CURRICULUM VITAE Sue-Jane Wang, Ph.D., Associate Director for Adaptive Design and Pharmacogenomics, Biostatistics Leader for Biomarker Qualification Program, Office of Biostatistics/Office of Translational Sciences/Center for Drug Evaluation and Research U.S. Food and Drug Administration 10903 New Hampshire Ave., HFD-700, WO 21, Room 3526, Silver Spring, MD 20993 Tel: 301-796-0831 Fax: 301-796-9734 Email: [email protected] PROFESSIONAL EDUCATION University of Southern California, Los Angeles, California University of California at Los Angeles, California University of Missouri at Columbia, Columbia, Missouri

Ph.D. 1991-3 Biostatistics M.S. 1985-6 Biostatistics M.A. 1982-4 Statistics

HONORS AND AWARDS • American Statistical Association (ASA) Fellow for her significant contributions to statistical application and data collection, administration of statistical activities & statistical research,2011 • Thomas Teal Award for Excellence in Statistics Publishing, Drug Information Association, 2011 • FDA/CDER Award for DDT Qualification Guidance Group for “creating and publishing draft guidance & developing a process that describes an approach for review and qualification of drug development Tools intended for potential use in multiple drug development programs”, 2011 • FDA/CDER Award for Adaptive Design Guidance Group for “creating and publishing comprehensive draft guidance on adaptive designed clinical trials for implementation by the Agency”, 2011 • FDA/CDER Award for Non-Inferiority Designs Guidance Group for “creating and publishing comprehensive draft guidance on non-inferiority design strategies for implementation by the Agency”, 2011 • FDA Outstanding Intercenter Science Collaboration Award to the Microarray (MAQC-II) Predictive Modeling Workgroup (for exemplary scientific collaboration across FDA centers in the development and validation of predictive modeling using microarray data, furthering regulatory science at the FDA), 2011 • FDA/CDER Commissioner’s Special Citation – FDA Group Recognition Award to Galactomannan Biomarker Qualification Group (for exceptional achievement in the review of the first clinical biomarker qualification creating a precedent for multi-disciplinary teams) 2010 • FDA Scientific Achievement (Individual) Award on Excellence in Analytical Science (for a sustained record of published regulatory research in statistical design and methodology advancing complex and emerging clinical trial designs and analysis that support regulatory guidance, policies and review), 2010 • FDA Outstanding Intercenter Scientific Collaboration Award to Pharmacogenomics Working Group (for outstanding performance contributing to the development of the Guidance for Industry on Clinical Pharmacogenomics: Premarketing Evaluation), 2010 • FDA Outstanding Intercenter Scientific Collaboration Award for MicroArray Quality Control Project I (Group recognition), 2007 • FDA/CDER Team Excellence Awards for Visiting Professor Lecture Series Efforts Representing Statistics Discipline, 2005 • International Chinese Statistical Association (ICSA) Outstanding Service Award, 2005 • FDA Statistical Association (FDASA) Winner Poster Awards – Replicates Needed in Trials Involving Microarray Experiment, 2004 • FDA/CDER Team Excellence Awards to Vardenafil New Drug Application (NDA) QT Risk Management Review Team, 2003

Sue-Jane Wang, page 2 of 5

•

•

• •

• • • •

FDA/CDER Scientific Achievement Award for Non-inferiority Active Controlled Trials (for outstanding achievements in evaluation and development of statistical methods for active control non-inferiority clinical trials that enhanced the scientific basis of FDA's regulatory decisions), 2003 FDA Outstanding Service Group Award to the Active Controlled Non-inferiority Trial Design/Analysis Development Team (for outstanding performance in evaluating the utility and pitfalls of recent statistical methods and development new statistical methods for evaluating active control NI clinical trials), 2002 FDA Commissioner’s Poster Award representing CDER (novel use of multiple event times analysis to demonstrate short of complete abstinence in alcoholism treatment trials) displayed in the FDA Commissioner’s Guest Office, Rockville, MD, 2002 FDA/CDER Regulatory Science Research (RSR) Award #01-20, Principle Investigator: Dr. Wang’s presentation on the research result was chosen to be one of the top four highest rated RSR projects for fiscal year 2000-2001 and Dr. Wang was invited to present at CDER Scientific Seminar in 2002 FDA Award of Merit (for exceptional performance in developing innovative adaptive statistical testing methods and evaluating impacts of mid-course modification of trial conducts for evaluation of confirmatory clinical trials), 2001 FDASA Science Forum Best Poster Award, Two (tied) Winner Posters: (1) Non-inferiority Active Controlled Trials, 2001 (2) Utility of Multiple Event Times in Alcoholism Treatment Trials, 2001 FDA/CDER (Group) Honor, Reviewer Affair Committee, 2000 FDA/CDER (Individual) Excellence in Communication Award, 2000

