Breaking Down Silos In The Field of Pharma
By Louis Garguilo, Chief Editor, Outsourced Pharma
Agricultural references in business are abundant. We spread seed funding, and grow our companies. But silos should have stayed on the farm.
In 1987, the management guru Tom Peters wrote that if you do a post-mortem on poorly developed projects, you “unfailingly find” 75 percent attributable to “siloing … and sequential problem-solving.”
But silos are sturdy structures, and attempts at their disassembly aren’t often successful. A recent, detailed study of 95 teams in 25 leading corporations found that nearly 75 percent of cross-functional teams … are dysfunctional.
So nearly 30 years after Phil S. Ensor of Goodyear Tire and Rubber Company is credited with coining the term “functional silo syndrome,” our medicine may be equal parts as bad as the malady.
Silos are as prevalent in the Bio and Pharma industries as anywhere else. The most recent, publicly announced attempt to reorganize out of silos, and into a more cross-functional approach, is at Catalent Pharma Solutions. I spoke with Sharon Johnson, who was tapped to lead this new initiative, to find out how it’ll work.
(Ultimately) Not a Silo in Sight
Johnson is four months into her new leadership role. It takes a perceptive eye to differentiate between her former and new SVP positions at Catalent: from Global Quality & Regulatory Affairs, to Quality, Product Development & Regulatory Affairs. Drop the “Global” because it’s redundant: What isn’t global nowadays? Add “Product Development,” and everything from research up to commercial is now under one roof. If there’s no “outside,” there’s no place for silos.
According to Johnson, while reorganization is an internal affair, it’s all on behalf of the customer. Catalent’s New Product Introduction Excellence (NPIX) program is a key component of the revised approach to product development and launch.
“NPIX is a framework for customer and new product onboarding, and taking products through a structured, stage-gate development process,” says Johnson. “It’s the commitment that an entire organization is involved in getting to product launch and commercial manufacturing.”
In other words, out with the silos and in with the cross-functionality. “The success of any product introduction and development program depends on the overall integrated, multi-discipline team,” says Johnson.
Easier said than done. The report mentioned above on the dysfunction of cross-functional teams lists five potential, failing factors:
- Maintaining alignment with corporate goals
- Adhering to specifications
- Meeting a planned budget
- Staying on schedule
- Meeting customer expectations
Catalent, having organized most of the company around the concept of cross-pollination, would seem to have addressed the first pitfall. The second – adhering to specifications – is perhaps inherent in the very appointment of Johnson to this leadership role, which reports directly to CEO John Chiminski. She’s an educated, trained and highly experienced quality professional in the pharmaceutical industry. Ultimately, she says, “it’s still all about quality.”
Seemingly anticipating the remaining three flash points regarding cross-functional teams (i.e., budgets, schedules, customer expectations), Johnson says the integrated organization begins with understanding clients’ needs and expected outcomes. This includes an early calculation of project risk-factors, and the plans for their mitigation. That then allows for the setting of, if not always accelerated, realistic timelines. All of which aids in setting budgets and keeping them in line.
According to Johnson, some customers have already experienced an accelerated project-team formation, and a more effective mobilization of resources as needs arise, “particularly in the development environment, where you can experience challenges or unexpected outcomes.”
She sites a recent example of mobilizing experts from different sites, functions, and technologies within the same week that a project experienced some challenges. Johnson says the operative question internally is: Assuming you are unconstrained, who do you need to solve the issues? “The named people were on site within days, which may not have been the case before the re-organization,” she says.
More specifically, she mentions the increasing number of drugs in development that exhibit low solubility. “Many of our facilities are known for specific dose forms, but the best solution may require expertise from various development teams,” she says. “For example, for a project at Catalent Biologics, we talk about the drug substance with the second generation ADC [antibody drug conjugate] team and with GPEX [technology group], and for the drug product with OptiGel Bio or Zydis Bio [technology groups]. Connecting the drug-substance development and the drug-product development teams may seem an obvious thing to do, but now its part of the same function.”
Fields Of Focus
As noted, silo-busting is serious business, and often unsuccessful. Structural resistance can overcome even the best efforts at reorganization. Nonetheless, Johnson says, “There hasn’t been much resistance. Certainly not to the extent I might have anticipated. I believe that’s because there is a wide recognition – and we were already headed in this direction – that we could handle customer projects more robustly, and make things more seamless.”
Leadership is focusing on three main areas for change. The first we noted above: enhancing project management. The second, according to Johnson, is continuing Catalent’s strength in developing science and technology. “We’re always looking for that new, disruptive technology or platform,” she says. “In fact, I’m intent on making our scientists more accessible internally, and externally through academic and other relationships, and of course with customers. This in itself is a silo we are breaking down to benefit the extended scientific community.”
The third area of focus brings us back to the difficult task of transitioning functional operations: How do you operate as a single function? Johnson asks for advice from customers, and leads in the initial assessments of whether the right mechanisms and metrics are in place to affect change. “I’ve always had a continuous improvement mind-set,” she interjects. “It’s actually easy to have complicated ways of working. The challenge, too often, is keeping it simple.”
Johnson has personally focused where she is a bit less familiar. “The first months I’ve inserted myself into what is happening with research,” she says. “Maybe it’s a novel approach in R&D – this idea of making standard something that is not perceived as standard. Understanding what you can actually simplify has been really interesting.”
Open Leadership for Open Spaces
Finally, Johnson knows you can’t preach an open environment but have senior management walled off. “I have a very global role, so my email is my open door,” she says. “I want our employees to tell me anything I need to know – good or bad – and to please have a suggestion if they have a concern. It’s about having an engaged group that feels connected with the leadership teams.”
In her office, Johnson keeps a copy of a short paragraph she once saw on-line. It says leadership is about making others better as a result of your presence, and making sure your impact lasts in your absence. One way she does this is by visiting facilities and meeting with customers around the world. “Just being visible can help break down the feeling of silos,” she says. “You also leave people with a positive impression through that personal interaction, ensuring the direction, energy, and enthusiasm for the vision is sustained.”
A final piece of advice: “Make sure everyone in your organization clearly understands what your expectations are, and what is and is not negotiable concerning those expectations,” she says. Hopefully we’re all learning that working in isolated, cylindrical structures falls in the latter category.