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«Anastasia Ivanova, Ph.D. 1 4/1/2014 Anastasia Ivanova Department of Biostatistics University of North Carolina at Chapel Hill 3103-C ...»

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Anastasia Ivanova, Ph.D. 1 4/1/2014

Anastasia Ivanova

Department of Biostatistics

University of North Carolina at Chapel Hill

3103-C McGavran-Greenberg Hall, CB # 7420

Chapel Hill, NC 27599-7420

Work: (919) 843-8086

Fax: (919) 966-3802

E-mail: aivanova@bios.unc.edu

Education

Ph.D. in Statistics, 1998

University of Maryland Baltimore County

Dissertation Advisor: Professor W. F. Rosenberger

Dissertation title: A Birth and Death Urn for Randomized Clinical Trials Ph.D. in Mathematics, 1992 St. Petersburg State University, St. Petersburg, Russia Dissertation Advisor: Professor S. M. Ermakov Dissertation title: Stochastic Stability of Algorithms when Solving Partial Differential Equations with the Monte Carlo Method M.S. in Mathematics, 1988 St. Petersburg State University, St. Petersburg, Russia Professional Experience Associate Professor Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill 2006 – Present Member Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill 2001 – Present Assistant Professor Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill 1999 - 2006 Assistant Professor Department of Epidemiology and Biostatistics, Case Western Reserve University Cleveland, OH 1998 – 1999 Biostatistician Lombardi Cancer Center, Georgetown University, Washington, DC 1998 – 1998 Statistician Intern Anastasia Ivanova, Ph.D. 2 4/1/2014 Food and Drug Administration, Center of Biologics Evaluation and Research, Rockville, MD 1997 - 1998 Principal Investigator 2014 – Present Clinical Study of Vesicoureteral Reflux in Children Data Coordinating Center (Randomized Intervention for Children with Vesicoureteral Reflux - RIVUR DCC) 2014 – Present Careful Urinary Tract Infection Evaluation (CUTIE) 2014 – Present Folic Acid for Vascular Outcome Reduction in Transplantation (FAVORIT) Honors and Awards 1983 – 1988 Honor student scholarship, Department of Mathematics, St. Petersburg State University, St. Petersburg, Russia 2003 – 2008 Fellowship, Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill, Chapel Hill 2006 – 2007 Stanley S. Schor scholarship from Merck Research Laborator

–  –  –

Bibliography Peer-reviewed publications, Statistical Methods

1. Ivanova, A., Tamura, R.N. (2014). A two-way enriched clinical trial design: combining advantages of placebo lead-in and randomized withdrawal. Statistical Methods in Medical Research, available in Early View.

2. Ivanova, A., Hoberman, S. (2014). Higher order response adaptive urn designs for clinical trials with highly successful treatments. JRSS C, in press.

3. Wang, J.J., Ivanova, A. (2014). Dose finding with the sequential parallel comparison design. Journal of Biopharmaceutical Statistics, in press.

4. Farnan+, L., Ivanova, A., Peddada, S. (2014). Linear mixed effects models under inequality constraints with applications. PLOS ONE, 9(1): e84778, doi:10.1371/journal.pone.0084778.

5. Ivanova, A, Rosner, G.L., Marchenko, O., Parke, T., Perevozskaya, I., Wang, Y. (2014).

Advances in statistical approaches in oncology drug development. Therapeutic Innovation and Regulatory Science, 48, 81-89.

6. Bear, L., Ivanova, A. (2013). When should the sequential parallel comparison design be used in clinical trials? Clinical Investigation, 3, 832-833.

7. Ivanova, A., Xiao+, C. (2013). Dose-finding when the target dose is on a plateau of a Anastasia Ivanova, Ph.D. 3 4/1/2014 dose-response curve. Pharmaceutical Statistics, 12, 309-314.

8. Ivanova, A, Monaco, J, Stinchcombe, T. (2012). Efficient designs for phase II oncology trials with ordinal outcome. Statistics and Its Interface, 5, 463-469.

