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September 2018 CURRICULUM VITAE Name: Cyrus Rustam Mehta September 2018 CURRICULUM VITAE Name: Cyrus Rustam Mehta Address: Cytel Inc. 675 Massachusetts Avenue Cambridge, MA 02139 (617) 661-2011 Place of Birth: Bombay, India EDUCATION: 1967 B. Tech Civil Engineering Indian Institute of Technology 1970 S.M. Management Science MIT 1973 Ph.D. Operations Research MIT POSITION: 1987-present Co-Founder and President, Cytel Inc. ACADEMIC APPOINTMENTS: 2000- present Adjunct Professor of Biostatistics, Harvard University 1990-1999 Adjunct Associate Professor of Biostatistics, Harvard University 1985-1989 Associate Professor of Biostatistics, Harvard University 1979-1984 Assistant Professor of Biostatistics, Harvard University 1977-1979 Post Doctoral Fellow, Dana-Farber Cancer Institute 1973-1979 Assistant Professor, University of Pittsburgh AWARDS and HONORS: 1989 George W. Snedecor Award for the Best Paper in Biometry (joint award) 1995 Fellow of the American Statistical Association 1999 Massachusetts Technology Collaborative Small Business Award (to Cytel) 2000 Fredrick Mosteller Statistician of the Year, Boston Chapter of the American Statistical Association 2003 Enterpreneur of the Year, World Zoroastrian Chamber of Commerce 2015 Lifetime Achievement Award, International Indian Statistical Association 2016 Distinguished Alumni Award, Indian Institute of Technology, Bombay CURRICULUM VITAE Page 2 Cyrus Rustam Mehta EXPERIENCE: Academic Teaching: Harvard University. Design and analysis of adaptive clinical trials. Exact nonparametric inference. Sequential and adaptive design. Statistical methods for health policy and management. Regression, analysis of variance and design of experiments. Food and Drug Administration: Consultant to the Center for Drugs and Biologics, FDA, 1985-88. Review of NDA submissions, recommendation of appropriate statistical methodology. Numerous short courses on exact inference and flexible adaptive trial design, 1997-2007. Accompanying clients to FDA/EMEA to defend adaptive designs. Clinical Trials Consulting: Adaptive trial designs for Pfizer, Astra-Zeneca, Eli Lilly, Genzyme, Abbott, Wyeth, Biogen-Idec, Merck-Serono and numerous other pharmaceutical and biotech companies since 2003. Representation at the FDA to defend the designs. Support to data monitoring committees either as a voting member, independent statistician or steering committee member (see Data Monitoring Committees experience in separate section below). Short Courses and Invited Talks: Numerous short courses and invited talks to major pharmaceutical companies, the American Statistical Association, the American Society for Quality Control, the International Society for Clinical Biostatistics, the International Biometric Society, the Drug Information Association, the Interface Foundation of America, the FDA, the CDC, the American Association for Cancer Research, the American Thoracic Society, various universities in the USA, Europe and Australia. Major Research Interests: Adaptive and group sequential trial design and interim monitoring. Exact inference for ordinal categorical data and censored survival data. Network, graph theory and Monte Carlo techniques in statistical computing. Development of stochastic spreadsheets for teaching statistics with permutation and resampling methods. Doctoral Dissertations Supervised: Multi-arm Multi-stage Designs. Pranab Ghosh, Ph.D., 2017 (Boston University) Exact Logistic Regression. Karim Hirji, Ph.D., 1986 Exact Inference for Longitudinal Data. Steve Walsh, Ph.D., 1989 Conditional versus Unconditional Inference. Joan Hilton, Sc.D., 1990 Monte Carlo Variance Reduction. Pralay Senchaudhuri, Sc.D., 1993 Exact Inference with Correlated Binary Data. Chris Corcoran, Sc.D., 1999 Professional Activities: Associate Editor - Biometrics (1994-1997) Referee - Journal of the American Statistical Association, Biometrics, Biometrika, American Statistician, Communications in Statistics, Canadian Journal of Statistics, Cancer Treatment Reports, Psychological Bulletin, Statistics in Medicine. Member - The American Statistical Association, The Royal Statistical Society, The Biometric Society, The American Public Health Association. Service - President of the International Indian Statistical Association (IISA) for 2012-2014 CURRICULUM VITAE Page 3 Cyrus Rustam Mehta Biostatistical Collaborations and Consulting: 1977-87 Cooperative Oncology Groups. Coordinating Statistician (1984-86). Collaborations with medical oncologists on the planning and analysis of cancer clinical trials and on hospitalization cost containment studies for the Eastern Cooperative Oncology Group and the Radio Therapy Oncology Group 1978-87 Dana-Farber Cancer Institute, Boston. Collaborations with medical investigators and scientists in the areas of cell biology, multiple