TECHNICAL REPORT

1. A paradigm for class prediction using gene expression profiles Michael D. Radmacher, Lisa M. McShane, and Richard Simon Journal of Computational Biology 9:505-511, 2002.

2. Methods for assessing reproducibility of clustering patterns observed in analyses of microarray data Lisa M. McShane, Michael D. Radmacher, Boris Freidlin, Ren Yu, Ming-Chung Li, and Richard Simon Bioinformatics 18:1462-1469, 2002.

3. Controlling the number of false discoveries:Application to high-dimensional genomic data Edward L. Korn, James F. Troendle, Lisa M. McShane, and Richard Simon Journal of Statistical Planning and Inference 124:379-398, 2004.

4. Design of studies using DNA microarrays Richard Simon, Michael D. Radmacher, and Kevin Dobbin Genetic Epidemiology 23:21-36, 2002.

5. Bioinformatics and Whole Genome Technologies Richard Simon

6. Comparison of Microarray Design Kevin Dobbin and Richard Simon Supplement

7. BRB Array-Tools Users Guide (version 3.2) Richard Simon and Amy Peng Lam

8. Statistical design of reverse dye microarrays Kevin Dobbin, Joanna Shih, and Richard Simon Bioinformatics 19: 803-10, 2003. Supplement

9. Pitfalls in the use of DNA microarray data for diagnostic and prognostic classification Richard Simon, Michael D. Radmacher, Kevin Dobbin, and Lisa M. McShane Journal of the National Cancer Institute 95:14-18, 2003. Supplement

10. Experimental Design of DNA Microarray Experiments Richard Simon and Kevin Dobbin Biotechniques 34: 1-5, 2002.

11. Phase I Clinical Trial Design L. V. Rubinstein and R. M. Simon

12. Clinical Trial Designs for Therapeutic Vaccine Studies Richard Simon Published as Chapter 34, pp519-525, Handbook of Cancer Vaccines, MM Morse, TM Clay, HK Lyerly (eds), Humana Press, 2004.

13. A random variance model for differential gene detection in small sample microarray experiments George Wright and Richard Simon Bioinformatics 19: 2448-55, 2003. Supplement and Tables & Figures

14. Using DNA Microarrays For Diagnostic and Prognostic Prediction Richard Simon Expert Review of Molecular Diagnostics 3(5) 587-595, 2003.

15. Statistical issues in the design and analysis of gene expression microarray studies of animal models Lisa Mcshane, Joanna Shih, and Aleksandra Michalowska Journal of Mammary Gland Biology and Neoplasia 8, 359-374, 2003.

16. Questions and Answers on Design of Dual Label Microarrays Kevin Dobbin, Joanna Shih, and Richard Simon Journal of the National Cancer Institute 95, 1362-1369, 2003.

17. Diagnostic and prognostic prediction using gene expression profiles in high-dimensional microarray data Richard Simon British J of Cancer 89:1599-1604, 2003.

18. Supervised analysis when the number of candidate features (p) greatly exceeds the number of cases (n) Richard Simon Association of Computing Machinery, SIGKDD Explorations 5(2) 31-36, 2003.

19. Sample Size Determination in Microarray Experiments for Class Comparison and Prognostic Classification Kevin Dobbin and Richard Simon Biostatistics, 8, 107-17, 2007. Supplement

20. On the efficiency of targeted clinical trials Aboubakar Maitournam and Richard Simon Statistics in Medicine 24:329-339, 2005. Supplement

21. Evaluating the efficiency of targeted designs for randomized clinical trials Richard Simon and Aboubakar Maitournam Clinical Cancer Research 10:6759-6763, 2005. Supplement and Correction (Clinical Cancer Research 12:3229, 2006)

22. Experimental Design Kevin Dobbin and Richard Simon Encyclopedia of Genetics, Genomics, Proteomics and Bioinformatics. John Wiley and Sons, New York.

