Collins, F. S. 2011. Reengineering translational science: The time is right. Science Translational Medicine 3(90):90cm17.
Eichler, H. G., B. Bloechl-Daum, E. Abadie, D. Barnett, F. König, 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 (Food and Drug Administration). 2011. Advancing regulatory science at FDA: A strategic plan, http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/RegulatoryScience/UCM268225.pdf (accessed June 18, 2012).
Goldman, M. 2012. The Innovative Medicines Initiative: A European response to the innovation challenge. Clinical Pharmacology and Therapeutics 9(3):418–425.
Herper, M. 2012. The truly staggering cost of inventing new drugs. Forbes, February 10.
Hewitt, J., J. D. Campbell, and J. Cacciotti. 2011. Beyond the shadow of a drought: The need for a new mindset in pharma R&D. Oliver Wyman, http://www.oliverwyman.com/media/OW_EN_HLS_PUBL_2011_Beyond_the_Shadow_of_a_Drought%283%29.pdf (accessed June 19, 2012).
Huang, R., N. Southall, Y. Wang, A. Yasgar, P. Shinn, A. Jadhav, D. T. Nguyen, and C. P. Austin. 2011. The NCGC pharmaceutical collection: A comprehensive resource of clinically approved drugs enabling repurposing and chemical genomics. Science Translational Medicine 3(80):80ps16.
IOM (Institute of Medicine). 2011. Establishing precompetitive collaborations to stimulate genomics-driven product development: Workshop summary. Washington, DC: The National Academies Press.
Kris, M. G., B. E. Johnson, D. J. Kwiatkowski, A. J. Iafrate, I. I. Wistuba, S. L. Aronson, J. A. Engelman, Y. Shyr, F. R. Khuri, C. M. Rudin, E. B. Garon, W. Pao, J. H. Schiller, E. B. Haura, K. Shirai, G. Giaccone, L. D. Berry, K. Kugler, J. D. Minna, and P. A. Bunn. 2011. Identification of driver mutations in tumor specimens from 1,000 patients with lung adenocarcinoma: The NCI’s Lung Cancer Mutation Consortium (LCMC). Journal of Clinical Oncology 29(Suppl 18):CRA7506. http://meeting.ascopubs.org/cgi/content/abstract/29/18_suppl/CRA7506?sid=582aea71-36a2-4117-96c7-9e783602272f (accessed June 19, 2012).
Lillie, E. O., B. Patay, J. Diamant, B. Issell, E. J. Topol, and N. J. Schork. 2011. The N-of-1 clinical trial: The ultimate strategy for individualizing medicine? Personalized Medicine 8(2):161–173.
Mullard, A. 2012. FDA drug approvals. Nature Reviews Drug Discovery 11(2):91–94.
Munos, B. 2009. Lessons from 60 years of pharmaceutical innovation. Nature Reviews Drug Discovery 8(12):959–968.
NRC (National Research Council). 2011. Toward precision medicine: Building a knowledge network for biomedical research and a new taxonomy of disease. Washington, DC: The National Academies Press.
Patil, S. T., L. Zhang, F. Martenyi, S. L. Lowe, K. A. Jackson, B. V. Andreev, A. S. Avedisova, L. M. Bardenstein, I. Y. Gurovich, M. A. Morozova, S. N. Mosolov, N. G. Neznanov, A. M. Reznik, A. B. Smulevich, V. A. Tochilov, B. G. Johnson, J. A. Monn, and D. D. Schoepp. 2007. Activation of mGlu2/3 receptors as a new approach to treat schizophrenia: A randomized Phase 2 clinical trial. Nature Medicine 13(9):1102–1107.
Paul, S. M., D. S. Mytelka, C. T. Dunwiddie, C. C. Persinger, B. H. Munos, S. R. Lindborg, and A. L. Schacht. 2010. How to improve R&D productivity: The pharmaceutical industry’s grand challenge. Nature Reviews Drug Discovery 9(3):203–214.
