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?

In the area of drug discovery and development, the concept risks have increased because innovation pressure forces the companies to move into new modes of action and indication areas. At the same time, supply risks and regulatory requirements have intensified further due to squeezed timelines and stricter enforcement of quality-related regulations. In an effort to effectively manage the development process, pharma companies have to focus on managing their core processes such as research, clinical trials and the regulatory approval process. Other processes, such as route finding, process development, scale-up, optimization and production of the API itself, are equally important for approval, but do not represent core areas for pharma companies. Pharma has to join forces with reliable and strategic partners for development, scale-up and production to assure high quality for approval and supply for launch at reduced costs through efficient asset use and design to value.

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

We have observed an increased demand among pharma companies for quality and capacity under tight timelines with needs for innovative route finding, reliable and sustainable project management and short response times. Consequently, a CMO must meet these requirements by building best-practice project management and by providing flexible development and production capacities for various technologies in compliance with cGMP. Also, the CMO must have an impeccable regulatory track record.

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?

Outsourcing adds value if the supplier provides a more cost-effective service due to innovation, is faster thanks to its focus on development, and produces reliably at high quality levels. Close cooperation with the pharma company is essential as well, which requires strong project-management capabilities by the CMO. A well-defined technology platform, long-standing experience and reliability are the core prerequisites for a CMO to become a strategic and valuable development and manufacturing partner.

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

Sharing the risks and rewards can yield good results if it is done wisely. For this, it is important to identify the existing risks and to determine who in the value chain might be able to manage them best, at least partially. The risk for a drug-approval process in clinical trial Phases I-III, for instance, cannot be thoroughly estimated and managed by a CMO. However, an experienced CMO offers the know-how necessary to identify and manage the risk involved in finding a cost-effective alternative chemical route for API production. Wisely allocated risks and rewards as illustrated in this example create and add value along the value chain, allow for better risk management, and accelerate the drug discovery and development process. We are convinced by and committed to this approach.