GUEST COLUMNISTS

• In Case You Missed Them: Recapping The FDA's Recent Guidances For Cell And Gene Therapies

  I review 10 of the FDA’s guidances spanning the last 12 months, all of which aid cell and gene therapy companies to assure safety and efficacy of these medicines.

• Repurposing Three FDA-Approved Drugs For A New Stroke Recovery Strategy

  When three drugs become one — the polypharmacology strategy, 505(b)(2) pathway, and objective endpoints Nuero-Innovators is relying on to bring new hope to stroke patients.

• Coalition Takes Guesswork Out Of Charcot-Marie-Tooth Disease Research With New Guidance

  A new Charcot-Marie-Tooth guidance introduces practical recommendations to help sponsors design clearer, more patient-centered, regulator-ready trials.

• How AI Will Reshape Study Start-Up

  AI can help study start-up teams move from tracking delays to predicting risks—if human judgment, data quality, and governance stay central.

• Clinical Supply Systems Need IT General Controls

  Validating a clinical trial system does not prove it stays trustworthy. IT general controls can protect data, supply decisions and patient safety long after go-live.

• Medical Affairs: The Missing Link To Oncology Drug Adoption

  Learn how medical affairs can help oncology teams turn strong clinical evidence into real-world adoption by connecting development strategy with clinical practice.

• How Can We Influence Others For Better Outcomes In Clinical Research?

  Learn how to use the Delphi method to build consensus and drive better decisions in clinical research — even when stakeholders start far apart.

• What Will Life Science Orgs Do When The AI Bill Comes Through?

  AI is transforming clinical development, but what happens when usage costs spike? Jon Newton explains how to govern it before the bill lands.