sclerosis, behavioral intervention, immunogenetics and animal bioassay and toxicological risk assessment 1997-99 Dana-Farber Cancer Institute, Boston. Software development for 1982-82 World Health Organization. Design and analysis of studies for prevention and early detection of oral and cervical cancer in developing countries. Oral cancer workshops in Sri Lanka and India Since 2005 Strategic consulting to numerous pharmaceutical and biotechnology companies. Services include adaptive trial design, protocol review and FDA representation. Data Monitoring, Steering and Advisory Committees for Industry Trials: Served as either a voting member or independent statistician on data monitoring committees for the following companies and disease areas since 2006. Provided design input on all the trials below classified as adaptive. Partial list of of DMC support activity shown below. Amarin: Phase 3 group sequential cardovascular REDUCE-IT trial for hypertriglyceridemic patients (2014-ongoing; independent statistician). Beigene: Phase 3 clinical trial in chronic lymphocytic leukemia (2017-ongoing; DMC member) Boehringer Ingleheim: Member of steering committee for phase 3 SGLT2 inhibitor trial of heart failure hospitalization (2016-onward). Genzyme: Phase 3 adaptive trial for treatment of late onset Pompe disease (2006-2008; independent statistician) Halozyme: Phase 3 adaptive trial for treatment of patients with pancreatic cancer (2015-ongoing; independent statistician). Medicines Company: Three phase 3 adaptive trials of platelet inhibition for patients undergoing percutaneous coronary intervention (2007 onward) Merck an Company: Scientific advisory committee for MK-3102, a phase 3 trial to evaluate safety and efficacy of subjects with type 2 diabetes mellitus (2012 onwards) Merck-Serono: Phase 3 trial of relapsing multiple sclerosis and phase 3 trial of optic neuritis (2007 onward; independent statistician) Napo Pharmaceuticals: Phase 3 adaptive trial for treament of HIV induced diarrhea (2007 onwards; both DMC member and independent statistician) Oncomed: (i) Alpine Trial -- Phase 1b/2 adaptive trial of patients with previously untreated pancreatic cancer. (2013 onward); (ii) Pinnacle Trial -- Phase 1b/2 adaptive trial of patients with previously untreated small cell lung cancer (2014 onward) Organon: Phase 3 adaptive trial for treatment of negative symptoms schizophrenia (2006-2008) Otsuka: Three phase 3 trials in Schizophrenia (2008 onward) PharmaMar: Phase 3 group sequential trial in patients with platinum-resistant ovarian cancer (2015-onward; DMC member) Pierre-Farbre: Phase 2/3multi-arm, multicenter adaptive trial in infants with proliferating infantile hemangiomas. (2007 onward, DMC member) Pfizer: (i) Phase 3 adaptive trial for treatment of negative symptoms schizophrenia (2006-2007) (ii) Phase 3 trial of osteoarthritis of the knee (2007-2011) (iii) Phase 3 adaptive trial of non small cell lung cancer (2007-2011) Serono: Phase 3 trial of moderate to severe plaque psoriasis (2004-2005; independent statistician) Sunesis: Phase 3 adaptive trial of acute myeloid leukemia (2008-2014; independent statistician) CURRICULUM VITAE Page 4 Cyrus Rustam Mehta Takeda: (i) Member of steering committee for EXAMINE, a large CV risk outcomes trial for patients with type-2 diabetes mellitus (2010 onward) (ii) Member of steering committee for TAK-875, a large phase 3 outcomes trial to evaluate the first GPR-40 agonist to reach clinical development for patients with type-2 diabetes mellitus (2012 onward) Wyeth: Phase 2/3 trial of recombinant human bone morphogenetic protein in closed diaphyseal tibial fractures (2007 onward; independent statistician) CURRICULUM VITAE Page 5 Cyrus Rustam Mehta PUBLICATIONS: 1. Mehta CR. Optimal strategies for raising the wellhead price of natural gas. J Appl Cybern Mgmt Sci. 1975; 14(1&2)::40-63. 2. Carroll PG, DeWolf WC, Mehta CR, Rohan J, Yunis EJ. Centroid cluster analysis of the primed lymphocyte test. Transpl. Proceedings. 1979; 11(4):1809. 3. McDonald JA, Li FP, Mehta CR. Cancer mortality among beekeepers. J Occupat Med. 1979; 21(12):811-813. 4. DeWolf WC, Carroll PG, Mehta CR, Martin SL, Yunis EJ. The genetics of PLT response II: HLA-DRW is a major stimulating determinant. J Immunol. 1979; 123(1):37-42. 5. Vogl S, Mehta CR, Cohen M. MACC chemotherapy for adenocarcinoma and epidermoid carcinoma of the lung. Cancer. 1979; 44(3):864-868. 6. Begg CB, Mehta CR. Sequential analysis of comparative clinical trials. Biometrika. 1979; 66(1):97-103. 7. Browman GP, Gorka C, Mehta CR, Lazarus H, Abelson HT. Studies with a DDMP-resistant L1210 leukemia cell line without cross-resistance to Methotrexate. Biochem Pharmac. 1980; 29:2241-2245. 8. Vincent RG, Mehta CR, Sealy R. Chemotherapy of extensive large cell and adenocarcinoma of
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