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Last Updated: 07/25/14

2009 BRN Symposium Workshop 1:
Markers of Biospecimen Molecular Integrity

Session 1 — (9:30 am - approximately 11:45 am)
Defining “biospecimen quality” as it relates to “fit-for-purpose”


Stephen Hewitt MD, PhD (NCI)
Scott Patterson PhD (Amgen, Inc)
Steven Gutman MD (Univ. Central Florida, Former Director FDA’s Office of In-vitro Diagnostics)

Questions to be answered by this workshop:

  • How does biospecimen quality relate to “fit-for-purpose?” How does fit-for-purpose relate to the platform that is being used for its analysis? How does fit-for-purpose relate to the intended use of a biomarker (i.e., qualification of clinical relevance vs. validation of the method used to measure the biomarker)?
  • What analytical platforms are the most sensitive to pre-analytical variability? Is it possible to make a list of analytical platforms that are ranked by minimum biospecimen quality? In other words, can a biospecimen quality grading system be developed, based on an analytical platform's sensitivity to pre-analytical variations?
  • Are there examples of biomarkers which can be used to grade biospecimen “suitability” or “below quality” for different analytical platforms?
  • What platforms are suitable for quantifying biospecimen quality?
Tentative Agenda: (times are approximate)
Time Session
9:30-9:45 a.m. The charge, purpose and organization of the workshops
Stephen Hewitt MD, PhD (workshop co-chair)
Scott Patterson PhD (workshop co-chair)
9:45-10:15 a.m. “Fit-for-purpose” and biospecimen quality
PDF Document: 495 KB
Steve Gutman, MD
10:15-11:30 a.m. Discussion
Chairs and Workshop Participants
11:30-11:45 a.m. Session wrap-up, conclusions, next steps
Pick up lunch and proceed to Session 2

Session 2 — (following Session 1 until approximately 2:15 pm)
Defining biospecimen-specific minimum criteria for “fit-for-purpose”


Stephen Hewitt MD, PhD (Tissues, NCI)
Steven Gutman MD (Tissues, Univ. of Central Florida)
Scott Patterson PhD (Blood, Amgen)
Niels Heegaard MD DSci (Blood, Staten Serum Institute)
Robert Star MD (Biofluids, NIH/NIDDK)


To develop a list of biospecimen quality biomarkers defined by the type, analytical platform, SOPs and evidence available. The list will resemble the following table.

Biospecimen Type/
Biomarker Type
(genomic, proteomic, small molecule, etc)
What is it an indicator of? Biomarker name Analytical Platform SOP’s available?
Citations or data
Tentative Agenda: (times are approximate)
Time Session
noon-12:30 pm

Defining biospecimen-associated specifications needed for reporting quality (ex: tumor grade, serum/plasma, etc)

Workshop Chairs

Tissue biospecimens

  • Stephen Hewitt MD, PhD (NIH/NCI)
  • Steven Gutman MD (Univ. Central Florida)

Blood biospecimens

  • Scott Patterson PhD (Amgen)
  • Niels Heegaard MD DSci (Staten Serum Institute)


  • Robert Star MD (NIH/NIDDK)

12:30 - 2:00 pm

Discussion and development of a consensus list of biospecimen quality markers

Workshop Participants

2:00- 2:15 pm

Session wrap-up, conclusions, next steps

End of workshop 1
Chair discussion (all invited to participate