AI Assesses Passion At CDMOs, But Humans Think Differently

By Louis Garguilo, Chief Editor, Outsourced Pharma

I won’t take offense if some readers consider two editorials a bit much to cover a topic like passion at CDMOs. (part one is here)

Some professionals at CDMOs may be thinking: "I’ll give you passion. It’ll cost you $XXXX for a passionate delivery of a kilo of cGMP material.”

So that’s out there.

And that's why we follow part one’s more intangible (but appreciable) factors of passion at CDMOs by clearly defining passion as directly applied to development and manufacturing outsourcing.

For this purpose, I employed another somewhat nebulous entity for help. Me and my AI agent came up with a three-pronged definition of passion in our milieu.

• Sustained commitment to advancing shared objectives that strengthen projects and collaboration.
• Organizational dedication to excellence that supports mutual growth and innovation.
• Unifying conviction around common goals that create alignment and long-term value.

Coincidentally (“Like minds …,” as they say), Todd Mabe, AVP Quality at Lilly del Caribe, guided his own personal AI agent through a more rigorous exploration of the topic after I queried the Outsourced Pharma Board on the subject.

Don’t Overdo it, AI

Mabe’s AI agent suggested this headline for an editorial:

Passion in CDMO Due Diligence: The Hidden Indicator That Matters Most

Most? Excuse my sentient noodling, but let’s not get carried away. (We already have skeptics in the room.)

It’s more than a stretch to suggest passion is the most important factor among a myriad to be weighed when selecting and working with external development and manufacturing partners.

Moreover, earlier we demonstrated that while passion is difficult to detect, it is not exactly hidden. It's evident in attitudes, responses, customer service aspects, the entire outsourcing experience at a CDMO, and (albeit more difficult to evaluate) results.

A additional sentient source, David A. Dodd, Chairman and CEO, GeoVax, weighed in on our discussion:

“For us, ‘passion’ as reflected in the desire to obtain a long-term relationship is a factor, but not a primary factor in the selection process.”

Others on our Advisory Board thought similarly.

So having duly put AI in its place (wherever that is), let’s now acknowledge the salient suggestions Mabe coaxed from his agent.

Four Corners Of Passion At CDMOs

Here are four areas to ascertain an emotional connection, if you will, with your CDMO.

1. Engagement and Curiosity

Is the CDMO asking meaningful questions — yes about specs, but also your challenges, goals, and patient impact? Do they understand your science, and do the individuals there appear genuinely energized by it?

2. Team Dynamics and Floor Culture

How do their operators, quality professionals, technicians, and other lab or plant staff speak about their work? Is there clarity and energy in how they describe their culture, internal processes, procedures, and outcomes? Or does it feel rather routine and transactional?

What is the organization's turnover rate? High employee turnover often reflects cultural or leadership issues that affect consistency and quality over time.

3. Leadership Presence

Are senior-level leaders involved? Do they appear genuinely interested in your project (and attend meetings)? Are they accessible? Passionate leadership sets the tone across the organization.

4. A Continuous Improvement Mindset

When appropriate and desired by the sponsor – important caveats – a passionate CDMO doesn't just run the process –  they propose more efficient ways of performing, and take a form of ownership.

Is the CDMO candid about laying out risks, and are they ready with mitigation strategies? Passionate professionals talk about next steps, scaling, future phases, and next projects.

Following these points, Mabe’s AI agent tones down mid-stream, if you will. It subsequently states that when comparing timelines, capability, skilled labor, cost, and capacity – passion does not replace those fundamentals. It works to elevate them.

How? Passion drives a more agressive

• dedication to “right first time” as a core value
• determination to adhere to timelines
• upgrading of capabilities to remain “best in class”
• recognition that all costs and pricing matters to customers

Bottom line, says AI: Passion is connective tissue, and can serve as a strategic asset.

The Economics Of Passion

Leave it up to Vadim Klyushnichenko, VP Bio/Pharmaceutical Development & Quality, Calibr-Skaggs Institute for Innovative Medicine (Scripps Research), to walk us over to the balance-sheet of outsourcing.

He suggests we can think of reframing passion at CDMOs as an “indicator of financial position.”

“In my 20-plus years working with CDMOs,” he says, “there have been cases where they were extremely eager to win our projects.” He provides three examples:

• A large project that made up a substantial amount of a CDMO’s annual revenue
• A project that was important to a CDMO, but less so from an annual income standpoint
• A CDMO that was clearly under some financial stress, and the new CEO was desperate to bring in business

“In all three instances, the C-suite assured us of a dedicated effort and flexibility. However, in the first two cases, the CDMOs actually failed within a year. The third managed to survive, but had to delay our project twice.”

Did embellished enthusiasm blind Klyushnichenko’s team to other issues at the CDMO?

He doesn’t say specifically, but concludes sponsors should understand the reason behind a CDMO's passion.

“High enthusiasm may actually mask challenges such as financial fragility at a service provider.”

His point is to weigh demonstrated and sustained technical and business competence at the CDMO more heavily than a display of affection for you and/or your project.

Somewhat darkly stated, but find out what's really going on behind those smiles.

An Artful Doger

And so, over two editorials, passion at CDMOs has grown from a topic I was leery to introduce, to a philosophical and psychological discussion, and at the same time economic- and finance-related variable. 

But not done yet. Sai Prathyusha Bhamidipati Director, Reg CMC, Moderna, says we’ve still missed a categorization – passion as art.

“If we consider the adage, 'Passion is the art of creating,'  then in biotechnology this translates into a CDMO’s ability to generate creative solutions that lead to real results,” she avers.

While due diligence rightly prioritizes capability, capacity, timelines, and cost, a partner’s “passion signals if they go further, and are invested in your program’s success.”

But let’s (finally) end with words from Brian James, COO and Managing Director, Rondaxe Pharma.

“An obvious lack of passion is a major red flag,” he says. “You can get a feeling for the CDMO’s interest in your project, and more importantly, whether they are aligned with your goals.

“No alignment, no passion, then run as fast as you can!”