You Want Success With CDMOs? Think In Threes

By Louis Garguilo, Chief Editor, Outsourced Pharma

Twenty-eight years at Gilead, but Reza Oliyai’s new pursuit is no mere second act. It’s another main event that has him thinking in threes.

Since November 2022, he’s parlayed his vast experience in development and manufacturing outsourcing to establish Oliyai Consulting Corporation. His team of varied professionals primarily focuses on Chemistry and Manufacturing Controls (CMC), and has already assisted over 65 organizations.

At the time of Oliyai’s departure from Gilead, he was responsible for 1,600 professionals at seven global sites, had contributed to the development of over 200 candidates and the commercialization of 27 drug products. He is also an inventor on U.S. and international patents.

Oliyai first reached out to me regarding my recent editorial series on the WuXi Apptec-BIOSECURE Act.

“Our clients rely on us for CDMO selection, management, and decision-making” he wrote. “Recent events underscore the criticality of outsourcing in our global industry.”

He’ll have salient points on that subject subsequently. First, we’ll explore a series of guiding "triads" that Oliyai and his consulting team apply to all activities related to drug development and manufacturing outsourcing.

Model The Modality

“During my tenure at Gilead, we saw this significant evolution in our product development and product commercialization,” Oliyai starts off our conversation.

“We ended up working with hundreds of CDMOs, CROs, and CPLs across the globe.”

What, then, was the secret to managing all those relationships? How does that translate to advice for the many small and emerging biotechs that are now his clientele?

Including his experiences now as the head of a consultancy, he says he’s learned that pivotal to the growth of drug sponsors is the recognition “there’s an evolution of what’s required for a successful outsourcing model.”

And while circumstances may differ, this leads us to Oliyai’s first three-part analysis.

1.  First, it’s essential to have representatives from each function to form what we call a CXO Team. 'X' can stand for CRO, CMO, or CDMO. For example, when working with a partner focused on drug substance manufacturing, you need subject matter experts from contracting, quality, analytical, and technology development—internal employees or highly experienced consultants forming a single matrix-structure management team.
2. Additionally, particularly for larger CDMO relationships, creating executive-level sponsorship is crucial. Senior-level involvement can be very beneficial at times.
3. Another vital consideration is that CDMOs must be managed differently depending on the modalities involved.

Of interest, regarding the CXO team he mentions, Oliyai states that each member must have “a functional responsibility so they truly understand the project.” CDMO management should not be their sole work, but and important part of an individual’s job.

“Listen,” he says seriously, “there is no other way to manage the infrastructure. You can't just allocate a contract with a CDMO and forget about it. You trust and you verify.”

As for item three above – the consideration of modality – he adds a sub-triad:

1. Reason number one is each modality has its own set of technologies and business requirements.
2. The second piece depends on the modality because the expertise at the CDMOs is variable.
3. Lastly, depending on the modality also anticipates capacity availability will be divergent.

“If you need small-molecule drug substance,” he says, “there's typically available capacity. If you do conventional drug-product oral solid dosage (OSD), there’s tremendous capacity. But if, for example, it’s an ADC [antibody-drug conjugate], biologic, spray-dried dispersion, or sterile-fill manufacturing, the capacity is more limited.”

Timing (think the COVID years) and other market factors can also impact availability and capacity.

“Therefore, how you interact with a CDMO depends on your modality,” Oliyai iterates.

Which begs the question:

If you are a biotech pursuing a modality where CDMO capacity is limited, how do you handle that?

There’s no hesitation before reply:

“Seriously consider buying capacity upfront to secure your supply chain.”

Moreover, he says, provide your CDMO “a tremendous level of visibility” into your plans, expectations, as well as current needs to get you there.

This, he says, provides economic incentive and the flexibility your CDMO will need to effectively assist you.

The Relationship

The third triad, Oliyai says, should be forever in the forefront of your mind when contracting CDMOs. “They are equally important.”

You must have:

1. Control
   • Basically, the way you gain control is to buy capacity. There's no other way because if you don't buy capacity, someone else will.
2. Visibility
   • You achieve visibility by having high-level discussions at the strategic and executive levels.
3. Efficiency
   • By efficiency, I mean clearly understanding your partner's needs, your own needs, your molecules, and your program.

Expertise levels within emerging biotechs, Oliyai says, can be limited when it comes to later-stage development and CDMO management. Virtual organizations can have thin resources.

“Professionals who work in small companies are tremendously talented, super smart, but it's unfair to ask one or a few professionals to cover end-to-end development from a CMC perspective,” he explains.

One way to gain control, visibility, and the ability to work efficiently is to hire consultants. Providing that assistance is what Oliyai has now devoted his “second” career to.

“For starters, we work closely with our clients – big and small – on CDMO selection.”

And that selection process is, of course, triad-based.

Selection Process

An excellent external partner for one organization may be, for a variety of reasons as discussed above, certainly includes size, funding, and stage of development, a terrible partner for another.

Oliyai considers these points/interrogations crucial when selecting CDMOs.

1. Access to Product Requirements
   • How much data and knowledge do we actually have about the product? In other words, what do we know about your molecule?
2. Access to the Internal Capabilities of the Client
   • What expertise, capacities, and human resources are available at the biotech company looking to outsource to CDMOs?
3. Access to the CDMO's Capabilities
   • Aim to match product requirements and the company's internal capabilities with this final part: What exactly can the CDMO offer?

Based on answers to the questions above, says Oliyai, “We customize the development strategies and supply chain design to each client.”

He says it’s a mistake for entrepreneurs to believe in a “rinse-and-repeat strategy,”and he’s experienced more than three reasons to prove it.

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Next up with Reza Oliyai: thoughts on global outsourcing within today’s geopolitical climate.