Drug-Diagnostic Co-Development Strategies for Oncology: Critical Aspects of Development and Launching an Oncology Companion Diagnostic

Brad Smith, Ph.D., Vice President, Translational Medicine, Center for Integrated Drug Development, Quintiles

Dr. Smith brings over 20 years of experience in development and use of research and clinical assays for oncology research, drug development and clinical use including the biotech and pharma industry and in partnership with academic and clinical practitioners. Dr. Smith currently leads development and implementation of clinical, laboratory and biomarker strategies for targeted drug and companion diagnostic development at Quintiles, the leading CRO driving global drug development across all therapeutic areas. Dr. Smith has authored multiple basic research, translational medicine, and clinical publications and patents in this field.

Prior to Quintiles, Dr. Smith led Corporate Development for Cell Signaling Technology, in new diagnostic development and clinical partnerships, as well as serving in other roles leading antibody and clinical assay development efforts for the company. Previous to Cell Signaling Technology, Dr. Smith directed product development and production at Santa Cruz Biotechnology, helping to build that company into one of the largest supplier of research tools for basic research. Dr. Smith’s scientific background includes research positions at Stanford University and University of California, San Francisco focused on cellular signaling mechanisms of disease. Dr. Smith holds a Doctoral degree from Stanford University and Master’s and Bachelor’s degrees from University of California, Santa Cruz.

Eric Faulkner, MPH, Director, Global Market Access – Diagnostics / Personalized Medicine, Quintiles

Eric is the Director of Global Market Access for Quintiles Consulting, with responsibilities for reimbursement, pricing and market access and commercialization strategy consulting. He has approximately 15 years of experience focusing on product market access, reimbursement and commercialization strategy for bioPharmaceuticals, medical devices, and diagnostics.

Previously, Mr. Faulkner managed a portfolio of consulting projects at RTI Health Solutions, the Littell Group, and The Lewin Group. Key projects have included global market strategy analysis, qualitative and quantitative research, evidence-based practice and policy, design of clinical trials to meet third-party decision requirements, life sciences portfolio due diligence, and decision support. He also has led health policy assessments, including CMS’s Coverage with Evidence Development (CED) and Clinical Trial Policy, value-based purchasing, competitive bidding, cost-effectiveness, comparative effectiveness, and pharmacogenomics for life sciences manufacturers, industry and medical professional associations, and government agencies, including HHS, NIH, FDA, CDC, and ASPE.

Mr. Faulkner is a recognized global thought leader in personalized medicine, bioPharmaceutical, medical and emerging technology market access. He has recently served as an expert advisor to the Personalized Medicine Subcommittee of the President’s Council of Advisors on Science and Technology. He serves on the Leadership Committee of the HTA Special Interest Group, including the working groups on Pharmaceuticals and for Medical Devices and Diagnostics and as the Chair of ISPOR’s Personalized Medicine Special Interest Group. He also serves as the Executive Director of the Genomics Biotech and Emerging Medical Technology Institute of the National Association of Managed Care Physicians and as an adjunct Assistant Professor for the Institute for Pharmacogenomics and Individualized Therapy at the University of North Carolina at Chapel Hill.

He earned his master’s degree in public health from the University of North Carolina, Chapel Hill, NC and a bachelor of science degree in biology from Radford University, Radford, VA.