Predicine Partners with FMD to Accelerate Biomarker-driven Clinical Trials and Regulatory Approvals in the U.S. and China
The combination of FMD’s regulatory and clinical operation expertise and Predicine’s molecular testing expertise will assist biopharmas in taking a significant step forward toward a concurrent regulatory approval of their novel therapies.
HAYWARD, Calif. (PRWEB) May 30, 2019
Predicine today announced a strategic partnership with FMD to help biopharma companies accelerate biomarker-driven clinical trials and concurrent New Drug Application (NDA) submissions in the U.S. and China. The collaboration structure allows for global development of novel oncology therapies for biopharmaceutical companies, including global clinical trial support, regulatory support, and biomarker-driven drug development, and CDx development.
FMD is a leading provider of clinical development services that rigorously adhere to ICH standards and it is the first CRO that is capable of providing joint drug development services in China and simultaneously in the U.S., Europe, Japan, Australia, and Taiwan. This partnership enables FMD to leverage Predicine’s cfDNA + cfRNA liquid biopsy technology to accelerate patient screening and enrollment, and ultimately expedite clinical development and regulatory approval of novel therapies to benefit patients worldwide. Predicine and FMD will jointly manage patient screening services, client support in precision clinical trials, business development, and marketing.
“Harmonized biomarker assay is essential for precision clinical trials and cross-border new drug application. It is imperative that we collaborate with FMD to help our biopharma partners to expedite biomarker-driven drug development and regulatory approvals, and ultimately bring more personalized treatment options to patients worldwide,” said Dr. Shidong Jia, Founder and CEO of Predicine.
“Healthcare is transforming at a rapid pace, and there is an urgent need to develop strategies that can advance personalized medicine development and regulatory approvals in the U.S. and China concurrently to bring high quality innovated new drugs to global patients in a faster and cost-effective fashion while strictly meeting ICH standards. We believe that the combination of FMD’s regulatory and clinical operation expertise and Predicine’s molecular testing expertise will assist biopharmas in taking a significant step forward toward a concurrent regulatory approval of their novel therapies,” said Dr. Dan Zhang, Executive Chairman and CEO of FMD.
About Fountain Medical Development
Headquartered in Bejing China with global operations in North America, Europe, and other Asian countries, Fountain Medical Development (FMD) is a leading full-service Contract Research Organization (CRO) providing one-stop high quality clinical development services of the ICH standards for global pharmaceutical and medical device companies. FMD offers services and integrated solutions in all phases from IND filing to Phase IV clinical trials including Regulatory Affairs, Medical Affairs, Clinical Operations, Data Management, Biostatistics, Pharmacovigilance, and third-party audits, etc. FMD is the first CRO that can provide joint drug development services in China and simultaneously in the U.S., Europe, Japan, Australia, and Taiwan. For more information about FMD, please visit http://www.fountain-med.com
About Predicine
Predicine is a molecular insights company that is committed to advancing biomarker-driven precision medicine. Predicine has developed a breakthrough RNA- and DNA-based liquid biopsy technology for non-invasive cancer profiling, disease monitoring and assessing minimal residual diseases. Through its CLIA/CAP facilities in the U.S. and China, Predicine partners with leading biopharma companies and hospitals to support global clinical trials and personalized cancer therapy. For more information, please visit http://www.predicine.com