NMN in ITP: A Phase 1/2 Signal That Should Rewrite How We Design Rare Disease Trials
A phase 1/2 NMN trial in immune thrombocytopenia just posted a clean safety signal and platelet response data that...
Moe Alsumidaie
The Process Is the Point: Why One Enterprise Leader Says Pharma Keeps Automating the Wrong Thing
Poonam Rihel Senior Enterprise Leader, R&D Poonam Rihel has watched a decade of digital transformation initiatives in pharma produce...
The 35% Problem: Why Isolate-Based AST Is Systematically Under-Detecting Resistance in Complicated Urinary Tract Infection
The 35% Problem — The Clinical Trial Vanguard The clinician prescribed empirically. The lab report said susceptible. Three weeks...
FDA Real-Time Clinical Trials: Why AI Systems That Update Themselves Are Breaking Clinical Trial Design
FDA's April 2026 real-time clinical trial push exposes a fatal flaw: when AI updates itself mid-study, your protocol is...
Five Approvals, Nine Expansions: What the EMA’s April CHMP Meeting Reveals About Where Global Drug Development Is Heading
EMA's CHMP recommended 5 new medicines and 9 indication expansions in its April 20–23 meeting — here's what the...
BIOMEDE Missed Its Primary Endpoint — And Still Changed Pediatric CNS Trial Design Forever
The BIOMEDE Phase 2 trial in DIPG missed OS superiority but exposed a biomarker-survival link that should rewrite how...
Loper Bright Is Rewriting FDA’s Authority Over Synthetic Biology — Before the Industry Knows It
The Supreme Court's Loper Bright ruling is quietly dismantling FDA's deference-based regulatory hold over synthetic biology, and clinical programs...
EU Clinical Trials Face Cost, Speed, and China Competition Pressure
At the Clinical Trial Innovation Summit 2025 in Basel, industry leaders from UCB, Novo Nordisk, Novartis, and Medable debated...
How LLMs Can Audit LSD Clinical Trial Ratings in Real Time
MindMed is running three phase three trials of pharmaceutically optimized LSD with a two-person AI team and a custom...
AI Platform Predicts Clinical Trial Outcomes with High Accuracy
At the Clinical Trial Innovation Summit 2025 in Basel, QuantHealth's Chief Medical Officer presented AI-driven trial simulation technology capable...