23. Guidelines for the Design of Clinical Studies for Development and Validation of Therapeutically Relevant Biomarkers and Biomarker Based Classification Systems Richard Simon to appear in Biomarkers in Breast Cancer, DF Hayes & G Gasparini (eds)

24. When is a Genomic Classifier Ready for Prime Time Richard Simon Nature Clinical Practice Oncology 1:4-5, 2004.

25. An agenda for Clinical Trials: clinical trials in genomic era Richard Simon Clinical Trials 1:468-470, 2004.

26. Characterizing dye bias in microarray experiments Dobbin,K.K., Kawasaki, E.S., Petersen, D.W., and Simon, R.M. Bioinformatics, 21, 2430-2437, 2005. Supplement1, Supplement2

27. Estimating the number of rate limiting genomic changes for human breast cancer Xinan Zhang and Richard Simon Breast Cancer Research and Treatment 2005;91:121-124 Supplement

28. Bioinformatics in Cancer Therapeutics - Hype or Hope? Richard Simon Nature Clinical Practice Oncology 2:223, 2005.

29. BRB Array-Tools Users Guide (version 3.3) Richard Simon and Amy Peng Lam

30. Prediction Error Estimation: A Comparison of Resampling Methods Molinaro AM, Simon R, Pfeiffer RM.

31. Development and Validation of Therapeutically Relevant Multi-Gene Biomarker Classifiers Richard Simon Journal of the National Cancer Institute, Vol 97, No. 12, 866-867, 2005.

32. Appropriateness of some resampling-based inference procedures for assessing performance of prognostic classifiers derived from microarray data Lusa L, McShane LM, Radmacher MD, Shih JH, Wright GW, and Simon R. submitted to Statistics in Medicine

33. Road map for developing and validating therapeutically relevant genomic classifiers Richard Simon Journal of Clinical Oncology Vol 23, No.29, 2005.

34. Designing prospective clinical pharmacogenomic(PG) trials: meeting report on drug development strategies to enhance therapeutic decision making WL Trepicchio, D Essayan, ST Hall, G Schechter, Z Tezak, SJ Wang, D Weinreich and R Simon. The Pharmacogenomics Journal Vol 6:89-94 2006.

35. Development and validation of biomarker classifiers for treatment selection Richard Simon Journal of Statistical Planning & Inference 138:308-320, 2008.

36. Validation of pharmacogenomic biomarker classifiers for treatment selection Richard Simon To appear in Disease Markers 21 1-8, 2005.

37. An evaluation of randomized discontinuation design Boris Freidlin & Richard Simon Journal of Clinical Oncology 23, 5094-5098.

38. Adaptive signature design: An adaptive clinical trial design for generating and prospectively testing a gene expression signature for sensitive patients Boris Freidlin & Richard Simon Clinical Cancer Research 11:7872-7878.

39. Bias in error estimation when using cross-validation for model selection Sudhir Varma & Richard Simon BMC Bioinformatics 7:91, 2006.

40. On estimating diagnostic accuracy with multiple raters and partial gold standard evaluation Paul S. Albert and Lori E. Dodd under review at the Journal of the American Statistical Association.

41. Imputation approaches for estimating diagnostic accuracy for multiple tests from partially verified designs Paul S. Albert under review at Biometrics

42. Sample size planning for developing classifiers using high dimensional data Kevin Dobbin and Richard Simon Biostatistics 8:101-117, 2007.

43. Sample size determination in microarray experiments for class comparison and prognostic classification Kevin Dobbin and Richard Simon Biostatistics 6:27-38, January 2005.

44. Use of genomic signatures in therapeutics development in oncology and other diseases Richard Simon and S-J Wang The Pharmacogenomics Journal 6:166-173, 2006.

45. A checklist for evaluating reports of expression profiling for treatment selection Richard Simon Clinical Advances in Hematology & Oncology 4:219-224, 2006.

46. BRB Array-Tools Users Guide (version 3.4) Richard Simon and Amy Peng Lam

47. Sample Size Planning for Bayesian Randomized Clinical Trials Richard Simon Statistical Science 15:103-105, 2000.

48. Development and validation of therapeutically relevant predictive classifiers using gene expression profiling Richard Simon Journal of the National Cancer Institute 98:1169-71, 2006.

49. How large a training set is needed to develop a classifier for microarray data? Kevin K. Dobbin, Yingdong Zhao, and Richard M. Simon Clinical Cancer Research 14:108-114, 2008 Supplement and Correction

50. The Norton-Simon hypothesis: designing more effective and less toxic chemotherapeutic regimens Richard Simon and Larry Norton Nature Clinical Practice Oncology 3(8):406-7, 2006

51. Clinical Trial Designs for Therapeutic Cancer Vaccines Richard Simon Cancer Treatment Research 123:9-350, 2005.

52. Identification of Pharmacogenomic Biomarker Classifiers in Cancer Drug Development Richard Simon To appear as a chapter in Pharmacogenomics, Anticancer Drug Discovery and Response, (F Innocenti editor), Humana Press.

