What Are CMOS and What Are They Good For? (Part 2) [Phillipe Tschopp from Glatt]

What is a “Contract Development and Manufacturing Organization” or CDMO?

In our last session with Kurt In Albon, we learned about Contract Manufacturing Organizations (CMOs) and their different types. CDMOs are different from CMOs in the way that they also do the development part, in addition to manufacturing.

The standard pharmaceutical companies that we see in the market, can outsource the manufacturing and development part of their products to CMDOs.

Types of CDMOs:

As in the case of CMOs, CMDOs can also be seen as different types on the basis of the services they provide. For example, as Philippe tells us, Glatt Pharmaceutical Services is specialized in solid dosage forms and equipments. That is their niche.

Similarly, if a CDMO is specialized in providing some other service to its customers, we can categorize it into another type. These services may include different phases of drug development, clinical trials, regulation, filing, etc. There may be CDMOs that provide all these services in a single package to their clients, they will fall into a distinct category of CDMOs.

About Glatt Pharmaceutical Services as a CDMO:

We asked Philippe some interesting questions about Glatt Group, including his experience at the company, what type of CDMO they are, what kind of customers they have, and how do they work with them.

Philippe’s Role at Glatt Pharmaceutical Services:

Philippe tells us that in the early two-thousands, the Glatt Group launched some excipients and Philippe was one of the persons who brought those to the market. He got familiar with the company and then got the role of the business developer at Glatt in 2012. Since then, he has been working as the Head of BD and is involved in working with a broad range of clients with interesting projects.

What Type of CDMO is Glatt Pharmaceutical Services?

Somewhere in the middle field between a CDO and a CMO, says Philippe. Glatt jumps into the game in the very early phases of the development of a drug and follows up to the commercial scale. Involving all the phases of clinical trials, formulation, and optimization. They also develop the manufacturing process and the equipment.

That is the niche, that makes them unique among other CDMOs. Glatt Group not just produces the equipment but also has the latest knowledge and expertise regarding it. They have their scientists and experts working within the organization.

What Range of Clients does Glatt have?

They have a full range of clients from small startups and even universities to big multinational pharma companies. Philippe says that Glatt has access to some very interesting university projects as well, where they bring up new, exciting ideas and that is what keeps him so motivated towards his work.

These projects are concerned with all the age groups from children to the old population, ultimately targeted towards bringing value to patients. They have medium to big-sized pharmaceutical companies as well, including multinationals, and also some successful spinoffs from universities.

How the CDMO takes up a Project:

Philippe says that he is always in an open exchange with academia universities because they provide a creative resource for what is possible ahead in the future. But it’s not like the CDMO is scouting on the projects of these universities or keeping an eye on them. No, the CDMO is contacted by the researchers.

If somewhere, some brilliant people are working and they find a promising molecule, they would want to go ahead with that. Maybe with the development, trials, dosage, or commercial production. At that point, they will be needing help, and for that purpose, they will contact the CDMO.

How do they come to know about Glatt Group? Philippe says that Glatt is always participating in activities like conferences and webinars/seminars. Probably the potential clients see them in conferences or get to know about their technologies at seminars, and then contact them for a project.

How to Choose the Right CDMO?

As CMOs and CDMOs are working from behind the curtains, most people don’t really know about them. So, if a company, a startup, or people from a university need to get to a CDMO, what should they do?

Use your network. Carry out good market research. Talk to similar companies to yours. Know about their experiences with outsourcing.

Once you find a CDMO, check their history, their reputation, their quality track record. Apart from collecting reviews about them, you can go yourself and perform an audit.

“You have to find the smiles in the face of your partner.”

That’s what Philippe says in this regard.

In your meetings, or even in video calls, analyze the comfort on the faces of the other side. When you ask your questions and ask about their previous experiences with similar projects, you have to find the smiles and comfort in your partners’ expressions.

And it’s not just your partner, you ‘both’ have to feel comfortable with each other. And how do you communicate in your initial meetings is a first sign of how that mutualism would look like.

