Latest Articles

  • Rethinking the Architecture of Adverse Event Processing

    Deploying AI agents to handle data collection, coding, medical review, and quality-checking makes signal management autonomous at the processing stage. read more

  • Rethinking Early-Phase Outsourcing

    The CDMOs that bridge the fulfilment gap and truly become partners are likely the best choice for biotechs and pharma looking to develop their early-stage asset. While most CDMOs are well-versed in providing services with regular communication, sharing strategic objectives with clients, and ultimately providing the final material, it’s the “above and beyond” CDMOs that provide the real added value. read more

  • Patient-Centric Drug Delivery

    Across modalities and markets, patient-centric drug delivery is converging on three themes: self-administration at home, integration of drug delivery device platforms earlier in clinical trials, and alignment of formulations with device and human factors requirements. read more

  • The Evolving Regulatory Landscape for Cell and Gene Therapies

    The regulatory landscape for CGTs is moving towards more explicit, risk-based assessment of intended editing outcomes, off-target activity, and genomic integrity. This evolution reflects both the promise of new editing technologies and the need to understand their potential consequences in clinically relevant biological settings. read more