A Cost-Utility Analysis Of Vertex’s CF Drugs — What It Teaches Us About Trial Design
A Cost-Utility Analysis Of Vertex’s CF Drugs — What It Teaches Us About Trial Design

Commercial success in the pharmaceutical industry requires that clinical programs, in addition to demonstrating clinical effectiveness, also provide data supporting a drug’s value. The Institute for Clinical and Economic Research (ICER), a U.S.-based cost-effectiveness watchdog, recently released an analysis suggesting that Vertex Pharmaceuticals’ cystic fibrosis (CF) franchise — Kalydeco, Orkambi, and the recently launched Symdeko — while offering meaningful clinical efficacy, would require discounts of approximately 70 percent1 to be cost-effective.

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    Improving Imaging Biomarkers In Oncology

    This article summarizes progress from the initial imaging biomarkers developed to evaluate tumor shrinkage in response to cancer therapeutics, to the challenges posed by contemporary treatment paradigms which may produce new patterns of response.

  • Clinical Trials: Not Broken, But In Need Of Repair
    Clinical Trials: Not Broken, But In Need Of Repair

    The many challenges sponsors face performing clinical trials led Janet Woodcock, director of the Center for Drug Evaluation and Research at FDA, to remark in 2017 that the clinical trial system is broken. But if that’s the case, how do we uncover the underlying problems and bring all stakeholders together to fix them?

  • The Importance Of Real World Evidence In Oncology
    The Importance Of Real World Evidence In Oncology

    There is a significant need to collect Real World Evidence (RWE) to demonstrate the benefit of these drugs in clinical practice which can then be used as the wrap around to demonstrate true clinical benefit and address all stakeholder needs.

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