This comfort and belief factor is a far greater indicator of a healthy contract. Even more than those mind-blowing brochures with their amazing features listed. That’s because once you get into a contract, it is a years-long partnership and you can’t afford to work with people who won’t communicate with reassurance, and are not very comfortable with your project.

Is it important for the CDMO to believe in a project?

Or is it fine if the CDMO just helps the outsourcer in doing what they say? No, that is the whole point. It is crucial for the CDMO to have faith in the project. The belief is what becomes the motivation, the driving force of the whole project. Philippe says that he prefers those projects in which his organization believes. Work should make sense in the heads of everybody. And these kinds of projects are actually those that bring real value to science, to people, and the ultimate benefit goes to the patients.

How Glatt Group Deals with its Customers as a CDMO:

With Glatt Group as an example, we tried to understand how a CDMO works and how does it deal with its customers. Here are the steps that Philippe told us about how the conversation continues between the client and the CDMO.

1)     Understanding the Customer’s Need:

Firstly, we need to deeply understand what our customer needs us to do, says Philippe. We need to completely understand the drug profile. Once we are clear about the end product the customer needs, then we proceed ahead.

2)     Drafting the Project Plan:

This is something like 30 pages long, detailed layout of the project. This is what the CDMO foresees at that point. The plan includes all the activities including the trials, feasibility study, and manufacturing processes. This can be altered according to the demands of the company. For example, some companies need a full-fledged budget and that can be included as well.

3)     Explaining and Discussing the Plan:

They tell their customers that, let’s have a call as soon as you have a look at this detailed project plan. We’ll go through it step by step. Philippe says that they explain the rationale behind everything that’s mentioned in the layout.

And this step is quite important, as it makes things clear in-depth on both sides. Sometimes it comes out that the company has, for example, carried out some parts of trials already. So we can skip that out of our plan. Or they may say hey, we have screened these excipients already so we don’t need to repeat that.

This way, they get a crystal-clear picture of what has to be done.

4)     Early Engagement of the Scientific Team:

They involve their scientific team in the project in these very early phases. That is crucial because a business development guy doesn’t necessarily know the whole details, the intricacies of the project. And that, later on, might stem problems. Engaging the scientists early just enhances the comfort and confidence level on both sides.

5)     Client’s Role after Signing the Contract:

After the contract has been signed, does the client sit with the CDMO on the table or can it leave everything to them? Philippe says that it depends on them. But it is very good for the project if the client remains an integrated part of the work. That is obvious because the customer has more knowledge of the API and the drug, and the CDMO has command over their work. So, it becomes a fruitful blend of ideas and streamlines the project.

6)     Tech Transfer to the Next Partner:

As Philippe told us that Glatt Pharmaceutical Services lies somewhere in the middle field between a CDO and a CMO, so there is usually another partner in the project that does the mass manufacturing. That is most probably a CMO. And Glatt fully supports tech transfer to that CMO. Philippe says that it is something to celebrate as we move forward and our project is heading towards success. As Glatt is the developer of its equipment as well, so chances are high that the next partner would be needing the equipment too.

CDMO Industry: What to Expect in the Next 20 Years?

The CDMO industry will have to face certain challenges in near future. The shift of mindsets plays a big role. The knowledge-sharing trend that currently exists between the pharmaceutical companies and CDMOs, may change ahead due to mindset changes, who knows. There may be an increasing trend of sharing projects remotely. And that may blur the concept of local partners and connect CDMOs with companies throughout the world. There is a chance that new countries will emerge in the industry.

Philippe believes that Artificial Intelligence has much to do in the coming years. AI will change the outlook throughout the pharma industry. And the CDMOs that will be more flexible, will win the leading ranks. We may see a trend towards individualized medicine as well. The bottom line is that the organizations that will be quicker to react, and in the right direction, will be ahead of others. And it might mean taking risks.

[simple-author-box]