Excelra’s GOBIOM Licence Extension to the Biomarker Qualification Group of FDA
Biomarker’s potency in reshaping the drug development process in oncology has become quite apparent by its increasing utility in the early diagnosis of the disease. GOBIOM is a vast database of preclinical, clinical and exploratory biomarkers which encompasses about 80,000 Biomarkers of 18 therapeutic areas and more than 1,800 therapeutic indications found in scientific and regulatory literature.
Biomarker qualification process of FDA utilized the GOBIOM database since its collaboration with Excelra in 2008. They collaborated to build the safety biomarker content in GOBIOM. GOBIOM database can facilitate FDA’s decision making power whether to take a compound further for development or not. Thereby, reducing the development cost. They will help in understanding the structure-activity relationship between the drug and the target and its effect on biological pathway. Therefore, GOBIOM will help in the overall designing of the clinical trials and selection of outcome measures.
GOBIOM will guide FDA to answer the fundamental questions regarding biomarkers raised during regulatory review and decision making and will assist in the identification of new biomarker candidates.
Anandbir Brar, President, Excelra, said, “We are delighted to extend our collaboration with the USFDA after starting our collaboration back in 2008. With over 80,000 Biomarkers and more importantly the content and coverage of the database, we hope that the utility of the database to the NCTR and the Reviewers at the USFDA is further maximized.”
“We are delighted that the prestigious USFDA has renewed its license. We look forward to further collaborating with the agency and enhancing the value of the database. Inputs from the NCTR have been invaluable in enhancing the database since its inception in 2008,” said Dr. Sreeni Devidas, Vice President, Business Development at Excelra.
Biomarker development will offer insights to the history, risks and future outcomes associated with the disease. It will help in the efficient, rapid and affordable drug development and targeted therapies. The collaboration between the FDA and Excelra over GOBIOM database is certainly reinforcing the road for it.
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