DIA 2015 – Back to Manufacturing Basics

I work a lot with end of pipe functions in Life Sciences organizations (especially Quality and Manufacturing) and it always strikes me as strange that Life Sciences organizations don’t typically view themselves as manufacturers who happen to make specialized products that rely on scientific research, but rather as scientific research organizations that happen to make products.

Now, I know this is a broad generalization, but I think it holds true for lots of companies out there. And certainly, the Life Sciences industry as a whole seems to identify much less with mainstream manufacturing than with health care…which makes a certain amount of sense given what Life Sciences does for a living. And the close relationships and peer networking with providers and payers confer significant benefits on Life Sciences organizations.
But this focus on health care rather than manufacturing also has negative effects on Life Sciences organizations, because, after all, we can’t lose sight of the fact that what Life Sciences organizations do for a living is to make products that they sell to customers. In this, the Pfizers and Mercks of the world are no different from the Hondas, Krafts, Apples, Boeings, or GEs.

Where Life Sciences organizations tend to differ, unfortunately, is that they lag far behind their non-Life Sciences counterparts in adopting continuous improvement (CI) approaches to their product life cycle, e.g., six sigma, LEAN, TQM, etc. The only manufacturing sector that is worse off than Life Sciences in this respect is Oil and Gas, where the boom and bust mentality has made a sustained, widespread adoption of CI almost impossible in petroleum operations as a whole.

Without remaining on my soap box and devoting an entire post to this topic, suffice it to say that I’m looking forward to the following DIA sessions devoted to CI and manufacturing best practices:

Continuous Improvement and Innovation in Manufacturing Approaches – Tuesday 6/16, 1:30 – 3:00

A Transformational Approach to Development, Manufacturing and Distribution
Michael K O’Brien, PhD, Vice President, Leadership, Pharmaceutical Science, Technology and Innovation, Pfizer Inc

Return On Investment from Manufacturing Technology Innovation: Opportunities and Realities
Andrew Mark Buswell, PhD, MBA, Head of Advanced Manufacturing Technologies, GlaxoSmithKline

Innovation in the Pharmaceutical Industry: Regulatory Opportunities and Challenges
Stephanie Krogmeier, PhD, RPh, Senior Director, Global CMC Regulatory Affairs Strategy, Vertex Pharmaceuticals

Knowledge Management for the Product Life Cycle – Wednesday 6/17, 3:30 – 5:00

Recommendations for a Streamlined, Global Assessment of CMC Changes and Optimized Dossier Preparation Process
Kim S. Northam, Associate Manager, Regulatory Affairs, Accenture

Compliance and Change Control: Checking That the Manufacture/CMC is Maintained in Accord With the Terms of the License
Peter Lassoff, PharmD, Vice President and Head, Global Regulatory Affairs, Quintiles Inc.

Opportunities for Industry
Paige Kane, Director, Knowledge Management, Pfizer Inc

I’m excited to hear what Pfizer, GSK, and Vertex are doing for CI and to see how Pfizer (as well as other clients Quintiles and Accenture have seen) are leveraging knowledge management to improve the product life cycle. I hope to see some of you in DC and to get a chance to connect and keep the conversation going!