Late planning and communication with CROs in the early stages of drug development can mean delays and loss of long-term value of products. David Lathbury, vice-president, Chemical Development, AMRI, argues the value of discussing GMP issues early in development.
The benefits of integrating discovery, development and scale-up with a quality CRO has the potential to offer more efficient chemistry that could save time and money in the short-term while increasing the overall long-term value of a project. Working with CROs armed with knowledgeable process r&d chemists – as well as the ability to integrate small-scale, non-GMP supply with slightly larger scale GMP campaigns – can provide some of the same project benefits seen within large pharmaceutical organisations. To receive the most benefit from working with a CRO during development, a strong and upfront dialogue is encouraged as early as lead optimisation.
A myriad of barriers can get in the way of driving a compound straight through development. Losing one to two years of patent life as a result of poor chemistry can reduce the net present value (NPV) of a drug substance by 30% or even 50%. The complexity of a process, plant issues and raw material lead times are among the many other factors that have the potential to increase development timelines. Early development plans are critical to identify and mitigate many of these risks.
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