Convergence Conference II: Biospecimen Standards for Proteomic Biomarkers, Analyzed by Mass Spectrometry
December 10-11, 2014
Montelucia Resort, Scottsdale, AZ
In this conference, we propose to rethink the technical, biological, statistical and logistical issues associated with human biospecimen collection, handling, processing, and stabilization that impact the molecular quality, consistency, and biomedical veracity of the samples employed for biomarker development using mass spectrophotometric platforms. Further, we propose to define the critical steps of essential (universal) protocols for tissue and for blood that would assure quality and consistency and, on a practical level, would be widely implementable in medical care settings across the country.
The audacious goal is to make all biospecimens from all patients of uniform quality and fit for the purpose of cutting edge molecular analysis. If achieved, this would revolutionize biomarker development across the board as well as improve the quality of medical care.
Biospecimens are the staring materials for the vast majority of biomarker measurements. At best, compromised specimens may lead to compromised data that is biased, incorrect, and irreproducible. At worst, compromised specimens may preclude analysis altogether. The quality of human biospecimens used for research and, ultimately, for patient care will become even more important as we face the reality of drug and diagnostics development in a new era where “omics” offers a host of emerging molecular targets.
This conference will bring together experts and thought leaders in the realms of pathology and laboratory medicine, surgery, clinical trials, genomics, proteomics, medical care delivery and reimbursement, biomarker research funding, FDA regulation of devices and drugs, professional medical societies that set and enforce standards of care, and patient advocacy. It will take all of us working together to meet this challenge successfully.
We are looking forward to a creative dialogue and new thinking around the concept of biospecimen quality. Do we agree on the definition of fitness for purpose? What are the practical experience and scientific data that inform the biospecimen quality requirements for proteomics platforms? Is the concept of a universal protocol too broad? Is it not broad enough? Is a universal protocol achievable on a practical level? Who will reimburse the effort and expertise required to achieve compliance with such a protocol? Who will assure compliance? The list goes on – driven in large measure by what we are learning about the molecular basis of selected diseases and the rapidly evolving technical requirements of the analysis platforms.