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- 1. ROBERT C. SHEPARD, M.D., F.A.C.P. Professional Summary: I have been doing cancer research since my freshman year in college. I was graduated Magna cum Laude in Biochemical Sciences and Molecular Biophysics from Harvard College and spent my last year in the Harvard-M.I.T. Health Sciences Program. I earned my MD degree in the Medical Scientist Training M.D.-Ph.D. Program at Duke University which included two years in graduate school in immunology. My specialty (fellowship) training in both hematology and oncology was at Tufts-New England Medical Center where I did laboratory research in leukemias, myeloma, and myelodysplasia, and at the Dana-Farber Cancer Center and Harvard Medical School where I did a postdoctoral fellowship in Pharmacology and Molecular Genetics. My medical internship was at Memorial Sloan Kettering Cancer Center. I am triple board-certified in oncology, hematology, and internal medicine, and have had extensive experience in basic (bench), translational and clinical research in oncology. While at UVa, I served as Associate Professor, Director of Gastrointestinal and Genitourinary Oncology, Phase I trials, Developmental Therapeutics, and PI for ECOG. I also spent 6 months during that time in CBER at the FDA and was involved in the medical review of Avastin and Erbitux as well as other NMEs. I have extensively published in the peer-reviewed literature, and was study chair for numerous ECOG clinical trials in myeloma as well as breast and GI cancers, as well as Co-Chair with Dr. Bob Kyle of the ECOG Myeloma Committee from 1985 to 2002. Since 2005, I have also been completely responsible for the clinical development of the drugs and immune therapies for six biotech companies as the consulting CMO. My penultimate consulting was as the global lead medic running a global registration trial for another biotech company. For the last year and a half, I have been the global lead medic for a both a registration trial in breast cancer as well as a phase I/II trial in prostate cancer for a major pharmaceutical company. My special expertise is in all phases of clinical trials including design, implementation, and successful enrollment. 2010-Present Consultant in Oncology Drug Development and Clinical Trials Attending Physician, Hematology/Oncology, Duke University School of Medicine VAMC (Vol) Professor of Medicine, Hematology/Oncology, UNC (Hon) 2011 Consultant and then Executive Director of Medical Affairs, Kendle 2009-10 Cornerstone Pharmaceuticals Consulting and then Chief Medical Officer 2007-9 PRA International Global Head of Oncology, VP, Scientific and Medical Affairs Responsible for writing scientific critiques of new clinical trials and leading bid defenses, training CRAs on new clinical trials Consultant for Infinity Pharmaceuticals; global medical affairs advisor for phase 3 registration trial and medical monitor for the Americas 2005-7 i3 Oncology Senior Director, Head of Oncology for the Americas Responsible for writing scientific critiques of new clinical trials and leading bid defenses Responsible for training CRAs, monitors, and project directors Responsible for global medical affairs, supervising CRAs and medical monitors on all oncology, hematology, and immunology clinical trials 2005-9 Callisto Pharmaceuticals Consulting Chief Medical Officer Designed, wrote, and implemented 2 phase 1 and 2 phase 2 trials
