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. He is the founder of Bloom Consulting Services, advising clients in the area of companion diagnostics.
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.
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.
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.
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.