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 , 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 . 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 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)

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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 the lung. A randomized trial in 210 patients. Cancer. 1980; 46(2):256-260.

9. Mehta CR, Patel NR. A network algorithm for the exact treatment of the 2xk contingency table. Commun in Statist. 1980; B9(6):649-664.

10. Creech RH, Mehta CR, Cohen M. Phase II Master Protocol for evaluation of new chemotherapeutic regimens in patients with inoperable non-small cell lung carcinoma (EST 2575, Generation I). Cancer Treat Rep. 1981; 65(5-6):431-438.

11. Kilton LJ, Bradley M, Mehta CR, Livingston DM. A rapid and sensitive quantitative immunoassay for the large SV40 T Antigen. J Virol. 1981; 38(2):612-620.

12. Ruckdeschel JC, Mehta CR, Salazar O, Creech R, Sponzo RW. Chemotherapy of metastatic non-small cell bronchogenic carcinoma: EST 2575 Generation III, HAM vs CAMP. Cancer Treat Rep. 1981; 65(11-12):959-963.

13. Ruckdeschel JC, Mehta CR, Salazar OM, Cohen M, Vogl S, Koons LS, Lerner H. Chemotherapy of inoperable, non-small cell bronchogenic carcinoma. EST 2575, Generation II. Cancer Treat Rep. 1981; 65(11-12):965-971.

14. Mehta CR. Sequential comparison of two exponential distributions with censored survival data. Biometrika. 1981; 68(3):669-675.

15. Mehta CR, Beranek WM. Estimating asset volatility by means of a Bayesian switching regression. J Financial and Quantitative Analysis. 1982; 17(2)241-263.

CURRICULUM VITAE Page 6 Cyrus Rustam Mehta

16. Mehta CR, Patel NR. A network algorithm for performing Fisher's exact test in rxc contingency tables. Journal of the American Statistical Association. 1983; 78(382)427-434.

17. Tsiatis AA, Rosner GL, Mehta CR. Exact confidence intervals following a group sequential test. Biometrics. 1984; 40:797-803.

18. Mehta CR, Cain KC. Charts for the early stopping of Pilot Studies. J Clin Oncol. 1984; 2(6):676-682.

19. Mehta CR, Patel NR, Tsiatis A. Exact significance testing to establish treatment equivalence ordered categorical data. Biometrics. 1984; 40:819-825.

20. World Health Organization Group Report. Control of Oral Cancer in Developing Countries. Bull WHO. 1984; 62(6):817-830.

21. Gelber R, Lavin P, Mehta CR, Schoenfeld D. Acute and Chronic Toxicity Testing. In: Rand GM, Petrocelli SR, eds. Fundamentals of Aquatic Toxicology. Washington: Hemisphere Publishing Corporation, 1985:110-123.

22. Mehta CR, Patel NR, Gray R. On computing an exact confidence interval for the common odds ratio in several 2 x 2 contingency tables. Journal of the American Statistical Association. 1985; 80(392):969-973.

23. Mehta CR, Patel NR. A hybrid algorithm for Fisher's exact test in unordered r x c contingency tables. Communic in Statist. 1986; A15: 2.

24. Gupta PC, Mehta CR. An intervention study of tobacco chewing and smoking habits for primary prevention of oral cancer among 12,212 Indian Villages. Tobacco: A Major International Health Hazard. IARC Sci Publ. No. 74, 1986.

25. Gupta PC, Mehta CR, Pindborg JJ. Intervention of tobacco chewing and smoking habits. Am J Pub Heal (letter). 1986; 76(6):709.

26. Mehta CR, Patel NR. FEXACT: A Fortran Subroutine for Fisher's exact test on unordered r x c contingency tables. ACM Transactions on Mathematical Software. 1986; 12(2):154-161.

27. Cassileth BR, Knuiman MW, Abeloff MD, Mehta CR. Anxiety levels in patients randomized to adjuvant therapy versus observation for early breast cancer. J Clin Oncol. 1986; 4(6):972-74.

