Contract manufacturing organization

So the capital shifts toward contract development and manufacturing organizations.

CDMOs.

Right.

CDMOs.

And CDMOs now handle roughly 25 to 30 percent of global development and production.

And the space is heavily consolidated, too.

How consolidated?

Doesn't the risk of cross contamination seem exponentially higher?

We develop handheld auto injectors for drugs that don't typically fit into a conventional auto injector, either because of viscosity, some complexity around stability or volume, all things I think that we'll talk about today.

Prior to taking this role at Windgap, I've spent about 12 years in the drug delivery space across devices and formulation and CDMO services.

A couple of places I've spent some time, I ran corporate development at a CDMO called Phillips Metasize, working across a wide range of drug delivery devices globally.

Also ran 3M's drug delivery systems business, which is more about inhalation, transdermal systems, all kinds of combination products.

and actually carved that out from the company with some investors to create Condeva drug delivery, which is now a large CDMO focused across all sorts of combination products.

And so really have seen this volume problem in particular from the manufacturer's floor, from a pharma partner's side, and from the inventor's bench.

In fact, just this month, we have an article in on drug delivery in industry publication on exactly this gap, the three to 10 ml band and how the industry is working to solve the opportunity that's there.

And we do that by discussing manufacturing questions every developer should be asking early.

We also talk about what it makes a CDMO relationship work.

how companies can make smarter decisions about development costs and geography.

We also take a closer look at in vivo therapies and why solving the industry's core challenges still matters.

The thing that I find most interesting is that the issue is a systemic one.

This is not the issue when it comes to a pure biotech.

The topic is shared with CDMOs.

And it's quite interesting because when you, and we've a couple of years ago invested in a cell and gene therapy company who had felt that they had addressed the manufacturing issues in cell and gene therapy.

So API, active pharmaceutical ingredient, or in simple terms, think of it as the drug substance, the stuff that makes your drugs.

you order 100 kg of it, let's call it, you know, maybe five to seven years ago, the CDMOs, which is a contract development, manufacturing and outsourcing, or you could think of them as the Foxconn or the contract manufacturers that supply the pharmaceutical guys.

Those guys will be popping champagne because that would be considered a super large order, probably put you in the top 10 globally for the year.

You're done for the year.

When you combine these factors, I think it's quite an interesting setup where you have generics entering the market, you have oral pills, which are also coming in.

What excites me is the value chain that sits underneath the innovators.

We can talk about the CDMOs, we can talk about the consumables that are used to manufacture peptides, but With volume growth, there's going to be a lot of beneficiaries and the inflection point where some of these companies are starting to become big enough to enter our investable universe.

Can you talk just a little bit more on the oral side? It's my understanding that you mentioned APIs before.

You order 100 kg of it, let's call it, you know, maybe five to seven years ago.

The CDMOs, which is a contract development, manufacturing and outsourcing, or you could think of them as the Foxconn or the contract manufacturers that supply the pharmaceutical guys.

Those guys will be popping champagne because that would be considered a super large order, probably put you in the top 10 globally for the year.

You're done for the year.

When you combine these factors, I think it's quite an interesting setup where you have generics entering the market, you have oral pills, which are also coming in.

What excites me is the value chain that sits underneath the innovators.

We can talk about the CDMOs, we can talk about the consumables that are used to manufacture peptides, but With volume growth, there's going to be a lot of beneficiaries and the inflection point where some of these companies are starting to become big enough to enter our investable universe.

Can you talk just a little bit more on the oral side? It's my understanding that you mentioned APIs before.

So the data collection and really like is the key player in the biopharma in order to be faster, to be more agile and to keep up with all the innovations that we have.

That's also what I see in the Vaxan business and also the CDMO services that we offer, that we really have to be just more on edge and using the digital transformation in order to get products faster to the patients.

Yes, happy to chime in as well.

I mean, this is an interesting question.

So the data collection is the key player in the biopharma in order to be faster, to be more agile and to keep up with all the innovations that we have.

That's also what I see in the Vaxam business and also the CDMO services that we offer, that we really have to be just more on edge and using the digital transformation in order to get products faster to the patients.

Yes, happy to chime in as well.

I mean, it's an interesting question.

But it also means that we work with external partners.

We own the whole commercial infrastructure in-house prematurely, and may be We will never actually completely bring it into a house, similar to how we work with the chief, with the CRO organization for clinical development for our phase three trial in non-small cell lung cancer, similar to how we work with the CDMO for manufacturing.

So we use the same model for commercialization.

So you asked me the question, where do you start now? Medical affairs or commercial? And I don't think in terms of either or.

There may be issues in manufacturing, it's biology, you cannot predict everything.

And then you have this whole commercial organization and a commercial sales force working and you need to pay them to do nothing and keep them engaged.

So we have invented almost a whole new model that is not that new because it is normal already to work with CROs in development, the CDMOs, it's the same principle.

But I don't think many biotech companies have worked like this.