Posted by Michael Wonder on 02 Feb 2017
Drug development challenges for small biopharmaceutical companies
1 February 2017 - 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. 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 success than that of large companies owing to limited internal experience in clinical development and limited infrastructure, which may also affect manufacturing and clinical supply. However, these challenges are largely overshadowed by limited resources and funding, which in turn fuel demand for short timelines owing to the need to demonstrate progress to investors. As such, these companies must focus their resources on small, less-costly development programs for very specific targets and often must spearhead new approaches to testing new products in order to survive.
