Carl Haakon

AI Access Brief Podcast

Business EN ↓ 58 episodes

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. 

Author

Carl Haakon

Category

Business

Latest episode

Jul 11, 2026

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Episodes

Global HTA Divergence 11.07.2026

Episode 52 — 11 July 2026 Examining divergent HTA approaches across emerging markets, with contrarian views on RWE utility and gene therapy valuation. 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

JCA Reports & Regulatory Divergence 10.07.2026

Episode 51 — 10 July 2026 Analysis of latest JCA reports, CDF recommendations, NICE reversals, and cross-jurisdictional regulatory challenges with HEOR implications. 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

JCA Reports & Regulatory Divergence 09.07.2026

Episode 50 — 09 July 2026 Analysis of emerging JCA reports, CDF recommendations, NICE reversal on MRD endpoints, and transatlantic regulatory divergence with HEOR implications. 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

JCA Reports & Global HTA Shifts 08.07.2026

Episode 49 — 08 July 2026 EU JCA reports reveal methodological tensions, ADC CDF recommendations signal HTA gaps, NICE reversals challenge MRD endpoints, and regulatory divergence complicates HEOR 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

HTA Method Shifts & Digital Evidence 07.07.2026

Episode 48 — 07 July 2026 Examining evolving HTA methodologies in Asia-Pacific, RWE adoption challenges in emerging markets, digital therapeutics evidence gaps, and orphan drug RWE complexities. 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

PRAC Valproate, Middle East HTA, Canada Pricing, RWE Latin America, Asia Gene Therapy 06.07.2026

Episode 47 — 06 July 2026 This episode covers PRAC valproate conclusions, HTA methodological updates in the Middle East, Canadian pricing policy developments, RWE integration challenges in Latin America, and gene therapy HEOR strategies in Asia. Hosted by Marcus and Sara. Access Brief — Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes...

JCA Reports & Regulatory Divergences 05.07.2026

Episode 46 — 05 July 2026 Analysis of recent JCA reports, NICE reversals, and transatlantic regulatory divergences with HEOR implications. 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

JCA Reports & Regulatory Divergences 04.07.2026

Episode 45 — 04 July 2026 Deep dive into emerging JCA assessments, ADC portfolio implications, surrogate endpoint reversals, transatlantic regulatory crises, and pharmacovigilance precedents. 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

Gene Therapy & RWE Challenges 03.07.2026

Episode 44 — 03 July 2026 Examining gene therapy cost-effectiveness hurdles, RWE integration in HTA, PRO utility in value assessments, and evolving HTA approaches for digital health technologies. 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

HTA Thresholds & Geopolitical HTA 02.07.2026

Episode 43 — 02 July 2026 Examining emerging market HTA thresholds, orphan drug RWE demands, digital therapeutics evidence gaps, geopolitical HTA challenges, and precision medicine HEOR shifts. 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

HTA Methodology Shifts & Pricing Pressures 30.06.2026

Episode 42 — 30 June 2026 Examining evolving HTA methodologies in emerging markets, pricing pressures in Canada, RWE adoption hurdles in Latin America, and gene therapy evidence strategies in Asia-Pacific. 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

CHMP Approvals, Aligned Pathway, JCA Scale-up 29.06.2026

Episode 41 — 29 June 2026 EMA CHMP approves eight treatments including rare disease; MHRA-NICE issues first aligned guidance; EU JCA scales up to 50 assessments with capacity challenges. 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

JCA Reports & Regulatory Divergence 28.06.2026

Episode 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

RWE, Gene Therapy, IRA Evidence Challenges 27.06.2026

Episode 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

HTA Realities & RWE Gaps 26.06.2026

Episode 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

Divergent Pathways 25.06.2026

Episode 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

Regulatory Divergence HEOR Impacts 25.06.2026

Episode 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

PRAC Valproate, JCA Scale-Up, EMA Emergency Trials 22.06.2026

Episode 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

Avacopan Crisis, D-VRd Reversal, Mirvetuximab Access 17.06.2026

Episode 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-set...

First JCA Report, Oral Wegovy, Camizestrant Divergence 17.06.2026

Episode 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 valproat...

JCA Devices Live, Camizestrant Divergence, JSC Window Open 17.06.2026

Episode 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 ac...

PRAC Valproate Review, JCA Scale-Up, Emergency Trial Guidance 15.06.2026

Episode 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 trans...

EU JCA Medical Devices Launch, MHRA-NICE First Guidance 14.06.2026

Episode 30 — 14 June 2026 The EU JCA framework expands into medical devices this month while MHRA-NICE alignment delivers its first coordinated guidance. Europe's HTA infrastructure shows sustained momentum across multiple operational tracks. Hosted by Marcus and Sara. Access Brief — Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcom...

MHRA-NICE Aligned Pathway and EU JCA Operationalization 13.06.2026

Episode 29 — 13 June 2026 The UK's MHRA-NICE aligned pathway delivers first guidance this month with 27 early adopter companies, while the EU publishes its second JCA report on tovorafenib. These developments signal coordinated evolution in European HEOR infrastructure prioritizing accelerated patient access. Hosted by Marcus and Sara. Access Brief — Daily briefings on HEOR, HTA strategy and...

First JCA Published, CHMP Patterns, Device Expansion 12.06.2026

Episode 28 — 12 June 2026 The EU published its first joint clinical assessment report for tovorafenib, marking a milestone in HTA coordination. CHMP approval patterns show a pipeline increasingly skewed toward rare diseases and indication extensions over novel molecules. Hosted by Marcus and Sara. Access Brief — Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcri...

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