Drug-Development Challenges for Small Biopharmaceutical Companies

Small biopharmaceutical companies encounter challenges in designing and implementing clinical development programs. This article discusses the approaches these companies take toward addressing such obstacles. Small biopharmaceutical companies are becoming increasingly important as drivers of innovation in drug development. It has recently been estimated that the majority of drugs currently in development are in the hands of small biopharmaceutical companies. 1 Such companies range in size from virtual companies with no commercial products and no revenue to those with only a few commercial programs. Small biopharmaceutical companies often encounter important challenges in designing and implementing clinical development programs. In a context in which only approximately 10% of clinical programs result in drugs that achieve regulatory approval, small-company clinical programs may have an even lower rate of . . .