The Art, Science And Discipline Of Biomarker Study And Program Design



June 24, 2013
11:00 AM to 12:00 PM EDT

 

Sponsored by
SomaLogic
 


Symposium Course Description: 

Biomarkers serve a key role in fingerprinting changes throughout the body; biologic changes such as cancer development, onset of metabolic disease, the effects of pharmacology, nutrition, or even risk of future heart attack or stroke. Unfortunately, many apparently interesting biomarker discoveries fail to replicate or translate into products or productivity because the discipline of biomarker study and program design is not sufficiently respected This symposium will illustrate how to optimally design fit-for-purpose biomarker studies with appropriate attention to false discovery rates, the existence of truth standards and the nature and weight of evidence required for the context of use.

Learning Objectives: 

  • How to define the purpose and context of use for biomarkers in drug discovery and drug development programs to drive the requirements for the nature and weight of evidence required
  • Pros and cons of different Biomarker Discovery Study types
  • Appropriate control of false discovery rates
  • Design of integrated programs to deliver products and/or productivity improvements

Who Should Attend:
Researchers and Scientists in

  • Biomarker Discovery
  • Proteomics
  • Translational Medicine
  • Preclinical Pharmacology
  • Clinical Pharmacology

Program Agenda: 

1) How different purposes for biomarker studies drive the appropriate evidentiary standards; examples will be discussed from hypothesis generation in uncovering biology to rigorous applications in drug development and disease diagnostics.

2) Pros and cons of different study designs: case/control, cohort and paired studies.

3) How to manage false discovery rates and pre-analytic variables so that discoveries really do translate into practice.

4) Why clinical truth standards matter and what to do if there isn’t a good one.

Stephen Williams, MD, Ph.D.

Chief Medical Officer

SomaLogic

Steve Williams joined SomaLogic in 2009 as chief medical officer. Steve trained as a physician at Charing Cross and Westminster medical school, University of London, where he also obtained a Ph.D. in medicine and physiology. He subsequently trained in diagnostic imaging at the University of Newcastle upon Tyne. He joined Pfizer in the U.K. in 1989 in experimental medicine, and worked on a variety of programs including asthma, irritable bowel syndrome, migraine [eletriptan], depression [sertraline] and urinary incontinence [darifenacin]. He moved to the U.S. in 1993 with Pfizer and worked in inflammatory bowel disease, stroke, psychosis [ziprasidone] and head injury. He created the clinical technology group in 1997, was made vice president of this global group in 2006. Steve helped to create the FNIH-PhRMA-FDA biomarkers consortium and was on the inaugural Executive Committee, and he was on the National Advisory Committee for the National Institute of Biomedical Imaging and Bioengineering from 2003-2007. He is currently on the Board of Directors for Venaxis, a publicly-held diagnostics company.


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