Podcast
AI Access Brief Podcast
Hosted by Carl Haakon · EN
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 evidence strategy.
35episodes
Episodes
Newest firstAll episodes
JCA Reports & Regulatory Divergence
Yesterday00:03:35Tap to summarizeEpisode 40 — 28 June 2026 JCA reports reveal HTA evolution, while ADC evidence gaps and regulatory divergence challenge commercial strategies. 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
Transcribe →RWE, Gene Therapy, IRA Evidence Challenges
2d ago00:06:24Tap to summarizeEpisode 39 — 27 June 2026 Examining evolving HTA evidence demands, gene therapy value hurdles, and IRA-driven HEOR shifts. Contrarian perspectives on RWE adoption and evidence generation priorities. 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
Transcribe →HTA Realities & RWE Gaps
3d ago00:03:16Tap to summarizeEpisode 38 — 26 June 2026 Examining FDA accelerated oncology approvals, EMA adaptive trial updates, NICE's new cell gene therapy framework, and emerging Asia-Pacific HTA collaboration. 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
Transcribe →Divergent Pathways
4d ago00:04:51Tap to summarizeEpisode 37 — 25 June 2026 Interim CDF recommendations for ADCs, NICE reversal on MRD endpoints, regulatory crises, JSC submissions, and EMA emergency trials. 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
Transcribe →Regulatory Divergence HEOR Impacts
4d ago00:06:05Tap to summarizeEpisode 36 — 25 June 2026 Examining regulatory divergence impacts on HEOR strategies and recent NICE reversals on MRD endpoints. 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
Transcribe →PRAC Valproate, JCA Scale-Up, EMA Emergency Trials
1w ago00:03:51Tap to summarizeEpisode 35 — 22 June 2026 Examining PRAC valproate conclusions, EU JCA capacity expansion, EMA emergency trial frameworks, oral semaglutide UK access, and tovorafenib JCA procedural timelines. 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
Transcribe →Avacopan Crisis, D-VRd Reversal, Mirvetuximab Access
2w ago00:12:21Tap to summarizeEpisode 33 — 17 June 2026 Episode 33 covers NICE's interim CDF recommendation for mirvetuximab soravtansine in platinum-resistant ovarian cancer, the D-VRd reversal and what it signals about population-segmented cost-effectiveness modelling, the convergent avacopan regulatory crisis spanning MHRA, NEJM, PRAC and FDA, and the PRAC's valproate paternal exposure conclusion — a precedent-setting decision to maintain precautions despite explicitly inconsistent evidence. 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
Transcribe →First JCA Report, Oral Wegovy, Camizestrant Divergence
2w ago00:13:57Tap to summarizeEpisode 34 — 17 June 2026 Episode 34 unpacks the publication of Europe's first completed JCA report for tovorafenib and what it signals for submissions in the pipeline, the MHRA approval of oral semaglutide and the distinct NICE appraisal challenge it creates, AstraZeneca's camizestrant caught between EU approval and US ODAC rejection, and the PRAC's conclusions on paternal valproate exposure. Marcus and Sara disagree on whether the JCA's handling of indirect comparisons is reassuring or a false comfort, and on whether the camizestrant EU approval is strategically premature. 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
Transcribe →JCA Devices Live, Camizestrant Divergence, JSC Window Open
2w ago00:11:25Tap to summarizeEpisode 32 — 17 June 2026 Episode 32 covers the publication of the tovorafenib JCA report and what its procedural timeline means for submission planning, the operational launch of medical device JCAs in June 2026, the newly opened JSC window, and the camizestrant case — where the EMA and FDA have reached categorically different conclusions from the same dataset, creating one of the most complex active HEOR files in oncology. 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
Transcribe →PRAC Valproate Review, JCA Scale-Up, Emergency Trial Guidance
2w ago00:05:02Tap to summarizeEpisode 31 — 15 June 2026 EMA's PRAC concludes valproate neurodevelopmental risk remains uncertain while EU JCA programme scales to 50 assessments in 2026. Emergency clinical trial guidance opens for consultation as oral GLP-1 approvals expand market access complexity. 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
Transcribe →