Featured Articles

1. Omics-Driven Immune Challenge Design: What Early Human Data Tells Us 10/31/2026

   Transcriptomic and proteomic profiling of controlled human immune challenges shows which pathways, compartments, and time windows a model engages, helping match challenge choice to a drug's mechanism.

2. What Can Healthy Participants Tell Us In Early Immuno-oncology Development? 10/31/2026

   Healthy participants may help answer early immuno-oncology questions when targets, endpoints, and risks align. Human data shows where this approach works and where it doesn’t.

3. Combining Multiple Challenge Models Within A Single Individual 10/8/2026

   Pairing immune challenges in healthy volunteers tests whether pharmacology is consistent across cells, tissue, and systemic responses before patient trials.

4. What Most Psychiatric Drug Development Programmes Learn Too Late 10/8/2026

   Clinical phase completion doesn’t end uncertainty. Six key questions on brain exposure, pharmacology, therapeutic window, and patient variability can reveal whether the molecule failed, or the mechanism.

5. Defining Meaningful Anti-Inflammatory Response: What Early Human Data Tells Us 9/22/2026

   Controlled immune challenges link drug exposure to biological effects, helping refine dose selection, test mechanisms and support better decisions before patient trials.

6. 5 Questions That Reveal Whether A Drug Programme Is Built To Succeed 9/22/2026

   Explore how Question-Based Drug Development helps teams build knowledge, reduce avoidable surprises and make stronger scientific and investment decisions.

7. Proving CNS Target Engagement With Neuroimaging In Early Clinical Drug Development 8/27/2026

   The key question is not whether a scan changes, but what link in the dose-to-effect chain it resolves. Combining PET, MRI, PK/PD, and functional measures reduces uncertainty.

8. 7 Practical Implications Of ICH E6(R3) For Early-Phase Trial Design 8/10/2026

   A risk-based quality approach can enhance participant protection, data integrity, and development success through focused oversight, strong governance, and clear documentation.

9. What Controlled Immune Challenges Reveal Before Patient Studies Begin 7/30/2026

   Controlled immune challenges can reveal target engagement and pharmacology before efficacy is measurable, supporting earlier and more informed development decisions.

10. Making Early Decisions In Psychiatric Drug Development 7/30/2026

    Quantitative PD measures provide objective evidence of target engagement, support dose selection, strengthen early go/no-go decisions, and help reduce development risk in psychiatric