V600 mutation test and the Qiagen BRAF RGQ PCR kit on melanoma specimens with challenging attributes. Journal of Molecular Diagnostics 14(6):716.

Moore, M. W., D. Babu, and P. D. Cotter. 2012. Challenges in the co-development of companion diagnostics. Personalized Medicine 9(5):485–496.

Quinn, B. 2010. Payers and the assessment of clinical utility for companion diagnostics. Clinical Pharmacology & Therapeutics 88(6):751–754.

van Krieken, J. H., N. Normanno, F. Blackhall, E. Boone, G. Botti, F. Carneiro, I. Celik, F. Ciardiello, I. A. Cree, Z. C. Deans, A. Edsjo, P. J. Groenen, O. Kamarainen, H. H. Kreipe, M. J. Ligtenberg, A. Marchetti, S. Murray, F. J. Opdam, S. D. Patterson, S. Patton, C. Pinto, E. Rouleau, E. Schuuring, S. Sterck, M. Taron, S. Tejpar, W. Timens, E. Thunnissen, P. M. van de Ven, A. G. Siebers, and E. Dequeker. 2013. Guideline on the requirements of external quality assessment programs in molecular pathology. Virchows Archiv 462(1):27–37.

Suggested Citation:"References." 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. doi: 10.17226/18617.
×
Page 55
Suggested Citation:"References." 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. doi: 10.17226/18617.
×
Page 56
Next: Appendix A: Workshop Agenda »
Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests: Workshop Summary Get This Book
×
 Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests: Workshop Summary
Buy Paperback | $35.00 Buy Ebook | $27.99
MyNAP members save 10% online.
Login or Register to save!
Download Free PDF

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.

READ FREE ONLINE

  1. ×

    Welcome to OpenBook!

    You're looking at OpenBook, NAP.edu's online reading room since 1999. Based on feedback from you, our users, we've made some improvements that make it easier than ever to read thousands of publications on our website.

    Do you want to take a quick tour of the OpenBook's features?

    No Thanks Take a Tour »
  2. ×

    Show this book's table of contents, where you can jump to any chapter by name.

    « Back Next »
  3. ×

    ...or use these buttons to go back to the previous chapter or skip to the next one.

    « Back Next »
  4. ×

    Jump up to the previous page or down to the next one. Also, you can type in a page number and press Enter to go directly to that page in the book.

    « Back Next »
  5. ×

    Switch between the Original Pages, where you can read the report as it appeared in print, and Text Pages for the web version, where you can highlight and search the text.

    « Back Next »
  6. ×

    To search the entire text of this book, type in your search term here and press Enter.

    « Back Next »
  7. ×

    Share a link to this book page on your preferred social network or via email.

    « Back Next »
  8. ×

    View our suggested citation for this chapter.

    « Back Next »
  9. ×

    Ready to take your reading offline? Click here to buy this book in print or download it as a free PDF, if available.

    « Back Next »
Stay Connected!