Program Director/Principal Investigator (Last, First, Middle): Meyskens, Frank L. 5P30CA062203-17 BIOGRAPHICAL SKETCH Provide the following information for the Senior/key personnel and other significant contributors in the order listed on Form Page 2. Follow this format for each person. DO NOT EXCEED FOUR PAGES. NAME POSITION TITLE Shen, Violet -CHOC Clinical Director, Research -Director of Clinical Research Office at UC Irvine Chao Family Comprehensive Cancer Center eRA COMMONS USER NAME (credential, e.g., agency login) EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable.) DEGREE INSTITUTION AND LOCATION MM/YY FIELD OF STUDY (if applicable) National Taiwan University College of Medicine, Taiwan MD Cornell Medical College North Shore University Hospital, Manhasset, N.Y. 06/79 06/83 Memorial Sloan-Kettering Cancer Center and Cornell Medical College-New York Hospital 08/86 Medicine Pediatric residency Fellowship in Pediatric Hematology-Oncology A. Personal Statement I am a strong believer in oncology clinical research. As a pediatric oncologist for 25 years, I witness tremendous advance in cancer research translating into significant improvement of survival and the quality of life in children with cancer. As a cancer survivor myself, I truly appreciate the advent of cancer research which saved my life. I did laboratory research in cancer genetics during my fellowship at Memorial Sloan-Kettering Cancer Center and assistant professor years at University of California Irvine. Later when I became the principle investigator of Children’s Oncology Group (COG) at Children’s Hospital of Orange County (CHOC) in 1998, I strived to build a strong clinical research team by cultivating the high awareness and appreciation of the clinical research within the institute. We opened over hundreds of studies and screened every new and recurrent cancer patient for eligibility of research studies. With high patient accrual rate, successful audits and the overall high quality of the research program, CHOC was selected as one of only 21 institutions in the North America to participate in the COG Phase One Consortium in 2006. We have since opened 30 COG phase one studies at CHOC and became one of the top enrolling institutions within the consortium. We have successfully renewed our membership of the Phase One Consortium in 2011. I have also collaborated with pharmaceutical companies to bring the cutting edge therapeutic and supportive care studies to CHOC. I have been the local principle investigator for the following studies: Sequential high dose thiotepa for CNS tumor (investigator-initiated), Clofarabine single agent and combination for refractory acute leukemia, anti-IGF1R antibody for recurrent sarcoma, Erlotinib vs. Etoposide for recurrent ependymoma, L-MTP-PE for recurrent Osteosarcoma. I conducted supportive care studies of hematopoietic growth factors, antiemetics, analgesics, thrombolytic therapy and rasburicase for hyperuricemia. Working with industry sponsored studies gave me different perspectives in study design, patient accrual strategies, data management and manuscript preparation. I have reviewed many concept proposals and the study design of clinical trials as the principle investigator and the member of COG study committees. Having been involved with many clinical trials over the years gives me a good sense of feasibility and the merit of the study. Because of these experiences, I was offered an appointment as Director of Clinical Research Office (CRO) at the UC Irvine Chao Family Comprehensive Cancer (CFCCC) starting October, 2011. In this position, I serve as a liaison between center investigators, center’s research administration, various university entities and the community. My focus will be to enhance translational oncology research at UCI and to support HDII protocol development through continuous evaluation of cancer center’s protocol portfolio and health need of the community. I will