Flagship Biosciences establishes partnership with Beaufort, an industry-leading CRO, to provide a full range of clinical trial services to advance initiatives that bring image analysis based Companion Diagnostics (CDx) into the clinical market.
Westminster, CO – February 2, 2016 – Flagship Biosciences, Inc. announces that Beaufort, LLC., www.beaufortcro.com, an industry leading diagnostic-CRO with extensive experience in clinical regulatory services, quality solutions and staffing solutions; will be the preferred resource to strengthen its clinical trial services for Companion Diagnostics (CDx) for its pharmaceutical clients. This announcement now provides Flagship with a partner to conduct rigorous and customized end-to-end clinical trial services for pivotal PMA registration trials for immunohistochemistry (IHC) and in-situ hybridization (ISH) based CDx. This includes support of standard, manual pathology based CDx, as well as development of advanced tissue image analysis based CDx.
“This partnership allows Flagship to strengthen our commitment of providing our customers a continuous path for the development of their exploratory tissue image analysis solutions into Companion Diagnostics.” said Dr. David Young, CEO and President. “Working with Beaufort further positions our company to more effectively drive our image analysis based Companion Diagnostics (CDx) as a sponsor and to manage all relevant aspects of a PMA registration trial.”
Dr. Holger Lange, Chief Technology Officer at Flagship, has led the initial phases of this collaboration, which have yielded fully developed Standard Operating Procedures (SOPs) for Good Clinical Practice (GCP) for Clinical Trials according to the harmonized ICH guideline for good clinical practice (E6), to support IVD-track assay and image analysis development strategies.
“The continued collaboration will enable the development of novel, high complexity assay and image analysis interpretations to meet the needs of immuno-oncology patient selection strategies, under efforts which have been sponsored by Flagship Biosciences and its pharmaceutical customers” said Dr. Holger Lange.
“Tissue image analysis allows us to bring more complex biomarker assays into the clinic, allowing our Pharma customers to provide more effective drugs, and ultimately to save lives. The fast growing field of immuno-oncology is requiring the creation of in-situ based tests which are too complex for human interpretation, and must be interpreted using tissue image analysis.” said Dr. Joseph Krueger, Chief Scientific Officer. “The application and adoption of our technology is being adopted quickly in this space, and we must be sure to enable success for obtaining regulatory approval for our technology for our customers”.
“Beaufort’s success is rooted in helping our clients and partners accelerate medical innovation,” said Clay Gill, President of Beaufort, LLC. “We are excited for the opportunity to collaborate with Flagship, a leading innovator in specialty tissue image analysis, to deliver clinical services and solutions that will help advance drug development in the clinical market.”
About Flagship Biosciences
Flagship Biosciences, the industry leader in tissue image analysis, advances precision medicine by quantifying and simplifying complex pathology utilizing advanced image analysis technology. The company’s comprehensive “fit for purpose” image analysis solutions transform conventional, subjective methods of histopathology with clear actionable data to speed global drug development and approval.
Beaufort, LLC, is a contract research organization that provides in-vitro diagnostic, medical device and biopharmaceutical clinical and regulatory services, and a full range of quality solutions and staffing solutions. For more than a decade, companies worldwide have trusted Beaufort for its client-oriented approach to research. With operations spanning the globe, Beaufort has a proven track record working closely with clients and regulatory agencies internationally to bring complex and therapeutic-specific products to market. Learn more at BeaufortCRO.com.