RECENT OUTSIDE PROFESSIONAL ACTIVITIES Clinical Trials Conference Chair Co-Chairperson, International Conference on Multiple Comparison Procedure, MD, USA, 2011 Special Advisor The 4th Annual FDA/DIA Statistics Forum, Integrating Knowledge in Clinical development: Meta-Analysis, Non-Inferiority, and Related Topics, 2010 Faculty/Program/Steering Committee Member Member, American Statistical Association Committee on Outreach Education (COE), 2010-12 FDA Representative and Member, Program Committee, DIA/FDA Conference on Ensuring Quality and Balancing Risks for Multiregional Trials: Clinical, Regulatory, Ethnical Factors, Bethesda, MD, 2010 Chair/Organizer Quality by Design at the DIA Conference on Ensuring Quality and Balancing Risks for MultiRegional Clinical Trials Conference: Clinical, Regulatory, and Ethnical Factors. Bethesda, MD, October 2010 U.S. FDA Education on Draft Guidance on Adaptive Design Clinical Trials for Drugs, FDA campus, Silver Spring, MD, October 2010 Adaptive Design Clinical Trials: Part I. Practical Experiences from Case Studies and Panel Discussion. The 46th DIA Annual meeting, Wash. DC, June 2010 Adaptive Design Clinical Trials: Part II. Adaptive Design Clinical Trials Guidance for Industry. The 46th DIA Annual meeting, DC, June 2010 Meta-Analysis in the Integrated Summary of Efficacy & in Defining a Non-inferiority Margin, FDA-DIA Statistics Forum, Bethesda, MD, April 2010