- 2. ROBERT C. SHEPARD, M.D., F.A.C.P. PAGE 2 Presented results of a phase 1 in ALL and a phase 2 in carcinoids at ASCO 2008 and 2009 2004-5 AstraZeneca Pharmaceuticals Medical Director Oncology Clinical Research & Development 2003-2004 CBER. FDA Medical Officer, Cancer Biologics Research, Clinical Trial Design & Analysis, Oncology Branch, New Therapeutic Biologics Oncology Products 2000-2004 UNIVERSITY OF VIRGINIA ASSOCIATE PROFESSOR, DIVISION OF HEMATOLOGY/ONCOLOGY AND DEPARTMENTS OF MEDICINE AND SURGERY Director of GI and GU Oncology; PI for ECOG Director of oncology clinical research and developmental therapeutics 1997-2000 MAPMG: CHIEF OF ONCOLOGY RESEARCH THE CANCER CENTER AT GBMC: DIRECTOR OF CLINICAL RESEARCH 1985-1997 MEDICAL WEST ASSOCIATES: Clinical Hematologist-Oncologist 1985-1997 TUFTS UNIVERSITY SCHOOL OF MEDICINE 1994-1997 Assistant Clinical Professor of Medicine 1985-1993 Senior Clinical Instructor in Medicine UNDERGRADUATE AND GRADUATE EDUCATION 1970-1974 HARVARD COLLEGE CAMBRIDGE, MA A.B. Magna Cum Laude in Biochemistry and Molecular Biophysics Sigma Xi Honorary Society; Harvard College and John Harvard Honorary Scholarships; Deans List; Harvard-M.I.T. Program in Health Sciences 1974-1978 DUKE UNIVERSITY SCHOOL OF MEDICINE DURHAM, NC Doctor of Medicine Awarded NIH M.D.-Ph.D. Medical Scientist Training Program Scholarship 1985-1989 AMERICAN COLLEGE OF PHYSICIAN EXECUTIVES Certificate in Health Care Management 1989-1991 WESTERN NEW ENGLAND COLLEGE SPRINGFIELD, MA Advanced Certificate in Health Care Management 2003 NATIONAL LIBRARY OF MEDICINE BETHESDA, MD Accepted into and completed 6-day Medical Informatics course INTERNSHIP AND RESIDENCY 1980-1981 CORNELL COOPERATING HOSPITALS NEW YORK Internship in Internal Medicine North Shore University Hospital and Memorial Sloan-Kettering Cancer Center 1981-1983 BOSTON V.A. MEDICAL CENTER BOSTON, MA Junior and Senior Residency in Medicine FELLOWSHIPS: 1983-1985 TUFTS-NEW ENGLAND MEDICAL CENTER BOSTON, MA
- 3. ROBERT C. SHEPARD, M.D., F.A.C.P. PAGE 3 Hematology and Oncology Fellow American Cancer Society Clinical Fellow 1978-1980 DANA-FARBER CANCER CENTER BOSTON, MA HARVARD MEDICAL SCHOOL Research Fellow in Oncology American Cancer Society Postdoctoral Fellow in Pharmacology and Molecular Genetics TEACHING EXPERIENCE 2000-2004 UNIVERSITY OF VIRGINIA CHARLOTTESVILLE, VA Associate Professor of Medicine and Surgery 1998-2000 JOHNS HOPKINS SCHOOL OF MEDICINE BALTIMORE, MD Instructor in Medical Oncology 1985-1998 TUFTS UNIVERSITY SCHOOL OF MEDICINE BOSTON, MA 1994-1998 Assistant Clinical Professor of Medicine 1985-1993 Senior Clinical Instructor in Medicine 1984-1985 TUFTS UNIVERSITY SCHOOL OF DENTISTRY BOSTON, MA Instructor in Hematology-Oncology 1981-1983 TUFTS UNIVERSITY SCHOOL OF MEDICINE BOSTON, MA BOSTON UNIVERSITY SCHOOL OF MEDICINE BOSTON, MA Teaching Fellow in Physical Diagnosis 1982-1983 BOSTON UNIVERSITY SCHOOL OF NURSING BOSTON, MA Instructor in Physical Diagnosis Nurse Practitioner Training Program 1978-1980 HARVARD UNIVERSITY CAMBRIDGE, MA Advisor to Pre-Medical Students 1976-1978 DUKE UNIVERSITY SCHOOL OF MEDICINE DURHAM, NC Instructor in Physical Diagnosis BOARD CERTIFICATION 1985 AMERICAN BOARD OF ONCOLOGY 1984 AMERICAN BOARD OF HEMATOLOGY 1983 AMERICAN BOARD OF INTERNAL MEDICINE
- 4. ROBERT C. SHEPARD, M.D., F.A.C.P. PAGE 4 CURRENT MEMBERSHIPS American College of Physicians Fellow; Health and Public Policy Committee American Federation for Clinical Research American Medical Association American Society of Clinical Oncology American Society of Hematology Eastern Cooperative Oncology Group (ECOG) Myeloma Committee: Co-Chairman Gastrointestinal, Thoracic and Breast Cancer Committees Massachusetts Medical Society Leadership Council, Delegate, Executive Committee Vice President, President-Elect - Hampden District National Surgical Adjuvant Breast Project (NSABP) New England Cancer Society Society for Biological Therapy American College of Physician Executives European Society for Medical Oncology American Federation for Medical Research American Association for Cancer Research (AACR) Association of Clinical Research Professionals (ACRP) American Medical Informatics Association
