DIA 2015 – The Future of Regulatory

One of the topics I’m most passionate about in Life Sciences is the strategic importance of Regulatory Affairs and Operations. Too often, the work of Regulatory is viewed as administrative overhead and a cost center rather than part of the core value chain activities related to drug/device development, like R&D, Clinical, and Commercial are. Rather than get on my soap box here, you can read a recent white paper I published that gets into the nitty gritty details on the subject. However, I am excited for one session at DIA 2015 in particular that looks like it’s going to address, at least in part, the need to transform how we approach Regulatory:

Evolving Your Regulatory Information Management Strategy to Meet the Changing Business Environment – Monday 6/15, 11:00 – 12:00

Adapting Business Process to Support Global RIMS
Michelle L. Charles, MPH, Associate Director, Regulatory Affairs, Merck & Co., Inc.

Lean Six Sigma For Delivering High-Velocity RIMS Strategies
Christopher P Hanna, PhD, PMP, Principal, Kattner-Thalmann Partners

These presentations hit on two topics–global processes and continuous improvement–that I think are key for getting the most out of Regulatory. In terms of a global view of Regulatory processes, just about every Life Sciences organization I talk to struggles with getting the same levels of efficiency and effectiveness out of their affiliates in Most of World (MOW), i.e., countries outside the US and EU. Some of this is due to the difficulties of managing processes and teams half a world a way; some is due to poor document management practices; some is due to outdated or low functioning technology for collaboration. But the result is the same in every case: increased time to market, increased cost of compliance, increased risk of non-compliance.

In terms of continuous improvement, it’s high time that Life Sciences organizations view themselves not only as scientific research organizations but also as manufacturers…and not just at the end of pipe in Quality and Manufacturing, but upstream in the product development functions such as R&D, Clinical, and, yes, Regulatory. Too often, Life Sciences organizations forget the critical lessons learned in other manufacturing sectors about the need for tight integration between all parts of the product value chain, from design and development, through process engineering, to manufacturing, quality, supply chain, sales, and marketing.

I’m looking forward to how the sessions tackle these issues and hope to connect with folks to continue the conversation in DC!