Harmonization of Anatomic Pathology + Histology services in Support of Global Oncology Clinical Trials

Oncology continues to be a key therapeutic area for drug developers and researchers, resulting in bio-pharmaceutical companies contributing a significant (and growing) portion of their R&D resources toward Oncology. Anatomic Pathology and Histology (APH) plays a foundational role in oncology clinical studies as researchers analyze tumors and various tissue types for cell proliferation, mutation and the various other forms in which cancers present in tissues.

As with many aspects of global clinical trials, process standardization reduces variability and ultimately yields more powerful and reliable results.

This talk will focus on lessons learned and applied to the standardization of global clinical trials and reducing variability in APH services supporting global clinical trials.

Factors discussed will include:

• Supporting global oncology clinical trials
• The role of LIMS and digital pathology
• The importance of a world class pathology network
• Key APH capabilities to support global clinical trials
• Flexibility and “sponsor choice” in pathology review/ diagnosis

Speakers

Paul Kirchgraber, MD, MBA, FCAP, Vice President, Global Testing Services, Medical & Technical Affairs, General Manager of the Americas, Covance Central Laboratory, Indianapolis, Indiana, USA

Dr. Kirchgraber is currently the Vice President of Global Testing Service, Medical & Technical Affairs, and General Manager CLS for the Americas. He is responsible for strategic and operational management of all five clinical trials central laboratories (US, Switzerland, Singapore, China and Japan), along with directing the Global Medical Affairs department. Prior to joining Covance, Dr. Kirchgraber held roles of increasing responsibility at Quntiles Laboratories Ltd, leading to his role as Global Medical Director. Dr. Kirchgraber is a board certified pathologist in both Anatomic and Clinical Pathology, with added qualification in Cytopathology. Previous to Quintiles he practiced pathology in Syracuse, New York and was Assistant Medical Director of Laboratory Alliance of Central New York. He received his MD from Cornell University Medical College, and his MBA from Bingham University School of Management.

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Steven G. Brodie, PhD, FACMG, Director of Molecular Genetics and Cytogenetics, NeoGenomics Laboratories

Dr. Brodie is the Director of Molecular Genetics and Cytogenetics at NeoGenomics Laboratories, Fort Myers, FL. He received his Ph.D. from UNM School of Medicine and completed Clinical Genetics training in Cytogenetics and Molecular Genetics at UCLA. Dr. Brodie is Board Certified by the American Board of Medical Genetics in these specialties and holds Directors Licenses in the States of Florida, California, and New York. Throughout his career, Dr. Brodie has held various research and clinical positions at the NIH, UNM, and UCLA, and comes to us after directing high through put testing in Cytogenetics, FISH, Molecular Genetics and Oncology for Quest Diagnostics, Nichols Institute. He is also a CAP approved inspector.

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