Scientific Advisory Board to help drive pathology innovation in preclinical toxicology and oncology clinical trials
Flagstaff, AZ (PRWEB) August 27, 2010
Flagship Biosciences LLC, a provider of digital pathology services, has formed a Scientific Advisory Board composed of experienced leaders in the pharmaceutical industry. Flagship is a pathologist-owned company committed to improving the use ofdigital pathology and tissue assessment in pharmaceutical and medical device development. This team of remarkable individuals will help guide Flagship in the delivery of digital pathology services across discovery, preclinical, and clinical trials in pharmaceutical drug development.
“Flagship Biosciences is committed to using digital pathology techniques and innovations to provide quantitative tissue assessments in research, development and clinical arenas,” said Steve Potts, CEO of Flagship Biosciences. “We are working aggressively on improving applications specifically in preclinical toxicology and oncology clinical trials, two areas where traditional pathology is central to successful outcomes. We are honored to have this remarkable group of distinguished industry leaders to help Flagship better match new technology with current and emerging needs in pharmaceutical drug development. The discipline of pathology is vitally important in effective drug development, and digital pathology is a valuable tool in pathologists’ hands for delivering more quantitative efficacy and toxicology results. The Scientific Advisory Board is composed of both pathologists and scientists who are innovation leaders in the use of digital pathology analysis.”
The Scientific Advisory Board members represent two areas where Flagship focuses: oncology clinical trials and preclinical toxicologic pathology.
John C. Bloom, VMD, PhD. (co-chair) Dr. Bloom took early retirement after a distinguished career in translational medicine at Eli Lilly and GlaxoSmithKline. He developed the central laboratory model for the industry, and recruited and managed multiple teams of medical and veterinary pathologists serving the needs of clinical trials.
Joseph Krueger, Ph.D. (co-chair) Dr. Krueger is an emerging leader in development of oncology therapeutics in industry, and Senior Scientist at OSI Pharma (now Astellas). He has developed novel applications of digital pathology in early drug development and in patient stratification and oncology clinical trials.
David Eberhard, M.D., Ph.D. Dr. Eberhard is an anatomic/molecular pathologist recognized for his leadership in oncology clinical trials. He is the Director of Clinical Trials Pathology Services at LabCorp’s Center for Molecular Biology and Pathology, where he joined after a distinguished career at Genentech and as an industry consultant. He is an Adjunct Associate Professor at University of North Carolina, Chapel Hill, and has been active in developing standardized approaches for molecular pathologic analyses of solid tumors in clinical trials.
Hadi Yaziji, M.D. Dr. Yaziji is President of Vitro Molecular, a physician-owned, high-quality anatomic pathology specialty laboratory. He is internationaly recognized for leadership in the fields of immunohistochemistry (IHC) and fluorescent in-situ hybridization (FISH) testing for pathology. He and other Members of the Standardization Ad-hoc Consensus Committee recently wrote the standards for the estrogen receptor testing in breast cancer by immunohistochemistry that is widely utilized within the industry.
Holger Lange, Ph.D. Dr. Lange was previously Director of Image Analysis at Aperio, where his team led the development of digital IHC, and received five FDA 510k clearances in three years, two of which involved digital read, a new approach in the industry. He is a leading expert in the use of image analysis in a regulated clinical environment.
Robert Dunstan, DVM, Ph.D., DACVP. Dr. Dunstan is Distinguished Investigator at Biogen-Idec, and well known in the industry for pioneering new uses of digital pathology in discovery and preclinical pathology.
Lewis B. Kinter, Ph.D., D.A.B.T., Fellow A.T.S. Dr. Kinter is currently Senior Director: Regulatory Toxicology and Head: Toxicological Operations, Safety Assessment (US) at AstraZeneca in Wilmington, PA. Dr. Kinter has been engaged in pharmaceutical research and development and comparative physiology/medicine for 30 years and is an expert in the areas of regulatory toxicology, safety pharmacology, and cardiovascular-renal function assessments in animals. Dr Kinter was until recently Chair of the PhRMA Preclinical Safety Leadership Committee (PSLC, formerly DruSafe), and is currently (2010) an inaugural member of the PhRMA Clinical and Preclinical Development Committee and International Consortium for Innovation and Quality in Pharmaceutical Development (IQ Consortium), and organizer and Chair of the Preclinical Safety Discussion Group
Jens R. Nyengaard, MD, DrMedSc. Dr. Nyengaard is Professor at the University of Aarhus in Denmark and President of the International Society for Stereology. He is a leader in the use of stereology in brain/kidney and other organs, and is working to advance the use of stereology as regular toxicologic and efficacy measurements in the pharmaceutical industry.
Jerry Hardisty, DVM. DACVP. Dr. Hardisty is the CEO of EPL a private, employee-owned company that is recognized nationally and internationally for its ability to meet the demands of the scientific community and the challenges of safety testing and toxicologic pathology.
Neal Goodwin, Ph.D. Dr Goodwin serves as the founding Program Director of JAX® Cancer Services based in Sacramento, CA that supports the global cancer drug development community. Notably, he recently spearheaded the establishment of the JAX-UC Davis Cancer Center Consortium which currently performs high-throughput human tumor engraftment and efficacy studies for the advancement of new personalized cancer therapeutics and diagnostics.
David Fairley. Mr. Fairly is Managing Director and Owner at Histologix, a European provider of GLP compliant histology and pathology services. He is well regarded for his leadership in therapeutic antibody cross-reactivity testing in human and animal tissue.
No one on the Flagship Scientific Advisory Board receives any compensation for their service in this capacity.
About Flagship Biosciences
Flagship Biosciences is a pathologist-owned company whose mission is to improve tissue assessment in pharmaceutical and medical device development. Flagship’s services include quantitative pathology assessment on-demand, low-cost digital pathology slide scanning, secure hosting, pathologist-supervised IHC and histology placement, and custom image analysis and companion diagnostics development. All of their services are reviewed and supervised by board-certified pathologists.