“The problem lies not with the new process, but with the old people.”

I have had a peek into the fantasy life of clinical development executives. It is not pretty. Not the kind of fantasies you might imagine – more like fifty shades of self-delusion. The fantasy goes something like this: clinical development is inefficient, a performance drag to drug commercialization – it is no faster than a caterpillar moving along a tree branch. By some form of magic (“extra-lean sigma”, or outsourcing, or motivational posters in the hallways), the caterpillar will turn into the beautiful butterfly that C-officers and stockholders want to look at. This metaphor is precise, because management wants the same development staff to transform themselves from caterpillar to butterfly, without making any meaningful (and painful) changes to people or process. I have been calling this fantasy goal, perhaps too politely, “transforming in place” – that somehow we can change what we do, and how we do it, without making the tough choices. Referencing our butterfly metaphor, I think I will call it “the chrysalis fallacy.”

It is most distressing to see organizations invest heavily in a high-level strategic review, or new information technology, or a major shift in resourcing, after which they then exhibit very little change in their fundamental performance. Often, the problem lies not with the new process, but with the old people.

Most biopharmas have people in place in clinical development, especially in management, who have been in their positions for many years. When confronted with changes in process, technology or strategy, they are naturally resistant. Their managers, in turn, are reluctant to push too hard on these managers because of various reasons: it engenders a difficult conversation, it requires lots of follow-through (and therefore continuing discomfort), or the managers also may not embrace or understand the change. The resistance is not remarkable. What is remarkable is how frequently biopharma development is in a turmoil of change, and yet rarely replace the people in pivotal roles responsible for the change.

There are many examples of process, technology and strategy changes facing us. Reducing source data verification is a big process change; introducing information technology like a new CTMS, web-based subject randomization, or an electronic master file, is highly disruptive; a change in resourcing strategy to more (or less) use of CROs or more (or less) use of functional in-sourcing is an increasingly common, threatening situation.

These changes can be implemented successfully, if not painlessly, even with all the current staff in place. But usually, one or even many key staff are resistant or incapable of managing in the new environment. This is understandable, but must be corrected. Nothing protects people in place like history, loyalty, avoidance and fear. If you or your company have worked with someone for many years, you naturally resist asking that person to leave his or her position. Indeed, there may have been many glorious achievements that they were once responsible for. We feel loyal to people who have performed for us in the past, “watched our backs,” maybe even hired us. Most commonly, we leave people in place to avoid the unpleasantness of trying to move them out, and usually, the company’s policies or national employment laws make the task even more arduous. Last but not least, there can be considerable fear in the situation: how will things work without the people in place who always did the job in the past?

Why can’t we avoid the pain and just leave underperformers in place? The consequences are deadly. The reader will recognize these examples:

— A clinical development executive spends millions with multiple consultants on a “best practices” strategy, but operationally nothing changes

— The latest clinical supplies tracking technologies are employed and a fatal error still ruins a trial

— Another clinical development executive tells her management team the kinds of changes she wants to see, “empowers” the same culpable managers to implement them, and then wonders years later why nothing improved

— A pharmacovigilance department installs the latest technology but the managers insist on using the traditional paper-based processes anyway

— A clinical monitoring leader simply rejects new processes, intimidates his staff, passively ignores the imperative to change, and through inertia, is able to successfully kill the changes over time.

Some people can change, and some people should be given the chance to shine elsewhere. In some cases, people previously stuck in old ways can prove to be highly valuable in a completely different department. In other cases, the classic move of shifting a failing people manager to a newly created position as a senior individual contributor can create a highly productive employee. Freed of daily production responsibilities and their own petrified loyalties to those underneath, they have the time and responsibility to contribute in an entirely new means.

Improving efficiency or timeline performance in clinical development requires considerable alteration in the way we have been used to working. But the chrysalis fallacy whispers that we need not rock the personnel boat; the butterflies will fill the office. It’s a beautiful idea, but probably a fantasy. Get real. Forget the caterpillars and find new worker bees. This metaphor may be mixed, but the results won’t be.