Barker, A., C. C. Sigman, G. J. Kelloff, N. M. Hylton, D. A. Berry, and L. J. Esserman. 2009. I-SPY 2: An adaptive breast cancer trial design in the setting of neoadjuvant chemotherapy. Clinical Pharmacology & Therapeutics 86(1):97–100.
Booth, B., and R. Zemmel. 2004. Prospects for productivity. Nature Reviews Drug Discovery 3(5):451–456.
CEO Life Sciences Consortium and NCI (National Cancer Institute). 2008. Proposed standardized/harmonized clauses for clinical trial agreements. http://transformingtrials.cancer.gov/files/StClauses.pdf (accessed September 1, 2011).
Cheever, M. A. 2008. Twelve immunotherapy drugs that could cure cancers. Immunological Reviews 222:357–368.
Cosimo, S. D., J. C. Bendell, A. Cervantes-Ruiperez, D. Roda, L. Prudkin, M. N. Stein, A. Leighton-Swayze, Y. Song, S. Ebbinghaus, and J. Baselga. 2010. A phase I study of the oral mTOR inhibitor ridaforolimus (RIDA) in combination with the IGF-1R antibody dalotozumab (DALO) in patients (pts) with advanced solid tumors. Journal of Clinical Oncology 28(15S):3008.
Dilts, D. M., and A. B. Sandler. 2006. Invisible barriers to clinical trials: The impact of structural, infrastructural, and procedural barriers to opening oncology clinical trials. Journal of Clinical Oncology 24(28):4545–4552.
DOJ (U.S. Department of Justice). 2008. Response to the CEO Roundtable on Cancer’s request for business review letter. http://www.justice.gov/atr/public/busreview/237311.pdf (accessed April 19, 2010).
Engelman, J. A., K. Zejnullahu, T. Mitsudomi, Y. Song, C. Hyland, J. O. Park, N. Lindeman, C.-M. Gale, X. Zhao, J. Christensen, T. Kosaka, A. J. Holmes, A. M. Rogers, F. Cappuzzo, T. Mok, C. Lee, B. E. Johnson, L. C. Cantley, and P. A. Jänne. 2007. MET amplification leads to gefitinib resistance in lung cancer by activating ERBB3 signaling. Science 316(5827):1039–1043.
FDA (U.S. Food and Drug Administration). 2010. Guidance for industry: Qualification process for drug development tools. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM230597.pdf (accessed September 1, 2011).
FHCRC (Fred Hutchinson Cancer Research Center). 2011. Cancer Immunotherapy Trials Network (CITN). http://www.fhcrc.org/science/vidd/programs/citn/index.html (accessed September 1, 2011).
FNIH (Foundation for the National Institutes of Health). 2010. The Biomarkers Consortium Launches I-SPY 2 breast cancer clinical trial. http://www.fnih.org/work/key-initiatives-0/i-spy-2-investigation-serial-studies-predict-your-therapeutic-response (accessed September 1, 2011).
FNIH. 2011a. Our work: Working toward a healthier world. http://www.fnih.org/work (accessed September 1, 2011).
FNIH. 2011b. Policies and procedures. http://www.biomarkersconsortium.org/policies.php (accessed September 1, 2011).
FTC (Federal Trade Commission) and DOJ. 2000. Antitrust guidelines for collaborations among competitors. http://www.ftc.gov/os/2000/04/ftcdojguidelines.pdf (accessed September 29, 2011).
Grupp, S. A., and C. H. June. 2011. Adoptive cellular therapy. In Cancer immunology and immunotherapy, edited by G. Dranoff. Heidelberg: Springer.
HHS (U.S. Department of Health and Human Services). 2011. Human subjects research protections: Enhancing protections for research subjects and reducing burden, delay, and ambiguity for investigators. Federal Register 76(143):44512–44531.
Hsieh, A. C., and M. M. Moasser. 2007. Targeting HER proteins in cancer therapy and the role of the non-target HER3. British Journal of Cancer 97(4):453–457.
Infante, J. R., G. S. Falchook, D. P. Lawrence, J. S. Weber, R. F. Kefford, J. C. Bendell, R. Kurzrock, G. Shapiro, R. R. Kudchadkar, G. V. Long, H. A. Burris, K. B. Kim, A. Clements, S. Peng, B. Yi, A. J. Allred, D. Ouellet, K. Patel, P. F. Lebowitz, and K. T. Flaherty. 2011. Phase I/II study to assess safety, pharmacokinetics, and efficacy of the oral MEK 1/2 inhibitor GSK1120212 (GSK212) dosed in combination with the oral BRAF inhibitor GSK2118436 (GSK436). Journal of Clinical Oncology 29(15S):CRA8503.
IOM (Institute of Medicine). 2010a. Extending the spectrum of precompetitive collaboration in oncology research: Workshop summary. Washington, DC: The National Academies Press.
IOM. 2010b. A national cancer clinical trials system for the 21st century: Reinvigorating the NCI Cooperative Group Program. Washington, DC: The National Academies Press.
