They Said What? Unexpected Insights Into CDMO Selection

By Louis Garguilo, Chief Editor, Outsourced Pharma

An assortment of conversations with experienced biopharma executives have generated some surprising commentary.

One such example.

“A trend I’ve noticed – because it is competitive out there – is a willingness of the CDMOs to engage with the startups and earlier phase programs, and they are actually offering incentives and services to get you in the door.

That didn't happen ten, or even five years ago. CDMOs are offering regulatory CMC, even capital equipment.

I ran into a situation where a CDMO was working on an lipid polymer hybrid nanoparticle – LPN – and we came in with a different nanoparticle, and a specific piece of equipment was needed.

It was about a million dollars. The CDMO was willing to purchase it and put the cost on the backend of the project to get paid back. More of this is happening.

“You're also seeing CDMOs bring in a lot of redundancy options. That's something I personally believe in. When you go into a CDMO, if something goes wrong, you’ve got a backup.

They want to get you from start to development, formulation selection, all the way to commercial if possible, and more of them offer all that … that’s what I'm seeing. CDMOs catering more to get you in early.”

A surprising solioquy?

I’ll reference this earlier editorial, the title of which will remind you of a more common line of thought: Emerging Biotechs Judge CDMOs More Harshly.  

Perhaps such prior pronouncements have had some effect, reversing often less than stellar experiences that emerging biotechs have told us they’ve experienced over the years.

Who Decides Which CDMO?

Here’s a second eye-opener from a recent conversation.

First, I believe most would agree the process by which a sponsor organization selects the CDMO most suited to work with is a team effort.

However, it appears that’s not universal. The following is from a long-tenured outsourcing professional.

“I’ve had the privilege to work in big and small pharma. When you work at small or virtual pharma companies, you can outsource everything: development, CMC, analytical, to formulation and manufacturing.

Several times from the beginning, you are not in the decision-making chair.

Your boss says, ‘We’ll go to this CDMO because I've always worked with them in the past.’ So you don't have a choice.”

In that case, it’s your responsibility to carefully look into the creation of the service agreement and the scope of work, because if it's not written correctly for what you want and need, you cannot deliver the results your boss expects.

On the other side, from the position of a manager for Big Pharma, I was always able to choose the external partners I worked with for my needs. The responsibility was mine.

I researched their prior achievements and deliverables, and evaluated their current level of science and technology. I worked with CDMOs who I knew were proven in the field, and I was sure could deliver what I wanted.”

The nuance here is, of course, the lack of agency at the biotech, and the freedom to operate at the Big Pharma.

Therefore, important considerations in (or before joining) any sized organization is which of these is operative.

• You are able to and responsible for selecting your CDMO.
• Even for projects directly related to your needs, a group of colleagues will collaborate for CDMO selection.
• You’ll be advised (at times directed) to work with certain CDMOs.

The Gap Analysis

Our third and final bit of intrique may not be quite as surprising as the two above, but the veracity is certainly noteworthy:

Get your own house in order! Prepare internally so you can actually outsource successfully.

And this energetic response is a common refrain.

One development and manufacturing outsourcing executive interprets this mainly as initiating “a serious internal gap analysis.”

“A big thing I've seen in my own companies and at others is a lack of a gap analysis.

But it is paramount to spend a lot of time early to understand where your knowledge gaps are, where your equipment gaps are, and so forth. And then build that strategy to fill them.

Only then, in the specific context of CDMOs, is finding partners who have multiple capabilities the most expeditious and effective.

For example, you might have a service provider  help you with formulation, but it would be beneficial if  they can help you with analytical, too. Especially if a problem arises and you need to develop a method quickly.

I’ve found services all together has been a great asset, as opposed to now you're managing multiple partners to solve the same problem. Again, my thinking here, revolves around gaps.

“Look for gaps in knowledge and physical capabilities; make sure your management knows where these gaps exist. Don't just address it privately, make sure it's everyone's problem.

Then do everything you can, whether that be through consultants or other means, to fill them as soon as you can.

You need professionals with the foresight and humility to know what they don’t know, and understand that gap before it hurts you.  

In the past, when we knew we're going to file an IND – and this is complex – we knew we needed regulatory and specific biologics expertise to help. We always brought a professional on internally, or we brought in consultants –  and often a year ahead of time.

Of course if you are a small biotech, you're not necessarily looking to build out your head count.

So you're never going to have enough people, and you are never going to have enough money, but you can't make excuses. You've got to find ways to supplement those gaps.

CDMOs then can help you understand what expertise they can bring. It's more than just capacity. Do they have formulation people that can help you? Do they have analytical development people?

You can extend your organization almost clandestinely by the right kind of partnership strategy, and filling those gaps successfully.”

... and these are some of the things professionals have been saying of late.