28. Hirji K, Mehta CR, Patel NR. Computing distributions for exact logistic regression. Journal of the American Statistical Association. 1987; 82(400):1110-1117.

29. Mehta CR, Patel NR, Wei LJ. Constructing exact significance tests with restricted rules. Biometrika. 1988; 75(2):295-302.

30. Hirji K, Mehta CR, Patel NR. Exact inference for matched case-control studies. Biometrics. 1988; 44(3):803-814.

31. Mehta CR, Patel NR, Senchaudhuri P. Importance sampling for estimating exact probabilities in permutational inference. Journal of the American Statistical Association. 1988; 83(404):999-1005.

CURRICULUM VITAE Page 7 Cyrus Rustam Mehta

32. Hirji K, Tsiatis A, Mehta CR. Median unbiased estimation for binary data. American Statistician. 1989; 43:7-11.

33. Wei LJ, Smythe R, Mehta CR. Interval estimation with restricted randomization rules. Biometrika. 1989; 76(2):363-368.

34. Agresti A, Mehta CR, Patel NR. Exact inference for contingency tables with ordered categories. Journal of the American Statistical Association. 1990; 85(410):453-458.

35. Mehta CR. StatXact: A Statistical Package for Exact Nonparametric Inference. Journal of Classification. 1990; 7:111-114.

36. Mehta CR, Walsh SJ. Comparison of exact, mid-p and Mantel-Haenszel confidence intervals for the common odds ratio across several 2x2 tables. American Statistician . 1992; 46(2):146-150.

37. Mehta CR. Action and Contemplation. Prabuddha Bharata, Volume 96, April, 1991.

38. Mehta CR. StatXact 2: A statistical package for exact nonparametric inference. The American Statistician. 1991; 45(1):78-79.

39. Mehta CR, Patel NR, and Senchaudhuri P. Exact stratified linear rank tests for ordered categorical and binary data. Journal of Computational and Graphical Statistics, 1992; 1:21-40.

40. Mehta CR. Comment: An interdisciplinary approach to exact inference for contingency tables. Statistical Science. 1992; 7:167-170.

41. Strawderman RL, Mehta CR. On the validation of exact tests for nonparametric inference. Computational Statistics and Data Analysis. 1992; 14:263-266.

42. Mehta CR, Walsh S. Rejoinder to letter concerning "Comparison of exact, mid-p and Mantel- Haenszel confidence intervals for the common odds ratio across several 2x2 tables". American Statistician. 1992; 47, 1, 86-87.

43. Agresti AB, Lang JB, Mehta CR. Some empirical comparisons of exact, modified exact, and higher order asymptotic tests of independence for ordered categorical variables. Communications in Statistics: Simulation and Computation. 1993; 22(1).

44. Mehta CR and Hilton JF. Exact power of conditional and unconditional tests: Going beyond the 2x2 contingency table. American Statistician. 1993; 47:91-98.

45. Hilton J, Mehta CR. Power and sample size calculations for exact conditional tests with ordered categorical data. Biometrics. 1993; 49, 609-616.

46. Hilton J, Mehta CR, Patel NR. Exact Smirnov p-values using a network algorithm. Computational Statistics and Data Analysis. 1994; 17, 4, 351-361.

47. Mehta CR. The exact analysis of contingency tables in medical research. Statistical Methods in Medical Research. 1994; 3, 2:135-156.

48. Mehta CR, Hilton JF. Rejoinder to letter concerning "Exact power of conditional and unconditional tests: Going beyond the 2x2 contingency table". American Statistician. 1994; 48, 2:175. CURRICULUM VITAE Page 8 Cyrus Rustam Mehta

49. Mehta CR, Patel NR, Senchaudhuri P, Tsiatis AA. Exact permutational tests for group-sequential clinical trials. Biometrics. 1994; 50, 1042-1053.

50. Senchaudhuri P, Mehta CR, Patel NR. Estimating exact p-values by the method of control variates, or Monte Carlo rescue. Journal of the American Statistical Associations. 1995; 90(430):640-648.

