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 DCTD: BIOMETRIC RESEARCH PROGRAM

PRESENTATIONS
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. Latest version
Lisa M. McShane, Eric C. Polley
May 16, 2011
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).
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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.
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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.
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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.
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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.
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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.
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37. BRB-ArrayTools Workshop
Richard Simon
Presented at BRB-ArrayTools workshop, NIH on July 13, 2006.
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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.
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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. Microarray Data Analysis Using BRB-ArrayTools Version 4.2.0 Latest version
Supriya Menezes
NIH CIT course on BRB-ArrayTools, Nov.2-3, 2011.
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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
86 Use of Archived Tissue in Evaluating the Medical Utility of Prognostic & Predictive Biomarkers
Richard Simon
Presented at the American Association of Cancer Research, Denver, Colorado, April 19, 2009.
87 New Designs for Phase III Clinical Trials
Richard Simon
Presented at the American Society of Clinincal Oncology, Orlando FL., May 31, 2009.
88 Use of Genomics in Clinical Trial Design and How to Critically Evaluate Claims for Prognostic & Predictive Biomarkers
Richard Simon
Presented at the 14th Congress of the European Hematology Association in Berlin, June 5, 2009.
89 Use of Prognostic & Predictive Genomic Biomarkers in Clinical Trial Design
1) Introduction; 2) Expression Profiling; 3) Do's and Don'ts; 4) Clinical Trial Design.
Richard Simon
Presented at the Workshop on Development & Use of Predictive Biomarkers at University of Toronto, Canada, July 24, 2009.
90 Development and Use of Predictive Biomarkers in the Design of Clinical Trial
1) Introduction; 2) Expression Profiling; 3) Clinical Trial Design.
Richard Simon
Presented at the Workshop sponsored jointly by The New Jersey Chapter of the American Statistical Association and the Dept of Biostatistics, School of Public Health, New Jersey School of Medicine & Dentistry, July 31, 2009.
91 Statistical Challenges for Predictive Onclogy
Richard Simon
Presented at University of Michigan/GSK Pharmacogenomics Symposium in Ann Arbor, Michigan, Oct. 1, 2009.
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92 Developing a Predictive Biomarker as a Companion Diagnostic for a Molecularly Targeted Cancer Drug
Richard Simon
Presented at the European Cancer Meetings ECCO15-ESMO34 Scientific Symposium on Biomarkers in Clinical Drug Development in Berlin on September 22, 2009.
93 Integration of Diagnostic Markers into the Development Process of Targeted Agents
Richard Simon
Presented at the European Cancer Meetings ECCO15-ESMO34 Special Session on Trial Methodology in Berlin on September 24, 2009.
94 The Use of Predictive Biomarkers in the Design of Clinical Trials
Richard Simon
Presented at the FDA-NCI Workshop on Therapeutic Cancer Vaccines at the National Institutes of Health, Bethesda, Maryland on October 27, 2009.
95 Some Statistical Aspects of Predictive Medicine
Richard Simon
Presented at the Department of Biostatistics, School of Public Health, University of Michigan, Ann Arbor, Michigan on December 8, 2009.
96 On the Road to Predictive Oncology: Challenges for Statistics and for Clinical Investigation
Richard Simon
Presented at the Distinguished Scholars Lecture, University of Buffalo, February 18, 2010.
97 Advanced Clinical Trial Educational Session
Richard Simon
Presented at the American Society of Clinical Oncology Meeting in Chicago on June 4th at the Education Session on Methods of Clinical Trials, 2010.
98 Design & Analysis of Phase III Trials for Predictive Oncology
Richard Simon
Presented at the AACR Conference on Translational Cancer Medicine, San Francisco, July 11-14, 2010.
99 Novel Clinical Trial Designs for Oncology
Richard Simon
Presented at the 39th Meeting of the American Congress of Clinical Pharmacology, Baltimore, September 13, 2010.
100 Personalized Predictive Medicine and Genomic Clinical Trials
Richard Simon
Presented at a Workshop on "Clinical Trials: Past, Present and Future" sponsored by the National Heart, Lung and Blood Institute, Bethesda, Maryland, September 14, 2010.
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101 Personalized Predictive Medicine and Genomic Clinical Trials
Richard Simon
Presented at the FDA-Industry Statistical Workshop, Washington D.C., September 23, 2010.
Short Course on Use of Genomics in the Design of Therapeutic Clinical Trials
Lecture 1; Lecture 2; Lecture 3; Lecture 4.
Richard Simon
Presented at the 17th Annual Biopharmaceutical Applied Statistics Symposium, November 2010.
103 Personalized Predictive Medicine and Genomic Clinical Trials
Richard Simon
Presented at the 4th Seattle Symposium on Biostatistics, November 21, 2010.
104 Use of Candidate Predictive Biomarkers in the Design of Phase III Clinical Trials
Richard Simon
Presented at the Androgen Receptor Signaling Workshop in Prostate Cancer: Translating Biology into Clinical Practice. December 6-7, 2010, Arlington VA.
105 Opportunity and Pitfalls in Cancer Prediction, Prognosis and Prevention
Richard Simon
Presented at the DARPA-NCI Cancer Prediction, Prognosis, and Prevention Workshop, April 25, 2011, Bethesda MD.
106 Clinical Trial Designs for the Evaluation of Prognostic & Predictive Classifiers
Richard Simon
Presented at the NCI Workshop on the Use of Omics-based predictors in Clinical Trials, June 23-24, 2011, Bethesda MD.
107 Predictive Analysis of Clinical Trials
Richard Simon
Presented at a workshop for the Department of Biostatistics & Computational Biology, Yale University, April 10, 2012.
108 On the Road to Genomic Predictive Medicine: An Interim Analysis
Richard Simon
Presented at a workshop at the International Chinese Statistical Association, June 24, 2012.
109 Predictive analysis of clinical trials
Richard Simon
Presented at a workshop at the FDA Statisticians Association on July 9, 2012.
110 Cancer Clinical Trials in the Genomic Era
Richard Simon
Presented at Sixty-Eighth Annual Deming Conference on Applied Statistics in Atlantic City NJ, Dec 5, 2012.
111 New designs and paradigms for science- based oncology clinical trials
Richard Simon
Presented at a workshop in Amesterdam, Netherland, March 13, 2015.

Updated on Nov. 2, 2015