Market Access 2026: Transatlantic Pivot Toolkit A Strategic Resource for Founders & VCs Navigating the EU JSC & NHS Threshold Shifts Prepared by Michael A. S. Guth, Ph.D., J.D. | Strategic Systems Architect for High-Complexity Biologics, Drugs, and Device combinations Executive Summary The 2026 regulatory-access landscape has fundamentally shifted with two parallel developments: EU’s Joint […]
Archive for the ‘Pharma and Medical Device’ Category
The 2026 Transatlantic Market Access Pivot: An Architectural Framework
๐๐๐ฒ๐จ๐ง๐ ๐๐๐๐๐-๐๐: ๐๐ก๐ ๐๐๐ฑ๐ญ ๐ ๐ซ๐จ๐ง๐ญ๐ข๐๐ซ๐ฌ ๐๐จ๐ซ ๐ฆ๐๐๐ ๐๐ง๐ ๐๐๐ฅ๐ข๐ฏ๐๐ซ๐ฒ ๐๐ฅ๐๐ญ๐๐จ๐ซ๐ฆ๐ฌ ๐ข๐ง ๐๐ฅ๐จ๐๐๐ฅ ๐๐ฆ๐ฆ๐ฎ๐ง๐ข๐ณ๐๐ญ๐ข๐จ๐ง
๐๐ก๐ ๐ซ๐๐ฉ๐ข๐ ๐ฆ๐๐ญ๐ฎ๐ซ๐๐ญ๐ข๐จ๐ง ๐จ๐ ๐ฆ๐๐๐-๐๐๐ ๐ญ๐๐๐ก๐ง๐จ๐ฅ๐จ๐ ๐ฒ ๐ข๐ฌ ๐๐๐ญ๐๐ฅ๐ฒ๐ณ๐ข๐ง๐ ๐ ๐ง๐๐ฐ ๐๐ซ๐ ๐ข๐ง ๐ฏ๐๐๐๐ข๐ง๐จ๐ฅ๐จ๐ ๐ฒ, ๐ฆ๐จ๐ฏ๐ข๐ง๐ ๐๐๐๐ข๐ฌ๐ข๐ฏ๐๐ฅ๐ฒ ๐๐๐ฒ๐จ๐ง๐ ๐ฉ๐๐ง๐๐๐ฆ๐ข๐ ๐ซ๐๐ฌ๐ฉ๐จ๐ง๐ฌ๐. ๐๐ก๐ ๐๐๐๐ ๐จ๐ฎ๐ญ๐ฅ๐จ๐จ๐ค ๐ก๐ข๐ ๐ก๐ฅ๐ข๐ ๐ก๐ญ๐ฌ ๐ฌ๐๐ฏ๐๐ซ๐๐ฅ ๐๐จ๐ง๐ฏ๐๐ซ๐ ๐๐ง๐ญ ๐ญ๐ซ๐๐๐ค๐ฌ: ๐๐ฅ๐๐ญ๐๐จ๐ซ๐ฆ ๐๐ฑ๐ฉ๐๐ง๐ฌ๐ข๐จ๐ง: ๐๐ก๐ ๐๐จ๐ซ๐ ๐ข๐ง๐ง๐จ๐ฏ๐๐ญ๐ข๐จ๐งโ๐ฎ๐ฌ๐ข๐ง๐ ๐๐๐๐ฌ ๐ญ๐จ ๐๐๐ฅ๐ข๐ฏ๐๐ซ ๐๐๐ ๐ฌ๐๐ช๐ฎ๐๐ง๐๐๐ฌ ๐๐ง๐๐จ๐๐ข๐ง๐ ๐ฉ๐ซ๐จ๐ญ๐๐ข๐ง ๐ข๐ฆ๐ฆ๐ฎ๐ง๐จ๐ ๐๐ง๐ฌโ๐ข๐ฌ ๐๐๐ข๐ง๐ ๐๐๐ฉ๐ฅ๐จ๐ฒ๐๐ ๐๐ ๐๐ข๐ง๐ฌ๐ญ ๐ก๐ข๐ฌ๐ญ๐จ๐ซ๐ข๐๐๐ฅ๐ฅ๐ฒ ๐ข๐ง๐ญ๐ซ๐๐๐ญ๐๐๐ฅ๐ ๐ฉ๐๐ญ๐ก๐จ๐ ๐๐ง๐ฌ. ๐ ๐จ๐ซ ๐๐๐, ๐ ๐๐ซ๐ฆ๐ฅ๐ข๐ง๐-๐ญ๐๐ซ๐ ๐๐ญ๐ข๐ง๐ ๐ฌ๐ญ๐ซ๐๐ญ๐๐ ๐ข๐๐ฌ ๐ฐ๐ข๐ญ๐ก ๐ฌ๐๐ช๐ฎ๐๐ง๐ญ๐ข๐๐ฅ ๐ฆ๐๐๐ ๐๐จ๐จ๐ฌ๐ญ๐๐ซ๐ฌ ๐๐ข๐ฆ ๐ญ๐จ ๐ ๐ฎ๐ข๐๐ […]
