Peter Gilbert1Curriculum Vitae

CURRICULUM VITAE

Peter Gilbert1Curriculum Vitae

Peter B. Gilbert, Ph.D.

March, 2011

1. Biographical Information

FredHutchinsonCancerResearchCenter

Statistical Center for HIV/AIDS Research and Prevention

1100 Fairview Avenue North, M2-C202

PO Box 19024

Seattle, WA98109

Tel: (206) 667-7299

Fax: (206) 667-4378

e-mail:

webpage:

2. Education

University of Washington, B.S., Mathematics, 1992

University of Washington, M.S., Biostatistics, 1994

University of Washington, Ph.D., Biostatistics, 1996

Postdoctoral Training:

Harvard School of Public Health, Department of Biostatistics, 1997

3. Licensure: not applicable

4. Professional Positions

Research Assistant, Department of Mathematics, University of Washington, 1991

Graduate Research Assistant, Coronary Artery Surgery Study, University of Washington, 1992-1993

Graduate Research Assistant, HIVNET, University of Washington, 1995-1996

Research Fellow, Department of Biostatistics, HarvardSchool of Public Health, 1997

Assistant Professor, Department of Biostatistics, Harvard School of Public Health, 1998-2001

Assistant Member, Fred Hutchinson Cancer Research Center, 2001-2002

Associate Member, Fred Hutchinson Cancer Research Center, 2002-2007

Member, Fred Hutchinson Cancer Research Center, 2007-present

Research Assistant Professor, Department of Biostatistics, University of WashingtonSchool of Public Health, 2002-2004

Research Associate Professor, Department of Biostatistics, University of WashingtonSchool of Public Health, 2004-2007

Research Professor, Department of Biostatistics, University of Washington School of Public Health, 2008-present

Deputy Director of Statistical Sciences, Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, 2005-2006

Co-Director, Statistical Data Management Center of the HIV Vaccine Trials Network, Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, 2004-present

5. Honors, Awards, Scholarships

Dean's List, University of Washington, 1988-1992

Phi Beta Kappa, 1992

Golden Key National Honor Society, 1992

B.S., Magna Cum Laude, 1992

Honorary Donovan J. Thompson Award for outstanding performance as a student in biostatistics,

University of Washington, 1994

School of Public Health and Community Medicine Outstanding Student Scholarship, University

of Washington, 1995

Senior Biostatistics Student Award, University of Washington, 1996

Excellent Teaching Rating, each of two semester courses, Harvard School of Public Health,

2000-2001

Ross L. Prentice Professorship at the Department of Biostatistics, University of Washington,

2005-2006

NIAID MERIT award for RO1 application “Statistical Methods in HIV Vaccine Efficacy Trials”

2010

6. Professional Activities (outside of UW)

Reviewer of Grants and Proposals

Reviewer of AIDS clinical trials grants for the Canadian Institutes of Health Research (CIHR), March and August, 2001

Member of a Technical Evaluation Panel for a Contract Proposal Review for the National Institutes of Health, National Cancer Institute, August, 2002

Member of an HIV Special Emphasis Panel to review grant applications received in response to PAR-03-095: The Integrated Preclinical/Clinical AIDS Vaccine Development Program (IPCAVD), February 2004

Member of the Gates Foundation Intermittent Preventive Treatment of Infants and Children for Malaria (IPTi) Review Committee, 2004

Temporary Member of the NIH AIDS Clinical Studies and Epidemiology Study Section: AIDS and Related Research Integrated Review Group, 2004

Member of the NIH AIDS Clinical Studies and Epidemiology Study Section: AIDS and Related Research Integrated Review Group, 2005-2008

Alternate Member of the Institute of Medicine’s Study on Intermittent Preventive Therapy for Malaria in Infants (IPTi), 2008-present

Member of The Vaccines and Related Biological Products Advisory Committee to the Food and Drug Administration, 2008-present

Reviewer of NIH proposals for American Renewal and Recovery Act Challenge Grants, 2009-2010

Strategic Planning Committee, Vaccine Infectious Disease Division, Fred Hutchinson Cancer Research Center, 2011

