In a keynote session at CPHI North America, Stephanie Gaulding, executive director of regulatory compliance at Pharmatech Associates, calls for innovators to look closely at the frameworks they agree to, and work with an experienced consultant to mitigate for future challenges as products progress through clinical phases.
The drug pipeline has an increasing number of orphan and rare disease indications within it that have smaller batch volumes and accelerated pathways – which, together, means both innovator and CDMO have a greatly reduced time to work on optimal pathways. Gaulding states that preparation for this post approval work starts before signing with a CDMO, as it is this framework that will be invaluable in guiding future improvements.
“With a compressed timeline it’s very likely that further refinement will be needed post approval, but innovators must accept that as part of the strategy, and potentially conduct parallel programmes in later development – one for approval and one for post-approval process improvements. What is essential for this to run smoothly is having a good communication and governance framework in place so that the drug sponsor and the outsourcing partner are aware of what these issues are, and what the plan is for post approval remedial action,” said Gaulding.