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Program Director/Principal Investigator (Last, First, Middle): BIOGRAPHICAL SKETCH NAME POSITION TITLE Anthony F. Shields, M.D., Ph.D. eRA COMMONS USER NAME ashields Professor of Medicine INSTITUTION AND LOCATION DEGREE YEAR(s) FIELD OF STUDY Massachusetts Institute of Technology, Cambridge, MA BS 1974 Biology Massachusetts Institute of Technology, Cambridge, MA BS 1974 Chemistry Harvard Medical School, Boston, MA MD 1979 Medicine Massachusetts Institute of Technology, Cambridge, MA PhD 1979 Cell Biology A. Personal Statement The goal of the clinical trials methodology workshop is to instruct and guide faculty in learning the fundamentals of designing and conducting clinical evaulations using imaging methods. Dr. Shields has been involved for a long time in laboratory, translational and clinical research and leads efforts by investigators at Wayne State University/Karmanos Cancer Institute in these arenas. As a fellow he began work on the development and testing of tracers for use with positron emission tomography (PET) for the assessment of a variety of tumors (e.g. GI, lung, breast, and prostate cancers) and their response to treatment. Dr. Shields led the development of FLT {3’-deoxy-3’-fluorothymidine}; a promising tracer for tumor proliferation, which is being tested in centers worldwide. He has also worked on the development of 18 F- FMAU {1-(2’-deoxy-2’-fluoro-beta-D-arabinofuranosyl)-thymine} to image cellular stress. Dr. Shields is also on the Steering Committee of the American College of Radiology (ACRIN) and the National Oncology PET Registry (NOPR) and works to incorporate innovative imaging in the multicenter clinical trials. Dr. Shields training as a Medical Oncologist provides the insight to guide studies in patients with cancer and the foresight to design trials that are appropriate. He is the sub-chair for colorectal cancer at the Southwest Oncology Group (SWOG) and serves on the NCI Colon Task Force, which is charged with overseeing clinical research studies in colorectal cancer. Dr. Shields is also on the NCI Investigational Drug Steering Committee. In the clinic, his work concentrates on the treatment of patients with gastrointestinal (GI) cancer and he continues to develop and lead new clinical trials for GI tumors. Dr. Shields understands the challenges clinicians and researchers have in guiding and developing new treatments for cancer. As a clinician and scientist, Dr. Shields has participated in bringing new agents from the laboratory to the clinic. As an Associate Center Director for Clinical Sciences, and member of the Human Investigation Committee Medical Investigational Review Board for phase I studies, he helps to oversee a large number of clinical studies within our Institute and comprehends the complexities and challenges of the approaches to successful evaluation of new agents. B. Positions and Experience and Honors 1979 -1981 Residency in Internal Medicine, Univ of Washington School of Medicine, Seattle, WA 1981 -1984 Senior Fellow, Division of Oncology, University of Washington School of Medicine 1985 -1995 Assistant Member, Clinical Res Division, Hutchinson Cancer Research Ctr, Seattle, WA 1987 -1993 Assistant Professor of Medicine, Oncology Division, U of WA, Seattle, WA 1987 -1995 Staff Physician, VA Medical Center, Seattle, Washington 1993 -1995 Associate Professor of Medicine, Div of Oncology, U of WA, Seattle, WA 1995 -1999 Associate Professor, Medicine and Oncology, tenured, Wayne State, Detroit, MI 1995 -2006 Chief, GI Oncology Section, Karmanos Cancer Institute, Harper Hospital/ Detroit Med Ctr 1999 -present Professor, Medicine and Oncology, (tenured) Wayne State U School of Medicine, Detroit, MI 2003 -present Associate Center Director for Clinical Research, Karmanos Cancer Institute Other Experience 1995 -present Scientific Member, Karmanos Cancer Institute 1997 -present Program Leader, Developmental Therapeutics, Karmanos Cancer Institute 2000, 2004-05 Chair, Michigan Department of Community Health Task Force on Colorectal Cancer Honors 1983 -1985 National Research Service Award Fellow 1984 -1985 American Cancer Society Junior Faculty Fellow 1999 -2004 Midcareer Investigator Award, National Cancer Institute 2005 Peter Valk Distinguished Clinical Scientist Award, Academy of Molecular Imaging 2005 The European Association of Nuclear Medicine and Springer-Verlag Award - Best Clinical Paper PHS 398/2590 (Rev. 11/07) Page Biographical Sketch Format Page Program Director/Principal Investigator (Last, First, Middle): 2007 Wayne State University Distinguished Faculty Fellowship