51. Mehta CR, Patel NR. Exact logistic regression: theory & examples. Stats in Med. 1995; 14:2143-21

52. Podgor MJ, Gastwirth JL, Mehta CR. Efficiency robust tests of independence in contingency tables with ordered classifications. Stats in Med. 1996; 15:2095-2105.

53. Mehta CR. Discussion of paper on multiple testing by Wei and Glidden. Stats in Med. 1997; 16:848- 849.

54. Mehta CR, Patel NR. Exact inference for categorical data. Encyclopedia of Biostatistics, vol 2, 1411-1422. John Wiley & Sons (1998).

55. Mehta CR, Patel NR, Senchaudhuri P. Exact power and sample-size computations for the Cochran- Armitage trend test. Biometrics. 1998; 54:1615-1621.

56. Mehta CR, Patel NR, Senchaudhuri P. Approximately exact inference for the common odds ratio in several 2 x 2 tables: Comment. Journal of the American Statistical Association. 1998; 93(444):1313-1316.

57. Mehta CR, Patel NR. Exact permutational inference for categorical and nonparametric data. Statistical Strategies for Small-Sample Research. Hoyle R (ed). Sage Publications (1999).

58. Mehta CR, Patel NR, Senchaudhuri P. Efficient Monte Carlo methods for conditional logistic regression. Journal of the American Statistical Association. 2000; 95(449): 99-108.

59. Corcoran CD, Ryan L, Senchaudhuri P, Mehta CR, Patel NR, Molenbergs G. An exact trend test for correlated data. Biometrics. 2001; 57:931-948.

60. Corcoran CD, Mehta CR, Senchaudhuri P. Power comparisons for tests of trend in dose-response studies. Stats in Med. 2000; 19:3037-3050.

61. Corcoran CD, Mehta CR, Patel NR, Senchaudhuri P. Computational tools for conditional logistic regression. Stats in Med. 2001; 20:2723-2639.

62. Corcoran CD, Mehta CR. Interval estimation for a binomial proportion. Comment. Statistical Science. 2001; 2:122-123.

63. Mehta CR, Tsiatis AA. Flexible sample size considerations using information based interim monitoring. DIA Journal. 2001; 35(4):1095-1112.

64. Corcoran CD, Mehta CR. Exact level and power of permutation, bootstrap and asymptotic tests of trend. Journal of Modern Applied Statistical Methods. 2002; 1, 42-51.

65. Rabbee N, Coull BA, Mehta CR, Patel NR, Senchaudhuri P. Power and sample size for ordered categorical data. Statistical Methods in Medical Research. 2003; 12, 73-84. CURRICULUM VITAE Page 9 Cyrus Rustam Mehta

66. Tsiatis AA, Mehta CR. On the inefficiency of the adaptive design for monitoring clinical trials. Biometrika. 2003; 90, 367-378.

67. Kim K, Tsiatis AA, Mehta CR. Computational issues in information-based group sequential clinical trials. Journal of the Japanese Society for Computational Statistics. 2003; 15.2, 153-167.

68. Han KE, Catalano PJ, Senchaudhuri P, Mehta CR. Exact analysis of dose response for multiple correlated binary outcomes. Biometrics. 2004; 60, 216-224.

69. Mehta CR, Patel NR. Adaptive, group sequential and decision theoretic approaches to sample size determination. Statistics in Medicine. 2006; 25, 3250-3269.

70. Mehta CR, Jemiai Y. A consultant's perspective on the regulatory hurdles to adaptive trials. Biometrical Journal. 2006; 4, 48, 598-603.

71. Santner TJ, Pradhan V, Senchaudhuri P, Mehta CR, Tamhane A. Comparisons of confidence intervals for the difference of two independent binomial proportions. Computational Statistics and Data Analysis. 2007; 51, 5791-5799.

72. Mehta CR, Bauer P, Posch M, Brannath W. Repeated confidence intervals for adaptive group sequential trials. Statistics in Medicine 2008; 26, 5422-5433.

