Episodes

  • ACT Brief: FDA Capacity Strains Timelines, Sponsors Rethink Site Support, and Regulators Align on AI

    ACT Brief: FDA Capacity Strains Timelines, Sponsors Rethink Site Support, and Regulators Align on AI
    Jan 30 2026

    In today’s ACT Brief, we examine how reduced FDA capacity is extending regulatory timelines, why sponsors are rethinking operating models to reduce site burden in 2026, and how the FDA and EMA are aligning around guiding principles for artificial intelligence in drug development.
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    2 mins
  • ACT Brief: RWE Refines Trial Design, Oncology CRO Scale Expands, and Feasibility Pressures Persist

    ACT Brief: RWE Refines Trial Design, Oncology CRO Scale Expands, and Feasibility Pressures Persist
    Jan 29 2026
    In today’s ACT Brief, we look at how real-world evidence is reshaping trial design rather than replacing trials, what Worldwide Clinical Trials’ acquisition of Catalyst Clinical Research signals for oncology-focused CRO models, and new data showing feasibility and enrollment challenges remain stubborn across global trials.
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    2 mins
  • ACT Brief: ESG Moves Into Vendor Oversight, RWE Faces Governance Hurdles, and Roche Advances Obesity Pipeline

    ACT Brief: ESG Moves Into Vendor Oversight, RWE Faces Governance Hurdles, and Roche Advances Obesity Pipeline
    Jan 28 2026
    In today’s ACT Brief, we examine why ESG efforts in clinical development are shifting into vendor oversight, what data and governance barriers still limit broader use of de-identified RWE in submissions, and new Phase II obesity data from Roche as its program moves toward Phase III.
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    2 mins
  • ACT Brief: Decentralized Innovation Faces Reality, RWE Finds Its Lane, and Clinical Ops Reset for 2026

    ACT Brief: Decentralized Innovation Faces Reality, RWE Finds Its Lane, and Clinical Ops Reset for 2026
    Jan 27 2026
    In today’s ACT Brief, we explore why decentralized trial innovations struggle to scale without better change management, where real-world evidence most realistically complements traditional trials, and how efficiency, AI, and platformization are expected to reshape clinical operations in 2026.
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    2 mins
  • ACT Brief: De-Identified Data Expands Trial Design, Global Production Normalizes, and FDA Updates Quality Framework

    ACT Brief: De-Identified Data Expands Trial Design, Global Production Normalizes, and FDA Updates Quality Framework
    Jan 26 2026
    In today’s ACT Brief, we examine how large de-identified datasets are reshaping trial design and site strategy, why global pharmaceutical production is expected to cool after a tariff-driven surge, and what FDA’s new M4Q(R2) draft guidance means for quality submissions.
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    2 mins
  • ACT Brief: De-Identified RWE Gains Ground, HHS Funding Stabilizes Research, and U.S. Finalizes WHO Exit

    ACT Brief: De-Identified RWE Gains Ground, HHS Funding Stabilizes Research, and U.S. Finalizes WHO Exit
    Jan 23 2026
    In today’s ACT Brief, we look at how FDA policy is accelerating the use of de-identified real-world evidence in clinical development, why a new bipartisan funding package could stabilize federal research agencies, and how the US withdrawal from the World Health Organization reshapes global health coordination.
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    2 mins
  • ACT Brief: Global Trials Scale Up, Site-Centric Startup Gains Focus, and Pfizer Expands Vaccine Partnerships

    ACT Brief: Global Trials Scale Up, Site-Centric Startup Gains Focus, and Pfizer Expands Vaccine Partnerships
    Jan 22 2026
    In today’s ACT Brief, we look at how global clinical development is evolving through decentralized models and emerging markets, why site-centric practices are becoming critical to faster study activation, and how a new Pfizer–Novavax agreement reflects shifting vaccine development strategies.
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    2 mins
  • ACT Brief: Life Sciences Hold the Line on DEI, Startup Timelines Stretch Further, and Regulators Align on AI Governance

    ACT Brief: Life Sciences Hold the Line on DEI, Startup Timelines Stretch Further, and Regulators Align on AI Governance
    Jan 21 2026
    In today’s ACT Brief, we examine why life sciences companies are maintaining DEI commitments amid political pressure, what’s driving longer site activation timelines and how sponsors can reverse the trend, and how FDA and EMA are aligning on principles for AI use in drug development.
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    2 mins