Other Reviewer Activities

Member of HIV Vaccine Trials Network Protocol Committee, 2007-2009

Data Safety Monitoring Boards

Member of Safety Monitoring Committee for a Phase II Extended Safety Study of Tenofovir, Centers of Disease Control and Prevention, 2004-present

Member of Safety and Efficacy Monitoring Committee for an AIEDRP/ACTG Phase II trial of Cyclosporine A, Trizivir, and Kaletra in subjects with primary HIV infection, 2005-present

Member of Safety Monitoring Committee for Phase I trial of a recombinant Adenovirus serotype 4 influenza vaccine, 2009-present

Associate Editor

Associate Editor, Annals of Applied Statistics, 2006-2010

Referee

The American Journal of Epidemiology

The Annals of the Institute of Statistical Mathematic

The Annals of Applied Statistics

The Annals of Statistics

Antiviral Therapy

Biometrics

Biometrical Journa

Biometrika

The Canadian Journal of Statistics

Communications in Statistics

Controlled Clinical Trials

Epidemiology

Journal of AIDS

Journal of the American Medical Association

Journal of the American Statistical Association

Journal of Human Virology

The Journal of Infectious Diseases

Journal of the Royal Statistical Society B

Journal of Statistical Planning and Inference

The Lancet Infectious Diseases

PLoS Medicine

Nature Medicine

Nonparametric Statistics

Scandinavian Journal of Statistics

Statistica Sinica

Statistical Communications in Infectious Diseases

Statistics in Medicine

Memberships in Professional Organizations:

American Statistical Association

International Biometric Society

7. Bibliography

a) Refereed Research Articles

1.De Gruttola V, Hughes M, Gilbert P, Phillips A. Trial design in the era of highly effective antiviral drug combinations for HIV-1 infection. AIDS, 1998; 12:S149 – 56.

2.Gilbert P, De Gruttola V, Hammer S. Efficient trial designs for studying combination antiretroviral treatments in patients with various resistance profiles. The Journal of Infectious Diseases, 1998; 178:340 – 348.

3.Gilbert P, Self S, Ashby A. Statistical methods for assessing differential vaccine protection against human immunodeficiency virus types. Biometrics, 1998; 54:799 – 814.

4.Scharfstein D, Tsiatis A, Gilbert P. Semiparametric efficient estimation in the generalized odds-rate class of regression models for right-censored time to event data. Lifetime Data Analysis, 1998; 4:355 – 391.

5.Christie P, Edelberg J, Picard M, Foulkes A, Mamuya W, Weiler-Guettler H, Gilbert P, Rosenberg R. A murine model of myocardial microvascular thrombosis. Journal of Clinical Investigation, 1999; 104:533 – 539.

6.Gilbert P, Lele S, Vardi Y. Maximum likelihood estimation in semiparametric selection bias models with application to AIDS vaccine trials. Biometrika, 1999; 86:27 – 43.

7.Renjifo B, Gilbert P, Chaplin B, Vannberg F, Mwakagile D, Fawzi W, Essex M. Emerging recombinant human immunodeficiency viruses: uneven representation of the V3 loop envelope region. AIDS, 1999; 13:1613 – 1621.

8.Gilbert P. Large sample theory of maximum likelihood estimates in semiparametric biased sampling models. Annals of Statistics, 2000; 28:151-194.

9.Gilbert P. Some statistical issues in the design and analysis of HIV-1 vaccine and treatment trials. Statistical Methods in Medical Research, 2000; 9:207-229.

10.Gilbert P. Comparison of competing risks failure time methods and time-independent methods for assessing strain variations in vaccine protection. Statistics in Medicine, 2000; 19:3065-3086.

11.Gilbert P. Interpretability and robustness of sieve analysis models for assessing HIV-1 strain variations in vaccine efficacy. Statistics in Medicine, 2000; 20:263-279.

12.Gilbert P. Developing an AIDS vaccine by sieving. Chance, 2000; 13:16-21.

13.Gilbert P, Hanna G, De Gruttola V, Martinez-Picado J, Kuritzkes D, Johnson V, Richman D, D'Aquila R. Comparative analysis of HIV-1 type 1 genotypic resistance across antiretroviral trial treatment regimens. AIDS Research and Human Retroviruses, 2000; 16:1325-1336.

