Latest Articles

  • Post-Approval Change Management

    Achieving global approval for a single change may take three to five years, but inefficient lifecycle change management rarely registers as a crisis. read more

  • From Data to Tissue

    The national-security regulatory landscape now layers a geopolitical framework onto the data flows, sample logistics, and vendor relationships that make modern clinical research possible. This architecture will not simplify. The DSP’s country-of-concern list may expand, the BIOSECURE Act’s designated-entities list will likely grow, and state legislatures continue adding requirements. read more

  • Building Resilient Pharma Supply Chains to Strengthen Patient Healthcare

    Continuity of care is generally defined in terms of a patient’s ongoing contact with a clinical team and how smoothly their care progresses between providers. Often overlooked is the pharma supply chain and its role in ensuring this continuity. 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