By Louis GarguiloChief Editor, Outsourced Pharma
Follow Me On Twitter @Louis_Garguilo
We’re told that in the ranks of drug companies, more often than not, individuals wait for the “culture” to descend from the highest levels of the organization to miraculously instill the mindset that they can be innovative, and won’t be faulted if at times they come up short.
To whit: A Pharma CEO advocates for more flexible thinking and a more energetic pursuit of opportunities. A mid-level manager takes that to task, and decides to slightly delay an early deliverable of API to test-run development material on a more advanced process-train at a partner CDMO. A frontline engineer at the sponsor then opts to go with the recommendation of her CDMO counterpart engineer to install a more suitable filter dryer on the new line, which again adds to a readjusting of the time for initial deliverables.
Meanwhile, and in reverse, at the CDMO that counterpart engineer informs his project manager of the additional change (to the new filter dryer). The project manager reports up to senior management of the elongated project delivery forecast.
Even if all goes well – i.e., a subsequently confirmed better-suited equipment train and more robust process by which to manufacture future material – do those involved in these decisions: (a) get singled out for credit, or (b) share blame for the delays in delivery and additional upfront project costs?
“Instant Innovation” For Long-Term Success
This isn’t a new scene in the amphitheater of pharmaceutical outsourcing.
Today, though, it’s one amplified by global competition, quicker and more frequent project turnover, and simply the fact of more outsourcing. How the credit or blame question above gets answered – by senior management, investors and other stakeholders – demonstrates whether the original clarion call for a more innovative culture was sincere or not.
And here’s another question: Are in fact those “counterpart engineers” and their colleagues actually knowledgeable and skilled enough to be empowered with innovative decision-making?
Evan Guggenheim, Sr. Manager, Technical Development at Biogen, believes that biotechs and pharma companies alike need to hire scientists and development professionals, project managers, and plant engineers who “possess more ideal characteristics for today’s working needs.”
“We can’t wait for innovative culture to transpire around us,” he says. “Our working network of drug discovery, development and manufacturing partnerships and supply-chain organizations are just too complex nowadays.”
Guggenheim says these frontline positions used to be filled by people who could “put their head down and plow forward, or who had ‘good hands’ in the lab, or a deep technical understanding of the field.” But today it’s necessary to have hires who actually exhibit some of the characteristics usually sought after on the management level, someone who can “understand the business end-to-end, who can influence others, communicate inside and outside the organization, and make informed innovative decisions.”
Where once the common refrain to employees was “When you’re a manager, you’ll have to worry about things like that,” today frontline scientists in the labs and technicians in the plants – particularly as they must deal with more external partners – need to have that skillset early in their career. “You build that culture correctly from hiring the right people into your organization,” Guggenheim adds.
In other words, you build from the bottom up what you espouse from the top down. Executives and managers then reward individual (or collaborative) efforts to introduce new technologies and equipment, and practice different ways of thinking. You recognize that what we might call these “instant innovations” throughout your organization may delay a development project timeline, but increase your ultimate business success, and indeed patient outcomes.
Business Realities Set In
“Is there a larger strategy directed at this kind of small “i” innovation? Because these innovations also bring risk with them. For example, the clinical developers are of the mindset, ‘Give me something that’ll work, that’s proven. Let’s get this product launched on time and reduce the risk as much as possible. We can save the improvements for the second generation.’”
Ekambaram continued: “But then the second generations bring its own challenges of lifecycle management, and approvals in other countries and markets. How do you resolve that tension between first, putting innovation solutions up front so the product can then have the immediate benefits, but with the incremental risks you pose to the product launch, versus saving the incremental improvements or innovations for the second generation, with the other problems that you have at that juncture?”
Thomas Holmes, Senior Director, Global External Manufacturing, Biogen, calls this “an interesting dilemma.” For example, consider “a product that has a new indication – maybe a rare disease – and one that’s well known, characterized and studied, that has gone all the way through phase III, but then you launch it with a device that you may not have a lot of experience with. That being said, this late-stage innovation will help you in a competitive market, and ensure you’re thinking of patients who take their medicine at home.
“So it’s a product-by-product case study. We’ve been on either side of launching, with or without device capabilities, and have had various experiences. You have to look at competitive features, at the marketplace, and especially the patient population you’re serving, and also your confidence level and the delivery system you’re going out with.”
How does Holmes think the industry as a whole measures up with these types of decisions?
“My thought on innovation in our industry is that it could be much better, honestly. If I just look at it from a pure business standpoint, our industry against a lot of the other technical industries out there, doesn’t drive innovation.”
Todd Mabe, Director, Drug Substance Quality, Merck, brings the discussion full circle: “I’ve been in a small organization, in Genentech and Roche, and now Merck. It’s the culture … It’s all about the culture and what type of leaders will accept failure for ultimate success. It’s a huge issue today.”