53. Biomarker Adaptive Threshold Design: A Procedure for Evaluating Treatment with Possible Biomarker-defined Subset Effect Wenyu Jiang, Boris Freidlin and Richard Simon Journal on National Cancer Institute 99:1036-43, 2007.

54. Critical Review of Published Microarray Studies for Cancer Outcome and Guidelines on Statistical Analysis and Reporting Alain Dupuy and Richard Simon Journal of the National Cancer Institute 99:147-157, 2007.

55. A comparison of bootstrap methods and an adjusted bootstrap approach for estimating prediction error in microarray classification and Supplement Wenyu Jiang and Richard Simon Submitted to Statistics in Medicine

56. Calculating Confidence Intervals for Prediction Error in Microarray Classification Using Resampling and Supplement Wenyu Jiang, Sudhir Varma and Richard Simon Submitted to publication

57. An Investigation of Two Multivariate Permutation Methods for Controlling the False Discovery Proportion Korn EL, Li MC, Mcshane LM and Simon R. Statistics in Medicine 26:4428-40, 2007.

58. Design Issues of Randomized Phase II Trials and a Proposal for Phase II Screening Trials Lawrence V. Rubinstein, Edward L. Korn, Boris Freidlin, Sally Hunsberger, S. Percy Ivy, and Malcolm A. Smith Journal of Clinical Oncology 23(28):7199-7206, 2005.

59. Analysis of Gene Expression Data Using BRB-Array Tools Richard Simon, Amy Lam, Ming-Chung Li, Michael Ngan, Supriya Menenzes, Yingdong Zhao Cancer Informatics 2:11-17, 2007.

60. Questions and Answers on Design of Dual-Label Microarrays for Identifying Differentially Expressed Genes Kevin Dobbin,Joanna H.Shih, Richard Simon Journal of the National Cancer Institute 95:1362-1369, 2003.

61. Validation of pharmacogenomic biomarker classifiers for treatment selection Richard Simon Cancer Biomarkers 2:89-96,2006.

62. Accelerated Titration Designs Janet Dancey, Boris Freidlin and Larry Rubinstein Statistical Methods for Dose-Finding Experiments, S. Chevret, ed., John Wiley & Sons, 2006.

63. Random Effects Modeling Approaches for Estimating ROC Curves from Repeated Ordinal Tests without a Gold Standard Paul Albert In press at Biometrics (2007).

64. Modeling Longitudinal Biomarker Data With Multiple Assays Which Have Different Known Detection Limits Paul Albert Revised for Biometrics (2007).

65. Panel Discussion on Bayesian Methods in Clinical Trials Richard Simon FDA-NIH Conference on Bayesian Methods in Clinical Trials, Clinical Trials 2:352-58, 2005.

66. Bayesian Analysis for Longitudinal Semicontinuous Data Pulak Ghosh and Paul Albert Submitted for publication

67. Use of Predictive Biomarker Classifiers in the Design of Pivotal Clinical Trials Richard Simon To appear as a Chapter in Pharmacogenomics & Personalized Medicine, (N Cohen, editor).

68. New challenges for 21st century clinical trials Richard Simon Clinical Trials 4:167-169,2007

69. BRB Array-Tools Users Guide (version 3.6) Richard Simon and Amy Peng Lam

70. Interpretation of Genomic Data: Questions and Answers Richard Simon Seminars in Hematology 45:196-204, 2008.

71. Microarray based expression profiling and informatics Richard Simon Current Opinion in Biotechnology 19:26-29, 2008.

72. Lost in Translation: Problems and Pitfalls in Translating Laboratory Observations to Clinical Utility Richard Simon To appear in European Journal of Cancer.

73. Using Genomics in Clinical Trial Design Richard Simon Clinical Cancer Research 14:5984-93, 2008.

74. Designs and Adaptive Analysis Plans for Pivotal Clinical Trials of Therapeutics and Companion Diagnostics Richard Simon Expert Opinion in Medical Diagnostics, 2:721-29, 2008.

75. Drug and Pharmacodiagnostic Co-Development: Statistical Considerations Richard Simon To appear in Developing Molecular Diagnostics for Cancer (Winther & Jorgensen eds).