- 5. ROBERT C. SHEPARD, M.D., F.A.C.P. PAGE 5 PUBLICATIONS 1. Scher CD, Shepard R, Antoniades H, Stiles CD. Platelet-derived growth factor and the regulation of the mammalian fibroblast cycle. Biochem Biophys Acta 560:217-241, 1979. 2. Shepard R, Frantz C, Scher CD. Endocytosis and the platelet-derived growth factor. J Cell Biology 83:234, 1979. 3. Shepard R. Somatomedin and platelet-derived growth factor in atherosclerosis. New England Journal of Medicine 303:641-642, 1980. 4. Shepard R, Lopez W, Robert NJ. Chemotherapy of glomus jugulare tumors. J Clinical Oncology 6:1202-1204, 1988. 5. Shepard R. Chemotherapy for ovarian carcinoma. J Clinical Oncology 7:685-686, 1989. 6. Burris HA, Ravdin P, Gutheil J, Shepard R, et al. Eniluracil/5FU in anthracycline and taxane refractory breast cancer. Proceedings of ASCO 18:107a, 1999. 7. Rago R, et al. A phase II study of the safety, pharmacokinetics and efficacy of Incel in combination with mitoxantrone and prednisone in HRPC. AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, 1999. 8. Navari R., Reinhardt R., Gralla R., et al. Reduction of Cisplatin-induced emesis by a selective neurokinin-1-receptor antagonist. New England Journal of Medicine 340: 190-195, 1999. 9. Rago RP, Einstein AB, Lush RM, et al. A Phase II Study of Incel (Biricodar, VX-710) in Combination with Mitoxantrone and Prednisone in Hormone Refractory Prostate Cancer (HRPC). Proceedings of ASCO 19:180a, 2000. 10. Shepard RC, Levy D, Stuart K, et al. Pancreatic cancer: Biweekly gemcitabine/doceta xe l chemotherapy. Proceedings of ASCO 20: 154a, 2001. 11. Penberthy DR, Rich TA, Shelton CH, et al. A pilot study of Chronomodulated infusional 5- fluorouracil chemoradiation for pancreatic cancer. Ann Oncol 12:681-684, 2001. 12. Penberthy DR, et al. COX-2 expression in resected jpancreatic adenocarcinoma correlated with treatment outcome after postop chemoradiotherapy. Int J Rad Onc 51:273, 2001. 13. Friedenberg WR, Blood EA, Graham D, et al. The treatment of relapsing or refractory multiple myeloma with docetaxel (an ECOG study). Proc of ASCO 2002, abstract 1104, 2002. 14. Holmes FA, Jones SE, OShaughnessy J, et al. Comparable efficacy and safety profiles of once- per-cycle pegfilgrastim and daily injection filgrastim in chemotherapy-induced neutropenia: a multicenter dose-finding study in women with breast cancer. Ann Oncol 13:903-909, 2002. 15. Nikolova Z, et al. A rationally designed, targeted tumor treatment approach: A phase II study of imatinib mesylate (Gleevec) in patients with life threatening diseases known to be associated with imatinib-sensitive tyrosine kinases. Proc of ASCO 21: 195, 2002. 16. Holmes FA, OShaughnessy JA, Vukelja S, et al. Blinded, randomized, multicenter study to evaluate single administration pegfilgrastim once per cycle versus daily filgrastim as an adjunct to
- 6. ROBERT C. SHEPARD, M.D., F.A.C.P. PAGE 6 chemotherapy in patients with high-risk stage II or stage III/IV breast cancer. J Clin Oncol 20:727- 731, 2002. 17. Apperley J, et al. Response to imatinib mesylate in patients with chronic MPD with rearrangements of the platelet derived growth factor receptor beta. N Engl J Med 347: 481-487, 2002. 18. Friedenberg WR, Graham D, Greipp P, et al. The treatment of multiple myeloma with docetaxel (an ECOG study). Leuk Res 27: 751-4, 2003. 19. Rago RP, et al. Safety and efficacy of the MDR inhibitor Incel in combination with mitoxantrone and prednisone in hormone refractory prostate cancer. Cancer Chemother Pharmacol 51: 297-305, 2003. 20. Corless CL, et al. Correlation of imatinib response with activation of KIT and PDGF receptors in a variety of cancers: Results of the CSTIB2225 trial. Proc of ASCO 22: 195, 2003. 21. Shepard RC, Cohen RB, De Souza, P. Preclinical and clinical modeling of vinca/taxane combinations for prostate cancer. Proceedings of ASCO 22: 434, 2003. 22. Rich T, Shepard RC, Cohn SM, et al. Clinical experience with daily capecitabine and celecoxib, combined with irradiation for cancer of the esophagus: widening the therapeutic window with targeted chemoradiation. Abstract 250173, American Radium Society, 2003. 