AI Access Brief Podcast
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.
AI Access Brief Podcast
Latest Episodes
CHMP Pipeline Shift and Critical Medicines Act Mandates
Episode 26 — 09 June 2026 CHMP's May approvals reveal a structural shift toward rare disease development while the Critical Medicines Act introduces mandatory supply chain transparency requirements. AI maintains its dominance in HEOR methodology ...
Medical Device JCAs Launch and Novel Mechanism Approvals
Episode 25 — 08 June 2026 Medical device Joint Clinical Assessments begin in June 2026 as the EU HTA Regulation expands beyond oncology medicines. FDA approves first-in-class aldosterone synthase inhibitor baxdrostat while ISPOR signals a shift t...
NICE Diabetes Revolution, EU Device JCAs, Clinical Trial Acceleration
Episode 24 — 07 June 2026 NICE's revolutionary diabetes guideline makes SGLT-2 inhibitors first-line therapy while EU HTA regulation expands to high-risk medical devices. FDA accelerated approvals surge and EU clinical trial acceleration shows ea...
Orphan Dominance and Oral Semaglutide Market Shifts
Episode 23 — 06 June 2026 Marcus and Sara examine the CHMP's May session showing 42% orphan designation rates and debate whether oral semaglutide represents genuine innovation or market expansion. They clash over emergency regulatory collaboratio...
DMD Access Breakthrough and CHMP Pipeline Shift
Episode 22 — 05 June 2026 NICE approves third DMD treatment givinostat via Innovative Medicines Fund while CHMP's May output signals structural shift toward rare disease therapies. ISPOR 2026 highlights HEOR's expanding role in policy and value f...