76. Gene Set Expression Comparison kit for BRB-ArrayTools Xiaojiang Xu, Yingdong Zhao and Richard Simon Bioinformatics 24(1):137-139, 2008.

77. Use of Partial Surrogate Endpoints in Integrated Phase II/III Designs Sally Hunsberger, Yingdong Zhao and Richard Simon Submitted.

78. Tumor Markers: A new standard of breast cancer care Bob Carlson Biotechnology Healthcare, May/June 2008.

79. BRB Array-Tools Users Guide (version 3.7) and Chinese translation Richard Simon and Amy Peng Lam Translated by YU Jian, MS in Bioinformatics, Tongji University and Shanghai Center for Bioinformation Technology. Email: yujian@scbit.org.

80. A Class Comparison Method with Filtering Enhanced Variable Selection for High-Dimensional Data Sets Lara Lusa, Edward L. Korn, and Lisa M. McShane Accepted for publication in Statistics in Medicine.

 

TALKS

1. Myths and Statistical Principles in DNA Microarray Research. Richard Simon

2. Statistical Analysis of Microarray Data. Richard Simon, Lisa M. McShane, & Michael D. Radmacher

3. The State of the Art of Microarray Informatics. Richard Simon

4. Molecular Biometry in the Genomic Era DNA Microarrays. Richard Simon

5. Statistical Issues in the Analysis of Gene Expression Microarray Data. Lisa M. McShane

6. Microarray Myths and Microarray Truths. Richard Simon

7. CIT Training Class: Statistical Analysis of Gene Expression Microarray Data. Lisa M. McShane, Joanna H. Shih & Richard Simon

8. Design Issues in DNA Microarray Based Studies. Richard Simon

9. CIT Training Class: Statistical Analysis of Gene Expression Microarray Data. Lisa M. McShane, Joanna H. Shih, and Kevin K. Dobbin Jan. 29, 2008

10. Myths & Truths About Microarray Expression Profiling. Richard Simon

11. Statistical design, analysis and interpretation of gene expression microarray data. Lisa M. McShane

12. Design and Analysis of DNA Microarray Studies for Translational Medicine. Richard Simon Presented at the NIH Research Festival (October 15, 2003)

13. "Methods and Myths in Prognostic Prediction with Microarray and Proteomic Data" Richard Simon Presented at the Harvard Medical School International Conference on Analysis of Genomic Data (May 10-11, 2004)

14. Key Aspects in the Design and Analysis of DNA Microarray Studies for Diagnostic & Prognostic Prediction Richard Simon Presented at the Statistical Society of Canada in Montreal (June 1, 2004).

15. Genomics of Breast Cancer: Is it Ready for Prime Time? Richard Simon Presented at the American Society of Clinical Oncology, New Orleans, La (June, 2004). Audio & Slides

16. Development and Validation of Gene Expression Based Diagnostic Classification Richard Simon Presented in a session titled "Integrating Microarrays Into Clinical Trials" at the American Society of Clinical Oncology, New Orleans, La (June, 2004).

17. Strengths & Weaknesses of Observational Validation Designs for High Dimensional Data Richard Simon Presented at NCI/FDA Workshop on Study Designs & Statistical Approaches to Biomarkers Validation for Cancer Diagnosis and Detection, Bethesda, MD (July 27-28, 2004).

18. Developing and Evaluating Medical Diagnostics Based on Whole Genome Technologies Richard Simon Presented at Joint Statistical Meetings, Toronto (Aug 12, 2004).

19. Design of DNA Microarray Experiments Richard Simon Presented at Microarray Gene Expression Data Conference (MGED 7), Toronto (Sept. 9, 2004).

20. Key Features in the Design and Analysis of DNA Microarray Studies Richard Simon Presented at Fourth Virtual Conference in Genomics & Bioinformatics (Sept. 22, 2004).

21. Validation of therapeutically relevant diagnostic classifiers based on gene expression data Richard Simon Presented at the NCI Director's Challenge Meeting (Nov. 4, 2004).

22. Key Aspects of the Design and Analysis of DNA Microarray Studies Richard Simon Presented at the CAMDA-2004 conference at Duke University(Nov. 10, 2004).

23. Design of Experiments Using DNA Microarrays Richard Simon Presented at the American Association for the Advancement of Science, Feb 21, 2005, Washington D.C.

