Episodios

  • ACT Brief: FDA Approval of Oral Wegovy, 2025’s Most-Read ACT Coverage, and Data Quality as the Foundation for AI
    Dec 24 2025
    In today’s ACT Brief, we cover the FDA approval of oral Wegovy based on Phase III OASIS 4 results, recap the most-read Applied Clinical Trials articles of 2025, and examine why data quality remains critical to enabling AI in clinical trials.
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    2 m
  • ACT Brief: AI-Enabled Workflow Automation, Subcutaneous Lunsumio VELO Approval, and Pan-KRAS Early-Stage Development
    Dec 23 2025
    In today’s ACT Brief, we look at how AI-enabled workflows can automate existing site processes, review the FDA approval of subcutaneous Lunsumio VELO for relapsed or refractory follicular lymphoma, and examine early clinical development activity for a pan-KRAS inhibitor licensed by AstraZeneca.
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    2 m
  • ACT Brief: Building a Digital Thread in Life Sciences, CRO Sourcing Decisions and Site Burden, and Lilly’s Oral GLP-1 Phase III Results
    Dec 22 2025
    In today’s ACT Brief, we examine why fragmented data systems continue to slow life sciences research, review how sponsor sourcing decisions may affect site experience and study execution, and report on topline Phase III results for Eli Lilly’s oral GLP-1 therapy orforglipron.
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    3 m
  • ACT Brief: Neutral Tech Adoption at Sites, Scaling Unstructured Data for eSource, and Novo Nordisk’s CagriSema NDA
    Dec 19 2025
    In today’s ACT Brief, we examine how sponsors are reassessing new engagement technologies to avoid increasing site burden, review new research on integrating unstructured health data to scale eSource-enabled trials, and cover Novo Nordisk’s NDA submission for its fixed-dose amylin–GLP-1 obesity therapy, CagriSema.
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    2 m
  • ACT Brief: Rethinking Site Support in 2026, GSK’s New Severe Asthma Approval, and Priority Review Momentum in Multiple Myeloma
    Dec 18 2025
    In today’s ACT Brief, we look at emerging operational changes aimed at reducing site burden, review the FDA approval of GSK’s twice-yearly biologic for severe asthma, and examine a national priority voucher granted for a new multiple myeloma treatment combination.
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    2 m
  • ACT Brief: Patient Preferences in Remote Trials, Sanofi’s Neurology and Immunology Deals, and AI-Driven Biomarkers in Oncology
    Dec 17 2025
    In today’s ACT Brief, we examine new survey data revealing what patients value most in remote clinical trials, break down Sanofi’s latest partnerships aimed at advancing Alzheimer’s and autoimmune therapies, and look at how AI-powered digital pathology is being integrated into oncology research through a new biopharma collaboration.
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    2 m
  • ACT Brief: AI-Enabled End-to-End Trials, New Phase III Data in HIV, and a First-Line Shift in HER2-Positive Breast Cancer
    Dec 16 2025
    In today’s ACT Brief, we close out our McKinsey interview series with a look at how AI could transform clinical trials end to end, review new Phase III data supporting Gilead’s investigational HIV regimen, and examine an FDA approval that reshapes first-line treatment for HER2-positive metastatic breast cancer.
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    2 m
  • ACT Brief: Training Community Oncology Sites, Digital Tools for Patient-Centric Trials, and New Phase III Momentum in Obesity R&D
    Dec 15 2025
    In today’s ACT Brief, we look at new evidence showing how targeted training can build research readiness at community cancer centers, explore McKinsey’s view on how digital tools can make trials more patient-centric and geographically inclusive, and review new Phase III results that could reshape obesity and osteoarthritis treatment.
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    2 m