When medicinal chemistry hands over molecules of interest to chemical development, the quality of that handover can have a big impact on the speed of subsequent progress.
Early stage chemistry is often focussed on inventing molecules and finding routes to produce them. But the first route may not be the most suitable for later stages when large batches are needed. Nonetheless, once molecules progress to scale up, substandard chemistry is often accepted as it is viewed as the quickest option.
Inefficient chemistry can cost a project many months of delay and even if those occur early on, they will have an effect of the filing time and thus affect the NPV of the project. A delay of 18 months can impact the product value by up to 30%. It is generally quicker, and always cheaper, to solve chemistry problems in the lab than “firefight” in the plant.
A close working relationship between medicinal chemistry and chemical development, where they aim to understand challenges around material sourcing and chemical production, can significantly improve that early stage chemistry, in ways that improve the availability of material down the line, and so reduce timescales throughout the drug development process.
This paper discusses shifting thinking around early stage research to deliver that benefit when outsourcing to contract research organisation (CRO).