๐๐ฅ๐ ๐ช๐ ๐ก๐ข๐ช ๐๐ก ๐ง๐๐ ๐๐จ๐ฆ๐๐ก๐๐ฆ๐ฆ ๐ข๐ ๐ฅ๐๐๐ ๐๐จ๐ฅ๐ฆ๐๐ก๐ “๐ก๐ข๐ก-๐๐ก๐๐๐ฅ๐๐ข๐ฅ?”
๐๐ต๐ฎ๐น๐น๐ฒ๐ป๐ด๐ฒ ๐๐ต๐ฒ ๐ฝ๐ฟ๐ฒ๐บ๐ถ๐๐ฒ ๐ผ๐ณ ๐ฐ๐ฒ๐น๐ฒ๐ฏ๐ฟ๐ฎ๐๐ถ๐ป๐ด ๐ป๐ผ๐ป-๐ถ๐ป๐ณ๐ฒ๐ฟ๐ถ๐ผ๐ฟ๐ถ๐๐ ๐ถ๐ป ๐ฎ ๐บ๐ฎ๐๐๐ฟ๐ฒ ๐บ๐ฎ๐ฟ๐ธ๐ฒ๐ ๐ฎ๐ป๐ฑ ๐พ๐๐ฒ๐๐๐ถ๐ผ๐ป ๐๐ต๐ฒ ๐ต๐ฒ๐ฎ๐น๐๐ต ๐ฒ๐ฐ๐ผ๐ป๐ผ๐บ๐ถ๐ฐ ๐ฟ๐ฎ๐๐ถ๐ผ๐ป๐ฎ๐น๐ฒ. ๐๐ฒ๐ฎ๐ฑ๐น๐ถ๐ป๐ฒ: ๐ ๐ก๐ฒ๐ ๐ฃ๐ถ๐น๐น ๐ณ๐ผ๐ฟ ๐๐๐ฉ: ๐๐ป๐ฐ๐ฟ๐ฒ๐บ๐ฒ๐ป๐๐ฎ๐น ๐๐ต๐ฎ๐ป๐ด๐ฒ ๐ผ๐ฟ ๐ฃ๐ฟ๐ถ๐ฐ๐ฒ๐ฑ ๐ฎ๐ ๐๐ป๐ป๐ผ๐๐ฎ๐๐ถ๐ผ๐ป? ๐๐ถ๐น๐ฒ๐ฎ๐ฑ’๐ ๐๐ฅ๐ง๐๐ฆ๐ง๐ฅ๐ฌ-๐ฎ ๐๐ฟ๐ถ๐ฎ๐น ๐๐ต๐ผ๐๐ ๐ถ๐๐ ๐ป๐ฒ๐ ๐๐๐/๐๐๐ก ๐๐ถ๐ป๐ด๐น๐ฒ-๐๐ฎ๐ฏ๐น๐ฒ๐ ๐ฟ๐ฒ๐ด๐ถ๐บ๐ฒ๐ป ๐ถ๐ ๐ป๐ผ๐ป-๐ถ๐ป๐ณ๐ฒ๐ฟ๐ถ๐ผ๐ฟ ๐๐ผ ๐ถ๐๐ ๐ผ๐๐ป ๐ฏ๐น๐ผ๐ฐ๐ธ๐ฏ๐๐๐๐ฒ๐ฟ, ๐๐๐๐ง๐๐ฅ๐ฉ๐ฌ, ๐ณ๐ผ๐ฟ ๐๐ถ๐ฟ๐ผ๐น๐ผ๐ด๐ถ๐ฐ๐ฎ๐น๐น๐ ๐๐๐ฝ๐ฝ๐ฟ๐ฒ๐๐๐ฒ๐ฑ ๐ฝ๐ฎ๐๐ถ๐ฒ๐ป๐๐. ๐ง๐ต๐ฒ ๐๐ฐ๐ถ๐ฒ๐ป๐ฐ๐ฒ ๐ถ๐ ๐๐ผ๐๐ป๐ฑ, ๐ฏ๐๐ ๐ถ๐ ๐ฝ๐ฟ๐ผ๐บ๐ฝ๐๐ […]
A New Anchor in RRMM: Decoding the Practice-Changing MajesTEC-3 Data for Tec-Dara
The MajesTEC-3 results for teclistamab + daratumumab (Tec-Dara)ย in relapsed/refractory multiple myeloma (RRMM) aren’t just an incremental gainโthey represent a potential paradigm shift. The FDA’s concurrent award of aย priority review voucherย