Clinical data warehouses maximize veracity via schema-on-write and ACID guarantees, but ETL rework, limited modality support, ...

Johnson & Johnson’s Firelink degrader antibody conjugate strategy seeks tumor-selective delivery of degraders for KRAS-driven solid tumors, potentially overcoming toxicity and efficacy ceilings of ...

EMA, African Medicines Agency, and African national regulators initiated joint oversight to accelerate Ebola clinical trials ...

Q5A (R2) expects sponsors to build and justify a risk-based viral safety from overlapping controls: what you prevent from ...

The transition from a breakthrough molecule to a scalable product is the industry's greatest challenge, noted Meyer. As such, ...

Artificial intelligence is shifting formulation development from empirical trial-and-error to predictive, data-driven design ...

Sponsors are expected to justify relevance and applicability when relying on prior CMC, nonclinical, or clinical information to increase review efficiency. Platform knowledge can derive from internal ...

CMC teams can align with Q5A (R2)’s updated guidance to shorten testing timelines and strengthen assurance of participant ...

Tailored EMA and FDA pathways may waive comparative efficacy studies when analytical and functional similarity are convincingly demonstrated, while preserving clinical confirmation for ...

Regulatory collaboration between EMA ETF, AMA, and African NRAs aims to enable coordinated, timely reviews, building on prior Ebola outbreak experience and AVAREF joint assessment mechanisms.