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Summer 2009 Workshop

To Be Held on Thursday, June 18, 2008 at the Renaissance Hotel in Northbrook, IL.  For Registration Information, click here.

The 25th Annual Summer Workshop of the Northeastern Illinois Chapter of the American Statistical Association will be given on the topics of:

  1. Clinical Trial Designs for Biomarker Validation
    Sumithra J. Mandrekar, Ph.D., Associate Professor, Mayo Clinic
  2. FDA Experiences & Perspectives on Pharmacogenomics
    Li Zhang, Ph.D., Office of Clinical Pharmacology, CDER/FDA

 Clinical Trial Designs for Biomarker Validation
Sumithra J. Mandrekar, Ph.D., Associate Professor, Mayo Clinic


Biomarkers have the potential to add substantial value to medical practice by providing an integrated approach to prediction using the genetic makeup of the tumor and the genotype of the patient to guide the treatment selection for each individual patient. The current era of novel agents and targeted therapies combined with biomarkers is therefore mandating intelligent clinical trial designs. Three critical issues surround the validation of predictive biomarkers, specifically, the choice of endpoints, types of clinical trial designs and issues of added complexity (logistics, local versus central testing, and multivariate assays). We critically evaluate the methodology for the clinical validation of biomarker guided therapy. Designs for marker validation are broadly classified as retrospective versus prospective, where the latter can further be categorized into enrichment (or targeted), unselected (or all-comers), or hybrid designs. We discuss the salient features of these designs and explore the strengths and pitfalls of each design in the context of ongoing or completed trials. We conclude with the comparison of the prospective designs and a discussion of the recently proposed so-called adaptive designs. The review and evaluation of these designs is essential as we march toward the goal of personalized medicine.

Biographical Background

Sumithra J. Mandrekar, Ph.D. is Associate Professor of Biostatistics at the Division of Biomedical Statistics and Informatics at Mayo Clinic, Rochester MN, and adjunct associate professor of biostatistics, School of Public Health, University of Minnesota. Dr. Mandrekar received her interdisciplinary Ph.D. in Biostatistics, Psychology, Internal Medicine and Biomedical Engineering from the Ohio State University, Columbus OH in December 2002. Dr. Mandrekar is primarily involved in clinical trials and research grants in the areas of treatment and prevention of lung cancer and multiple myeloma. Her primary research interests are in adaptive dose-finding trial designs, designs for biomarker validation, pooled analyses, and general statistical inference.

FDA Experiences & Perspectives on Pharmacogenomics
Li Zhang, Ph.D., Office of Clinical Pharmacology, CDER/FDA


1) The FDA biomarker qualification procedure will be introduced and discussion will follow on the topics of biomarker development methodologies as well as clinical applications.
2) Case studies will be presented and discussed on the basis of published data on exploratory biomarkers presented in FDA
Voluntary eXploratory Data Submissions (VXDS) meetings. In addition to the exploratory biomarker information, those case studies will also cover why each sponsor decided to do a VXDS as well as the benefits each sponsor received from the VXDS meeting and the impact these benefits had on their drug development program strategies.


Biographical Background

Dr. Li Zhang is currently a key Pharmacogenomic Reviewer at Office of Clinical Pharmacology, Center for Drug Evaluation and Research (CDER), FDA. She received her Ph.D. in Genomics and Statistics in 2007. She has played a primary role in a number of regulatory and Voluntary eXploratory Data Submissions (VXDS) reviews, as well as research projects of biomarker development on drug safety, efficacy and product quality. She has statistics and genetics methodology papers published in journals including AJHG, Genetic Epidemiology etc., as well as drug discovery reviews published in Nature Reviews: Drug Discovery, etc.


Last updated: 04/14/09  by: Clint Lovell



Northeastern Illinois Chapter
American Statistical Association