RapidFACT– How does it work?

Integrated manufacturing and clinical testing processes enable a drug product to be manufactured at small scale (typically 20-100 units) and dosed to human volunteers in as little as 24 hours. This “real time” manufacturing, allows the clinical data from the drug product tested to inform the decision about which should be tested next – with typical cycle times being 10-14 days.

By using a flexible clinical protocol and carefully selecting which dosage form to make and test, the precision and value of each clinical study period can be maximised.  Decisions within a RapidFACT^TM program can be driven by PK, pharmacoscintigraphic, AE, or even, if it can be achieved following a single dose, efficacy data.

Flexibility of this process can be maximised by incorporating a “design space” into the in vitro formulation development programme [see figure]. This allows us to secure regulatory approval to test variable formulation compositions rather than discrete pre-defined systems. There is no need to select specific, restrictive formulation compositions up front. Instead, a range of formulation compositions (the design space) can be tested, maximising the probability of identifying the optimal drug product.