Sue-Jane Wang, page 3 of 5

Keynote The Role of Adaptive Designs in Drug Development, International Conference on Applied Statistics, Taipei, Taiwan, May 2011 Recent Advances and Challenges in Clinical Trials for Medical Product Development, Biometrics: Clinical Trials and Beyond Conference sponsored by Sino-American Pharmaceutical Professionals Association – Greater Philadelphia Chapter (SAPA-GP), Fort Washington, Pennsylvania, USA, 2010 U.S. FDA Draft Guidance: Roles of Adaptive Design in a Clinical Development Program, Adaptive Designs for Clinical Drug Development Conference, Philadelphia, PA, 2010 Panelist Multiregional Clinical Trials Regulatory Endpoints, FDA/Industry Statistics Workshop, Washington DC, USA, September, 2011 Getting it Done Seamlessly, the Perils and Pitfalls of Adaptive Design, FDA/CDER Scientific Rounds hosted by Office of Drug Evaluation II, Division of Pulmonary, Allergy and Rheumatology Products, Silver Spring, MD, USA, April 2011 Perspectives on the Use of Adaptive Designs in Clinical Trials, BBS Early Spring Conference, Basel, Switzerland, 2010 Discussant The ADAS-Cog as an endpoint and the potential utility of surrogate biomarkers in clinical trials of early Alzheimer’s Disease, FDA/Industry Statistics Workshop, Washington DC, USA, 2011 Adaptive design: balancing between hype and hope, JSM, Miami, Florida, USA, August 2011 Implementing adaptive designs, the 47th Annual DIA meeting, Chicago, Illinois, USA, June 2011 Recent Developments in Software Solutions for Adaptive Trial Designs, the 23rd Annual EuroMeeting, Geneva, Switzerland, March 2011 Applications of Adaptive Designs in Early to Mid-Phase Clinical Trials in Drug Development, the 2nd ISBS International Conference, Berlin, Germany, March 2011 Adaptive Clinical Trial Designs: New Paradigm in Clinical Development, the 2nd ISBS International Conference, Berlin, Germany, March 2011 Adaptive Designs: 4 years CHMP Reflection paper, 1 year draft FDA guidance – where are we now? the 2nd ISBS International Conference, Berlin, Germany, 2011 Adaptive Designs: To adapt or not to adapt? How adaptive designs have reshaped the clinical trial paradigm, the 2nd ISBS International Conference, Germany, 2011 Statistical Issues Related to Development and Use of Predictive Biomarkers Patient Enrichment Design, FDA/Industry Statistics Workshop, DC, 2010 Statistics of Early Dose-Determination: Ad-hoc versus Truly Adaptive, FDA/Industry Statistics Workshop, Washington DC, September 2010 Adaptive Design: Balancing Between Hype and Hope, JSM, Vancouver, Canada, August 2010 M&S in Clinical Development Beyond Trial Design and Exploratory Analyses, the 46th DIA Annual meeting, Washington DC, June 2010 Roles of Biomarkers or Genomic Biomarkers in Clinical Trials, the 46th DIA Annual meeting, DC, June 2010 Short Course Instructor Emerging Challenges in Clinical Trial Methodologies, FDA/Industry Statistics Workshop, 2010 Non-Inferiority Clinical Trials Without a Placebo Arm, FDA-DIA Statistics Forum, 2010 Referee Referee, Statistics in Biopharmaceutical Research, 2010, 2011 Referee, Clinical Trials, 2009-2010 Referee, Pharmaceutical Statistics, 2003, 2005, 2006, 2008, 2009, 2010 Referee, Journal of Biopharmaceutical Statistics, 2002, 2003, 2004, 2005, 2008, 2009, 2011

Sue-Jane Wang, page 4 of 5

Referee, Statistics in Medicine, 2000, 2001, 2002, 2003, 2004, 2005, 2008, 2009, 2010, 2011 Referee, Controlled Clinical Trials, 2004 Referee, Alcohol and Alcoholism, 2003 Referee, Journal of Biopharmaceutical Statistical, Special Issue: Microarray Data Analysis,2003 Referee, Biometrical Journal, 2001, 2002 Referee, Biostatistics, 2001 Ad-Hoc Referee, Communication in Statistics - Theory and Method, 1997 Bioinformatics/Pharmacogenomics/Biomarker Conference Chair Co-Chairperson, Tailored Therapeutics Workshop, Bethesda, MD, USA, October 2011 Faculty/Program/Steering Committee Member Member, Steering Committee, DIA Tailored Therapeutics Workshop, 2010-2011 Member, Steering Committee, DIA/FDA Pharmacogenomics Workshop #5, 2009-2010 Chair/Organizer Designing Pharmacogenomics Studies to be Fit for Purpose, Pharmacogenomics Workshop #5, 2010 Case Study HLA-B*5701 and Abacavir Hypersensitivity, Pharmacogenomics Workshop #5, 2010 Keynote “How Might Adaptive Design be Useful In Pharmacogenomics for Drug Development?” MiniSymposium on PGx and Common Disease Genetics, Cedars-Sinai Medical Genetics Institutes,2010 Panelist Using Patient-Initiated Study Participation in the Development of Evidence for Personalized Cancer Therapy, Brookings Conference Clinical Cancer Research, DC, 2010 Doing Better than Average: Tailored Therapeutics in Drug Development, JSM meeting, Vancouver, Canada, August 2010 Case Study k-RAS and Vectibix on Generating and Weighing Evidence in Drug Development and Regulatory Decision Making, 2010 Case Study HLA-B*5701 and Abacavir Hypersensitivity on Generating & Weighing Evidence in Drug Development & Regulatory Decision Making, 2010 Discussant Discussant, plenary session, Genotyping for Tailored Therapeutics from Clinical Trials at Bedside – When Can it be Useful? at DIA/FDA Tailored Therapeutics: Practical Issues and Methodologies for Selecting the Right Patients, Bethesda, MD, USA, October 2011 Discussant, invited session, Genomic Biomarker Applications in Clinical Trials, ICSA Applied Statistics Symposium, New York, NY, USA, June 2011 Discussant, Invited session, Statistical Issues Related to Development and Use of Predictive Biomarker as Patient Enrichment Design, FDA/Industry Statistics Workshop, DC, 2010 Short Course Instructor Biomarker Embedded Pharmacogenomics Clinical Trial: Development, Qualification, Design and Analysis, ASA New Jersey Chapter, NJ, 2010 Pharmacogenomics Clinical Trials: Genomic Biomarker Associated Design and Analysis Issues, ICSA Applied Statistics Symposium, Indianapolis, Indiana, 2010 Referee Referee, Journal of Clinical Oncology, 2009, 2010, 2011 Referee, Bioinformatics, 2006, 2008 Referee, The Pharmacogenomics Journal, 2006, 2008, 2009, 2011 Referee, Journal of Biopharmaceutical Statistics, Microarray Studies, 2003, 2005, 2006 PROFESSIONAL SOCIETY MEMBERSHIP

