『Pharma Unscripted』のカバーアート

Pharma Unscripted

Pharma Unscripted

著者: RTI Health Solutions
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Pharma Unscripted explores how evidence is evolving across the biopharma landscape—and what that means for patients, access, and decision-making.

Through expert-led conversations, the series examines how organizations are generating and applying evidence to bring meaningful therapies to the people who need them most.

From patient-centered outcomes and real-world evidence to value demonstration and AI in medical communications, each episode breaks down the trends shaping how therapies move from development to real-world impact.

2026 RTI Health Solutions
生物科学 科学
エピソード
  • Delphi Methodology: Turning Expert Judgment into Actionable Evidence
    2026/08/31
    How can Delphi studies address critical evidence gaps?

    When traditional evidence is limited or unavailable, Delphi methodology offers a structured way to turn expert judgment into credible, actionable insights.

    In this episode, Ash Menon and Mark Price discuss when to use Delphi research, what rigorous study design looks like, and how findings can support publications, regulatory submissions, HTA, and market access strategy.


    Key Topics

    • When Delphi methodology is appropriate
    • Panel and questionnaire design
    • Consensus thresholds and iterative rounds
    • CREDES and ACCORD reporting standards
    • Regulatory, HTA, and market access applications
    Continue Exploring Delphi Methodology

    Get a practical, step-by-step approach to designing, conducting, analyzing, and reporting a rigorous Delphi study.

    Download the Delphi methodology guide

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    26 分
  • The First EU JCA Report: Methodological Learnings and Implications for Future Submissions
    2026/07/10

    What can manufacturers learn from the first EU JCA report?

    The first EU Joint Clinical Assessment report offers an early look at how evidence may be evaluated under the EU HTA Regulation. This episode explores key methodological learnings from the tovorafenib assessment and what they may mean for future submissions, especially in rare diseases.

    Key Topics:
    • PICO scope and consolidation
    • Systematic literature review expectations
    • Indirect treatment comparisons
    • Single-arm evidence in orphan diseases
    • Future JCA submission planning

    Guests:
    • Caroline Ling, Vice President, Health Outcomes – Europe
    • Vijay D’Souza, Associate Director, European Value and Access

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    24 分
  • The Patient Experience: Evaluating Tolerability in Oncology Treatments
    2026/06/03

    Why is patient-centered evidence critical in oncology?

    As oncology treatments become more targeted and long-term, organizations need evidence that captures real-world patient experience. This episode explores how PROs, tolerability, and patient-centered evidence are shaping adherence, evidence strategy, and market access.

    Key Topics:

    • Real-world patient experience
    • Tolerability and treatment burden
    • Patient-reported outcomes (PROs)
    • Patient-centered evidence strategy
    • Adherence and market access

    Guests:

    • Ari Gnanasakthy, Principal Scientist, Patient-Centered Outcomes Assessment
    • Dawn Odom, Vice President, Biostatistics

    Learn more about tolerability research

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    26 分
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