Why Amazon Thinking Might be the Shot in the Arm Regulatory Needs to Transform
By Steve Gens
When John Cogan and I connected at the February DIA show in Washington DC this year, we began chatting about “what’s holding regulatory back”?
Life sciences companies began increasing their investments in regulatory information management (RIM) capabilities between 2014 and 2016 and many are still not seeing measurable improvements. Regulatory has long worked in silos, addressing specific capabilities — documents, registrations, publishing, labelling, and archiving – rather than a macro end-to-end process approach.
During our conversation, we agreed to put together a conversational paper to prompt the wider community to consider different ways to address entrenched issues and highlight some potential structural challenges. The result was “The Promise of Enterprise RIM – What’s Slowing the Innovation Potential?” which was posted to LinkedIn and our website early this summer.
Bold thinking requires provocative ideas and the paper offers up several of these. Perhaps most provocatively John wondered, “How would Amazon do RIM in their complex ecosystem?” They have mastered the “connectivity” of information. An Amazon-driven RIM process would be focused first and foremost on the consumer rather than the participant, supported by a single, common set of data and with all activities managed in a single system.
After we wrote the paper, Scott Cleve of Boehringer Ingelheim responded on LinkedIn that he felt the Amazon comparison was both “valid and also frightening as other disruptors may bring changes that have us playing catch-up rather than being part of the solution.”
Potential Root Causes – Profit Margins, Perfect is the Enemy of Good, Silo Thinking
The paper touched on several contributing factors that could limit RIM’s potential for regulatory or what we could consider real and substantive change. Our first observation was gross profit margin vs the propensity to innovate, meaning that industries with low profit margins tend to spend less for their innovation as a mere few points margin with high volumes are very significant. If profit margins are high, however, the potential benefits of small improvements may get dismissed.
High profits have allowed the biopharma industry to build an entire industry around validation, quality assurance, and risk aversion. This over-engineering is, we believe, holding the industry back as validation is a significant cost to any system or process initiative. These programmes were important for the entry of electronic records, but have not progressed with business and technology change.
The regulatory mindset surrounding perfection (it has to be perfect before going to the health authority) was another observation which we believe gets in the way of continuous improvement. Regulatory staff are the gate keepers and this mind-set is required but can get in the way of innovation and continuous improvement. Other functions have a mindset of constant improvement, such as manufacturing (how do we reduce waste and cycle times on the manufacturing line daily), that support innovative “outcomes”. For regulatory, in our experience, there are many innovative “aspirations” and “concepts”, but the struggle is with the details and outcomes.
Finally, regulatory affairs involves the execution of processes in order to get new products to the global market and then to keep them there. Why is it not as simple as this? In the paper we explored an area, ERP systems, where macro processes have led to a fundamental redesign and simplification of a very complex environment. What is remarkable about ERP is the total focus on process above all else. You will hear terms like “order to cash”, “procure to pay”, “record to report” and “hire to retire” as the all-encompassing definitions of how these systems operate. Multiple sub-processes hang from these high-level processes, but as a rule, these processes are accepted as standard.
