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Oncology Value Coalition: The Evolution of Clinical Research—Expedited Pathways, RWE, and Decentralized Trials, Part 2
In segment 2, the panelists discuss FDA's efforts to modernize drug evaluation.
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 FDA's efforts to modernize drug evaluation.
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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Closing the Gaps in Cardiac Care With Technology, Collaboration
March 12th 2025Cardiologists, primary care physicians, and value-based care leaders convened in Phoenix, Arizona, on November 12, 2024, to share case studies and insights on how to align cardiology with the principles of value-based care, including through the application of digital tools.
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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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NSCLC Advancements Offer Hope, but Disparities Persist
February 20th 2025Ioana Bonta, MD, Georgia Cancer Specialists, discusses the evolving state of non-small cell lung cancer (NSCLC) treatments, their impact on patient outcomes, and the need to address ongoing disparities in these populations.
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Balancing Innovation and Equity in Oncology Value-Based Care: Panel Discussions
January 27th 2025Discussions also delved into the complexities of value-based oncology care, the growing role of real-world data, and strategies to improve access to care in hematology. Across all sessions, a common theme emerged: the need to balance innovation with patient-centered, equitable, and sustainable care models.
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