participate in Clinical Research Advisory Council (CRAC) and Clinical Trials Protocol Review and Monitoring Committee (CTPRMC) to evaluate the scientific merit and accrual of clinical research conducted PHS 398/2590 (Rev. 06/09) Page Biographical Sketch Format Page Program Director/Principal Investigator (Last, First, Middle): Meyskens, Frank L. 5P30CA062203-17 at the Cancer Center. I will work with CRO staffs and the Data Safety Monitoring Board (DSMB) to ensure timely reporting of adverse events, safety of protocol participants and the integrity and comprehensiveness of the reported data. Clinical Cancer research is at a very exciting time as many new agents targeting different molecular pathways are in various phases of development. We will be able to achieve personalized medicine in the treatment of many cancers by applying genomics and biomarkers to select best combination of target therapies. I will continue to promote oncology clinical research at both Children’s Hospital of Orange County and UC Irvine CFCCC, two premier institutions in Orange County, CA. B. Positions and Honors Positions 1996-2002 19961998-2001 199820012000-2010 200620092011Honors 1986 1987 1988 1989 2005-2010 2011 Chairman, CHOC Cancer Committee Chairman, Oncology Section of Medical Staff Director, Oncology Program at CHOC COG Principal Investigator for CHOC Clinical Research Director at CHOC Investigator of Pediatric Cancer Research Foundation Principle Investigator of COG phase I consortium at CHOC Director of CHOC Cancer Institute Neuro-Oncology Program Director of Clinical Research Office at UC Irvine Chao Family Comprehensive Cancer Center Upjohn Travel Award for the abstract presented in 1986 American Association for Cancer Research annual meeting Faculty Research Grant, UC Irvine Faculty Research Grant, UC Irvine Faculty Developmental Award, UC Irvine Selected as one of the Top Doctors of Orange County by OCMA Invited speaker to Grand Round of Department of Pediatrics, National Taiwan University, April 11 Memberships American Society of Pediatric Hematology-Oncology American Society of Clinical Oncology Children Oncology Group Society of Neuro-Oncology Member of COG Brain Tumor Study Committees (9941, 99702, 99703, ACNS02B1) Vice chair of CCG 99702 study PI auditor for COG (2006-2008) C. Selected Peer-reviewed Publications 1. Shen W.V., Aldrich T, Perez G., Franza B.R., Furth M. Expression of normal and mutant ras protein in human leukemia. Oncogene 2:157-165(1987). PMID: 3325880 2. Meyers MB, Shen V, Spengler BA et al: Increased epidermal growth factor receptor in multidrug-resistant human neuroblastoma cells. Journal of Cellular Biochemistry 38:87-97 (1988). PMID: 246460 3. Shen WV, Walter B, Young R, Choi B., Smith M, Katz J: Molecular analysis of a myxoid chondrosarcoma showing rearrangement in chromosome 10 and 22. Cancer Genetics and Cytogenetics 45:207-215 (1990). PMID: 1969328 4. Shen, W.V., Chapparro M., Young R., Bernstein R.: Absence of isochromosome 12p in a pineal region malignant germ cell tumor. Cancer Genetics and Cytogenetics 50:153-160 (1990). PMID: 2253184 PHS 398/2590 (Rev. 06/09) Page Biographical Sketch Format Page Program Director/Principal Investigator (Last, First, Middle): Meyskens, Frank L. 5P30CA062203-17 5. Shen V, Woodbury, Killen R, Van de Ven C, Sender L, Cairo MS: Collection and use of peripheral blood stem cells in young children with refractory solid tumors. Bone Marrow Transplantation 19:197-204. (1997). PMID: 9028545 6. Bracho F, Krailo M, Shen V, Bergeron S,, Liu-Mares W, Blazer B, van der Ven, C, Secola R, Ames M, Reaman G, Cairo MS: A phase I clinical, pharmacologic and biological trial of interleukin-6 (IL-6) following Ifosfamide, Carboplatin, Etoposide (ICE) in children with recurrent/refractory solid tumors: Enhanced hematological responses but a high incidence of grade III/IV toxicities. Clinical Cancer Research 7:58-67,2001. PMID: 11205919 7. Cairo MS, Shen V, Krailo M, Bauer