73 Mehta AM, Mehta CR. Improving golf instruction with the iClub motion capture technology. Journal of Quantitative Analysis in Sports. 2008; volume 4, issue 2. (Berkeley Electronic Press. http://www.bepress.com/jqas/vol4/iss2/12 )

74. Gao P, Ware JH, Mehta CR. Sample size re-estimation for adaptive sequential design. J.Biopharmaceutical Statistics 2008; 18 (6): 1184-96.

75. Mehta CR, Gao P, Bhatt DL, Harrington RA, Skerjanec S, Ware JH. Statistical primer for cardiovascular research: optimizing trial design; sequential, adaptive and enrichment strategies. Circulation 2009; 119:597-605.

76. Brannath W, Mehta CR, Posch M. Exact confidence bounds for adaptive group sequential tests. Biometrics. 2009; 65, 539-546.

78. Orloff J, Pinheiro J, Mehta CR, others with the McKinsey Trial Design Team. The Future of Drug Development: Clinical Trial Design. Nature Reviews Drug Discovery; on-line, 9 Oct. 2009.

77. Tamhane AC, Mehta CR, Liu L. Testing a primary and a secondary endpoint in a group sequential design. Biometrics 2010; 66, 1174-1184.

78. Mehta CR, Pocock SJ. Adaptive increase in sample size when interim results are promising: a practical guide with examples. Statistics in Medicine 2011; 30: 3267-3284.

79. Mehta CR, Pocock SJ. Response to Comments by Emerson, Levin and Emerson on "Adaptive Increase in Sample Size when Interim Results are Promising". Statistics in Medicine 2012; 31:98-9.

80. Mehta CR, Gao P. Population enrichment designs: case study of a large multinational trial. Journal of Biopharmaceutical Statistics 2011; 21(4):831-45.

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81. White WB, Bakris GL, Bergenstal RM, Cannon CP, Cushman WC, Fleck P, Heller S, Mehta CR, Nissen SE, Perez A, Zannad F. A cardiovascular safety study of the dipeptidyl peptidase 4 inhibitor Algoliptin, in type 2 diabetic patients with acute coronary syndrome: the EXAMINE trial. American Heart Journal 2011; 162: 620-626.

82. Mehta CR, Pocock SJ. Response to Letter by E. Glimm on "Adaptive Increase in Sample Size when Interim Results are Promising". Statistics in Medicine 2012; 31, No. 1, 99.

83. Tamhane AC, Wu Y, Mehta CR. Adaptive extensions of a two-stage group sequential procedure for testing a primary and a secondary endpoint (I): Unknown correlation between endpoints. Statistics in Medicine 2012; 31(19):2027-40.

84. Tamhane AC, Wu Y, Mehta CR. Adaptive extensions of a two-stage group sequential procedure for testing a primary and a secondary endpoint (II): Sample size re-estimation. Statistics in Medicine, 2012; 31(19):2041-54.

85. Mehta CR. Sample size reestimation for confirmatory clinical trials. Chapter 4, Designs for Clinical Trials: Perspectives on Current Issues, 2012. D. Harrignton (ed.), Springer, New York.

86. Mehta CR. Adaptive clinical trial designs with pre-specified rules for modifying the sample size: a different perspective. Statistics in Medicine 2013, volume 32, No. 8, 1276.

87. Gao P, Liu L, Mehta CR. Adaptive designs for non-inferiority trials. Biometrical Journal 2013, volume 55, 3, 310-321.

88. Gao P, Liu L, Mehta CR. Exact inference for adaptive group sequential designs. Statistics in Medicine, 2013; volume 32, 3991-4005.

89. White WB, Cannon CP, Heller SK, Nissen SE, Bergenstal MD, Bakris GL, Perez AT, Fleck PR, Mehta CR, Kupfer, S, Wilson C, Cushman WC, Zannad F. Alogliptin after acute coronary syndrome in patients with type 2 diabetes. New England Journal of Medicine, 2013; vol 369, No 14, pages 1327-35.

