A systematic approach to biomarker discovery; Preamble to "the iSBTc-FDA taskforce on immunotherapy biomarkers"

Abstract

The International Society for the Biological Therapy of Cancer (iSBTc) has initiated in collaboration with the United States Food and Drug Administration (FDA) a programmatic look at innovative avenues for the identification of relevant parameters to assist clinical and basic scientists who study the natural course of host/tumor interactions or their response to immune manipulation. The task force has two primary goals: 1) identify best practices of standardized and validated immune monitoring procedures and assays to promote inter-trial comparisons and 2) develop strategies for the identification of novel biomarkers that may enhance our understating of principles governing human cancer immune biology and, consequently, implement their clinical application. Two working groups were created that will report the developed best practices at an NCI/FDA/iSBTc sponsored workshop tied to the annual meeting of the iSBTc to be held in Washington DC in the Fall of 2009. This foreword provides an overview of the task force and invites feedback from readers that might be incorporated in the discussions and in the final document.

Turning laboratory findings into therapy: a marathon goal that has to be reached

“…By integrating molecularly-based technologies, systematic tissue procurement and medical informatics it is now possible to identify clinically applicable “genotype-phenotype” associations across cohorts of patients, which can be translated into useful diagnostic and therapeutic strategies. 13,22,23 Yet, the collection of human material is hampered in the translational medicine pipeline by several roadblocks of practical and ethical nature. Collection of materials needs to be standardized and assays require validation; extensive work is being done in this regard but certain issues still remain unresolved.…”

“…Collection of materials needs to be standardized and assays require validation; extensive work is being done in this regard but certain issues still remain unresolved. Much has been achieved in the immune monitoring studies 22,24–27 or by the cancer network consortia 28–33 . At the same time, critical ethical issues covered by Institutional Review Boards such as the Health Insurance Portability and Accountability Act (HIPAA), as well as issues related to potential conflicts of interest, strategies for data standardization and sharing of information have proven difficult to overcome in an efficient manner.…”

“…This problem also results from the difficulty in standardizing the process of protocol design, sample accrual, collection, storage, and analysis. 22,24–26,46,47 For these reasons, guidelines for statistically valid studies, standardization of assays, possibility for evaluating large data sets have to be introduced. Multidisciplinary workshops and consensus conferences that involve scientists, industry and regulatory agencies will be necessary.…”

“…A good example is the upcoming workshop on biomarker validation sponsored by the International Society for the Biological Therapy of Cancer and the United States Food and Drug Administration. 22 Another important event is the NIH Biomarker Consortium developed to encourage government, academia, and commercial partnership to speed the identification of useful biomarkers relevant to clinical trials (http://www.biomarkersconsortium.org). …”

New technologies for autoimmune disease monitoring

“…Much recent attention has been put on the discovery of disease-related biomarkers [1]. These are generally proteins or peptides whose expression level is correlated with a particular disease, or with its prognosis or therapeutic responsiveness.…”