1. Food and Drug Administration. Advancing Regulatory Science at FDA: A Strategic Plan (August 2011). 2011.
2. President’s Council of Advisors on Science and Technology. Priorities for Personalized Medicine. 2008.
3. National Research Council (US) Committee on a Framework for Developing a New Taxonomy of Disease. Toward Precision Medicine: Building a Knowledge Network for Biomedical Research and a New Taxonomy of Disease. Washington, DC: National Academies Press, 2011.
4. Slatko, BE, Gardner, AF, Ausubel, FM. Overview of next-generation sequencing technologies. Current Protocols in Molecular Biology 2018; 122: e59.
5. Glenn, TC. Field guide to next-generation DNA sequencers. Molecular Ecology Resources 2011; 11: 759–769.
7. National Human Genome Research Institute. The NHGRI Genome Sequencing Program. 2018.
8. Rivers, RC, et al. Linking cancer genome to proteome: NCI’s investment into proteogenomics. Proteomics 2014; 14: 2633–2636.
9. Duarte, TT, Spencer, CT. Personalized proteomics: the future of precision medicine. Proteomes 2016; 4: 29.
12. Beger, RD, et al. Metabolomics enables precision medicine: “A White Paper, Community Perspective”. Metabolomics 2016; 12: 149.
14. Tong, W, et al. Genomics in the land of regulatory science. Regulatory Toxicology and Pharmacology 2015; 72: 102–106.
15. Jorgensen, JT, Hersom, M. Clinical and regulatory aspects of companion diagnostic development in oncology. Clinical Pharmacology and Therapeutics 2018; 103: 999–1008.
16. Food and Drug Administration. FoundationFocus CDxBRC: Premarket Approval (PMA) next generation sequencing oncology panel, somatic or germline variant detection system. 2016.
26. Kuo, T-T, Kim, H-E, Ohno-Machado, L. Blockchain distributed ledger technologies for biomedical and health care applications. Journal of the American Medical Informatics Association 2017; 24: 1211–1220.
27. Durmowicz, AG, et al. The U.S. Food and Drug Administration’s experience with ivacaftor in cystic fibrosis. Establishing efficacy using in vitro data in lieu of a clinical trial. Annals of the American Thoracic Society 2018; 15: 1–2.
28. Smith, ED, et al. Classification of genes: standardized clinical validity assessment of gene-disease associations aids diagnostic exome analysis and reclassifications. Human Mutation 2017; 38: 600–608.
29. Li, MM, et al. Standards and guidelines for the interpretation and reporting of sequence variants in cancer: a joint consensus recommendation of the Association for Molecular Pathology, American Society of Clinical Oncology, and College of American Pathologists. The Journal of Molecular Diagnostics 2017; 19: 4–23.
30. Richards, S, et al. Standards and guidelines for the interpretation of sequence variants: a joint consensus recommendation of the American College of Medical Genetics and Genomics and the Association for Molecular Pathology. Genetics in Medicine 2015; 17: 405–424.
31. Vicini, P, et al. Precision medicine in the age of big data: the present and future role of large-scale unbiased sequencing in drug discovery and development. Clinical Pharmacology and Therapeutics 2016; 99: 198–207.
32. Schmidt, C. Mammaprint reveals who can skip chemotherapy for breast cancer. Journal of the National Cancer Institute 2016; 108: 7–8.
33. Becker, AM, et al. SLE peripheral blood B cell, T cell and myeloid cell transcriptomes display unique profiles and each subset contributes to the interferon signature. PLoS One 2013; 8: e67003.
35. Darwich, AS, et al. Why has model-informed precision dosing not yet become common clinical reality? Lessons from the past and a roadmap for the future. Clinical Pharmacology and Therapeutics 2017; 101: 646–656.
36. O’Donnell, PH, et al. Pharmacogenomics-based point-of-care clinical decision support significantly alters drug prescribing. Clinical Pharmacology and Therapeutics 2017; 102: 859–869.
37. Food and Drug Administration. Software as a Medical Device (SAMD): Clinical Evaluation - Guidance for Industry and Food and Drug Administration Staff, in Federal Register, 2017, pp. 57994–57996.
38. Vassy, JL, Korf, BR, Green, RC. How to know when physicians are ready for genomic medicine. Science Translational Medicine 2015; 7: 287fs19.
39. Adamo, JE, Wilhelm, EE, Steele, SJ. Advancing a vision for regulatory science training. Clinical and Translational Science 2015; 8: 615–618.