”Don’t be left short-changed post approval – plan in change orders early for accelerated pathways,” Stephanie Gaulding said in her keynote address at CPHI North America
In a keynote session at CPHI North America, Stephanie Gaulding, Executive Director of Regulatory Compliance at Pharmatech Associates, called for companies to look closely at the frameworks they agree to, and work with an experienced consultant to anticipate future challenges as products progress through clinical phases.
A post approval change order is often necessary, but businesses should plan and prepare for this pre-approval. Planning alongside outsourcing partners will help ensure that only a small-scale study is needed—not a full additional clinical study.
The drug pipeline has an increasing number of orphan and rare disease indications with smaller batch volumes and accelerated pathways, meaning both developer and CDMO have less time to work on optimal pathways. Gaulding stated 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.
The aim of the planning process is to ensure future change orders can be fulfilled in the shortest time frame possible, ideally taking just 30-45 days. One approach to mitigate risk according to Gaulding is to concentrate on one or two markets initially, rather than embarking on a multi-market entry model.
“You want to plan for change and minimise future complexity. So, if you've got accelerated pathways in multiple markets, and they classify a single post-approval change differently, then that’s going to make the situation more challenging to execute post approval. Nothing is insurmountable if you plan it sequentially, but the innovator needs to have detailed plans in place often for as long as one year post approval to map out the manufacturing improvements to get a fully optimised process - whether it's for improving yield or improving impurity profiles or reducing cycle time” said Gaulding.
When questions arise, the drug sponsor has to be able to work with their partner to get the data quickly to address any regulator query, so setting the framework up and having it in-built into agreements is vital.
CPHI North America took place at the Pennsylvania Convention Center from May 17-19, 2022. As a SMART event, the online learning and networking platform will continue to run throughout the month (May 9-27), with on demand sessions available.