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COPD Biomarker Qualification Consortium Making Strides with Plasma Fibrinogen as New Biomarker

The COPD Biomarkers Qualification Consortium (CBQC) recently announced at the European Respiratory Society Annual Congress that it has submitted a Qualification Package to the Food and Drug Administration (FDA) for plasma fibrinogen as a new drug development tool. The Qualification Package is the result of progressive discussions between the FDA’s Qualification Review Team and the CBQC. The CBQC looks forward to the results of FDA review while planning for a fall 2013 submission to the European Medicines Agency.

Dr. Ruth Tal-Singer, CBQC co-chair, vice president, Clinical Discovery, Respiratory Area Therapy Unit at GlaxoSmithKline, notes, “To the best of CBQC’s knowledge, fibrinogen is the first clinical biomarker achieving this milestone in the U.S. This is a major milestone for the CBQC, and it highlights the power of working together across multiple companies, academic centers and government organizations to achieve our common objective of improving the way we study novel medicines for patients who need them.”

To support the submission, the CBQC compiled a unique database of subjects from five individual studies, allowing integrated analyses to support two proposed uses as a prognostic biomarker to enrich clinical trial populations with Chronic Obstructive Pulmonary Disease (COPD) subjects at increased risk for all-cause mortality or COPD exacerbations.

A biomarker is a tool that can be used for early detection of a disease, selection of subjects for clinical trials or as an outcome for clinical trials. Fibrinogen, a protein that can be measured in the blood, is a promising biomarker which identifies a group representing 25 to 30 percent of all COPD patients (a COPD subtype).

Dr. Stephen Rennard, CBQC co-chair and Larson Professor of Medicine, University of Nebraska, adds, “COPD is extremely heterogeneous. This complicates development of new treatments, as individual COPD patients may respond differently. Fibrinogen has been submitted to the FDA as a tool that will help address this problem. Specifically, fibrinogen measurement can help identify COPD patients at risk for death or hospitalization, which can allow individuals to participate in studies of novel treatments designed to improve those outcomes.”

The CBQC, organized under the auspices of the COPD Foundation, is a public-private partnership among academic researchers, pharmaceutical companies and government parties and agencies.

John W. Walsh, president and co-founder, COPD Foundation, states, “The Consortium is providing a unique and productive opportunity to bring new drug development tools to the research community, with the ultimate goal of providing new treatments to patients who urgently need them.”

The CBQC Fibrinogen Working Group is composed of the following members:

  • Bruce Miller, industry co-chair, GlaxoSmithKline
  • Ruth Tal-Singer, GlaxoSmithKline
  • Mike Lowings, GlaxoSmithKline
  • Ubaldo Martin, AstraZeneca
  • Jeff Snyder, Boehringer-Ingelheim
  • Kay Tetzlaff, Boehringer-Ingelheim
  • Armin Furtwaengler, Boehringer-Ingelheim
  • Nicholas Locantore, GlaxoSmithKline
  • Nancy Leidy, Evidera
  • Amber Martin, Evidera
  • Jason Simeone, Evidera
  • David Mannino, academic co-chair, University of Kentucky
  • Stephen Rennard, University of Nebraska
  • David Lomas, University College London, U.K.
  • Jorgen Vestbo, University of Southern Denmark, University Hospital Manchester, U.K.
  • Graham Barr, Columbia University
  • Debora Merrill, COPD Foundation

Source: COPD Foundation

US FDA Extends License of the GVK BIO Biomarker Database

GVK Biosciences (GVK BIO) recently announced that it is extending its Clinical Biomarker Database (GOBIOM) license to the Biomarker Qualification Group of the US Food and Drug Administration (US FDA). The GOBIOM database, which has the latest and recently updated information on all the biomarkers reported in various clinical and preclinical studies, will be beneficial to the US FDA in its Biomarker Qualification Process.

The GOBIOM database is a comprehensive compilation of all the clinically evaluated, exploratory and preclinical biomarkers associated with different therapeutic areas reported in global clinical trials, clinical and preclinical studies. GOBIOM contains information on 20,000 biomarkers comprising biochemical, genomic, imaging, metabolite, cellular and physiological markers, along with multiple data points comprising experimental, analytical, clinical and statistical data with their qualifications under different medical interventions.

Sreeni Devidas, Vice President, Sales & Marketing, Informatics, said, “The collaboration with the US FDA has helped GVK BIO in developing the safety biomarker content in GOBIOM. The interconnectivity between organ toxicities to the drug, dose and population was developed with equal emphasis on its preclinical qualification. Biomarker analysis tools were integrated into the database in a manner that has facilitated the user to make a comparative analysis between the biomarkers of their interest. We look forward to continue working and collaborating with the FDA with a view to enhancing the utility of the product further.”

Source: Business Wire

NIH to Fund Studies on the Clinical Utility of Extracellular RNA for Biomarker Development

The National Institutes of Health announced last week that the National Institute of Neurological Disorders and Stroke (NINDS) on behalf of the NIH Common Fund Program on Extracellular RNA Communication will support studies that promote the identification and validation of extracellular RNA (exRNA)-based biomarkers readily available from human body fluids and to facilitate the assessment and qualification of biomarkers for their utility in the clinical setting.

The Scientist Webinar: Tackling the Challenges Involved with Protein Biomarkers

Protein biomarkers have been hailed as vital stepping stones in the race to personalize medicine. But many hurdles remain to be cleared before their application becomes routine. Currently, protein biomarkers have proven useful in drug discovery and development, as tools for target discovery and evaluation of a drug’s mechanism of action, and in therapies for prevention, early detection, diagnosis, and treatment of disease. Although single markers are in use, more widespread adoption will probably require a multiplexed panel capable of detecting and measuring biomarkers accurately, inexpensively, and easily in biological samples that are highly complex.

ALPCO and Argutus Medical Collaboration

ALPCO Diagnostics, a leading developer, manufacturer and distributor of assays, is pleased to announce the launch of their new site specific rat kidney injury biomarker, Alpha Glutathione-S-Transferase (aGST) a constitutive proximal tubule injury marker. The biomarker has been widely referenced in scientific publications as well as studied by the ILSI HESI Committee on the Application of Biomarkers of Toxicity, Nephrotoxicity Working Group. Results of this collaborative study have been submitted to various U.S., EU and Japanese regulatory as part of the FDA CDER biomarker qualification initiative.