Ariana® Pharma Collaborates with the FDA to Facilitate Signature Validation for Development of Biomarkers
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Ariana Pharma has announced that it has started a collaboration with the US Food and Drug Administration (FDA).
Ariana Pharma is providing its KEM® Biomarker technology to help enable FDA reviewers to analyze pharmacogenomic data combined with patient characteristics for biomarker signatures submitted through the FDA’s Voluntary Exploratory Data Submission (VXDS) program. This collaboration directly relates to the FDA’s desire to develop better tools for the analysis of genomic data in the context of the development of personalized medicine.
This collaboration is intended to help the FDA systematically identify potential genomic “fingerprints” and develop recommendations for the analysis of genomic data prior to submission of biomarker signatures.
“We are looking forward to this collaboration to help the agency systematically analyze all equivalent signatures combining both genomic and phenotypical date, this increasing chances of selecting the best biomarker signature,” said Federico Goodsaid, Ph.D., associate director for operations in genomics, Office of Clinical Pharmacology, Center for Drug Evaluation and Research at the FDA.
“This collaboration with the FDA is further confirmation of Ariana’s leading position in providing decision support tools to the pharmaceutical and biotechnology industry”, said Mohammad Afshar, CEO of Ariana Pharma. “Ariana fully supports FDA efforts to develop more effective biomarkers for personalized medicine.”
Ariana Pharma is providing its KEM® Biomarker technology to help enable FDA reviewers to analyze pharmacogenomic data combined with patient characteristics for biomarker signatures submitted through the FDA’s Voluntary Exploratory Data Submission (VXDS) program. This collaboration directly relates to the FDA’s desire to develop better tools for the analysis of genomic data in the context of the development of personalized medicine.
This collaboration is intended to help the FDA systematically identify potential genomic “fingerprints” and develop recommendations for the analysis of genomic data prior to submission of biomarker signatures.
“We are looking forward to this collaboration to help the agency systematically analyze all equivalent signatures combining both genomic and phenotypical date, this increasing chances of selecting the best biomarker signature,” said Federico Goodsaid, Ph.D., associate director for operations in genomics, Office of Clinical Pharmacology, Center for Drug Evaluation and Research at the FDA.
“This collaboration with the FDA is further confirmation of Ariana’s leading position in providing decision support tools to the pharmaceutical and biotechnology industry”, said Mohammad Afshar, CEO of Ariana Pharma. “Ariana fully supports FDA efforts to develop more effective biomarkers for personalized medicine.”
