1. What roles do contract research organizations (CROs) and contract manufacturing organizations (CMOs) play in the drug discovery/development value chain today, and how will their role change in the future?

I would start by saying that the classical and "old role" of supplier has gone.

In order to be successful with a project, and due to project complexity, a CMO such as Cerbios (drug substance CMO) has to bring value to the customer with unique expertise and act as a consultant.

If, in addition, the CMO brings on board innovative technologies that can help in providing better bioavailability or lower dosages, chances are that drug development there will have a higher success rate.

A real partnership approach is paramount to that.

2. How have the requirements by pharma companies changed over the years, and how can suppliers manage to live up to them?

While once there were many Big Pharma companies doing everything, many pharma companies have now concentrated on specific stages of drug development.

• Startup on discovery
• Biotech companies on moving the candidates through clinical trials
• Pharma companies taking care of marketing and commercialization
• Generic pharma companies

There are, of course, companies active at multiple stages, but the global trend is in this direction. This means that the requirements are very different when outsourcing to a CMO. This also means that the CMO either has to have different departments specialized in accommodating the customer need at the given stage or has to also specialize. For a CMO, it is more likely to have three different levels.

• Discovery
• Supplier for clinical and commercial supply
• Specialist in the development of innovative processes, either for generic companies or providing life-cycle-management possibility to originator

3. Which new business models, like project-based or value-based outsourcing, could turn out to be the most promising guarantors for a successful cooperation with the pharmaceutical industry?

Since the development of a new chemical entity or a future generic is related to risk (risk of failure of clinical trials or failure in the launch of a generic), production outsourcing to a CMO that brings certain values to the project is a good option for the pharma companies. At Cerbios, we have worked over the past five years on creating this value through innovation. Innovation in processes or technologies. We are one of the few companies offering HPAI (high-potency active ingredients) manufacturing of Safebridge category 4 compounds. But new players will join in the coming years. The addition of technologies around the containment such as

• Continuous flow chemistry
• Chromatography purification
• Particle size design, including nanoparticles
• Preformulation to lower the containment class
• Innovative drug delivery system for dermatology products

for HPAIs on one single site is unique, and this is what our partners are looking for: the possibility to increase their IP on their drug that will protect them longer.

4. The establishment of shared risk/shared reward partnerships has increased significantly. Can these partnerships accelerate drug discovery and fill up the innovation pipelines?

The main question is, "Do we speak about risk-sharing or risk-shifting?" I have the impression that many companies are thinking of shifting their risk at the CMO level when talking about risk-sharing. The co-developments model with real risk-sharing resulting in profit-sharing later on is becoming more and more popular. For a company like Cerbios (small/medium CMO), it is possible to consider this model on a case-by-case basis. In fact, we have already applied it, and it is considered, of course, as an investment. But this is not sustainable if applied to all projects. It is more easily applicable for future generics with an originator or generic company. There is lower risk of failure and shorter time-to-market compared with NCEs.