24. Conducting Definitive Phase III Trials Using Pharmacogenomcs Richard Simon Presented at the Pharmacogenomics in Drug Development & Regulatory Decision Workshop, April 11, 2005.

25. Is Expression Profile Transforming Clinical Oncology? Richard Simon Presented at the American Association for Cancer Research meeting, April 20, 2005.

26. A Roadmap for Development and Utilization of Therapeutically Relevant Genomic Classifiers Richard Simon Presented at the Center for Devices and Radiological Health of the Food and Drug Administration in Gaithersburg, Maryland, June 20, 2005.

27. A New Paradigm for the Utilization of Genomic Classifiers for Patient Selection in the Critical Path of Medical Product Development Richard Simon Presented at the FDA/Industry Statistics Workshop on "Safety and the Critical Path" in Washington D.C., September, 2005.

28. A Roadmap for Developing & Validating Genomic Classifiers for Treatment Selection Richard Simon Presented at the meeting on "Application and Validation of Genomic Biomarkers for Use in Drug Development and Regulatory Submissions" Bethesda, Maryland, October 6-7, 2005.

29. A Roadmap for Developing & Validating Genomic Classifier for Treatment Selection Richard Simon Presented at Intenational Meeting on Translational Genomics in Neuroblastoma, October 2005.

30. Roadmap for the Development of Targeted Therapeutics in the Genomic Era Richard Simon Visiting Professor Invited Presentation to Food & Drug Administration, Feb. 2, 2006. Audio

31. A Roadmap for Co-Development of Therapeutics and Diagnostics in the Genomic Era Richard Simon Presented at the International Conference on Drug Development. February 13-15, 2006 (Austin, Texas).

32. BRB-ArrayTools Richard Simon Presented at the NIH Microarray Special Interest Group , March 1, 2006. Audio

33. Clinical Trial Design and Biomarker-Based Tumor Classification Systems Richard Simon Presented at the Institute of Medicine Workshop on Developing Biomarker-based Tools for Cancer Screening, Diagnosis and Treatment, Washington D.C., March 21, 2006. Audio

34. Re-examination of the design of early clinical development trials for molecularly targeted agents Richard Simon Presented at ASCO at the Education Session, Atlanta, June 5, 2006. Audio

35. Moving from Correlative Studies to Predictive Medicine Richard Simon Presented at ASCO at the Education Session Integrating Evidence from Clinical and Lab Studies, Atlanta, June 4, 2006.

36. Design & Analysis of Microarray Studies for Diagnostic & Prognostic Classification Richard Simon Presented at pre-conference workshop on design and analysis of studies for the development of predictive classifiers" at CAMDA held at Duke University June 7, 2006. Audio Part 1Audio Part 2Audio Part 3

37. BRB-ArrayTools Workshop Richard Simon Presented at BRB-ArrayTools workshop, NIH on July 13, 2006. Audio

38. Using Biomarkers & Gene Expression Classifiers in Clinical New Drug Development Richard Simon Presented at a meeting titled "Development Strategies & clinical Trial Methods for Oncogenic Products" in Crystal City, Virginia on July 11, 2006.

39. Developing and Validating Therapeutically Relevant Genomic Classifiers Richard Simon Presented at the Ninth Annual West Hawaii Cancer Symposium, Hualalai Hawaii, September 2006.

40. Development & Validation of Genomic Classifiers for Treatment Selection Richard Simon Presented at the German Society of Medical Informatics, Biometry and Epidemiology , Leipzig Germany, September 2006.

41. Moving from Correlative Studies to Predictive Medicine Richard Simon Presented at the First International Conference on Molecular Diagnostics in Cancer Therapeutic Development, American Association for Cancer Research, Chicago Illinois, September 2006.

42. Myths about the Development & Validation of Predictive Classifiers Using Gene Expression Classifiers Richard Simon Presented at The 5th MicroArray Quality Control Project Meeting, National Center for Toxicological Research, Little Rock Arkansas, September 2006. Audio

43. Developing & Evaluating Genomic Classifiers Richard Simon Presented at the Symposium on Optimizing Drug Development With Genomics at Abbott Laboratories, Abbott Park Illinois, September 26, 2006.

44. New Paradigms for Clinical Drug Development in the Genomic Era Richard Simon Presented at the FDA/Industry Statistics Workshop, September 2006, Washington D.C.