underscores its transformative potential. Let’s break down the data that’s changing the standard of care: ๐ฌ Unprecedented Efficacy in the 1-3 Prior Lines Setting: โขย PFS:ย Hazard Ratio […]
๐๐ก๐ฒ “๐๐ข๐ซ๐ญ๐ฎ๐๐ฅ ๐๐๐ซ๐๐๐ง๐ข๐ง๐ ” ๐ข๐ฌ ๐๐จ ๐๐จ๐ง๐ ๐๐ซ ๐๐ง๐จ๐ฎ๐ ๐ก ๐๐จ๐ซ ๐๐ซ๐ฉ๐ก๐๐ง ๐๐๐๐๐ฌ
๐ ๐จ๐ซ ๐ฒ๐๐๐ซ๐ฌ, ๐ญ๐ก๐ ๐ข๐ง๐๐ฎ๐ฌ๐ญ๐ซ๐ฒ ๐ซ๐๐ฅ๐ข๐๐ ๐จ๐ง ๐ญ๐ซ๐๐๐ข๐ญ๐ข๐จ๐ง๐๐ฅ ๐ฏ๐ข๐ซ๐ญ๐ฎ๐๐ฅ ๐ฌ๐๐ซ๐๐๐ง๐ข๐ง๐ ๐ญ๐จ ๐๐ข๐ง๐ ๐ง๐๐๐๐ฅ๐๐ฌ ๐ข๐ง ๐ญ๐ก๐ “๐๐๐ซ๐ค ๐๐๐ง๐จ๐ฆ๐” ๐ก๐๐ฒ๐ฌ๐ญ๐๐๐ค. ๐๐ฎ๐ญ ๐๐จ๐ซ ๐จ๐ซ๐ฉ๐ก๐๐ง ๐ญ๐๐ซ๐ ๐๐ญ๐ฌ ๐ฅ๐ข๐ค๐ ๐๐๐๐๐๐, ๐ฐ๐ก๐๐ซ๐ ๐ฅ๐ข๐ ๐๐ง๐ ๐๐ก๐๐ฆ๐ข๐ฌ๐ญ๐ซ๐ฒ ๐ข๐ฌ ๐ฎ๐ง๐๐๐๐ข๐ง๐๐, ๐ฐ๐ ๐ง๐๐๐ ๐ฆ๐จ๐ซ๐ ๐ญ๐ก๐๐ง ๐ ๐๐๐ญ๐ญ๐๐ซ ๐ฌ๐๐๐ซ๐๐ก ๐๐ง๐ ๐ข๐ง๐. ๐๐ ๐ง๐๐๐ ๐ ๐๐๐ง๐๐ซ๐๐ญ๐ข๐ฏ๐ ๐๐ง๐ ๐ข๐ง๐. ๐๐ฌ ๐ฉ๐๐ซ๐ญ ๐จ๐ ๐ฆ๐ฒ ๐ฅ๐๐ญ๐๐ฌ๐ญ “๐๐ง๐๐ฎ๐ฌ๐ญ๐ซ๐ข๐๐ฅ ๐๐ฅ๐ฎ๐๐ฉ๐ซ๐ข๐ง๐ญ” ๐๐จ๐ซ ๐๐ซ๐ฎ๐ ๐๐ข๐ฌ๐๐จ๐ฏ๐๐ซ๐ฒ ๐๐จ๐๐๐ฒ, ๐โ๐ฏ๐ ๐จ๐ฎ๐ญ๐ฅ๐ข๐ง๐๐ ๐ฐ๐ก๐ฒ […]
๐ ๐ซ๐จ๐ฆ ๐๐ฌ๐ฌ๐ข๐ฌ๐ญ๐๐ง๐๐ ๐ญ๐จ ๐๐ ๐๐ง๐๐ฒ: ๐๐ก๐ฒ ๐๐ซ๐๐๐ข๐ฌ๐ข๐จ๐ง ๐๐๐ซ๐ ๐๐ข๐๐ง๐ญ๐ฌ ๐๐๐๐ ๐๐จ๐ฆ๐๐ข๐ง๐๐ ๐๐๐ ๐ฎ๐ฅ๐๐ญ๐จ๐ซ๐ฒ/๐๐ก๐๐ซ๐๐ฉ๐๐ฎ๐ญ๐ข๐ ๐๐ซ๐๐/๐๐ ๐๐ค๐ข๐ฅ๐ฅ๐๐ ๐๐๐ฅ๐๐ง๐ญ
๐๐ก๐ “๐๐ฎ๐ซ๐ฉ๐ฅ๐ ๐๐ช๐ฎ๐ข๐ซ๐ซ๐๐ฅ” ๐๐๐ฅ๐๐ง๐ญ ๐๐๐ฉ Recruiters often call this the โpurple squirrelโ profile: a “unicorn” blending deep regulatory strategy, therapeutic area such as neurology research expertise, with a fundamental understanding of AI application.
