Latest Articles

  • Leveraging AI and ML to Optimize Drug Discovery – a CRO Perspective

    CROs supporting early-stage drug discovery projects are establishing their own internal AI platforms to address their clients’ needs in an evolving field. read more

  • Rethinking the Oligonucleotide Journey

    The history of oligonucleotide therapeutics illustrates that transformative medical progress occurs when foundational scientific breakthroughs are matched by equally robust advances in development infrastructure. Over the next decade, oligonucleotides are poised to expand their clinical footprint beyond reactive treatment and toward proactive preventive intervention for highly prevalent chronic conditions. 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

  • The Importance of a Hybrid Testing Approach for Safety Assessments in the NAM-Enabled Era

    For decades, in vivo models have been the standard in preclinical testing before a drug moves to first-in-human (FIH) trials. But a recent evolution in regulatory expectations has accelerated a steady shift away from in vivo testing, in favor of New Approach Methodologies (NAMs). read more