AI Access Brief Podcast

AI Access Brief Podcast

By Carl HaakonBusinessManagement
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AI Access Brief Podcast episodes

  • MHRA-NICE Pathway Under Fire, Clinical Trial Targets Hit
    Episode 13 — 27 May 2026
    LSE expert challenges the new UK aligned drug approval pathway as industry-favoring while EU reports progress on 2030 clinical trial targets. NICE approves first HER2-targeted therapy for bile duct cancer as regulatory reforms reshape the clinical research landscape.
    Hosted by Marcus and Sara.
    Access Brief — Daily briefings on HEOR, HTA strategy and the evidence access landscape.
    Full transcript and sources at outcomes-analytica.no/podcast
    5 min
  • Critical Medicines Act and NICE Technology Priorities
    Episode 12 — 27 May 2026
    The EU Critical Medicines Act's provisional agreement introduces supply chain resilience metrics into HTA frameworks, while NICE advances systematic technology adoption and new prioritisation criteria. EMA maintains strong approval rates as European HTA bodies expand beyond traditional pharmacoeconomic assessments.
    Hosted by Marcus and Sara.
    Access Brief — Daily briefings on HEOR, HTA strategy and the evidence access landscape.
    Full transcript and sources at outcomes-analytica.no/podcast
    6 min
  • CHMP Pipeline Surge, NICE Threshold Jump, JCA Device Push
    Episode 11 — 27 May 2026
    EMA's CHMP recommended eight medicines including first-ever PROS treatment while NICE raised cost-effectiveness thresholds to £25,000-35,000 per QALY. The EU's Joint Clinical Assessment framework expands into medical devices with five assessments planned for June 2026.
    Hosted by Marcus and Sara.
    Access Brief — Daily briefings on HEOR, HTA strategy and the evidence access landscape.
    Full transcript and sources at outcomes-analytica.no/podcast
    6 min
  • Oral GLP-1s, AI Dominance, and Digital Health Parity
    Episode 10 — 27 May 2026
    EMA approves first oral GLP-1 for weight management while AI rises to top HEOR trend. NICE expands technology appraisals to digital health technologies and FDA raises real-world data standards.
    Hosted by Marcus and Sara.
    Access Brief — Daily briefings on HEOR, HTA strategy and the evidence access landscape.
    Full transcript and sources at outcomes-analytica.no/podcast
    6 min
  • UK Alignment Acceleration and EU JCA Implementation
    Episode 9 — 27 May 2026
    Marcus and Sara examine the NICE-MHRA aligned pathway's potential to accelerate UK medicine access by six months and debate whether 50 EU joint clinical assessments starting this year represents genuine coordination or administrative overhead. They disagree on US drug pricing policy effectiveness and discuss expanding international HTA collaboration benefits.
    Hosted by Marcus and Sara.
    Access Brief — Daily briefings on HEOR, HTA strategy and the evidence access landscape.
    Full transcript and sources at outcomes-analytica.no/podcast
    6 min
  • NICE Unified Prioritisation and EMA Regulatory Momentum
    Episode 18 — 27 May 2026
    NICE transforms guidance selection with unified prioritisation framework and EQ-5D-5L implementation while EMA shows regulatory momentum with eight May approvals. The episode examines operational impacts on evidence strategy and market access planning.
    Hosted by Marcus and Sara.
    Outcomes Analytica Podcast — Daily briefings on HEOR, HTA strategy and the evidence access landscape.
    Full transcript and sources at outcomes-analytica.no/podcast
    7 min
  • NICE Threshold Shift, Critical Medicines Act, and MFN Reality Check
    Episode 8 — 26 May 2026
    NICE confirms new £25,000-£35,000/QALY thresholds while EU reaches provisional agreement on Critical Medicines Act. Trump administration's MFN pricing projects $529 billion savings despite continued industry price increases.
    Hosted by Marcus and Sara.
    Outcomes Analytica Podcast — Daily briefings on HEOR, HTA strategy and the evidence access landscape.
    Full transcript and sources at outcomes-analytica.no/podcast
    4 min
  • CHMP Momentum, Critical Medicines Act, HTA Capacity Scaling
    Episode 17 — 26 May 2026
    EMA's CHMP delivered eight approvals including nerandomilast for pulmonary fibrosis while the Critical Medicines Act reached provisional political agreement. EU HTA capacity building expands with multilingual eLearning modules as joint clinical assessments scale to 35 oncology reviews despite persistent bottlenecks.
    Hosted by Marcus and Sara.
    Outcomes Analytica Podcast — Daily briefings on HEOR, HTA strategy and the evidence access landscape.
    Full transcript and sources at outcomes-analytica.no/podcast
    5 min
  • Critical Medicines Act Shapes EU HTA Landscape
    Episode 16 — 26 May 2026
    The EU's Critical Medicines Act provisional agreement combines regulatory tools with industrial policy to strengthen medicine supply resilience across 200+ active substances. HTACG scales joint clinical assessments while NICE operationalizes new thresholds amid evolving digital health technology frameworks.
    Hosted by Marcus and Sara.
    Outcomes Analytica Podcast — Daily briefings on HEOR, HTA strategy and the evidence access landscape.
    Full transcript and sources at outcomes-analytica.no/podcast
    8 min
  • HTACG Data Transparency and NICE Prioritisation Overhaul
    Episode 15 — 25 May 2026
    HTACG publishes crucial data transparency principles distinguishing commercially confidential information for joint clinical assessments. NICE launches unified prioritisation framework with eight principles from public dialogue, while EMA approves challenging orphan medicines and EFPIA raises MFN pricing access concerns.
    Hosted by Marcus and Sara.
    Outcomes Analytica Podcast — Daily briefings on HEOR, HTA strategy and the evidence access landscape.
    Full transcript and sources at outcomes-analytica.no/podcast
    3 min

About AI Access Brief Podcast

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AI Generated Daily briefings on HEOR, HTA strategy and the evidence access landscape. For pharmaceutical and biotech professionals navigating regulatory-payer alignment, HTA submissions, and…