The addition of Holger Lange gives Flagship’s pharmaceutical customers and industry partners a huge advantage in planning their regulatory programs for multiplexed IHC development.
Flagstaff, AZ (PRWEB) November 8, 2010
Flagship Biosciences announced today that Dr. Holger Lange has joined the firm as Chief Technology Officer. Holger brings a wealth of experience in FDA clearances of digital pathology companion diagnostics. He previously was the Director of Image Analysis and Product Development at Aperio, where his team successfully received five FDA 510k clearances in three years. Several of these were technology breakthroughs in the industry, including the “digital read” of IHC breast biomarkers and a tunable approach in a regulated environment.
“Companion diagnostics development of tissue biomarkers requires three things — expert image analysis, pathology expertise, and the ability to work with regulatory bodies in achieving widespread acceptance of new biomarkers and new technologies,” said Steve Potts, CEO of Flagship Biosciences. “Dr. Holger Lange is absolutely unique in the industry in his demonstrated ability to combine regulatory approval with novel image analysis technology. Holger and his team’s achievement of five FDA clearances at Aperio in three years is unprecedented in digital pathology. His addition to the Flagship team expands our ability to drive novel companion diagnostics and particularly IVDMIAs into clinical usage. We look forward to having Holger work closely with our large pharmaceutical customers and Flagship’s industry partners in our companion diagnostics programs.”
“Pharmaceutical companies who are serious about companion diagnostics require regulatory expertise, ” said Dr. John Bloom, an pharma industry veteran innovator and a board member of Flagship. “The addition of Holger Lange gives Flagship’s pharmaceutical customers and industry partners a huge advantage in planning in their regulatory programs for multiplexed IHC development. His balance of the FDA approval process with his image analysis expertise is unmatched in the industry.”
Holger Lange will be based in Germany, which will strengthen European alliances for Flagship Biosciences, and allow for more closely working with both FDA and EMEA guidelines for late-stage companion diagnostics.
About Flagship Biosciences
Flagship Biosciences is a pathologist-owned digital pathology services CRO that offers quantitative pathology and companion diagnostics development to pharmaceutical and medical device companies, including tissue biomarkers development and multiplexed IHC.