John Cogan, head of innovation at Kinapse, thinks otherwise – and he’s on a mission to inspire change.
New drives to boost efficiency and agility around regulatory operations are all well and good. But it is very hard to consider alternative delivery models for activities – for instance outsourcing of post-approval licence management - if existing processes are held together by chewing gum and string.
And yet, metaphorically, this is so often the case for marketing authorization lifecycle management. For all the fantastic technology designed to help companies get new drugs onto the market, the capabilities required for keeping them there do not measure up. Even though this is where 70 percent of regulatory information management efforts are expended – and where complexity, and the need for a solution, are acute. From the level of resource and skills dedicated to keep information accurate and consistent, to technology and service provision, post-approval information management has been the weak link for too long.
If ever there was a need for business process management…
It’s an investment gap I’ll be exposing during my session at AMPLEXOR’s BE THE EXPERT conference this June, where I’ll propose that regulatory information management (RIM) needs to be redefined to encompass proper business process management across the entire product lifecycle. I’ll argue that content management and workflow alone are not sufficient to keep pace with what could be tens of thousands of small information changes each year. Changes that could be triggered anywhere from manufacturing or along the supply chain to within safety functions - each affecting hundreds of marketing approvals and requiring the involvement of hard-pressed, multi-tasking affiliates scattered around the world.
Post-approval RIM may not be as sexy as the work to collate, manage and publish information for a new drug, but it’s a massive burden for organisations and one they badly need to streamline and bring under control. Which they can only do if they can first consolidate these activities into a reliable, visible and manageable form to which automation and/or managed services could be applied.
It’s a discussion that’s long overdue, and which will ruffle some feathers – so come prepared for a lively session!
I hope to see you there.
John Cogan, Head of Innovation and CTO at Kinapse, has worked in the biopharma industry for 30 years in roles spanning regulatory affairs and regulatory operations to global leadership positions in R&D IT, IT shared services and IT/innovation. At AMPLEXOR’s June BE THE EXPERT 2018 event, he will present the session Redefining RIM – Making Regulatory Technology Work for Lifecycle Management.