Guest Columns

  1. Europe's ATMP Opportunity Still Requires Local Navigation 8/27/2026

    European nations offer a welcoming environment for clinical-phase cell and gene therapies. Don't assume the same flexibility carries through to commercialization.

  2. The Unspoken Truth About Cell Therapy Product Understanding 8/27/2026

    Developers often discover important attributes after it's too late to act on them. A well-designed program asks what's needed for commercialization and works backward.

  3. Implementing And Optimizing Your eQMS 8/25/2026

    This article addresses everything that follows the signed contract for an eQMS: how a system is configured, validated, adopted, and maintained.

  4. Rebuilding America's Pharmaceutical Backbone Through Small-Batch Manufacturing 8/25/2026

    Many small molecule products no longer require massive production. Instead, flexible capacity is needed that can economically produce smaller commercial volumes while maintaining quality and compliance.

  5. CDMO Selection For Small Biotech: Amit Jain On Avoiding Costly Transfers 8/20/2026

    Make smarter outsourcing decisions early. Reduce the risk of costly tech transfers, evaluate capacity needs, speed development timelines, and strengthen manufacturing partnerships.

  6. The Complex Anatomy Of An ADC Tech Transfer 8/20/2026

    Unlike traditional biologics tech transfer, antibody-drug conjugates have many more moving parts. Here are some of the unique challenges that require close attention.

  7. Unlocking The Future Of Cell And Gene Therapies 8/19/2026

    We took the opportunity to speak with some BioPhorum members about issues such as emerging technologies, regulatory challenges, and engagement with regulators in the advanced therapy medicinal products (ATMP) space.

  8. What Goes Into Restarting A Shelved Orphan Drug Candidate? 8/19/2026

    The Orphan Therapeutics Accelerator wants to help viable clinical-phase products reach patients. Its cofounder describes the complexity of rebooting a shelved candidate.

  9. A Much-Improved Approach For Understanding And Managing Safety Risks 8/18/2026

    Learn how causal mechanism and effect analysis (CMEA) and its principles can be used to develop and maintain safer working environments in the pharma/biotech and medical device industries.

  10. CSV Assumes The AI System Sits Still — It Doesn't. 8/17/2026

    The computer system validation playbook was written for software that holds its shape. AI doesn't. Validating it has to become an act of governance.