This webinar will provide insight into current approaches and issues in co-developing novel oncology therapeutics and diagnostics. We will focus on critical aspects that can make or break development, regulatory submission, launch, and adoption of both the drug and the companion diagnostic.
Misalignment of oncology therapeutics with their companion diagnostic can have a significant negative impact on pharma’s planning, budget and operations, and market uptake of both products once regulatory approval is achieved. More broadly, misalignment of risk between pharma and IVD players may result in strained development programs and business relationships. In the last several years, the industry has seen two anti-cancer drugs (Xalkori and Zelboraf) demonstrate simultaneous therapeutic and diagnostic approval, illustrating successful scenarios for companion diagnostic and targeted oncologic parallel development. However, this is often not the reality for many oncology development programs, as exemplified by Tarceva and Iressa. These two cases lacked the benefits of co-development and the opportunity to influence the type and performance of the diagnostic test.
This webinar will examine key steps for Pharma in oncology development including:
- Key strategic priorities in the planning of oncology drug and diagnostic test development and launch
- Considerations for platform/assay selection and strategic partnering early in the clinical development program
- Generating the right evidence to gain regulatory approval and optimize pricing and reimbursement of both the drug and the diagnostic in global markets
The audience can expect to gain the following insights:
- Optimal timing for planning lock step development and commercialization of the drug/diagnostic combination
- The importance of a centralized data strategy
- How to select and work with IVD manufacturers, labs, and other potential partners during co-development
- Ensuring development plans are aligned to market access needs of various stakeholders groups
- Maximizing post-launch uptake of the drug and diagnostic
- Key issues in the choice of regulatory pathways for diagnostic test development and use
- The role and examples of risk in achieving reimbursement of the therapeutic-diagnostic combinations
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.
Who Should Attend?
- Oncology Clinical Development Programs- Leaders and Team Members
- Clinical Program Managers or Project Managers
- CDx Laboratory and Commercial Management
- VP, Director of Clinical Operations
- Pricing, Reimbursement, or Health Economics Outcome Research Leaders/Managers
- Medical Science Liaisons
- Chief Medical and Scientific Officers
- CEO/President of Oncology Pharma Business Unit or organization
Quintiles is the only fully integrated bioPharmaceutical services company offering clinical, commercial, and consulting solutions worldwide. The Quintiles network of more than 27,000 engaged professionals in 59 countries works with an unwavering commitment to patients, safety and ethics. Quintiles helps bioPharmaceutical companies navigate risk and seize opportunities in an environment where change is constant.