14.Gilbert P, Ribaudo H, Greenberg L, Yu G, Bosch R, Tierney C, Kuritzkes D. Considerations in choosing a primary endpoint that measures durability of virological suppression in an antiretroviral trial. AIDS, 2000; 14:1961-1972.

15.Segal S, Su M, Gilbert P. The effect of a rapid change in availability of epidural analgesia on the cesarean delivery rate: A meta-analysis. American Journal of Obstetrics and Gynecology, 2000; 183:974-978.

16.Gilbert P, DeGruttola V, Hammer S, Kuritzkes D. Virological and regimen termination surrogate endpoints in AIDS clinical trials. The Journal of the American Medical Association, 2001; 285:775-782.

17.Gilbert P, Novitsky V, Montano M, Essex M. An efficient test for comparing HIV-1 sequence diversity between populations. The Journal of Computational Biology, 2001; 8:123-139.

18.Gilbert P, Self S, Rao M, Naficy A, Clemens J. Sieve analysis: Methods for assessing how vaccine efficacy depends on genotypic and phenotypic pathogen variation from vaccine trial data. Journal of Clinical Epidemiology, 2001; 54:68-85.

19.Havlir D, Bassett R, Levitan D, Gilbert P, Tebas P, Collier A, Hirsch M, Ignacio C, Condra J, Gunthard H, Richman D, Wong J. Prevalence and predictive value of intermittent viremia with combination HIV-1 therapy. The Journal of the American Medical Association, 2001; 286:171-179.

20.Havlir D, Gilbert P, Bennett K, Collier A, Hirsch M, Tebas P, Adams E, Wheat LJ, Goodwin D, Schnittman S, Holohan MK, Richman D, and the ACTG 5025 Study Team. Effects of treatment intensification with hydroxyurea in HIV-infected patients with virologic suppression. AIDS, 2001; 15:1379-1388.

21.McKeague I, Gilbert P, Kanki P. Comparison of competing risks with adjustment for covariate effects. Biometrics, 2001; 57:818-828.

22.Novitsky V, Rybak N, McLane MF, Gilbert P, Chigwedere P, Klein I, Gaolekwe S, Chang SY, Peter T, Thior I, N'dungu T, Vannberg F, Foley BT, Marlink R, Lee TH, Essex M. Identification of human immunodeficiency virus type 1 subtype C Gag-, Tat-, Rev-, and Nef-specific Elispot-based CTL responses for AIDS vaccine design. Journal of Virology, 2001; 75:9210-9228.

23.Novitsky V, Smith UR, Gilbert P, McLane MF, Chigwedere P, Williamson C, Ndung'u T, Klein I, Chang SY, Peter T, Thior I, Foley BT, Gaolekwe S, Rybak N, Gaseitsiwe S, Vannberg F, Marlink R, Lee TH, Essex M. Human Immunodeficiency Virus Type 1 Subtype C molecular phylogeny: Consensus sequence for an AIDS vaccine design? Journal of Virology, 2002; 76:5435-5451.

24.Wu L, Gilbert P. Flexible weighted log-rank tests optimal for detecting early and/or late survival differences. Biometrics, 2002; 58:997-1004.

25.Gilbert P, Wei LJ, Kosorok MR, Clemens JD. Simultaneous inference on the contrast of two hazard functions with censored observations. Biometrics, 2002; 58:773-780.

26.Novitsky V, Cao H, Rybak N, Gilbert P, McLane MF, Gaolekwe S, Peter T, Thior I, N'dungu T, Marlink R, Lee TH, Essex M. Magnitude and frequency of Cytotoxic T-Lymphocyte responses: Identification of immunodominant regions of Human Immunodeficiency Virus Type 1 Subtype C. Journal of Virology, 2002; 76:10155-10168.

27.Mani I, Gilbert P, Sankale J-L, Eisen G, Mboup S, Kanki PJ. Intrapatient diversity and its correlation with viral setpoint in Human Immunodeficiency Virus Type 1 CRF02A\G-IbNG infection. Journal of Virology, 2002; 76:10745-10755.

28.Weiser S, Wolfe W, Bangsberg D, Thior I, Gilbert P, Makhema J, Kebaabetswe P, Dickenson D, Mompati KF, Marlink R. Barriers to antiretroviral adherence for patients living with HIV and AIDS in Botswana. Journal of the Acquired Immune Deficiency Syndrome, 2003; 34:281-288.