Award B. Selected peer-reviewed publications (from 101 publications, in chronological order). Most relevant to the current application 1. Shields AF, Zalupski MM, Marshall JL, Meropol NJ. Treatment of advanced colorectal cancer with oxaliplatin and capecitabine: a phase II trial. Cancer, 100:531-7, 2004. PMID: 14745869 2. Sun H, Sloan A, Mangner TJ, Vaishampayan U, Muzik O, Collins JM, Douglas K, and Shields AF. Imaging DNA synthesis with 18F-FMAU and positron emission tomography in patients with cancer. Eur J Nucl Med Mol Imaging, 32:15-22, 2005. The European Association of Nuclear Medicine and Springer-Verlag Award Best Clinical Paper, 2005. PMID: 15586282 3. Sun H, Collins JM, Mangner TJ, Muzik O, Shields AF. Imaging the pharmacokinetics of 18F-FAU in patients with tumors: PET studies. Cancer Chemother Pharmacol, 57:343-8, 2006. PMID: 16001172 4. Shields AF, Lawhorn-Crews JM, Briston DA, Zalzala S, Gadgeel S, Douglas KA, Mangner TJ, Heilbrun LK, Muzik O. Analysis and reproducibility of [18F] 3’-deoxy-3’-fluorothymidine PET imaging in patients with nonsmall cell lung cancer. Clin. Cancer Res, 14:4463-8, 2008. PMID: 18628460 5. Choi M, Heilbrun LK, Venkatramanamoorthy R, Lawhorn-Crews JM, Zalupski MM, Shields, AF. Using 18FFluorodeoxyglucose Positron Emission Tomography (FDG PET) to monitor clinical outcomes in patients treated with neoadjuvant chemo-radiotherapy for locally advanced pancreatic cancer. Am J Clin Oncol, Epub Oct 2, 2009. PMID: 19806035 Additional recent publications of importance to the field (in chronological order) 6. Shields AF, Briston DA, Chandupatla S, Douglas KA, Lawhorn-Crews J, Collins JM, Mangner TJ, Heilbrun LK, Muzik O. A simplified analysis of [18F] 3’-fluorothymidine metabolism and retention. Eur J Nucl Med Mol Imaging, 32:1269-75, 2005. PMID: 15991018 7. Nimmagadda S, Mangner TJ, Douglas KA, Muzik O, Shields AF. Biodistribution, PET imaging, and radiation dosimetry estimates of HSV-tk gene expression imaging agent (1-(2'-deoxy-2'-[18F]-fluoro-β-Darabinofuranosyl)-5-iodouracil) in normal dogs. J Nucl Med, 48:655-660, 2007. Society of Nuclear Medicine Education and Research Foundation, Alavi-Mandell Award, 2008. PMID: 17401105 8. Nimmagadda S, Mangner TJ, Douglas KA, Muzik O, Shields AF. Biodistribution, PET imaging, and radiation dosimetry estimates of HSV-tk gene expression imaging agent (1-(2'-deoxy-2'-[18F]-fluoro-β-Darabinofuranosyl)-5-iodouracil) in normal dogs. J Nucl Med, 48:655-660, 2007. Society of Nuclear Medicine Education and Research Foundation, Alavi-Mandell Award, 2008. PMID: 17401105 9. Fletcher FW, Djulbegovic B, Soares HP, Siegel BA, Lowe VJ, Lyman GH, Coleman RE, Wahl R, Paschold JC, Avril N, Einhorn LH, Suh WW, Samson D, Delbeke D, Gorman M, Shields AF. Recommendations for the use of FDG (fluorine-18, (2-[18F]fluoro-2-deoxy-D-glucose) positron emission tomography in oncology. J Nucl Med, 49:480-508, 2008. PMID: 18287273 10. Hillner BE, Siegel BA, Liu D, Shields AF, Gareen IF, Hanna L, Stine SH, Coleman RE. Impact of positron emission tomography/computed tomography and positron emission tomography (PET) alone on expected management of patients with cancer: initial results from the National Oncologic PET Registry. J Clin Oncol, 26:2155-61, 2008. PMID: 18362365 11. Tehrani OS, Douglas KA, Lawhorn-Crews JM, Shields AF. Tracking cellular stress with labeled FMAU reflects changes in mitochondrial TK2. Eur J Nucl Med Mol Imaging, 35:1480-8, 2008. PMID: 18265975 12. Hillner BE, Siegel BA, Shields AF, Liu D, Gareen IF, Hanna L, Stine SH, Coleman RE. The impact of Positron Emission Tomography on expected management during cancer treatment: findings of the National Oncologic PET Registry. Cancer, 115:410-8, 2009. PMID: 19016303 13. Coleman RE, Hillner BE, Shields AF, Duan F, Merlino DA, Hanna L, Stine SH, Siegel BA. PET and PET/CT reports: observations from the National Oncologic PET Registry. J Nucl Med. 51:158-63, 2010. Epub Dec 15, 2009. PMID: 20008997 14. Nimmagadda S, Mangner TJ, Lawhorn-Crews JM, Haberkorn U, Shields AF. Herpes simplex virus thymidine kinase imaging in mice with (1-(2’-deoxy-2’-[18F] fluoro-1-β-D-arabinofuranosyl)-5-iodouracil) and metabolite (1-(2’-deoxy-2’-[18F] fluoro-1-β-D-arabinofuranosyl)-5-uracil). Eur J Nucl Med Mol Imaging, 36:1987-93, 2009. Epub Jun 9 2009. PMID: 19506865 15. El-Rayes BF, Philip PA, Sarkar FH, Shields AF, Ferris AM, Hess K, Kaseb AO, Javle MM, Varadhachary GR, Wolff RA, Abbruzzese JL. A phase II study of isoflavones, erlotinib, and gemcitabine in advanced pancreatic cancer. Invest New Drugs, Epub Jan 27, 2010. PMID: 20107864 PHS 398/2590 (Rev. 11/07) Page Continuation Format Page