Ivanova, A., Xiao+, C., Tymofyeyev, Y. (2012). Two-stage designs for Phase 2 dosefinding trials. Statistics in Medicine, 31, 2872–2881.

Xiao+, C., Ivanova, A. (2012). Adaptive isotonic estimation of the minimum effective 10.

and peak doses in presence of covariates. Journal of Statistical Planning and Inference, 142, 1899-1907. PMC3375738

11. Ivanova, A., Qaqish, B.F., Schoenfeld, D. (2011). Optimality, sample size and power calculations for the sequential parallel comparison design. Statistics in Medicine, 30, 2793-2803.

12. Ivanova, A., Liu, K., Snyder, E., Snavely, D. (2009). An adaptive design for identifying the dose with the best efficacy/tolerability profile with application to a crossover dosefinding study. Statistics in Medicine, 28, 2941-2951. PMC2772210

13. Ivanova, A., Murphy, M. (2009). An adaptive first in man dose-escalation study of NGX267: Statistical, clinical, and operational considerations. Journal of Biopharmaceutical Statistics, 19, 247-255.

14. Ivanova, A., Flournoy, N. (2009). Comparison of isotonic designs for dose-finding.

Statistics in Biopharmaceutical Research, 1, 101-107. PMC2821065 Ivanova, A., Kim+, S. (2009). Dose-finding for binary ordinal and continuous outcomes 15.

with monotone objective function: a unified approach. Biometrics, 65, 307-315.

PMC2819822.

16. Zohar, S, Lian, Q., Levy, V., Cheung, K., Ivanova, A., Chevret, S. (2008). Quality assessment of phase I dose-finding cancer trials: Proposal of a checklist. Clinical Trials, 5, 478-486. PMC2819819.





17. Ivanova, A., Bolognese, J., Perevozskaya, I. (2008). Adaptive design based on t-statistic for dose-response trials. Statistics in Medicine, 27, 1581-1592. PMC2825484

18. Salama, I., Ivanova, A., Qaqish, B.F. (2008). Efficient generation of constrained block allocation sequences. Statistics in Medicine, 27, 1421-1428.

Ivanova, A., Flournoy, N., Chung+, Y. (2007). Cumulative cohort design for dosefinding. Journal of Statistical Planning and Inference, 137, 2316-2317.

20. Ivanova, A. (2006). Escalation, up-and-down and A+B designs for dose-finding trials.

Statistics in Medicine, 25, 3668-3678.

21. Qaqish, B.F., Ivanova, A. (2006). Multivariate logistic models. Biometrika, 93, 4, 1011Ivanova, A., Wang+, K. (2006). Bivariate isotonic design for dose-finding with ordered 22.

groups. Statistics in Medicine, 25, 2018-2026.

23. Ivanova, A. (2006). Urn designs with immigration: useful connection with continuous time stochastic processes. Journal of Statistical Planning and Inference, 136, 1836-1844.

24. Ivanova, A., Biswas, A., Lurie, A. (2006). Response adaptive designs for continuous outcomes. Journal of Statistical Planning and Inference, 136, 1845-1852.

25. Coad, S., Ivanova, A. (2005). Sequential adaptive urn designs with elimination for comparing K2 treatments. Statistics in Medicine, 24, 1995-2009.

26. Coad, S., Ivanova, A. (2005). The use of triangular test with response-adaptive treatment Anastasia Ivanova, Ph.D. 4 4/1/2014 allocation. Statistics in Medicine, 24, 1483-1493.

Ivanova, A., Barrier+, R., Berger, V.W. (2005). Adjusting for observable selection bias 27.

in block randomized trials. Statistics in Medicine, 24, 1537-1546.

28. Ivanova, A., Qaqish, B.F., Schell, M.J. (2005). Continuous toxicity monitoring in phase I trials in oncology. Biometrics, 61, 540-545.

Wang+, K., Ivanova, A. (2005). Two-dimensional dose finding in discrete dose space.

29.

Biometrics, 61, 217-222.