29.Renjifo B, Chung M, Gilbert P, Msamanga G, Mwakagile, Fawzi W, Essex M. In-utero transmission of quasi-species among HIV-1 genotypes. Virology, 2003; 15:278-282.

30.Novitsky V, Gilbert P, Peter T, McLane MF, Gaolekwe S, Rybak N, Thior I, Ndung'u T, Marlink R, Lee TH, Essex M. Association between virus-specific T-cell responses and plasma viral load in HIV-1 subtype C infection. J Virology, 2003; 77:882-890.

31.Montano MA, Russell MS, Gilbert P, Thior I, Lockman S, Shapiro R, Chang SY, Lee TH, Essex M. Comparison of viral load markers for predicting perinatal HIV-1 transmission. Journal of Infectious Diseases, 2003, 188:406-413.

32.Gilbert P. Goodness-of-fit tests for semiparametric biased sampling models with application to AIDS vaccine trials. Journal of Statistical Planning and Inference, 2003; 118:51-81.

33.Gilbert P, McKeague I, Eisen G, Mullins C, Guéye-NDiaye A, M'Boup S, Kanki P. Comparison of HIV-1 and HIV-2 infectivity from a prospective cohort study in Senegal. Statistics in Medicine, 2003; 22:573-593.

34.Gilbert P, Chiu Y-L, Allen M, Chapdu C, Israel H, Holman D, Lawrence D, Keefer MC, Wolff M, Frey SE, and the NIAID HIV Vaccine Trials Network: Long-term safety analysis of preventive HIV-1 vaccines evaluated in AIDS Vaccine Evaluation Group NIAID-sponsored Phase I and II clinical trials. Vaccine, 2003; 21:2933-2947.

35.Gilbert P, De Gruttola V, Hudgens M, Self S, Hammer S, Corey L. What constitutes efficacy for an HIV vaccine that ameliorates viremia: Issues involving surrogate endpoints in Phase III trials. Journal of Infectious Diseases, 2003; 188:179-193.

36.Gilbert P, Bosch R, Hudgens M. Sensitivity analysis for assessing vaccine effects on viral load in HIV-1 vaccine trials. Biometrics, 2003; 59:531-541.

37.Gilbert P, McKeague I, Sun Y. Tests for comparing mark-specific hazards and cumulative incidence functions. Lifetime Data Analysis, 2004; 10:5-28.

38.Renjifo B, Gilbert P, Chaplin B, Msamanga G, Mwakagile, Fawzi W, Essex M; Tanzanian Vitamin and HIV Study Group. Preferential in-utero transmission of HIV-1 subtype C as compared to HIV-1 subtype A or D. AIDS, 2004; 18:1629-1636.

39.Hudgens M, Gilbert P, Self S. Endpoints in vaccine trials. Statistical Methods in Medical Research, 2004; 13:89-114.

40.Evans TG, Frey S, Israel H, Chiu J, El-Habib R, Gilbert P, Gaitan A, Montefiori DC, and the HIV Vaccine Trials Network (HVTN 803). Long-term memory B-cell responses in recipients of candidate human immunodeficiency virus type 1 vaccines. Vaccine, 2004; 22:2626-2630.

41.Lee D, Graham BS, Chiu Y-L, Gilbert P, McElrath MJ, Belshe RB, Buchbinder SP, Sheppard HW, Koblin BA, Mayer KH, Keefer MC, Mulligan MJ, Celum CL. Breakthrough infections during phase I-II prime-boost HIV vaccine trials with canarypox vectors (ALVACTM) and recombinant gp120 or gp160.Journal of Infectious Diseases, 2004; 190:903-907.

42.Huang C, Barreda P, Mendoza V, Saavedra JM, Guzman L, Gilbert P. A comparative analysis of abandoned street children and formerly abandoned street children in La Paz, Bolivia. Archives ofDiseases in Childhood, 2004; 89:821-826.

43.Gilbert P, Rossini AJ, Shankarappa R. Two-sample tests for comparing intra-individual genetic sequence diversity between populations. Biometrics, 2005; 61:107-118.

