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Designing Rigorous Omics Studies for Biomarker Discovery and Development of Prognostic and Predictive Molecular Diagnostics 

Tuesday, February 2, 2010 ● 2:00 – 5:00pm ● Moscone North Convention Center, San Francisco, CA 


  • Why study design is decisive for success or failure
  • Critical review of examples
  • Dos and don'ts
  • A roadmap to the answers
  • Samples: How many are enough?
  • Apples and Oranges: Tackling confounding factors
  • Regulatory requirements for biomarker qualification
  • FDA perspective of companion diagnostics

Recorded at:
Cambridge Healthtech Institute’s 17th International Molecular Medicine Tri-Conference.

About the Conference:
Molecular Medicine Tri-Conference -- the flagship event of CHI –built this year's event around 6 scientific channels providing attendees more learning opportunities than ever before. Featured channels include diagnostics, chemistry, informatics, biologics, cancer and executive. This expanded program provides attendees a more in depth experience into each of the six areas of research and development. As the need for better information, new technologies, improved strategies and competitive intelligence becomes ever more acute, this event provides compelling research insight into the future of molecular medicine. In 2010, the event drew over 2,700 attendees, 1200 participating companies, 150 exhibitors, 100 posters, and representatives from over 38 countries.

Agenda At A Glance:

Experimental Design in Genomics, Proteomics and Metabolomics
Terry Speed, Professor, Department of Statistics, University of California, Berkeley; Head, Bioinformatics, WEHI, Australia
For most experiments in this area, we can recognize three main phases that are relevant to experimental design. I: choice and preparation of experimental material, choice of platform technology; II: assignment of experimental reagents to components of the technology; III: actual conduct of the experiment, including times, places and conditions of experiment, and protocols, reagents, operators and equipment used. In this talk we will mainly focus on examples where the experiments were poorly designed and led to unsatisfactory outcomes. This will show the need for good design

Biography: Professor Terry Speed is well known for his contributions to bioinformatics, and in particular to the analysis of microarrays data. He shares his time between the department of statistics at the University of California, Berkeley and the Walter and Eliza Hall Institute of Medical Research, in Melbourne, where he is head of the Bioinformatics division. He was president of the Institute of Mathematical Statistics in 2004.

A Roadmap for Omics Study Design
Juergen von Frese, Ph.D., Managing Director, Data Analysis Solutions DA-Sol GmbH, Germany
Any biomarker or predictive or prognostic signature can only be as good as the data it was derived from. Study design critically determines the inherent signal (i.e. information) in the data. This talk will provide a systematic overview and roadmap for designing omics studies. This will range from defining study aims, determining sample size, randomization and reference measurements to an in-depth discussion of tackling confounding factors. Examples from cancer diagnostics will be given and crucial issues and pitfalls will be highlighted.

Biography: As responsible bioinformatician and biostatistician J. von Frese has been involved in industrial translational research for more than a decade. He has designed and analyzed several large scale studies for developing microarray cancer diagnostics. "Invariably I find that my biggest contribution to the overall project success does not lie in the intricacies of bioinformatics analyses but by bringing about a quantum leap in data quality through rigorous study design."

Individual $345
Site License $1380
Over 98 minutes
More than 80 slides