Beyond the 16-Week Snapshot: Why Data Snapshots Mask the Reality of Chronic Therapy
Beyond the 16-Week Snapshot: Why Data Snapshots Mask the Reality of Chronic Therapy In my independent review of the CARES-310 trial (Camrelizumab-Rivoceranib), I analyzed a common pitfall in modern drug development: the reliance on 16-week primary endpoints to justify long-term therapeutic narratives. While a 16-week data cut can deliver a clean p-value for a regulatory […]
Pharyngeal Electrical Stimulation (PES) for Neurogenic Dysphagia: An Overview
Pharyngeal Electrical Stimulation (PES) for Neurogenic Dysphagia: An Overview Introduction to Neurogenic Dysphagia and the Need for Restorative Therapy Neurogenic dysphagia (ND) is a swallowing impairment resulting from neurological damage, most commonly caused by stroke, multiple sclerosis (MS), traumatic brain injury, or neurodegenerative diseases.1 ND is associated with severe complications, including malnutrition, dehydration, and aspiration […]
๐๐ก๐ ๐๐ง๐ ๐ข๐ง๐ ๐๐๐ก๐ข๐ง๐ ๐ญ๐ก๐ ๐๐จ๐ฅ๐๐๐ฎ๐ฅ๐: ๐๐ก๐ฒ ๐๐๐ฆ๐ฆ๐๐ฅ๐ข๐๐ง ๐๐๐ฅ๐ฅ ๐๐ง๐ ๐ข๐ง๐๐๐ซ๐ข๐ง๐ ๐ข๐ฌ ๐๐๐ง๐ญ๐ซ๐๐ฅ ๐ญ๐จ ๐๐จ๐๐๐ซ๐ง ๐๐ซ๐ฎ๐ ๐๐ข๐ฌ๐๐จ๐ฏ๐๐ซ๐ฒ.
