Emily Heffernan of Arcadis explains how facility scale, equipment, containment, and quality testing differ across ex vivo cell therapy, viral vector, and mRNA-LNP manufacturing.

Dr. Paz Vellanki discusses Bayesian methods, challenges in developing rare disease endpoints, and why sponsors should engage FDA early in clinical development.

METiS TechBio will apply its AI-driven AiLNP ionizable lipid platform to discover LNPs designed to deliver therapeutics beyond the liver, under a collaboration with Eli Lilly worth up to $1.1 billion in milestones.

Interim phase 1 data presented at UEG Week 2026 showed Bionyra Pharma’s Fc-engineered anti-TL1A antibody BYN-002 suppressed soluble TL1A with a half-life supporting potential every-3-to-6-month maintenance dosing in IBD.

The American Association of Pharmaceutical Scientists appointed former president Patrick J. Sinko as chief science officer to lead its scientific strategy, programming, and peer-reviewed journals.

The FDA grants accelerated approval to dostarlimab for rectal cancer, Lilly reports one-year remission data for pediatric ulcerative colitis, and Johnson & Johnson shares longer-term fistula remission results for Tremfya.

BMS's Dr Nathan Pennell outlines how biomarker testing barriers and trial diversity affect patient access to targeted oncology drugs.

In the phase 3 SHINE-2 trial, half of pediatric patients who responded to mirikizumab induction were in clinical remission at week 52. Lilly plans to file for a pediatric UC label expansion.