Pain And Pleasure In Project Management Of CDMOs
By Louis Garguilo, Chief Editor, Outsourced Pharma
Stoke Therapeutics, a biotech focused on oligonucleotides, is moving from early to late phase with lead candidate SCN1A targeting Dravet Syndrome). Thoughts of commercial success are not far away.
Consequently, says Tony Sampognaro, Director CMC, Project Manager, “We're having to rearrange and bolster the constellation of CDMOs we're working with. That's part of the reason I joined in 2023 – to help lead that process.” (see parts one and two.)
And downsides to an all-outsourced model?
“It can add hidden complexity,” Sampognaro suggests, “especially business complexity. And that’s something that often catches smaller biopharma sponsors off guard, and ultimately slows their development path into the clinic.”
But he and company are on top of it. For him personally(see: Outsourcing Needs More MBAs (Yes, You Read That Correctly), he utilizes an Executive MBA (Rochester Institute of Technology).
“It helps tremendously with the sort of role I have, and especially as we are moving into phase three and commercial.”
Applying Knowledge To CDMOs
I asked Sampognaro for an example.
“Once in my career, I ran into a situation with unexpectedly long delays executing what was supposed to be a six-month scope of work. It had ballooned to over a year, and the default power dynamics of the sponsor-CDMO relationship meant that the complaints were one-sided.
However, after some needed relationship-building, including a thorough site visit, I discovered that my own company – that is, the sponsor – was at least an equal contributor to the delays.
A lack of appreciation for how CDMOs operate, and how they communicate with clients from their perspective, led to the CDMO constantly having to restart work. The true scope of the project kept shifting — and it kept shifting because our internal knowledge management and communication capabilities weren’t terribly effective.
I eventually led both sides to agree mutually to a more frequent meeting cadence, and applied what might be considered basic, but sorely needed, project management and negotiation skills to those meetings, and the overall relationship.
The meetings and the elevated communications required the same – or even less time than previously – and was more effective. We quickly finished the entire scope of work, repaired a strained relationship, and set up both sides for future success.”
Enjoy Project Management
Have readers run into a project manager who obviously (or evidently) did not enjoy the role they were in?
If so, it can prove torturous to both the PM and everyone else.
More than an ephemeral musing, extracting enjoyment for your role – perhaps nowhere more so than with project management – is an important element of being successful.
Sampognaro, on the other hand, relishes his expanded role at Stoke, where he is “embedded with the CMC team, but part of the portfolio and alliance management function.”
He has, and advises others in similar roles to consider attaining, a Certified Associate In Project Management (CAPM) from the Project Management Institute, the same body that issues the PMP certification [Project Management Professional].
In many cases, says Sampognaro, it may be more realistic for today’s working professionals to attain this when sliding from the bench (or other scientific roles) to roles coordinating and managing related to external partners.
“The Project Management Institute has this triangle of different skills that a PM should have,” says Sampognaro. And one of them falls under the heading of “Business Acumen.”
As a scientist, he says, the basic questions are Why? or How? But as a business professional the basic question is So what?
“None of the answers to these questions in isolation will do,” he explains. “That’s where project managers come in.”
“PMs stand at the intersection of science and business, placing knowledge from all stakeholders into a wider context that all can understand. Until then, what we might consider knowledge only has the potential to impact business outcomes — and ultimately patients’ lives.”
In addition, sponsors and CDMOs have complementary but differing emphasis within the science and business of relationships.
Each side requires effective project managers that recognize this gap, appreciate the other’s point of view, and works “creatively across boundaries of all kinds” to promote mutual success.
“It's not enough to match your needs with a CDMO’s technical capabilities,” Sampagnaro concludes.
“It's also critical to know how well developed everyone’s business systems and practices are, the background and experience of key stakeholders, and increasingly these days, the history of the particular production site you’re working with.
“Although the shingle out front may bear the name of a corporate giant, it might have been a small independent CDMO not long ago. That matters. Integration and the synergies that promise to follow an acquisition can take a long time to materialize.
This is especially important if sponsors are looking for an end-to-end outsourcing solution that many larger CDMOs tout but not all consistently deliver.”
Sounds like you need a project manager with an MBA to figure it all out. Maybe one at both the sponsor and the CDMO.