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Oncology Value Coalition: The Evolution of Clinical Research—Expedited Pathways, RWE, and Decentralized Trials, Part 1
In the latest Oncology Value Coalition from The American Journal of Managed Care®, Bruce Feinberg, DO, led a discussion on how the traditional one-size-fits-all clinical development and regulatory approval paradigm has evolved to become an increasingly customizable process.
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 1, the panelists discuss the evolution of drug development.
In this interview with The American Journal of Managed Care®, Katie Queen, MD, addresses the complexity of obesity as a medical condition, pivoting to virtual care while ensuring that patients who lived in a rural location continued to receive adequate care, and the importance of integrating awareness of obesity and chronic disease prevention into local food culture.
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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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Overcoming Challenges to Value-Based Care Implementation: Grant Andres
November 10th 2023In an interview with The American Journal of Managed Care®, Grant Andres, BSc, DC, BSN, MSN-RN, senior director of clinical operations at Arizona Oncology, discussed the nuances of successfully implementing value-based care initiatives across a large organization.
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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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Dr Melissa Levine on Implementing Value-Based Care in the Primary Care Setting
October 26th 2023Melissa Levine, MD, a family medicine specialist at Arizona Community Physicians and medical director for the Abacus Health accountable care organization (ACO), discussed strategies for succeeding in an ACO and how primary care can complement oncology care for patients with cancer.
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