M, Miser J, Blatt J, Sato J, Liu W, Reaman G: Prospective randomized trial between two doses of granulocyte colony-stimulating factor after Ifosfamide, Carboplatin, and Etoposide (ICE) in Children with Recurrent of Refractory Solid Tumors: A Children’s Cancer Group Report. J Pediatr Hematol Oncol 23:30-38,2001. PMID: 11196267 8. Goldman SC, Bracho F, Davenport V, Slack R, Areman E, Shen V, Lenarsky C, Weinthal J, Hughes R, Cairo MS: A feasibility study of Interleukin-11 and G-CSF following myelosuppressive chemotherapy to mobilize peripheral blood stem cells (CD34+) from heavily pretreated patients. J Pediatr Hematol Oncol 23(5):300-5, 2001. PMID: 11464987 9. Hong R, Shen V, Rooney C, Hughes D, Smith C, Comoli P, Zhang L: Correction of DiGeorge Anomaly with EBV-induced lymphoma by transplantation of organ cultured thymus and Epstein-Barr specific T lymphocytes. Clinical Immunology 98:54-61,2001. PMID: 11141327 10. Jennings M, Sposto R, Boyett J, Vezina G, Pollack I, Shen V etc: Preradiation chemotherapy in primary high risk brain stem tumors: CCG-9941, a phase II study of the Childrens Cancer Group. J Clin Oncol 20:3431-3427, 2002. PMID: 12177103 11. Shen V, Li X, Murdock M, Resnansky L, McCluskey E, Semba C: Recombinant tissue plasminogen activator (Alteplase) for restoration of function to occluded central venous catheters in pediatric patients. J Pediatr Hematol Oncol 25: 38-45, 2003. PMID: 12544772 12. Jeha S, Kantarjian H, Irwin D, Shen V, Shenoy S, Blaney S, Camitta B, Pui CH. Efficacy and safety of rasburicase, a recombinant urate oxidase (Elitek), in the management of malignancy-associated hyperuricemia in pediatric and adult patients: final results of a multicenter compassionate use trial. Leukemia. 19(1):34-8, 2005. PMID: 15510203 13. S Jeha, PS. Gaynon, B Razzouk, J Franklin, R Kadota, V Shen, L Luchtman-Jones, M Rytting, L Bomgaars, S Rheingold, K Ritchey, E Albano, RJ. Arceci, S Goldman, T Griffin, A Altman, B Gordon, Ll Steinherz, S Weitman, P Steinherz. Phase II Study of Clofarabine in Pediatric Patients With Refractory or Relapsed Acute Lymphoblastic Leukemia. J Clin Oncol, Vol 24, No 12 , pp. 1917-1923,2006. PMID: 16622268 14. N Hijiya, P Gaynon, E Barry, L Silverman, B Thomson, R Chu, T Cooper, R Kadota, M Rytting, P Steinherz,V Shen, S Jeha, R Abichandan and WL Carroll: A multi-center phase I study of clofarabine, etoposide and cyclophosphamide in combination in pediatric patients with refractory or relapsed acute leukemia. Leukemia 23, 2259–2264,2009. PMID: 19741725 D. Research Support Ongoing Research Support 5P30CA062203-16 Meyskens (PI) 02/01/09-01/31/14 NIH/NCI University of California Irvine Cancer Center Support Grant Infrastructure and Research award to support cancer research at UC Irvine and beyond. Role: Director CRO research U01 CA97452-10 Susan Blaney (PI) 9/16/11-7/31/12 Children’s Oncology Group Phase 1/Pilot consortium Grant subcontract No.021368 Role: institutional PI ADVL0813 NCI Clinical Trial PHS 398/2590 (Rev. 06/09) Shen (PI) 06/01/09-05/31/12 Page Biographical Sketch Format Page Program Director/Principal Investigator (Last, First, Middle): Meyskens, Frank L. 5P30CA062203-17 Phase I/Pilot Consortium to identify and develop effective new agents for children and adolescents with cancer (prime award# U01CA097452, PI Susan Blaney). Role: Co:PI ADVL0911 Shen (PI) 06/01/09-05/31/12 NCI Clinical Trial Phase I/Pilot Consortium is to identify and develop effective new agents for children and adolescents with cancer through rational and efficient clinical and laboratory research (prime award# U10CA097452-07S1, PI Susan Blaney) ANBL0931 Shen (PI) 06/01/09-05/31/12 NCI Childhood cancers (Prime award# U10CA098543, PI Peter Adamson) Role: Co:PI Completed Research U10 CA98543-06 NCI NCCF subcontract Role: Co:PI 03/1/08-02/28/11 U01 CA097452-06 NCI COG Phase One Consortium Grant Role: Co PI PHS 398/2590 (Rev. 06/09) 08/01/07-07/31/11 Page Biographical Sketch Format Page