30. Berger, V.W., Zhou, Y., Ivanova, A., Tremmel, L. (2004). Adjusting for ordinal covariates by inducing a partial ordering. Biometrical Journal, 46, 48-55.

Ivanova, A., Wang+, K. (2004). A nonparametric approach to the design and analysis of 31.

two-dimensional dose-finding trials. Statistics in Medicine, 23, 1861-1870.

32. Ivanova, A. (2003). A new dose-finding design for bivariate outcomes. Biometrics, 59, 1003-1009.

33. Ivanova, A. (2003). A play-the-winner-type urn design with reduced variability.

Metrika, 58, 1-13.

34. Ivanova, A., Haghighi, A.M., Mohanti, S.G., Durham, S.D. (2003). Improved up-anddown designs for phase I trials. Statistics in Medicine, 22, 69-82.

35. Berger, V.W., Ivanova, A., Knoll, M. (2003). Minimizing predictability while retaining balance trough the use of less restrictive randomization procedures. Statistics in Medicine, 22, 3017-3028.

36. Berger, V.W., Ivanova, A. (2002). Adaptive test for ordered categorical data. Journal of Modern Applied Statistical Methods, 1, 269-280.

37. Berger, V.W., Ivanova, A. (2002). The bias of linear rank tests when testing for stochastic order in ordered categorical data. Journal of Statistical Planning and Inference, 107, 237-247.

38. Coad, D.S., Ivanova, A. (2001). Bias calculations for adaptive designs. Sequential Analysis, 20, 91-116.

39. Ivanova, A., Berger, V.W. (2001). Drawbacks of integer scoring of ordered categorical data. Biometrics, 57, 567-570.

40. Ivanova A., Flournoy, N. (2001). A birth and death urn for ternary outcomes: Stochastic processes applied to urn models. In Probability and Statistical Models with Applications.

(Charalambides, C.A., Koutras, M.V., Balakrishnan, N., eds.), Chapman and Hall/CRC, Boca Raton, 583-600.

41. Ivanova, A., Rosenberger, W.F. (2001). Adaptive designs for clinical trials with highly successful treatments. Drug Information Journal, 35, 1087-1093.

42. Rosenberger, W. F., Stallard, N., Ivanova, A., Harper, C., Ricks, M. (2001). Optimal adaptive designs for binary response trials. Biometrics, 57, 833-837.

43. Ivanova, A., Rosenberger, W.F. (2000). A Comparison of urn designs for randomized clinical trials of K2 treatments. Journal of Biopharmaceutical Statistics, 10, 1, 93-107.

44. Ivanova, A., Rosenberger, W.F., Durham S.D. Flournoy, N. (2000). A birth and death urn for randomized clinical trials. Sankhya B, 62, 104-118.

45. Berger, V.W., Permutt, T., Ivanova, A. (1998). The convex hull test for ordered categorical data. Biometrics, 54, 1541-1550.

46. Ermakov, S.M., Ivanova, A. (1991). Stochastic stability of difference schemes. Vestnik, Anastasia Ivanova, Ph.D. 5 4/1/2014 Mathematics Series, 24, 1, 36-40.

47. Barabanov, A.E., Ivanova, A. (1991). Minimax control of a discrete object with mixed perturbations. Automation and Remote Control, 54, 4, 2-11.

48. Barabanov, A.E., Ivanova, A. (1990). Minimax control of a nonminimally phased object with combination perturbations. Vestnik, Mathematics Series, 23, 1, 10-15.

+ student co-author

Peer-reviewed publications, Public Health and Medicine

49. Carpenter, M., John, A., Weir, M., Smith, S., Hunsicker, L. Kasiske, B.L., Kusek, J. W., Bostom, A., Ivanova, A., Levey, A.S, Weiner, D.E. Blood pressure, cardiovascular disease and death in the Folic Acid for Vascular Outcome Reduction in Transplantation trial. Journal of the American Society of Nephrology, in press.