Pirmohamed, M., S. James, S. Meakin, C. Green, A. K. Scott, T. J. Walley, K. Farrar, B. K. Park, and A. M. Breckenridge. 2004. Adverse drug reactions as cause of admission to hospital: Prospective analysis of 18,820 patients. British Medical Journal 329(7456):15–19.
Pollack, A. 2010. Awaiting the genome payoff. New York Times, June 14, B1.
Ramsey, B. W., N. G. Davies, E. McElvaney, E. Tullis, S. C. Bell, P. Devínek, M. Griese, E. F. McKone, C. E. Wainwright, M. W. Konstan, R. Moss, F. Ratjen, I. Sermet-Gaudelus, S. M. Rowe, Q. Dong, S. Rodriguez, K. Yen, C. Ordoñez, J. S. Elborn, and VX08-770-102 Study Group. 2011. A CFTR potentiator in patients with cystic fibrosis and the G551D mutation. New England Journal of Medicine 365(18):1663–1672.
Riess, J. W., and H. A. Wakelee. 2012. Metastatic non-small cell lung cancer management: Novel targets and recent clinical advances. Clinical Advances in Hematology & Oncology 10(4):226–234. http://www.clinicaladvances.com/article_pdfs/ho0412_reiss.pdf (accessed June 18, 2012).
Rikova, K., A. Guo, Q. Zeng, A. Possemato, J. Yu, H. Haack, J. Nardone, K. Lee, C. Reeves, Y. Li, Y. Hu, Z. Tan, M. Stokes, L. Sullivan, J. Mitchell, R. Wetzel, J. Macneill, J. M. Ren, J. Yuan, C. E. Bakalarski, J. Villen, J. M. Kornhauser, B. Smith, D. Li, X. Zhou, S. P. Gygi, T. L. Gu, R. D. Polakiewicz, J. Rush, and M. J. Comb. 2007. Global survey of phosphotyrosine signaling identifies oncogenic kinases in lung cancer. Cell 131(6):1190–1203.
Scannell, J. W., A. Blanckley, H. Boldon, and B. Warrington. 2012. Diagnosing the decline in pharmaceutical R&D efficiency. Nature Reviews Drug Discovery 11(3):191–200.
Sirota, M., J. T. Dudley, J. Kim, A. P. Chiang, A. A. Morgan, A. Sweet-Cordero, J. Sage, and A. T. Butte. 2011. Discovery and preclinical validation of drug indications using compendia of public gene expression data. Science Translational Medicine 3(96):96ra77.
Soda, M., Y. L. Choi, M. Enomoto, S. Takada, Y. Yamashita, S. Ishikawa, S. Fujiwara, H. Watanabe, K. Kurashina, H. Hatanaka, M. Bando, S. Ohno, Y. Ishikawa, H. Aburatani, T. Niki, Y. Sohara, Y. Sugiyama, and H. Mano. 2007. Identification of the transforming EML4-ALK fusion gene in non-small-cell lung cancer. Nature 448(7153):561–566.
Spear, B. B., M. Heath-Chiozzi, and J. Huff. 2001. Clinical application of pharmacogenetics. Trends in Molecular Medicine 7(5):201–204.
Trusheim, M. R., E. R. Berndt, and F. L. Douglas. 2007. Stratified medicine: Strategic and economic implications of combining drugs and clinical biomarkers. Nature Reviews Drug Discovery 6(4):287–293.
Trusheim, M. R., B. Burgess, S. X. Hu, T. Long, S. D. Averbuch, A. A. Flynn, A. Lieftucht, A. Mazumder, J. Milloy, P. W. Shaw, D. Swank, J. Wang, E. R. Berndt, F. Goodsaid, and M. C. Palmer. 2011. Quantifying factors for the success of stratified medicine. Nature Reviews Drug Discovery 10(11):817–833.
Tufts Center for the Study of Drug Development. 2010. Personalized medicine is playing a growing role in development pipelines. Impact Reports 12(6).
Wade, N. 2010. A decade later, genetic map yields few new cures. New York Times, June 12, A1.