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Oncology Value Coalition: The Evolution of Clinical Research—Expedited Pathways, RWE, and Decentralized Trials, Part 4
In segment 4, the panelists discuss regulatory considerations for real-world evidence and real-world data.
Precision medicine is redefining how we evaluate and treat disease. Cancer is no longer defined by organ, tissue, or cell type but rather by genotype.
Conducting traditional 3-phased clinical trials in orphan disease categories on a myriad of novel therapeutics, while trying to expedite therapies from lab bench to bedside is forcing a transformation of both the clinical development and regulatory process. From cohort expansion to accelerated pathways to decentralized trials, this transformation has placed real-world evidence at the center of the approval process.
In the latest Oncology Value Coalition from The American Journal of Managed Care®, panelists from Cardinal Health Specialty Solutions discuss how the traditional one-size-fits-all clinical development and regulatory approval paradigm has evolved to become an increasingly customizable process.
Bruce Feinberg, DO, chief medical officer, Cardinal Health Specialty Solutions, moderated the discussion with:
- Andy Klink, PhD, MPH, Director, Lead Scientist, Real-World Evidence & Insights, Cardinal Health Specialty Solutions
- Ajeet Gajra, MD, MBBS, FACP, Vice President, Chief Medical Officer, Cardinal Health Specialty Solutions
- Scott Swain, PhD, MPH, Director of Real-World Evidence and Regulatory Sciences, Cardinal Health Specialty Solutions
In segment 2, the panelists discuss regulatory considerations for real-world evidence and real-world data.
Nathan Walcker Discusses Value-Based Oncology Care Initiatives at FCS
September 8th 2023Nathan Walcker, CEO at Florida Cancer Specialists & Research Institute (FCS), highlights some of the recent partnerships and initiatives at FCS to improve community-based oncology care from a value-based perspective.
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How Health Care Institutions Can Leverage Biosimilars to Generate Savings
August 17th 2022On this episode of Managed Care Cast, Ryan Haumschild, PharmD, MS, MBA, from Emory Healthcare and the Winship Cancer Institute, explains the evolution of biosimilar pharmacoeconomics and the different strategies that health care institutions can implement to reap the benefits of biosimilar savings.
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Expanding Access to NSCLC Innovations: Challenges and Opportunities
October 18th 2024The current research focus for Umit Tapan, MD, Boston Medical Center, is reducing disparities in lung cancer care and improving treatment access, in particular for immunotherapy and targeted treatments.
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