Is Passion A Criteria For Your CDMO Selection?

By Louis Garguilo, Chief Editor, Outsourced Pharma

With a tinge of trepidation at being thought of as whimsical, I put this before our outsourcing-erudite Editorial Advisory Board members:

Can consideration of a CDMO’s passion play a role in due diligence for selecting a new partner?

In other words, is there some qualifiable measurement (intuition?) related to a CDMO’s enthusiasm for your development/manufacturing project, or desire to gain a relationship with your organization?

How would this feed into standard considerations of timelines, capability and capacity, available/stable skilled operators, cost, etc.?

I was surprised (and relieved) by the, well, passion with which some Board members replied.

“I like this subject!” said an enthusiastic Firelli Alonso, Founder/Principal Consultant, ConsultFi Biologics LLC, and a long-time former Senior Director, External Supply, Pfizer.

“A CDMO’s passion is an often overlooked, but vital element of due diligence when selecting a new outsourcing partner.”

The fly in her ointment? “It’s notoriously difficult to quantify.”

Alonso added that passion is embedded (or not) in the CDMO’s culture, “but this intangible quality rarely reveals itself during the early stages of evaluation.”

Thus, unfortunately, a lack of passion only becomes apparent to most sponsors “after the ink is dry on the contract and work has begun.”

Of course not every Board member was enthused by the subject.

“I’ve never heard of a client seeking ‘passion’ as a measurable attribute,” stated Darren Dasburg, CEO, Claris Bioligics, like Alonso also a long-time former employee of Big Pharma.

“Typically, I would not include a qualitative or subjective measure on anything so critical as selection of a CDMO.

“That said, I’ve seen lackluster proposals from CDMOs that could be equated to low passion. Generally, these off-sheet feelings tend to show up in other measures, such as quality, talent retention or even company growth.”

Back to Alonso, she does think that for a “seasoned outsourcing professional,” it is possible to at least sense a passion to perform early in discussions with CDMOs. She considers this “a gut instinct developed over years of experience.”

“The key is to spend time speaking directly with the ‘doers’ – the scientists, engineers, and project managers on the front lines – rather than relying solely on the polished narratives of executives [or for heaven’s sake, business development],” she advises (and I append).

“It’s in those candid, shop-level conversations where a CDMO’s true commitment for the specific job often comes to light.”

Does Real Motivation Exist?

Board member Marilyn Bruno, CEO, AEQUOR, Inc., has a different reaction to my pursuit of passion.

“I'm surprised by the question!” she begins her response.

“As a small biotech fueled by our passion to forge forward through a risk-filled business environment every day, we have never found a CDMO with even a remote sense of passion in the sense that we use it internally.”

Ouch.

“As service providers,” Bruno continues, “we appreciate CDMOs that strive for competence, efficiency, and close communication with the customer, but Aequor would welcome a partner that also shares our passion to develop and scale the novel small molecules we discovered in the ocean that have remarkable antibacterial and anti-fungal properties.”

Any passion-filled CDMO takers out there?

A Board member who once worked at a much larger biotech (Biogen for 24 years), Thomas Holmes says he’s never heard of passion as a criterion for selection in RFPs, “but there is always a qualitative aspect of the selection process.”

He has a prescription for uncovering that aspect. 

Holmes believes project teams at the sponsor and CDMO must have people skills, and rhetorically asks whether passion factors into the application of which.

Professionals on both sides, for example, “should have the ability to manage demanding cross-functional teams for the tech transfer-engine to work.”

Passion may not be the right word here, but he’s clearly talking about a sense of shared mission.

“What I generally coach my team is ‘become the customer of choice,’ meaning be a good customer that holds our own team as accountable as the CDMO’s,” Holmes explains.

He raises an important point that others on the Board echoed: passion is a shared requisite for both the service provider and sponsor. If you aren’t passionate internally and showing it externally, don’t expect your CDMO to be.

Spread The Good Feeling

We’ve also just hit on a crucial deliniation:

Sponsors can’t only have a positive attitude for your project; you must interject that positivity into your practice of the outsourcing format.

What's that mean?

CDMOs want to work with an organization comfortable with the activities of outsourcing; with a customer excited about working externally with a partner.

Love the project you are bringing to a CDMO, but loathe the efforts that entail working with external partners? Don’t expect a great reception. CDMOs have their own passion barometers.

More Than Vanilla Interest

I suppose if you have a title such as Board member Joseph Graskemper of Biogen – Director, External Network Transformation – you exude your own, identifiable brand of passion internally and externally. 

He describes a genuine interest from a CDMO is an important factor in due diligence, but “sponsor companies should take the opportunity to ‘sell’ their own company."

"You do this by sharing the company’s larger purpose, the program/project goals and importance, and how it ultimately impacts the patients you hope to serve together with the CDMO.”  

He advises face-to-face, on-site meetings as often as feasible. These provide the opportunities to meet with leadership, personally present your project and your team, and gauge firsthand the CDMO's reaction and enthusiasm.

You are looking to confirm that shared mission we mentioned briefly above.

“Without alignment and energy, the relationship will essentially be transactional – not the strong foundation needed for a productive partnership.”

Finally (for now), Board member, Bikash Chatterjee, President and Chief Science Officer, Pharmatech Associates (a USP company),  says “Passion manifests itself in a myriad of ways to help a drug sponsor select a CDMO,” including an upfront clarity and completeness of responses during the RFP period.

“Do they go an extra mile to document risks, dependencies, challenges, opportunities, timelines? If they do, this showcases clarity of thought and desire to engage,” says Chatterjee.

He asks whether their communication style includes a “willing accountability, and conveys an ownership that underscores a CDMO’s passion for a particular program.”

“If you get vanilla, then a drug sponsor should probably keep looking for more excitement elsewhere.”

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Chief Editor Louis Garguilo will bring readers specific actions to instill and gauge CDMO passion in part two, where more Outsourced Pharma Advisory Board members – and some savvy use of AI – further elucidate our subject.