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?

We indeed see a higher involvement of the contract manufacturer not only in drug development but also all along the development chain first - and after launch all along the supply chain, ideally till the dosage form is ready.

This surely speeds up developments and reduces development costs - and may be a solution to pharma's problems of having too few drug-development projects and too high development costs? It also requires a closer cooperation with the pharma client, as well as to expand the fields of expertise of the CMO. Building a one-stop shop - with the potential drawback of building a generalist that misses expertise in one or more fields. I expect as a consequence a series of consolidations aiming to build drug-development and manufacturing experts out of CROs, CMOs, and formulation and packaging specialists.

Umicore follows the trend, willing to stay in its niche of expertise, though, and is developing closer and deeper relationships with its current clients, expanding according to their needs its expertise in highly potent API development and manufacturing, including all necessary logistics and regulatory support.

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

We have also noticed the request for change from a catalyst and API supplier to a solution provider. As a catalyst supplier, we have improved our service, developing and customizing precious metal sourcing support, offering more efficiency and flexibility in precious metal recovery as well as more expertise in metal separation. We have also improved our development capabilities and can do accelerated catalyst development and scale-up, going from the idea to production in only a few weeks.

As a HPAPI - highly potent API - manufacturer, we have noticed that GMP and regulatory requirements are higher and higher, and that generic manufacturers need to start their developments earlier. And we cope with these requests with a better dedication and more focused resources, be it technology- or regulatory-wise.

We generally believe that bringing the best experts around the table leads to a better solution than trying to do everything alone. We have developed a network of complementary experts, and we encourage more and more of our clients to enter multiparty cooperation, in which we bring them on-demand and on-time world class expertise in drug development, process R&D, process optimization, catalyst or API development, scale-up and manufacturing, logistics, and regulatory affairs - a la carte.

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?

We consider a project-based outsourcing as the clearest option: with transparency towards targets, timelines, costs, risk-sharing, allocated resources. We believe it is the most value-creating cooperation mode, which may be because it is for Umicore the best compromise between the level of flexibility we want to offer to our clients as a solution provider and the level of flexibility that our research, development and production resources can handle.