23. Keene KS, et al. Chronomodulated infusional 5-fluorouracil chemoradiation for pancreatic adenocarcinoma. Int J Rad Onc 57:S379, 2003 24. Rich TA, Shepard RC, Mosley ST. Four decades of continuing innovation with 5-fluorourac il: Current and future approaches to 5-FU chemoradiation therapy. J Clin Onc in press. 25. Rich TA, Shepard R. Cox-2 inhibitors as radiation sensitizers for upper GI tract cancers: esophagus, stomach, and pancreas. Am J Clin Oncol 26: S110-113, 2003. 26. Friedenberg WR, Rue M, Dalton W, Schiffer C, et al. Phase 3 study of the multi-drug resistant modulator PSC-833 in relapsing or refractory multiple myeloma: An Intergroup study led by ECOG. Am Soc Hematology, Abstract 2559, 2003. 27. Rajkumar SV, Blood E, Vesole DH, Shepard R, Greipp PR. A randomized phase III trial of thalidomide plus dexamethasone versus dexamethasone in newly diagnosed multiple myeloma. J Clin Onc 22:560s, 2004. 28. Shepard R, Berlin J, Benson A, et al. Phase II study of gemcitabine in combination with docetaxel in patients with advanced pancreatic carcinoma. Oncology 66:303-309, 2004. 29. Rich TA, Shepard RC, Mosley ST. Four decades of continuing innovation with fluorouracil: Current and future approaches to fluorouracil chemoradiation therapy. J Clin Oncol 22:2214-2232, 2004. 30. Keene KS, Rich TA, Penberthy DR, Shepard RC, Adams R, Jones RS. Clinical Experience with chronomodulated infusional 5-fluorouracil chemoradiotherapy for pancreatic adenocarcinoma. Int J Rad Oncology Biol Phys 62: 97-103, 2005.
- 7. ROBERT C. SHEPARD, M.D., F.A.C.P. PAGE 7 31. Sung MW, Kvols L, Jacob G, Talluto C, Rodriguez E, and Shepard R. Phase II proof-of-concept study of atiprimod in patients with advanced low-to-intermediate grade neuroendocrine carcinoma. J Clin Oncol 26:240S, 2008. 32. Shepard RC, Talluto CC, Jacob G. Phase I study results of nanomolecular liposomal annamycin in refractory ALL. J Clin Oncol 27:372S, 2009 33. Shepard RC, et al A First in Class AEMD to Combat Cancer, Annals of Oncology 21: viii179, 2010. PROTOCOLS AND PAPERS 1. Shepard R, Phase II study evaluating oral idarubicin in refractory or relapsed multiple myeloma, ECOG Protocol Study, 1990. 2. Shepard R, Chemotherapy for Colon Cancer, submitted to J Clinical Oncology, 1993. 3. Shepard R, Phase II study evaluating low-dose synergistic cyclophosphamide and interleukin-2 immunochemotherapy for multiple myeloma, ECOG Protocol Study, 1994. 4. Shepard R, An ethical paradigm for the conundrum of conflicting DNR decisions, submitted to New England Journal of Medicine, 1993. 5. Shepard R and Chang, AY, Phase II study evaluating Topotecan in relapsed multiple myeloma, ECOG Protocol Study, 1993. 6. Friedenberg W. and Shepard R, Phase III Study of PSC-833 with VAD versus VAD alone for relapsed myeloma, ECOG Protocol Study, 1996. 7. Friedenberg W. and Shepard R, A Phase II study of the treatment of relapsing or refractory multiple myeloma with Docetaxel, ECOG Protocol Study, 1998. 8. Sparano J, Gradishar W and Shepard R, Phase III trial of marimastat in metastatic breast cancer, ECOG Protocol Study, 1998. 9. Shepard R. and Berlin J., "Phase II study of Gemcitabine and Docetaxel in pancreatic carcinoma," ECOG Protocol Study, 1999. 10. Shepard R and Cohen R, Phase I and II study of weekly vinorelbine and taxane for HRPC, 2000 (Presented at Prostate Cancer Symposium, October 2000). 11. Eckhardt G, Cohen R, Peck R, and Shepard R, A phase I trial to determine the safety and pharmacokinetics of chronic oral administration of farnesyl transferase inhibitor R115777 in combination with capecitabine in subjects with advanced incurable cancer, 2000. 12. Shepard R and Moskaluk C, Pilot study of STI571 in adenoid cystic carcinoma, 2001. 13. Rich T, Gillenwater H and Shepard R, Phase I/II trial of irinotecan and RT for NSCLC, 2001. 14. Rich T and Shepard R, Phase I/II trial of celecoxib/capecitabine/RT for pancreatic cancer.
