2 min read
Would your drug development program benefit from partnering with experts in scientific and medical communications and publications? Perhaps we should first address what exactly scientific and medical communications and publishing entail.As medical...
3 min read
For decades, oncologists and drug developers shared an undeniable truth: KRAS – one of the most commonly mutated genes in human cancer – was untargetable. Mutations in KRAS drive approximately 25% of all cancers, including most pancreatic...
4 min read
This May 2026 regulatory update highlights multiple guidances issued by the FDA across cell and gene therapy, clinical development, and pharmaceutical quality. The FDA also released new draft guidances focused on pain management, stimulant use disorders,...
3 min read
Key insights from my presentation at the AMWA Carolinas Spring 2026 Conference on the evolving global expectations for patient-facing clinical content
2 min read
Best Practices for Safety Narrative Writing in Clinical Research
3 min read
This April 2026 regulatory update highlights new policies on biomarker validation, expanded access to investigational drugs, genome editing safety assessments, and antibiotic impurity specifications. It also summarizes major FDA and industry...
2 min read
When an oncology drug is tested, the signal is often brutally clear. A tumor either shrinks on a scan or it does not. A patient either lives or does not. In psychiatric drug development, the endpoints are almost never so crisp. In PTSD trials in...
2 min read
In August 2024, the FDA declined to approve MDMA-assisted therapy for post-traumatic stress disorder. The decision followed a June advisory committee meeting in which panelists voted nine to two that the data had not shown MDMA was effective, and ten to...