As the FDA notes, many IND delays can be tied to CMC challenges. Quite often, warning signs are visible - analytical methods that are good enough but hard to scale- process steps that rely on the skills of an operator or one site- issues on stability or delivery that are shelved into future work.Such considerations … Continue reading Insidious CMC Risks in Regulatory Filings
cmc
Biotech M&A – Three Trends to notice
Most biotech M&A coverage correctly highlights where capital is flowing, which therapeutic areas are hot, and which companies are poised to shape the future of medicine. For BD, corporate strategy, or investing, such information is useful. It gives context. It sets benchmarks. And it surfaces the big moves worth watching. But that's only part of … Continue reading Biotech M&A – Three Trends to notice
BK talks Biopharm 