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This June 2026 regulatory update focuses on advancing innovative drug development through updated guidance on model-informed development, gene therapies, clinical trial design, and evidence generation. Key regulatory trends included increased use of AI,...
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June 22, 2026
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Antibody-drug conjugates — or ADCs — are not new. The concept of a "magic bullet" that delivers a cytotoxic payload directly to a tumour cell was articulated by Paul Ehrlich over a century ago. Gemtuzumab ozogamicin, the first modern ADC, received its...
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March 18, 2024
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Investigational New Drug Applications (INDs) and Clinical Trial Applications (CTAs) are regulatory submissions needed for the initiation of clinical trials, and these applications have commonalities and differences throughout the world. If clinical...
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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...
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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...
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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,...
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Key insights from my presentation at the AMWA Carolinas Spring 2026 Conference on the evolving global expectations for patient-facing clinical content