90. Selker HO, Oye KA, Eichler H-G, Stockbridge N, Mehta CR, Kaitin K, McElwee N, Honig P, Erban JK, D'Agostino R. A proposal for integrated efficacy-to-effectiveness (E2E) clinical trials. Clinical Pharmacology & Therapeutics , 2014; volume 95, No. 2, pages 147-153.

91. Gao P, Liu L, Mehta CR. Adaptive sequential testing for multiple comparisons. Journal of Biopharmaceutical Statistics, 2014; volume 24, pages 1-24.

92. Gewandter J, Dworkin RH, et. al., Mehta CR, et. al. Research designs for proof-of-concept chronic pain clinical trials: IMMPACT recommendations. Pain, 2014; volume 155, pages 1683-1695.

93. Mehta CR, Schäfer H, Daniel H, Irle S. Biomarker driven population enrichment for adaptive oncology trials with time to event endpoints. Statistics in Medicine, 2014, 33, 4515-4531.

94. Chaturvedi PR, Antonijevic Z, Mehta CR. Practical considerations for a two-stage confirmatory adaptive clinical trial design and its implementation:ADVENT Trial. Chapter 20, Practical Considerations for Adaptive Trial Design and Implementation, 2014. W. He et. al. (eds.), Springer Science, New York.

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95. Geiger MJ, Mehta CR, Turner RT, …, Gaydos B. Clinical development approaches and statistical methodologies to prospectively assess the cardiovascular risk of new antidiabetic therepies for type 2 diabetes. Therapeutic Innovation and Regulatory Science, 2015, vol 49(1) 50-64.

96. Léauté-Labrèze C, Hoeger P, …, Mehta CR, … Voisard JJ. A randomized controlled trial of oral propranolol in infantile hemangioma. New England Journal of Medicine, 2015; vol 372, p735-746.

97. Zannad F, Cannon CP, Cushman WC, Bakris GL, Menon V, Perez AT, Fleck PR, Mehta CR, Kupfer S, Wilson C, Lam H, White WB. Heart failure and mortality outcomes in patients with type 2 diabetes taking alogliptin versus placebo in EXAMINE: a multicenter, randomized, double-blind trial. Lancet, 2015; vol 385, No 9982, p2067-2076.

98. Ravandi F, Ritchie EK, …, Mehta CR, Stuart RK, Kantarjian HM. Vosaroxin plus cytarabine versus placebo plus cytarabine in patients with first relapsed or refractory acute myeloid leukemia (VALOR): a randomized, controlled, double-blind, multinational, phase 3 study. Lancet Oncology, 2015; vol 16(9):1025-36.

99. Mehta CR, Liu L. An objective re-evaluation of adaptive sample size re-estimation: Commentary on '25 years of Confirmatory adaptive designs'. Statistics in Medicine, 2016, 35, 350-358.

100. Mehta CR. Comment on "Some Challenges with Statistical Inference in Adaptive Design". Journal of Biopharmaceutical Statistics, 2016; Vol 26, No 2, 402-404.

101. White WB, Wilson CA, ..., Mehta CR, ...Kupfer S. Angiotensin converting enzyme inhibitor use and major cardiovascular outcomes in type-2 diabetes treated with DPP-4 inhibitor alogliptin. Hypertension. 2016. 68:00-00. DOI: 10.1161/HYPERTENSIONAHA.116.07797.

102. White WB, Kupfer S, ..., Mehta CR, ...Cannon CP. Cardiovascular mortality in patients with type 2 diabetes and recent acute coronary syndromes. Diabetes Care 2016; 39:1267-1273 .

103. Bhatt DL, Mehta CR. Adaptive Designs for Clinical Trials. New England Journal of Medicine, 2016; 375:65-74.

104. Heller SR, Bergenstal RM , ..., Mehta CR, ...Cannon CP. Relationship of glycated haemoglobin and reported hypoglycaemia to cardiovascular outcomes in patients with type 2 diabetes and recent acute coronary syndromes: the EXAMINE trial. Diabetes, Obesity and Metabolism, 2017; 1-8.