45. Moving from Correlative Studies to Predictive Medicine Richard Simon Danny Thomas Invited Lecture, St. Jude Childrens Research Hospital, Memphis Tenn. October 2006.

46. A Tutorial on Data Analysis Using BRB-ArrayTools version 3.5 Supriya Menezes NIH CIT course on BRB-ArrayTools, October 2006.

47. Cancer Clinical Trials in the Genomic Era Richard Simon Presented at Yale University, Division of Biostatistics, Dept Epidemiology & Public Health, New Haven, Connecticut, October 17th, 2006. Audio

48. Presentation to the Intra-NCI Committee on Bioinformatics & Computational Biology Richard Simon October 30, 2006

49. Design of Clinical Trials for Development of Molecularly Targeted Drugs Richard Simon Presented at the Workshop on Clinical Trial Designs for Molecularly Targeted Drugs given in Taipei, Taiwan on November 10, 2006. Audio Part 1 Audio Part 2

50. Design & Analysis of DNA Microarray Studies With BRB-ArrayTools Richard Simon Presented at the Workshop on Microarray Gene Expression Analysis Using BRB-ArrayTools held in Taipei on November 11, 2006. Audio Part 1 Audio Part 2 Audio Part 3 Audio Part 4

51. Development and Evaluation of Predictive Classifiers Richard Simon Presented at the 6th Meeting of the Microarray Quality Control Project, Food and Drug Administration, Silver Spring, MD on Nov. 29, 2006

52. Harnessing Biotechnology, Biostatistics & Bioinformatics for 21st Century Biomedical Research Richard Simon Presented at Duke University Medical Center on Dec. 13, 2006.

53. Using Genomic Classifiers in Clinical Trial Design Richard Simon Presented at the AACR Oncogenomics 2007 Conference in Phoenix, Jan. 31-Feb. 2, 2007 in Phoenix, Arizona.

54. Trial Designs for Therapeutic Vaccine Studies Richard Simon Presented at the FDA/NCI Workshop on Bringing therapeutic Cancer Vaccines and Immunotherapies Through Development to Licensure, Feb. 8-9, 2007, NIH. Audio

55. Relating Gene Expression to a Phenotype and External Biological Information Richard Simon Presented at the NIH Microarray Special Interest Group, Feb. 15, 2007.

56. Using predictive biomarkers in the design of pivotal trials Richard Simon Presented at the Pfizer Oncology Conference in La Jolla California, Feb. 27, 2007.

57. Design of Targeted Clinical Trials Richard Simon Presented at the Biometrics Society (ENAR) Meeting in Atlanta, GA on March 11, 2007.

58. Using Predictive Biomarkers in the Design of Phase III Clinical Trials Richard Simon Presented at the American Association of Cancer Research meeting in Los Angeles California, April 2007. Webcast with Audio and Slides

59. Re-examination of Study Designs for Early Clinical Trials of Molecularly Targeted Drugs Richard Simon Presented at the American Association of Cancer Research meeting in Los Angeles California, April 2007. Webcast with Audio and Slides

60. Using Predictive Biomarkers in the Design of Adaptive Phase III Clinical Trials Richard Simon Keynote Address at the Conference on Adaptive Designs for Clinical Trials in Boston May 10-11, 2007. Audio

61. Topics in the Development and Validation of Gene Expression Profiling Based Predictive Classifiers Richard Simon Presented at the Department of Biostatistics at Vanderbilt University, Nashville, Tennessee, May 16, 2007.

62. Developing Predictive Classifiers and their Use in the Design of Pivotal Clinical Trials Richard Simon Presented at the 30th Annual Midwest Biopharmaceutical Biostatistics Workshop in Muncie Indiana, May 22, 2007. Audio

63. Statistical Aspects of the Development and Validation of Predictive Classifiers for High Dimensional Data Richard Simon Presented at the University of Calgary at the Statistical Genomics Workshop sponsored by the Pacific Institute for the Mathematical Sciences, June 20, 2007.

64. Using Predictive Classifiers in the Design of Phase III Clinical Trials Richard Simon Presented at the Cancer and Leukemia Group B National Meeting, Baltimore MD, June 22, 2007.