44.Gilbert P. A modified false discovery rate multiple comparisons procedure for discrete data, with application to HIV genetics. Applied Statistics, 2005; 54;143-158.

45.rgp120 HIV Vaccine Study Group*. Placebo-controlled trial of a recombinant glycoprotein 120 vaccine to prevent HIV infection. Journal of Infectious Diseases, 2005; 191:654-665. [*P Gilbert the senior biostatistician for this clinical trial]

46.Gilbert P, Peterson M, Follmann D, Francis D, Gurwith M, Heyward W, Hudgens M, Jobes D, Popovic V, Self S, Sinangil F, Burke D, Berman P. Immunologic responses to rgp120 vaccine correlate with the incidence of HIV-1 infection in a Phase 3 preventive HIV-1 vaccine trial. Journal of Infectious Diseases, 2005; 191:666-677.

47.Gilbert P, Sun Y. Failure time analysis of HIV vaccine effects on viral load and antiretroviral therapy initiation. Biostatistics, 2005; 6:374-394.

48.Mascola JR, D’Souza P, Gilbert P, Hahn BH, Haigwood NL, Morris L, Petropoulos CJ, Polonis VR, Sarzotti M, Montefiori DM. Recommendations for the design and use of standard virus panels to assess neutralizing antibody responses elicited by candidate Human Immunodeficiency Virus Type 1 vaccines, Journal of Virology, 2005; 79:10103-10107.

49.Li M, Gao F, Mascola JR, Stamatatos L, Polonis VR, Koutsoukos M, Voss G, Goepfert P, Gilbert P, Greene KM, Bilska M, KotheDL, Salazar-Gonzalez JF, Wei X, Decker JM, Hahn BH,MontefioriDC. Human Immunodeficiency Virus Type 1 env clones from acute and early subtype B infections for standardized assessments of vaccine-elicited neutralizing antibodies, Journal of Virology, 2005; 79:10108-10125.

50.Meier A, Gilbert P. Issues in timing of data collection for estimating treatment effects in randomized clinical trials. Contemporary Clinical Trials, 2005; 26:598-610.

51.Gilbert P, Novitsky V, Essex M. Covariability of southern African HIV-1 subtype C amino acids. AIDS Research and Human Retroviruses, 2005; 21:1016-1030.

52.Gilbert P, Ackers M, Berman P, Francis D, Popovic V, Hu D, Heyward W, Sinangil F, Shepherd B, Gurwith M. HIV-1 virologic and immunologic progression and antiretroviral therapy initiation among HIV-1 infected participants in an efficacy trial of a recombinant glycoprotein 120 vaccine. Journal of Infectious Diseases, 2005; 192:974-983.

53.Wick WD, Gilbert P, Self SG. On modeling HIV and T cells in vivo: Assessing causal estimators in vaccine trials. PLoS Computational Biology, 2006; 6: e64. DOI: 10.1371/journal.pcbi.0020064. PMCID: PMC1479086

54.Shepherd B*, Gilbert P, Jemiai Y, Rotnitzky A. Sensitivity analyses comparing outcomes only existing in a subset selected post-randomization, conditional on covariates, with application to HIV vaccine trials. Biometrics, 2006; 62:332-342. [*University of Washington PhD student of P Gilbert]

55.Ndung'u T, Sepako E, McLane M, Chand F, Bedi K, Gaseitsiwe S, Doualla-Bell F, Peter T, Thior I, Moyo S, Gilbert P, Novitsky V, Essex M. HIV-1 subtype C in vitro growth and co-receptor utilization. Virology, 2006; 347:247-260.

56.Moodie Z, Rossini A, Hudgens M, Gilbert P, Self S, Russell N. Statistical evaluation of HIV vaccines in early clinical trials. Contemporary Clinical Trials, 2006; 27:147-160.

57.Novitsky V, Gilbert P, Shea K, McLane MF, Rybak N, Klein I, Thior I, Ndung’u T, Lee TH, Essex M. Interactive association of proviral load and IFN-γ–secreting T cell responses in HIV-1C infection. Virology, 2006; 349:142-155.

