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?

During the past years we have seen a trend by the innovators/drug-development companies to focus more and more on target molecule identification, drug design and computational chemistry. Consequently, the process development teams have been strongly reduced or even closed. Further, the innovative companies have decreased their capacity for the process validation phase, and first piloting campaigns, and will need to outsource those activities more and more to CRO/CMO service providers.

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

Basically, the existing capacity at the pharma companies for chemical processing has decreased over the years; this is also true for the production capacity. We have seen this trend with various companies in Europe and the USA, as well. As a consequence of this trend, those capacities must be provided by external companies. This is the chance for CROs/CMOs to step into the process of drug development. To support the innovators as a reputable CRO/CMO, you are strongly bound to the timeline of the customer. Therefore it is important to have sufficient capacity available and to be very flexible to follow the developmental stages very closely.

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?

From our perspective we have seen more project-based outsourcing requests. In these requests, the target molecule is well-defined and the existing basic process has to be developed. The target of this development is always a robust process that may be used on a commercial scale as well. For us, as a CMO service provider, our target would be to develop the process together with our customer to allow commercial production once the new drug may be launched. This always includes a very open communication, and we have experienced mostly positive results in talking to the customer openly from the very beginning.

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

We can confirm that partnerships have increased significantly in our business over the past two to three years. Innovators do have substantially big scientific groups to identify new target molecules and lead structures, trying to find the best fit for the next blockbuster. Further, the departments dealing with medicinal chemistry are rather big, especially as many molecules have to be tested before one promising new entity has been identified. While the process development teams are decreasing in capacity, the need to outsource this activity is increasing. This is the big chance for any CMO to accelerate the drug development. However, it is important to recognize that this model is not free of any risk, and risk-sharing between the pharma company and the CMO must be well-defined from the very beginning of each new project. From our point of view, a milestone concept ideally fits the interest of both partners for their future cooperation.