Ivory Tower To CDMO: Can Universities Successfully Outsource Development?

By Louis Garguilo, Chief Editor, Outsourced Pharma

Let’s be honest: for professionals working at CDMOs, dealing with university-based clients can feel like running a development campaign through a distortion field.

Even when the inventors and innovators are “spun out” into the “real world” as a biotech, breaking through to the realities of progressing molecules and therapeutics is a tricky, intricate business. And can be a costly one.

Before we go on here, apologies to those who might take some offense. Stick with us, this might prove helpful. In fact, that’s our mission: help sponors of all kinds understand how to work with CDMOs and optimize outsourcing.

Tech Transfer Offices

Rank-and-file and C-suite executives as well at CDMOs will tell you if asked:

University tech transfer offices – although exceptions are indeed long – and the academic researchers they represent are not quite up to snuff for forming productive CDMO relationships.

In other words, when the project is leaving research and discovery, the halls of CROs and confines of university labs, the altitude changes.

Tech transfer offices are staffed with savvy professionals, able to deal with university policies, the internal researchers at those universities, and they are “business savvy.”

But to map out a development path to IND-enabling studies? Foresee CMC requirements? Understand fair pricing of scale ups, method developments and analytics? There’s often a knowledge vacuum here.

CDMOs, for their part, make attempts to bring programs directly from the halls of science into their labs and facilities. Some are better than others at understanding the nuances of university-based customers.

Consultants, often hired by the tech transfer offices, can and do help. Without a translational presence with industry seasoning at the negotiation table, contracting can be painfully slow.

How do we bridge this gap between the ivory tower and the pilot facility? How might universities better position themselves – and their promising research – to engage CDMOs effectively?

The Missing Translation

There can be a language barrier when speaking about strict timelines, defined expectations, or definitions of success, and of course pricing.

Researchers in university labs may be laser-focused on mechanism of action or proof of biology. But CDMOs need to understand material purchases and processing, reasonable regulatory starting points and program milestones.

Good decisions early lead to better results later. A CDMO might need to explain what “tech transfer” actually entails, why certain assays must be validated, or what a drug substance spec sheet should include.

Once projects start, and inevitable development variances occur, miscommunication can lead to an inability to make quick decisions on how to move forward.

Consulting Universities

That brings us to a practical question: Should tech transfer offices hire consultants, or are they considered the consultants for the principle investigators (PI) and their universities? (After all, how many consultants do you need?)

Many suggest a best-case scenario may be when a university pairs its PIs with ex-industry, CMC-experienced consultants. These individuals can help assess a CDMO’s fit, scope out work orders, build a reasonable budget, and translate academic ambition into development milestones.

A tech-transfer office and/or consultants can help avoid common missteps, including miscalculating (by a lot) the time, money, and rigor needed to get from bench to IND.

For one thing, universities must bake into program budgets less rosy projections, and, for example, if there’s government funding and other early investor monies supporting translational work, earmark more of it to external CMC activities.

Don't Outsource; Just Out-License

There’s another school of thought: Why bother trying to go it alone to a CDMO at all?

Out-license the program as soon as you have access acquired a threshold of proven biology, and let a biotech or pharma – built for the journey – take it from there.

The crushing caveat here is that's a whole lot easier said than done. There is a current diminishing lack of investors and established biopharma interested in partnering or acquiring early programs.

Nonetheless, understand the logic here.

CDMOs overwhelmingly prefer working with established companies, those with outsourcing experience. We might say they arrive with a better sense of development logic.

Established biopharma can function in a fluid development environment, make quick(er) decisions, and they attribute to the efforts around first manufacturing runs the gravity deserved.

A quick interjection here:

CDMOs also are well aware that if there is success, your university-based program will end up in someone else’s hands. This can be an “in” for a CDMO to a bio or pharma client, but there's also a risk the program may go somewhere else.

Finally here, CDMOs see hundreds of molecules and proposed therapies. They may know more about your chances of success than you do. 

CDMOs want and need to be listened to. Academic enthusiasm should meet hard-nosed analysis. CDMOs may not want to work with you if they don't sense that receptivity. 

Toward a Smarter Interface

If we want more translational research from academia to reach the clinic – and ultimately the patient – then this interface between universities and CDMOs must be rethought.

A few ideas:

• Universities may want to engage external advisors before seriously scoping projects or reaching out to providers.
• CDMOs could develop more structured engagement models for university-originated programs, perhaps with pre-vetted templates, timelines, and costs.
• Early investors should insist on translational plans that include realistic development milestones and manufacturing strategies – not just research endpoints.
• Tech transfer offices should include development-savvy staff with CDMO experience.

We are talking about recognizing opportunities and challenges on all sides; about understanding "attitudes" and starting positions, and forging a better sponsor and provider relationship (and more funding). 

With universities reaching out for more direct ties with external service provides, it’s time to make this process less painful and a whole lot more fruitful.