50. Bhatnagar, S, Hoberman, A, Kearney, DH, Shaikh, N, Moxey-Mims, MM, Chesney, RW, Carpenter, MA, Greenfield, SP, Keren, E, Mattoo, TK, Mathews, R, GravensMueller, L, Ivanova, A. (2014). Development and impact of an intervention to boost recruitment in a multi-center pediatric randomized clinical trial. Clinical Pediatrics, 53(2), 151-7.

51. Rossi, E., Jackson, A., Ivanova, A., Boggess, J. (2013). Detection of sentinel lymph nodes for endometrial cancer with robotic assisted fluorescence imaging: cervical versus hysteroscopic injection. International Journal of Gynecological Cancer, 23, 1704-1711.

52. Raftery L, Tepper JE, Goldberg RM, Blackstock AW, Aklilu M, Bernard SA, Ivanova A, Davies JM, O'Neil BH. (2013). A Two-cohort Phase 1 study of weekly oxaliplatin and gemcitabine, then oxaliplatin, gemcitabine, and erlotinib during radiotherapy for unresectable pancreatic carcinoma. American Journal of Clinical Oncology, 36(3), 250Kimple, RJ, Horton, JK, Sartor, CI, Halle, J, Carey, L, Ollila, DW, Ivanova, A, Chiu, WM, Shields, JM, Livasy, CA, Dees, C. Phase I study and biomarker analysis of lapatinib and concurrent radiation for locally advanced breast cancer. The Oncologist, 17(12), 1496-503.

54. Foster, M.C., Amin, C., Voorhees, P.M., van Deventer, H.W., Richards, K.L., Ivanova, A., Whitman, J., Chiu, W.M., Barr, N.D., Shea, T. (2012). A Phase I, dose escalation study of clofarabine in combination with fractionated gemtuzumab ozogamicin in patients with refractory or relapsed acute myeloid leukemia. Leukemia and Lymphoma, 53(7), 1331-7, PMID: 22149206

55. Weiner, D.E., Carpenter, M.A., Levey, A.S., Ivanova, A., Cole, E.H., Hunsicker, L., Kasiske, B.L., Kim, J.S., Kusek, J.W., Bostom, A.G. (2012). Kidney function and risk of cardiovascular disease and mortality in stable kidney transplant recipients: post-hoc analysis of the FAVORIT trial. American Journal of Transplantation, 12(9), 2437-45.

56. Carey, L.A., Rugo, H.S., Marcom, P.K., Mayer, E.L., Esteva, F.J., Ma, C.X., Liu, M.C., Storniolo, A.M., Rimawi, M.F., Forero-Torres, A., Wolff, A.C., Hobday, T.J., Ivanova, A., Chiu, W.K., Ferraro, M., Burrows, E., Bernard, P.S., Hoadley, K.A., Perou, C.M., Anastasia Ivanova, Ph.D. 6 4/1/2014 Winer, E.P. (2012). TBCRC 001: randomized Phase II study of cetuximab in combination with carboplatin in stage IV triple negative breast cancer. Journal of Clinical Oncology, 30(21), 2615-23.

57. Rossi, E, Ivanova, A, Boggess, J.F. (2012). Robotically assisted fluorescence-guided lymph node mapping with ICG for gynecologic malignancies: a feasibility study.

Gynecologic Oncology, 124, 78-82.

58. Beaven, A, Shea, T., Moore, D., Feldman, Ivanova, A., Ferraro, M., Ford, Smith, Goy.

(2012). A Phase I study evaluating Ibritumomab Tiuxetan (Zevalin®) in combination with Bortezomib (Velcade®) in relapsed/refractory mantle cell and low grade B cell Non Hodgkin Lymphoma. Leukemia and Lymphoma 53(2):254-258.

59. Davies, J.M., Dhruva, N.S., Walko, C.M., Socinski, M.A., Bernard, S., Hayes, D.N., Kim, W.Y., Ivanova, A., Keller, K., Hilbun, L.R., Chiu, M., Dees, E.C., Stinchcombe, TE. (2011). A phase I trial of sorafenib combined with cisplatin/etoposide or carboplatin/pemetrexed in refractory solid tumor patients. Lung Cancer 71(2):151-5 PMID: 20580118



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