OCT 29, 2014 9:00 AM PDT

What's wrong with biomarker development for cancer

Speaker
  • Co-Director, Complex Adaptive Systems Initiative, Director, Transformative Healthcare Networks, Professor, School of Life Sciences, Arizona State University (ASU)
    Biography
      Co-Director of Complex Adaptive Systems at ASU, Dr. Barker designs and implements transformative networks to enable the convergence of knowledge, innovative teams and novel funding approaches to address major problems in biomedicine. Several initiatives are underway, including: the National Biomarker Development Alliance NBDA; a program to re-think diseases that are particularly difficult to diagnose and treat; and a consortium focused on deep phenotyping in silico medicine. Prior to joining ASU, Dr. Barker served for several years as Deputy Director of the National Cancer Institute (NCI) and Deputy Director for Strategic Scientific Initiatives. At the NCI she developed and led or co-led a number of transdisciplinary programs including the: The Cancer Genome Atlas (TCGA); Nanotechnology Alliance for Cancer; Clinical Proteomics Technologies Initiative for Cancer; and the Physical Sciences- Oncology Centers (PS-OCs). She co-chaired the NCI-FDA Interagency Task Force (IOTF) and was founding co-chair of the Cancer Steering Committee of the FNIH Biomarkers Consortium (FNIH-BC). Achievements from these groups included the exploratory IND (IOTF); and oversight of the design and implementation of the ISPY-2 Trial (FNIH-BC). She served as a research scientist and a senior executive at Battelle Memorial Institute for 18 years; and subsequently co-founded and served as the CEO of a public biotechnology company. Examples of her public service include: the National Coalition of Cancer Research; Partner and Member of the Board of Directors of C-Change; Chairperson, C-Change Cancer Research Team; Founding member, Department of Defense (DOD) Breast Cancer Research Program (BCRP) and Chairperson of the Integration Panel (IP); a number of roles for the American Association for Cancer Research (AACR), including the Board of Directors and chairperson, Science Policy and Legislative Affairs Committee; member of NCIs Board of Scientific Counselors, Division of Cancer Etiology; and Chairperson, NCI Cancer Center Support Review Study Section. Dr. Barker has received a number of awards for her efforts in science and advocacy for cancer research. Her research interests include complex adaptive systems science, biomarkers, experimental therapeutics and free-radical biochemistry in cancer etiology and treatment. Dr. Barker completed her M.A. and Ph.D. at The Ohio State University, where she trained in immunology and microbiology.

    Abstract

    Although robust and clinically meaningful biomarkers are key to achieving the current vision for precision (molecularly based), cancer medicine (patient stratification, early diagnosis, drug development), few ever successfully advance beyond discovery to the clinic. For example, protein biomarkers have received FDA approval at a rate of less than 1 per year since the mid 1990's. Numerous publications report the discovery of hundreds of thousands of cancer biomarkers, yet fewer than 100 are routinely used in the clinic. The staggering costs and dismal success rate of cancer clinical trials and the lack of development of the molecular diagnostics industry are tied to this history of biomarker failures.

    Achieving robust, reproducible and clinically important cancer biomarkers is one of the great "value propositions" in biomedicine. Realizing this value will require systemic changes which recognize that achieving success will require standards-based end-to-end systems approaches. Biomarker discovery and development occurs in overlapping but discrete phases; but there are currently no broadly accepted or applied standards (guidelines, best practices, standard operating procedures, etc.) to support evidence-based transition of a biomarker through these phases - much less robust systems-based models. Although complex, these problems can be solved.
    The National Biomarker Development Alliance (NBDA) is a non-profit, trans-sector network-based organization whose mission is to create/assemble the "standards" needed to support systems based approaches to biomarker development. The NBDA will partner with all affected stakeholders and the regulators to ensure that high value, robust standards are broadly employed to create the systems based approaches to biomarker development so desperately needed to transition precision medicine from a vision to reality for all cancer patients.


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