58.Shapiro RL, Thior I, Gilbert P*, Lockman S, Wester C, Smeaton LM, Stevens L, Heymann JS, Ndung’u T, Gaseitswe S, Novitsky V, Makhema J, Lagakos S, Essex M, and the Mashi Study Team. Maternal single-dose nevirapine versus placebo as part of an antiretroviral strategy to prevent mother-to-child HIV transmission in Botswana. AIDS, 2006; 20:1281-1288. [*P Gilbert the senior biostatistician (with Steve Lagakos) for this clinical trial]

59.Thior I, Lockman, S, Smeaton L, Shapiro RL, Wester C, Heymann JS, Gilbert P*, Stevens L, Peter T, Kim S, van Widenfelt E, Moffat C, Ndase P, Arimi P, Poloko K, Mazonde P, Makhema H, McIntosh K, Novitsky V, Lee T-H, Marlink R, Lagakos S, Essex M for the Mashi Study Team. Breastfeeding plus 6 months of infant Zidovudine prophylaxis vs formula feeding plus infant Zidovudine for 1 month to reduce HIV transmission in Botswana. A randomized trial: The Mashi Study. Journal of the American Medical Assocation 2006; 296:794-805. [*P Gilbert the senior biostatistician (with Steve Lagakos) for this clinical trial]

60.Mehrotra D, Li X, Gilbert P. A comparison of eight methods for the dual-endpoint evaluation of efficacy in a proof-of-concept HIV vaccine trial. Biometrics, 2006; 62:893-900.

61.Cai T, Gilbert P, Self S. Joint inferences on vaccine efficacy against infection and disease, with application to the first HIV vaccine efficacy trial. Journal of Biopharmaceutical Statistics, 2006; 16:517-538.

62.Li F, Malhotra U, Gilbert P, Hawkins N, Duerr A, McElrath J, Corey L, Self S. Peptide selection for human immunodeficiency virus type 1 CTL-based vaccine evaluation. Vaccine, 2006; 24:6893-6904.

63.Li F, Gilbert P, Self S. Identification of cross-neutralization determinants by GAP analysis: A mutational behavior approach. Current HIV Research, 2007; 5:85-94.

64.Li F, Horton H, Gilbert P, McElrath J, Corey L, Self S. HIV-1 CTL-based vaccine immunogen selection: Antigen diversity and cellular response features. Current HIV Research, 2007; 5:95-105.

65.Shepherd B*, Gilbert P, Mehrotra D. Eliciting a counterfactual sensitivity parameter. The American Statistician, 2006, 61: 56-63. [*University of Washington PhD student of P Gilbert]

66.Pitisuttithum P, Gilbert P*, Gurwith M, Heyward W, Martin M, van Griensven F, Hu D, Tappero JW; Bangkok Vaccine Evaluation Group. Randomized, double-blind, placebo-controlled efficacy trial of a bivalent recombinant glycoprotein 120 HIV-1 vaccine among injection drug users in Bangkok, Thailand. Journal of Infectious Diseases, 2006; 194:1661-1671. [*P Gilbert the senior biostatistician for this clinical trial]

67.Hudgens MG, Maathuis MH, Gilbert P. Nonparametric estimation of the joint distribution of a survival time subject to interval censoring and a continuous mark variable. Biometrics, 2007; OnLineEarly Articles. doi:10.1111/j.1541-0420.2006.00709.x. PMID 17688489

68.Follmann D, Duerr A, Tabet S, Gilbert P, Moodie Z, Fast, P, Cardinali M, Self S, for the Workshop participants. Endpoints and regulatory issues in HIV vaccine clinical trials: Lessons from a workshop. Journal of Acquired Immune Deficiency Syndrome, 2007; 44:49-60. PMCID:PMC2682948

69.Nickle D, Heath L, Jensen M, Gilbert P, Mullins J, Pond S. HIV-specific probabilistic models of protein evolution. PLoS ONE, 2007 June 6;2:e503.PMCID: PMC1479086

70.Forthal D, Gilbert P, Landucci G, Phan T. Recombinant gp120 vaccine-induced antibodies inhibit clinical strains of HIV-1 in the presence of Fc receptor-bearing effector cells and correlate inversely with HIV infection rate. Journal of Immunology, 2007, 178:6596-6603. PMID 17475891