GUEST COLUMNISTS

• Why Oncology Programs Can't Rely On An Inside View Alone

  Discover how looking outside a program can help oncology teams test assumptions, improve feasibility, and make stronger development decisions.

• 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.