๐๐ก๐ ๐๐ง๐ ๐ข๐ง๐ ๐๐๐ก๐ข๐ง๐ ๐ญ๐ก๐ ๐๐จ๐ฅ๐๐๐ฎ๐ฅ๐: ๐๐ก๐ฒ ๐๐๐ฆ๐ฆ๐๐ฅ๐ข๐๐ง ๐๐๐ฅ๐ฅ ๐๐ง๐ ๐ข๐ง๐๐๐ซ๐ข๐ง๐ ๐ข๐ฌ ๐๐๐ง๐ญ๐ซ๐๐ฅ ๐ญ๐จ ๐๐จ๐๐๐ซ๐ง ๐๐ซ๐ฎ๐ ๐๐ข๐ฌ๐๐จ๐ฏ๐๐ซ๐ฒ. ๐๐ง ๐ญ๐ก๐ ๐ซ๐๐๐ ๐ญ๐จ ๐๐๐ฏ๐๐ฅ๐จ๐ฉ ๐๐จ๐ฆ๐ฉ๐ฅ๐๐ฑ ๐ญ๐ก๐๐ซ๐๐ฉ๐๐ฎ๐ญ๐ข๐๐ฌ, ๐ญ๐ก๐ ๐๐ฑ๐ฉ๐ซ๐๐ฌ๐ฌ๐ข๐จ๐ง ๐ฌ๐ฒ๐ฌ๐ญ๐๐ฆ ๐ข๐ฌ ๐ ๐๐ซ๐ข๐ญ๐ข๐๐๐ฅ ๐ฌ๐ญ๐ซ๐๐ญ๐๐ ๐ข๐ ๐๐ก๐จ๐ข๐๐. ๐ ๐จ๐ซ ๐ฆ๐๐ง๐ฒ ๐๐ซ๐ฎ๐ ๐๐๐ง๐๐ข๐๐๐ญ๐๐ฌโ๐๐ฌ๐ฉ๐๐๐ข๐๐ฅ๐ฅ๐ฒ ๐๐ง๐ญ๐ข๐๐จ๐๐ข๐๐ฌ, ๐๐ฎ๐ฌ๐ข๐จ๐ง ๐ฉ๐ซ๐จ๐ญ๐๐ข๐ง๐ฌ, ๐๐ง๐ ๐๐จ๐ฆ๐ฉ๐ฅ๐๐ฑ ๐๐ง๐ณ๐ฒ๐ฆ๐๐ฌโ๐ฆ๐๐ฆ๐ฆ๐๐ฅ๐ข๐๐ง ๐๐๐ฅ๐ฅ๐ฌ ๐๐ซ๐ ๐ง๐จ๐ง-๐ง๐๐ ๐จ๐ญ๐ข๐๐๐ฅ๐. ๐๐๐ซ๐โ๐ฌ ๐ฐ๐ก๐ฒ ๐จ๐ฎ๐ซ ๐๐จ๐๐ฎ๐ฌ ๐ก๐๐ฌ ๐ข๐ง๐ญ๐๐ง๐ฌ๐ข๐๐ข๐๐ ๐จ๐ง ๐๐ง๐ ๐ข๐ง๐๐๐ซ๐ข๐ง๐ ๐ญ๐ก๐ ๐ฌ๐ฒ๐ฌ๐ญ๐๐ฆ ๐ข๐ญ๐ฌ๐๐ฅ๐: ๐ ๐ข๐๐๐ฅ๐ข๐ญ๐ฒ […]
COVID-19 Treatment Strategies: Dec 2025 update
Image:ย Computerย Simulation of SARS-CoV-2. Reprinted with kind permission of Janet Iwasa of http://animationlab.utah.edu/cova Should I Get a COVID-19 Vaccine in December 2025 or January 2026? As we move through the winter of 2025-2026, the question of whether to get a COVID-19 vaccine is highly relevant, especially as respiratory viruses typically peak during this time. The […]



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