105. Cavender MA, White WB, ..., Mehta CR, ...Morrow DA. Serial Measurement of High Sensitivity Troponin 1 and Cardiovascular Outcomes in Patients with Type 2 Dibetes Mellitus in the EXAMINE Trial. Circulation, vol 135, issue 9, 2017.

106. Ghosh P, Liu L, Senchaudhuri P, Gao P, Mehta CR. Design and Monitoring of Multi-arm Multi- stage Clinical Trials. Biometrics 2017; 73:1289-1299.

107. Liu L, Hsiao S, Mehta CR. Efficiency Considerations for Group Sequential Designs with Adaptive Unblinded Sample Size Re-assessment. Statistics in Biosciences, 2017. (In press. DOI: 10.1007/s12561-017-988-x.)

108. Tamhane A, Gou J, Jennison C, Mehta CR, Curto T. A Gatekeeping Test on a Primary and a Secondary Endpoint in a Group Sequential Design with Multiple Interim Looks. Biometrics, 2017. (In press. DOI: 10.1111/biom.12732.) CURRICULUM VITAE Page 12 Cyrus Rustam Mehta

109. Mehta CR. Commentary on Friedlin and Korn. Clinical Trials, 2017; vol 14(6) 605-608.

110. Marchenko O, Jiang Qi, Chuang-Stein C, Mehta CR, ..., Soomin Park. Statistical Considerations for Cardiovascular Outcome Trials in Patients with Type 2 Diabetes Mellitus. Statistics in Biopharmaceutical Research, 2017. (In press. On-line at http://dx.doi.org/10.1080/19466315.2017.1280411)

111. Butler J, Hamo CE, ..., Mehta CR,..., Anker DA, on behalf of the EMPEROR Trials Program. The potential role and rationale for treatment of heart failure with sodium-glocose co-transporter 2 inhibitors. European Journal of Heart Failure, 2017. (In press. DOI: 10.1002/ejhf.933.)

112. Hwang Y-C, Morrow DA, ..., Mehta CR, ..., White WB. High-sensitivity C-reactive protein, low- density lipoprotein cholesterol and cardiovascular outcomes in patients with type 2 diabetes in the EXAMNE trial. Diabetes, Obesity and Metabolism, 2017. (In press. DOI: 10.1111/dom.13136.)

113. Cavender M, White WB, ..., Cannon CP. Total Cardiovascular Events Analysis of the EXAMINE Trial in Patients with Type 2 Diabetes and Recent Acute Coronary Syndrome. Clinical Cardiology, 2018; 1-6. (In press. DOI: 10.1002/clc.22960.)

114. Green SJ, Mentz RJ, ..., Mehta CR, ...O'Connor CM. Reassessing the Role of Surrogate Endpoints in Drug Development for Heart Failure. Circulation, 2018. (In press; DOI: 10.1161/CIRCULATIONAHA).

115. Hsiao S, Liu L, Mehta CR. Optimal Promising Zone Designs. Biometrical Journal, 2018. (In press).

116. White WB, Jalil F, ..., Mehta CR, Zannad F. Average Clinician-Measured Blood Pressures and Cardiovascular Outcomes in Patients with Type 2 Diabetes and Ischemic Heart Disease in the EXAMINE Trial. Journal of the American Heart Association, 2018. (In press. DOI 10.1161/JAHA.118.009114).

SOFTWARE PACKAGES DEVELOPED:

1. StatXact. A software package for exact nonparametric inference; version 9, 2010.

2. LogXact. A software package for exact logistic regression; version 9, 2010.

3. EaSt. A software package for group-sequential and adaptive clinical trials; version 6.4, 2016

4. SiZ. Software for sample size calculations; version 2, 2011

5. StaTable. Electronic tables for statisticians and engineers, 1989.

6. Egret. A software package for epidemiological modelling, 1998.

7. Toxtools. Software for dose-response modeling and toxicological risk assessment, 2001.