- 8. ROBERT C. SHEPARD, M.D., F.A.C.P. PAGE 8 15. Rich T and Shepard R, Phase I and II trial of external irradiation combined with Xeloda and Celebrex as neoadjuvant therapy for esophageal cancer, 2001. 16. Boccon-Gibod L, Dawson NA, Fitzpatrick JM, Fossa SD, Shepard RC, A randomized transatlantic parallel group study to assess the efficacy, safety and tolerability of YM598 in combination with mitoxantrone and prednisone in androgen-independent prostate cancer patients with bone pain, 2001. 17. Shepard R and Paschold JC, Phase II trial of weekly epirubicin and docetaxel as first line therapy for metastatic breast cancer, 2002. 18. Carneiro B, Shepard R and Guerrant R, Phase III study of L-alanyl-glutamine to prevent chemotherapy induced stomatitis, 2002. 19. Foley E, Slingluff C, Adams R, Shepard R and Moskaluk C, Evaluation of vaccination with Her- 2/neu and CEA derived synthetic peptides with GM-CSF-in-Adjuvant in patients with resected stage IIB or III colon cancer, 2002. 20. Leung D, Shepard R and Adams R, Phase I/III study of systemic chemotherapy with or without hepatic chemoembolization for liver-dominant metastatic adenocarcinoma of the colon and rectum, 2002. 21. Shepard R, Densmore J, Fox J, and Williams M, Phase II trial of weekly gemcitabine with celecoxib and thalidomide as first-line therapy for patients with metastatic pancreatic cancer, 2002. 22. Rajkumar V and Shepard R, Phase II study of thalidomide and dexamethasone for multiple myeloma, ECOG protocol, 2002. 23. Shepard R, Capecitabine and Oxaliplatin as third line therapy for metastatic colorectal cancer and second line for pancreatic cancer, 2003. PRINCIPAL INVESTIGATOR FOR THE FOLLOWING PHARMACEUTICAL TRIALS Glaxo Wellcome 1. Eniluracil (GW776) for Advanced, Refractory Breast Cancer 2. Eniluracil for Advanced Pancreatic Cancer 3. Eniluracil for Advanced Colorectal Cancer 4. Navelbine for Advanced Non-small Cell Lung Cancer 5. Panorex (17-1A monoclonal antibody) for Stage III Colon Cancer Lilly 6. Gemcitabine for Advanced Pancreatic Cancer 7. Gemcitabine and Taxotere for Advanced Pancreatic Cancer 8. Gemcitabine, Cisplatin and Ethyol and RT for Non-small Cell Lung Cancer Rhone-Poulenc-Rorer 8. Taxotere and Gemcitabine for Advanced Pancreatic Cancer (with Lilly) Amgen 9. Adriamycin, Taxotere, and Pegylated Neupogen (Filgrastim-SD/01) for Breast Cancer
- 9. ROBERT C. SHEPARD, M.D., F.A.C.P. PAGE 9 Vertex 10. VX-710, Novantrone and Prednisone for Advanced Prostate Cancer Novartis 11. PSC-833 (Valdespar) and VAD for refractory myeloma 12. PSC-833, Ara-C and daunorubicin for AML 13. Zolendronate for Non-prostate solid cancers 14. Femara for adjuvant breast cancer post-Tamoxifen Schering 15. Pegylated Intron for CML 16. Toremifene vs. Tamoxifen for adjuvant breast cancer 17. Schering anti-estrogen (SCH 57050) vs. Anastrozole for breast cancer Bristol Myers-Squibb 18. LAMP trial with carbo/taxol and RT for Non-small cell lung cancer Merck 19. Anti-emetic study with selective neurokinin-1-receptor antagonist for cisplatin chemotherapy Pfizer 20. Anti-emetic study with CJ-11,974, a selective neurokinin-1-receptor antagonist for AC chemotherapy 21. Anti-emetic study with CJ-11,974, a selective neurokinin-1-receptor antagonist for cisplatin chemotherapy NSABP and Zeneca 22. STAR trial with tamoxifen vs. raloxifene for breast cancer prevention Roche 23. Capecitabine (Xeloda) for advanced, refractory breast cancer 24. Capecitabine (Xeloda) for advanced colon cancer 25. Capecitabine (Xeloda) plus irinotecan for advanced colorectal cancer. Sanofi 26. Irinotecan with or without oxaliplatin as second-line therapy for advanced colorectal cancer. Imclone 27. Phase II multicenter study of Erbitux (Cetuximab) in patients with metastatic colorectal carcinoma. 28. Randomized phase III trial to compare RT alone with RT and concomitant anti- EGFr antibody for locally advanced squamous cell carcinomas of the head and neck. Janssen 29. A phase I trial to determine the safety and pharmacokinetics of chronic oral administration of farnesyl transferase inhibitor R115777 in combination with capecitabine in subjects with advanced incurable cancer.