"Political" Supply-Chain Decisions In Time Of Crisis

By Louis Garguilo, Chief Editor, Outsourced Pharma

Biotech and pharma executives have been forthcoming in discussing the various dimensions of the coronavirus outbreak. These conversations follow two paths.

The first, naturally, is on the current mechanics of drug development and manufacturing outsourcing; at this juncture, readers are continuously working to assess and maintain supply-chain integrity, and reassess risk. To date, the challenges you’ve faced have as much to do with logistics (specifically air transportation of materials and API) as with actual manufacturing delays.

More broadly, most everyone exhibits a robust “scientific excitement” regarding the great (and profoundly fast) efforts of our drug industry to quickly develop drugs, therapies, and vaccines for COVID-19.

This moves us to our second subject. We discuss how this China-originated virus is impacting the U.S., and decision-making on a political – as well as economic and social – level.

When we hit on that sphere of politics, I note a more downbeat, reflexive refrain:

“I’m a scientist by background,” many say. “Data drives me. That’s how I approach all decisions.”

This, dare I say, sounds a tad bit ingenuous.

To whit: There is no full data set – or better said, there are many incomplete and competing sets – that could so readily drive the difficult political decisions that need now be made for purposes of national health and economics.

What’s to be done when decisions must be made within that environment?

“Leadership” is partly defined as decision-making in the absence of complete data.

The “data drives me” proclamations gets me thinking over the past 15 years or so of working in our industry with professionals like you. I wander into our many discussions on your decision-making practices for selecting CDMOs, and managing various difficult development, manufacturing and supply situations.

Qualitative Outsourcing   

Think about the decisions you and your organization have made with respect to selecting and working with CDMOs.

You want to be driven as much as possible by objective data – the CDMOs “track record,” inspections and audits, quality systems, etc. At the same time, you know that “data” will be to some degree incomplete; while it’ll greatly inform decisions, it may in fact not drive the final ones.

Why? Because the decision to partner does not reside silo-ed in science and metrics.

Did some of you just gasp? You shouldn’t have.

In fact, you speak frequently – and thus we create so many editorials – on the qualitative side of decision-making: the CDMO’s company “culture”; the “trust” factor; working hard at “communication”; and a “feeling” of working as a single “team.”

There are messy socio-economic considerations (e.g., tax localities and tariffs; exchange rates; union shops and worker conditions; less stable city, state or national governments, etc.).

You also make adjustments to some degree for internal (and external) political inputs on many decisions. Innocently defined, you can consider the “internal politics” as those human activities associated with governing a living and breathing organization.

But even with all of this, for the most part, you do quite well, even those of you at biotechs that outsource to partners a great deal if not all of your development and manufacturing.

You are, in fact, qualitatively proficient.

But It’s Political Now

Most (normal) humans in fact do like to avoid the world of “politics.” But in our lives, every once in a while, we tend to find ourselves involved directly in political spheres.

This is one such time for Outsourced Pharma readers. 

The China coronavirus has thrown into question a reliance on that country for our materials, API, and other drug products. Your decisions on whether to offshore outsourcing (anywhere) now moves from (perhaps) your more sought after quantitative state of data collection, to the realm of the qualitative (political) side (e.g., national security; societal impacts; trust).

And so while the inclination to keep your head under the (lab) hood, stick to your supply chain, stay directed at your development, and not to wax political, is certainly sound, the collective implications of your decisions are wide.

And, as I’ve suggested elsewhere, your voices need to be heard.

The Best Decisions

So the above put together, I submit that Outsourced Pharma readers know well how to effectively synthesize data and “politics,” the science with the gut-check, to weigh inputs, predict outputs, and plan for a future with limited vision (i.e., data).

However, all of us must be careful today in this larger coronavirus realm of health and political theatre, if you will, in avoiding a stumbling block to both data-driven and qualitative analysis.

Confirmation bias “is the mother of all misconceptions,” writes Rolf Dobelli in his book, “The Art of Thinking Clearly.”

“It is the tendency to interpret new information so that it becomes compatible with our existing theories, beliefs, and convictions. In other words, we filter out any new information that contradicts our existing views.”

To most effectively combat confirmation bias, says Dobelli, use the (literary critic) Arthur Quiller-Couch motto: “Murder your darlings.”

In other words: fully consider your beliefs, from worldview and politics, to career and family life, and then – here’s the important part – make strong efforts “to find disconfirming evidence.”

“Axing beliefs that feel like old friends is hard work but imperative,” concludes Dobelli.

And so here is what this has been leading to.

At this time of national distress – in a form (disease) and from a geopolitical location (China) that places you and our entire drug development and manufacturing industry in the middle of it all – don’t let “data proclamations” become a form of confirmation bias.

So often, of necessity, politics in practice is a stressful activity, fraught with a difficult mix of competing (and very incomplete) data, and competing worldviews. Please do consider how difficult today’s political decisions – quite literally of life and death, health and economy – are to make.

Particularly for the very highest elected officials in the land.

The nation as a whole needs your practiced mix of data centrality, and your experience in partnerships and (supply-chain) systems where qualitative analysis also play a major role.