65. Adaptive Designs for Using Predictive Biomarkers in Phase III Clinical Trials Richard Simon Presented at the Center for Biologics Evaluation, Food and Drug Administration, Rockville MD, Sept. 10, 2007.

66. Predictive Classifiers Based on High Dimensional Data: Development & Use in Clinical Trial Design Richard Simon Presented at the Glaxo Smith Kline Biostatistics Annual Conference, Collegeville, PA, September, 2007.

67. Prospective Subset Analysis in Therapeutic Vaccine Studies Richard Simon Presented at Annual Meeting of the Cancer Vaccine Consortium, Bethesda Maryland, September 28, 2007.

68. Validation of Predictive Classifiers Richard Simon Presented at the SPECS Conference, Washington University School of Medicine, St. Louis, MO, October 11, 2007.

69. Guidelines on Statistical Analysis and Reporting of DNA Microarray Studies of Clinical Outcome Richard Simon Presented at the Symposium on the Functional Genomics of Critical Illness and Critical Injury, NIH, Bethesda MD, Nov. 15, 2007.

70. New Approaches to Clinical Trial Design Development of New Drugs & Predictive Biomarkers Richard Simon Presented at the Hematology/Oncology Grand Rounds, Beth Israel-Deaconess Medical Center, Harvard University School of Medicine, Boston MA, Nov. 29, 2007.

71. Moving From Correlative Science to Predictive Medicine Richard Simon Presented at the Cleveland Clinic, Department of Quantitative Health, December 14, 2007.

72 Using Genomics in Clinical Trial Design Richard Simon Presented to the Clinical Genomics Interest Group, Food and Drug Administration on March 12, 2008.

73 Challenges in Moving Towards Predictive Oncology Richard Simon Presented at the Washington Cancer Institute on April 25, 2008.

74 Using Genomics in the Design of Phase III Clinical Trials Richard Simon Presented at the American Society of Clinical Oncology National Meeting in Chicago Illinois on May 31, 2008.

75 Predictive Biomarkers and Their Use in Clinical Trial Design Richard Simon Presented at Novartis, Livingston New Jersey, June 16, 2008.

76 Moving from Correlative Studies to Predictive Medicine Richard Simon Presented at the AACR Cofereence on Translational Cancer Medicine, Monterey CA, July 20, 2008.

77 Statistical Issues in the Evaluation of Predictive Biomarkers Richard Simon Presented at FDA/DIA Critical Path Initiative Conference, Bethesda MD, Sept.16, 2008.

78 Moving from Correlative Science to Predictive Medicine Richard Simon Presented at the Istituto Nazionale Dei Tumori Symposium on Use of Genomics in Treatment Decisions for Women With Breast Cancer in Milan, Italy on October 3, 2008.

79 Development and Validation of Predictive Classifiers using Gene Expression Profiles Richard Simon Presented at the Istituto Nazionale Dei Tumori at a Workshop on the Development of Predictive Gene Expression Based Classifiers and their Use in the Design of Phase III Clinical Trials in Milan, Italy on October 6, 2008.

80 Moving from Correlative Studies to Predictive Medicine Richard Simon Presented at the Istituto Nazionale Dei Tumori at a Workshop on the Development of Predictive Gene Expression Based Classifiers and their Use in the Design of Phase III Clinical Trials in Milan, Italy on October 6, 2008.

81 Steps on the Path to Predictive Medicine Richard Simon Presented at the University of Wisconsin, Department of Biostatistics & Medical Informatics on November 4, 2008.

82 Development of Prognostic and Predictive Biomarkers and Their Use in Clinical Trial Design Richard Simon Presented at Novartis in Emeryville California on October 14, 2008.

83 Steps on the Road to Predictive Medicine Richard Simon Presented at "Biomaker Adaptive Designs in Oncology Development Forum", Merck Research Labs, December 4, 2008.

84 When is Small Beautiful in the Design of Clinical Trials Richard Simon Presented at the FDA course on "The Science of Small Clinical Trials", in White Oak, Maryland on January 23, 2009.

85 Steps on the Road to Predictive Oncology Richard Simon Presented at Johns Hopkins University, Kimmel Comprehensive Cancer Center, January 27, 2009.

 

NEWS REPORT

1. The Scientist: Classifying Breast Cancer Models

2. Use of Norton-Simon Model Results in 31% Reduction in Breast Cancer Mortality in National Randomized Clinical Trial

 

Updated on Jan. 28, 2009