Regulatory Articles

  1. FDA's New Flexible CMC Framework For CGT 4/14/2026

    The FDA is rethinking CMC oversight for cell and gene therapies, prioritizing science‑based justification over rigid validation models. Learn how this lifecycle‑focused approach could reduce burden.

  2. Lessons Learned While Taking Glioblastoma Drug From Bench To Clinic 4/9/2026

    MimiVax CEO Mike Ciesielski recounts the company's transition from academia to industry, hitting on topics like vendor partnerships, FDA conversations, and manufacturer selection. 

  3. NAMs In France And Europe: The Current Landscape 3/20/2026

    The EU is establishing a credible and scalable NAM ecosystem, but challenges still need to be overcome before life sciences professionals and patients can reap the benefits.

  4. Thoughtful Supply Strategy Is No Longer Optional In Drug Development 2/16/2026

    In drug discovery and development, supply chain decisions are often treated as a downstream concern. In reality, supply strategy is a development decision from the very beginning.

  5. New Approach Methods In Practice: Where Are We Today? 2/10/2026

    NAMs have moved beyond a technological promise, but now the current challenge is to operationalize their adoption.

  6. Flow Chemistry For Contemporary Isotope Labeling 1/26/2026

    Gain insight into how late‑stage exchange and flow‑based methods enable efficient access to labeled molecules for pharmaceuticals, mechanistic studies, and analytical applications.

  7. Charting The Future Of Antimicrobial Resistance 1/21/2026

    We caught up with Ajit Parhi, Ph.D., CSO of TAXIS Pharmaceuticals, to discuss policy, precision science, and AI in battling antimicrobial resistance.

  8. Room For Improvement: Reformulating Existing Therapeutics 12/30/2025

    We caught up with Jed Litwiniuk, CEO, and Uwe Tigör, CMO, to talk about Auxilius Pharma’s work to improve and reformulate a treatment for chronic stable angina pectoris.

  9. Biotech Wasn't Ready For AI's Speed; Here's How We Catch Up 12/5/2025

    Computational success is no stand-in for therapeutic readiness. Innovators must learn to discern between models rooted in science and those that speculate.

  10. How The U.S. Can Beat China In Biotech 11/3/2025

    Lumen Bioscience's Brian Finrow breaks down China's biotech playbook and explores ways the U.S. can adapt it for its own continued success.