Expectations, oversight and transparency

From the early days of therapeutics development, a common refrain has been that GMP manufacturing takes longer and costs more than expected. This can be traced back to when programs often started in academic laboratories, which then needed substantial analytical and process development as a program moved towards clinical stages.

The Hidden Costs of Multiple Tech Transfers

Move fast. Limited funds. Novel ideas. These are consistent themes I’ve noticed in conversations with hundreds of biotechs over the last 20 years, and rightly so. However, these elements sometimes overshadow the need to evaluate the complexities and costs associated with GMP manufacturing in support of a clinical trial, along with what’s needed for manufacturing at phase III and beyond.