Sue-Jane Wang, page 5 of 5

American Statistics Association (ASA) – member of Committee of Outreach Education International Chinese Statistical Association (ICSA) FDA Statistical Association (FDASA) Elected Member, International Statistical Institute (ISI) PROFESSIONAL JOURNAL EDITORIAL ACTIVITIES Guest Co-Editor, Special Issue: Multiple Comparison Procedures, Biometrical Journal, 2011-13 Guest Editor, Special Issue: Personalized Medicine, Statistics in BioSciences, 2011-12 Guest Editor, Special Issue: Multi-Regional Clinical Trials: What Are The Challenges? Pharmaceutical Statistics, 2009-2010 Associate Editor, Statistics in Medicine, 2009-present Associate Editor, Statistics in BioSciences, 2009-present Editor-in-Chief, Journal of Pharmaceutical Statistics, 2006-2008 Advisory, Editorial Committee, The ICSA Bulletin, 2006-2008 Associate Editor, Journal of Pharmaceutical Statistics, 2005 Editor-in-Chief, The International Chinese Statistics Association Bulletin, 2000-2002 BIBLIOGRAPHY LEADERSHIP & OVERSIGHTS OF OFFICE OF BIOSTATISTICS PROGRAMS •

• • • • • •

Oversee the regulatory review programs of Office of Biostatistics (OB) on adaptive design, pharmacogenomics, and biomarker qualification submissions where OB provides statistical services for all Medical Divisions of Drug Products under 6 Medical Offices of Drug Evaluations of Office of New Drugs (OND), CDER, U.S. FDA. This covers 17 statistical review teams under 5 biometrics divisions of OB. The roles of oversights include Perform secondary or tertiary review on the statistical reviews Provide technical advices and statistical consultation to the statistical reviewers/team leaders/divisions Attend the internal and industry meetings and facilitate to streamline statistical/clinical review comments for adaptive designs submissions Attend the internal and industry meetings and facilitate to harmonize statistical review comments for biomarker qualification submissions representing the biostatistics discipline Resolve or facilitate to resolve the controversial statistical review issues Provide statistical expertise to resolve the complex statistical review issues, etc.

RESEARCH PUBLICATIONS Over 80 peer reviewed collaborative publications, book chapters, commentary on adaptive designs, non-inferiority, recurrent events, bridging study, multi-regional clinical trials, modeling/simulation, medical genetics, genetic epidemiology, pharmacogenomics, pharmacogenetics, bioinformatics, genomic biomarker classifier, and biomarker qualification as drug development tools for patient selection. LECTURES AND PAPER PRESENTATIONS Over 200 invited talks/papers/presentations/keynotes/discussants domestic and international during her tenure at U.S. Food and Drug Administration