The first digital pathology services company formed by pathologists to serve the needs of drug and device development
Boulder, CO – October 9, 2009 – Flagship Biosciences LLC,(Flagship) was created as a new company entity by two experienced pathologists to leverage the use of emerging digital pathology technology. Whole slide imaging allows a pathologist to view a tissue section from any geographical location via a computer monitor, and can subsequently utilize computer image analysis to make definitive quantitative measurements. A number of large pharmaceutical companies have adopted the technology in-house, where it provides advantages related to reducing geography, archiving, informal peer reviews, and computer-based quantitation.
However, the technology is disruptive in nature. Pharmaceutical industry pathology procedures are heavily regulated, and pathologists have decades of experience using glass slides and the microscope efficiently. Standard regulatory processes are built around shipping of glass slides between contract research organizations and the pharmaceutical companies they serve. And pathology images are generally of a small subset of tissue representation and not whole slide images. The industry will not evolve to full adoption overnight.
Two veterinary pathologists, Drs. David Young and Frank Voelker, together formed Flagship Biosciences to drive greater adoption of the technology within the industry. Through years of using the technology, they have experienced first-hand the challenges and opportunities it presents to discovery research.
“Particularly with advanced image analysis, unless you are utilizing the technology every day, it can actually make work slower rather than faster. There are almost unlimited applications when a pathologist can teach the software a given tissue type, lesion, or cell, and then identify these across an entire slide or set of slides. Similar to radiology, this technology will eventually vastly increase pathologists’ throughput, as well as allow us to provide quantitative results to our therapeutic area customers. However, this does not happen overnight, and without high investments in training, capital investment in digital pathology hardware / IT infrastructure, algorithm software, and pathologist time, pathologists are likely to be much slower with digital slides than with their existing microscope, ” said Dr. David Young DVM DACVP DABT, President of Flagship Biosciences LLC. “We formed this Flagship to help large companies utilize the technology more efficiently, and smaller biotech and medical device companies obtain quantitative tissue results and avoid capital investment and personnel costs. We strongly believe that pathologists must lead the way towards greater adoption in the industry, with the support from technology vendors.”
Dr. Frank Voelker, DVM DACVP, and Senior Pathologist at Flagship has significant experience with image analysis and quantitation, and has utilized whole section analysis for discovery applications through oncology clinical trials in his previous work at Novartis and several other large pharmaceutical companies. “There are many things that I can do with a digital slide that I cannot do with glass, I much prefer working from a whole slide image. The pressure from both inside pharmaceutical and device companies as well as from external regulatory bodies for quantitative data is increasing, and older manual pathology scoring will not be acceptable in the future. From a microscope, as an experienced pathologist I can visualize a drug effect between a control and drugged tissue — what our whole section analysis does is let my collaborators readily view my observation, as I can back it up with measured data overlaid in a tissue image.”
The company is based in Boulder CO, and will be opening a location for its scanning and pathology-based image analysis center.
