By Louis Garguilo, Chief Editor, Outsourced Pharma
This is the reality that 2016 has wrought: Big Pharma is continuing to organize for enhanced utilization of external partners and supply chains. More business models — biotechs, startups, virtuals – rely on outsourcing. CROs/CMOs are reacting to these client changes with their new service models, technologies and facilities, and M&As.
Add the fact of more but smaller projects at a quickened pace of delivery and turnover, and it all leads to, among other things, a weight and force landing on the backs of a particular set of individuals:
Ah, to be a project manager in the biopharma industry in 2016!
Are “PMs,” as they practice their trade today, up to the new challenges and intensifying outsourcing landscape?
WHO’S A PROJECT MANAGER ANYWAY?
“When we talk about managing projects in our industry,” says Heidi Hoffmann, senior director for manufacturing at Sutro BioPharma, “we’re often talking about it generically, in terms of how do we ensure both customer and supplier get what they need for a specific project, considering the time and money available and the activities that have to be done? But who is tasked with doing this on each side — sponsor and their service provider — varies with project and organization size.”
Hoffmann comes at this discussion with over 20 years of experience, including working on vaccines for influenza (FluMist) and plasmid DNA for gene therapy. She was also part of the team involved in the transfer of Bristol-Meyer Squibb’s Orencia (abatacept) production to a CMO facility in South Korea. Perhaps somewhat surprisingly at first, she suggests that in today’s fast-paced drug-development environment, small sponsors, and at times Big Pharma, may not actually need what might be considered “professional” project managers to succeed. The real requirement, she says, is simply ensuring you have someone authorized to make day-to-day decisions who can communicate effectively and directly with the CMO and is capable of weighing overall risks and tradeoffs as projects progress.
Sounds simple enough. No specific project management background, such as a Master of Project Management from Penn State or other universities, is needed. This opinion is bolstered by various conversations over the last two years with representatives from Big Pharma, biotechs, CMOs, and consultants. No one denies that a well-defined or pronounced subset of “professional PMs” exists in our industry. When asked how companies recruit or acquire project managers, the most often reply is the roles are filled internally with scientists (or engineers) who get “promoted.” These people climb the corporate ladder by successively managing a small team, an internal project, projects relying to a high degree on external partners, and culminating in alliance or relationship management positions. A PM in our industry is a scientist or engineer who’s the product of an incremental increase in responsibilities and on-the-job (OTJ) training.
There’s certainly nothing wrong with OTJ. But it serves us well to note carefully this means the project managers at sponsors today are experiential products of the way projects have been managed in the past. On the service provider’s side as well, it’s common to find PMs who are former pharma project managers. Can these individuals on either side evolve their roles to meet the trends in the industry? Or, if we understand Hoffmann and many others, is there actually less need of an evolution in the PM role than we might have anticipated? (Count me as an early member of this anticipatory group.) Instead, we see the industry further embracing the traditional role and selection of project managers: We’re not clamoring for new kinds of PMs; we just need more of what we have, we seem to be saying.
“For a well-defined and understood project a CMO has done before or involves a routine or proven platform,” Hoffmann explains, “a ‘regular’ project manager does a great job of keeping track of tasks and resourcing appropriately, while also keeping communication lines open when things aren’t going according to plan.
“For a new project or something that’s more outside of the normal paradigm, I find it works best to consider the role of a project team leader more than a project manager. These managers have a solid grasp of the science related to their project. They’re not as subject to, let’s say, manipulation by the external partner. I’ve found that ‘professional’ project managers, often with less science background, don’t know when to say, ‘Wait a minute, that doesn’t sound right. I’d better check on that.’”
THE ELUSIVE PM UNICORN
Hoffmann’s points may sound familiar to readers, and her thoughts lead us back to the well-worn discussion of the ideal makeup of the individual project manager. Like some Socratic dialogue, the discussion turns on a fundamental question: “Should PMs be more technical or business savvy, more scientist or manager?” Although Socrates might not have approved, a lot of us are prone to answer, “Yes to all the above.” Unfortunately, while that ideal sounds good in discourse, in reality this superior being is in fact still unicorn rare.
Since these advanced scientists-project managers are hard to come by, we expect the industry will focus on structured training and development of PMs within the current promotional system. If there are formal and rigorous programs at sponsors and service providers, it seems they are being kept secret.
Joe Guiles, head of development at Agilent Technologies’ Nucleic Acid Solutions Division, has heard this scientist- project manager dialogue before. Guiles, like Hoffmann, is a 20-plus-year veteran of the biopharma industry, including positions at biotech Medivation, service-provider Cedarburg Hauser, and pharmaceutical companies Sanofi- Aventis and Johnson & Johnson.
"A pet peeve of mine is when … strategic discussions are not productive because we get bogged down in tactical PM dialogue."
Head of development, Agilent Technologies’ Nucleic Acid Solutions Division
“We have project managers at Agilent serving in that role of scientist-manager for several of our clients,” he says. “We use them as an important tactical window, meaning that they are on the front lines, and their reporting flows up to a more senior management level. These front-line managers say things such as, ‘Here’s what we’re seeing, what’s working, and what’s not working.’ They are the ones actually interacting with the CMO and know whether the relationship within their individual project is going well. But their role more or less starts and ends there. These PMs need to be able to solve many of the day-to-day challenges themselves.”
The more senior management stratum Guiles just mentioned is, of course, the “Alliance Management” function and/or steering committees, often set up by larger sponsors like an Agilent or pharma company. “This next level up is the venue for the more strategic discussions,” notes Guiles, who then adds: “A pet peeve of mine is when these strategic discussions are not productive because we get bogged down in tactical PM dialogue.”
"I’ve found that ‘professional’ project managers, often with less science background, don’t know when to say, ‘Wait a minute, that doesn’t sound right. I’d better check on that.’"
Senior Director for Manufacturing, Sutro BioPharma
Unfortunately, we won’t be able to dive into this second level of project, relationship, or alliance management in today’s investigation. The point here is that both Guiles and Hoffmann, as well as so many others in the industry, agree (or simply don’t challenge) the fundamental role and type of individual still needed as project manager in today’s outsourcing (or internally, for that matter) hasn’t really changed. These managers are the scientific versions of the factoryfloor foremen, advanced tacticians able to keep people, equipment, and schedules humming … and with the knowledge to hit the reset or stop button when necessary.
Ultimately, today’s increased outsourcing, complex projects, new business models, advanced technologies and platforms, and faster timelines, all seem to add up to a simple need for more project managers in their current shape and form. While this has been a limited thought experiment, we have been able to demonstrate an industry mostly satisfied with the current roles of its project managers. I, for one, sit surprised at this result. Or perhaps we’ve missed something here. Maybe some readers have more to add. Please let us know. In the meantime, I’ll let you know we will further pursue this topic of project management at OutsourcedPharma.com, as well as in Life Science Leader magazine.