Episodi

  • How Bayer Reorganized Their Clinical Operations Structure for Efficiency and Cost Savings

    How Bayer Reorganized Their Clinical Operations Structure for Efficiency and Cost Savings
    Jan 29 2026
    About this podcast:
    Recorded at DPHARM 2025, Bayer's Dr Bernhard Glombitza reports on the development, implementation and early impact of their clinical operations reorgnization. He describes how shifting from a traditional hierarchical model to a network of highly empowered teams reduced management layers, broadening the scope of work and changed cross-country operations monitoring.

    Dr Glombitza details the results of the change thus far, including significant increases in efficiency and reduction in cost, maintaining quality levels and study targets, and improving employee job satisfaction.
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    13 min
  • How Amicus Embedded Patient Advocacy into its Corporate DNA

    How Amicus Embedded Patient Advocacy into its Corporate DNA
    Jan 29 2026
    About this podcast:
    In this keynote from Patients as Partners in Clinical Research 2025, Amicus Therapeutics' Chief Patient Advocate, Jayne Gershkowitz, shares how their organization established and embedded patient advocacy into their core structure for lasting impact.

    More specifically, Ms Gershkowitz focuses on:
    • Defining role standards and recruiting the right talent
    • Co-creatin research with patient communities and developing patient-centered outcomes
    • Generating metrics that demonstrate the impact on R&D
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    25 min
  • Designing Clinical Trials Balancing Simplicity with Complexity

    Designing Clinical Trials Balancing Simplicity with Complexity
    Jan 27 2026
    When designing clinical trials, CMOs aim to answer meaningful questions for a plethora of stakeholders. Inherently, this results in study protocols with more measures, biomarkers and data collection that both provides a platform for strategic decision-making but also impacts patient burden, operational foot-print, timelines and cost. In this panel discussion from the 2025 Chief Medical Officer Summit 360°, CMOs address how to develop a balanced strategy that takes into account the ambition to answer these questions with the realities of complicated clinical trials.

    More specifically:
    • Prioritizing data collection strategy to answer key scientific questions while avoiding overcomplication
    • Designing trials around real patients rather than ideal patients
    • Better understanding the objectives of the study and asking the questions that achieve those objectives
    • Better partnering with patients and PIs
    To learn more about the Chief Medical Officer Summit 360°, please visit CMO360.org.
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    31 min
  • Platform Approaches to Streamline Combination Product Development

    Platform Approaches to Streamline Combination Product Development
    Jan 27 2026
    Investing in developing a durable platform and strategy early leads to fewer delays throughout development. Locking requirements in early and educating teams to approach combination product development holistically lowers the time to development dramatically. In this panel discussion from the 2025 PODD: Partnership Opportunities in Drug Delivery Conference, pharma executives and drug delivery experts discuss how they used platform devices in concert with an internal engagement strategy to speed up development. Specifically, they address:
    • Advantages and disadvantages to platform approaches for device development
    • Opportunities to overcome technical limitations
    • Approaches to bring a platform into multiple product design history files
    • Regulatory hurdles
    • Assessing business case and getting organizational buy-in

    To learn more about the PODD Conference, please visit Drug-Delivery.org.
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    30 min
  • What is the State of Clinical Trial Patient Matching Right Now?

    What is the State of Clinical Trial Patient Matching Right Now?
    Dec 19 2025
    About this podcast:
    Recorded at the 2025 DPHARM conference, this state of the union panel convenes site, technology and pharma to discuss:
    • Different models and the pros and cons of the deployment models
    • What makes a great patient matching solution
    • Predicting what the future growth of this segment looks like
    • The role of AI in this space
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    40 min
  • Balancing Innovation and Practicality in Immuno-Oncology Dose Selection

    Balancing Innovation and Practicality in Immuno-Oncology Dose Selection
    Dec 19 2025
    About this podcast:
    Recorded at the 2025 IO360º Summit, this podcast addresses how Project Optimus is reshaping dose selection from maximum tolerated dose to a balance of efficacy and safety. More specifically, this panel addresses FDA objectives for multi-dose selection, alternative dose-selection strategies with imaging, biomarkers and tumor burden analysis, the higher costs and longer timelines, and financial impacts for early-phase oncology companies.

    For more information, go to IO360summit.com.
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    45 min
  • Leveraging Local HCPs to Decentralize Clinical Research in North Carolina

    Leveraging Local HCPs to Decentralize Clinical Research in North Carolina
    Dec 19 2025
    About this podcast:
    Recorded at the 2025 CRAACO meeting, UNC Lineberger’s Comprehensive Cancer Center shares an initiative to allow local HCPs to still provide clinical care to patients but decentralized research elements to the university system, following the FDA’s change in guidance on Form FDA 1572, which stopped requiring local healthcare professionals (HCPs) involved in DCTs to be listed if they’re only performing standard-of-care.


    Dr J Kaitlin Morrison talks about the process from an initial pilot of two sites to more than 23 today, providing cancer patients across the state the opportunity to access clinical trials. Specifically:
    • How they are managing relationships with sites
    • How they’re monitoring research elements
    • Goals, next steps and thoughts for industry sponsors
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    21 min
  • Using Patient Engagement and Digital Innovation to Elevate Patient Insights and Outcomes

    Using Patient Engagement and Digital Innovation to Elevate Patient Insights and Outcomes
    Dec 19 2025
    About this podcast:
    This podcast, recorded at the 2025 Patients as Partners Europe meeting, addresses how Novo Nordisk is consolidating patient insights to ensure greater knowledge-sharing, data integrity and traceability, addressing the unmet needs of patients, aligning product outcomes with patient expectations, and more.

    For more information, go to theconferenceforum.org.
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    20 min