Kim, E. S., R. S. Herbst, J. J. Lee, G. R. Blumenschein, Jr., A. Tsao, C. M. Alden, X. Tang, S. Liu, D. J. Stewart, J. V. Heymach, H. T. Tran, M. E. Hicks, J. Erasmus, Jr., S. Gupta, G. Powis, S. M. Lippman, I. I. Wistuba, and W. K. Hong. 2010. The BATTLE trial (Biomarker-integrated Approaches of Targeted Therapy for Lung Cancer Elimination): Personalizing therapy for lung cancer. Paper presented at AACR 101st Annual Meeting, Washington, DC.
Kim, E. S., R. S. Herbst, I. I. Wistuba, J. J. Lee, G. R. Blumenschein, Jr., A. Tsao, D. J. Stewart, M. E. Hicks, J. Erasmus, Jr., S. Gupta, C. M. Alden, S. Liu, X. Tang, F. R. Khuri, H. T. Tran, B. E. Johnson, J. V. Heymach, L. Mao, F. Fossella, M. S. Kies, V. Papadimitrakopoulou, S. E. Davis, S. M. Lippman, and W. K. Hong. 2011. The BATTLE Trial: Personalizing therapy for lung cancer. Cancer Discovery 1(1):44–53.
Kim, P. S., and R. Ahmed. 2010. Features of responding T Cells in cancer and chronic infection. Current Opinion in Immunology 22(2):223–230.
Mayfield, E. 2011. Combining targeted cancer therapies: Much promise, many hurdles. NCI Cancer Bulletin 8(10):6.
Munos, B. 2009. Lessons from 60 years of pharmaceutical innovation. Nature Reviews Drug Discovery 8(12):959–968.
Nagata, Y., K. H. Lan, X. Zhou, M. Tan, F. Esteva, A. Sahin, K. Klos, P. Li, B. Monia, N. Nguyen, G. Hortobagyi, M. Hung, and D. Yu. 2004. PTEN activation contributes to tumor inhibition by trastuzumab, and loss of PTEN predicts trastuzumab resistance in patients. Cancer Cell 6(2):117–127.
NCI (National Cancer Institute). 2011a. Center for advanced preclinical research. http://ccr.cancer.gov/research/Capr.aspx (accessed September 15, 2011).
NCI. 2011b. Docetaxel alone or in combination with vaccine to treat breast cancer. http://www.cancer.gov/clinicaltrials/search/view?version=healthprofessional&cdrid=442407 (accessed August 31, 2011).
OSU (Ohio State University). 2011. Cancer Drug Development Roundtable at Ohio State. http://cancer.osu.edu/research/researchnews/CancerDrugDevelopment/Pages/index.aspx?ref=homepage (accessed August 31, 2011).
Rathkopf, D. E., D. C. Danila, J. J. Chudow, M. J. Morris, S. F. Slovin, S. Fine, J. J. Fox, S. M. Larson, N. Rosen, and H. I. Scher. 2010. Anti-insulin-like growth factor-1 receptor (IGF-IR) monoclonal antibody cixutumumab plus mammalian target of rapamycin (mTOR) inhibitor temsirolimus in metastatic castration-resistant prostate cancer (CRPC). Journal of Clinical Oncology 28(15S):TPS242.
Shapiro, G., P. LoRusso, E. L. Kwak, J. M. Cleary, L. Musib, C. Jones, A. D. Crespigny, M. Belvin, M. McKenzie, M. R. Gates, I. T. Chan, and J. C. Bendell. 2011. Clinical combination of the MEK inhibitor GDC-0973 and the PI3K inhibitor GDC-0941: A first-in-human Phase Ib study testing daily and intermittent dosing schedules in patients with advanced solid tumors. Journal of Clinical Oncology 29(Suppl):3005.
Shen, L., S. Peterson, A. R. Sedaghat, M. A. McMahon, M. Callender, H. Zhang, Y. Zhou, E. Pitt, K. S. Anderson, E. P. Acosta, and R. F. Siliciano. 2008. Dose–response curve slope sets class-specific limits on inhibitory potential of anti-HIV drugs. Nature Medicine 14(7):762–766.
Shen, L., S. Rabi, and R. Siliciano. 2009. A novel method for determining the inhibitory potential of anti-HIV drugs. Trends in Pharmacological Science 30(12):610–616.
Wellcome Trust. 2011. Structural Genomics Consortium. http://www.wellcome.ac.uk/Funding/Biomedical-science/Funded-projects/Major-initiatives/Structural-Genomics-Consortium/index.htm (accessed August 31, 2011).
Woodcock, J., J. P. Griffin, and R. E. Behrman. 2011. Development of novel combination therapies. New England Journal of Medicine 364(11):985–987.
Zhang, S., and D. Yu. 2010. PI(3)king apart PTEN’s role in cancer. Clinical Cancer Research 16(17):4325–4330.