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?

CDMOs - contract development and manufacturing organizations - play an increasingly important role in the pharmaceutical supply chain, offering services from API - active pharmaceutical ingredient - synthesis through to packaging and shipping of finished dose products around the world. The drivers of growth within the CDMO sector remain the same as historically, with continued mergers within the pharma sector, reduced pipeline activity and the rise in generic prescribing all driving decisions around make versus buy.

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

A new future trend is that the CDMOs are changing themselves with merger activity driving scale, breadth of technology and geographic reach. Increasingly the CDMO sector, which was traditionally focused on development and manufacture, is overlapping with other sectors involved in electronic data transfer and management and supply-chain logistics, as they look for areas of expansion in nontraditional sectors.

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?

Quality and reliability remain the cornerstones of the pharmaceutical supply chain, and that has not changed. In fact, there are ever-increasing requirements from traditional regulators and agencies and also from newly emerging markets, which continue to drive the demands on the license holders and their supply-chain partners. CDMOs that can offer reliability and security of supply of product to international markets and work to reduce risk and help achieve inventory-management goals will continue to grow.

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

A challenge which both the CDMO and traditional pharma industry face is how to meet these requirements cost-effectively, particularly as localization of manufacture and market-specific regulatory requirements, such as serialization, drive an increased fixed-cost base in markets with small demand and often low reimbursement rates.