CPhI 2014 Experts Statements: Christian Jones, Associate Director — Business Development, Dr. Reddy’s
How the Pharmaceutical Ingredients and Custom Synthesis Industry Attunes to Rapidly Shifting Demands
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?
CMOs play a vital role in the value chain today. Many Big Pharma and biotech companies are outsourcing far more than they used to, which means the role of CMOs is much more important than it was 10 years ago. We believe this role will become even more critical in the future as competition increases and the dependency of pharma companies on their suppliers grows further. We will see changes in risk-management profiles: Pharma and biotech will be taking on more risk as they outsource more work, so there will be a need for greater trust and closer relationships between CMOs and their clients. The level of relationships with suppliers will change accordingly, and the value that CMOs bring to the relationship should also increase as the role and outputs grow. Speed is also becoming an increasingly important part of the CMO's role in the value chain. Pharma companies' need for getting products to market and reaching developmental milestones will continue to increase in the future and, as a result, speed of delivery will become a more important factor than cost alone.
2. How have the requirements by pharma companies changed over the years, and how can suppliers manage to live up to them?
In addition to the increased demand for outsourcing, there has been an increased requirement for quality and safety standards. All companies in this industry space have to meet these standards and see them as a basic requirement if they want to continue to do business with others; without them they will not succeed. Those suppliers who are serious about competing are willing to put the extra investment in, not only to meet today's standards but also to ensure they will be able to continue to do business with pharma companies in the future, as quality and safety requirements continue to increase. Speed and trust are also growing in importance, as are the needs for providing global delivery models and flexibility in the supply chain.
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?
Most CMOs operate on a project-based outsourcing approach, but others do offer alternative models. Both approaches have their own merits and their own challenges, and it really depends very much on the project and the CMO as to which should be chosen. No single model will be applicable to all deals, and the CMO should have the flexibility to look at different models to suit its respective partner and ensure that it wins the business, but on the basis that the business won does not pose a risk greater than that which the CMO is prepared to take. The best CMOs always seek to add value that will increase the chances of their client's success independently of the model chosen, which translates to success for the supplier, so the most important question to ask is whether the CMO in the relationship is the right one.
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 potential for success of shared-risk/shared-reward partnerships depends on both the client and the supplier's appetites for such business models. A partnership that successfully establishes projects on this basis can be an effective way to accelerate activity and fill up pipelines. It requires the right combination of client and supplier, where the supplier is willing to take on the additional risk; such suppliers need to be financially healthy and stable in order to support the arrangement. Suppliers with less appetite for risk are less likely to be able to speed up the process under a shared-risk/shared-reward arrangement, so project-by-project approaches are usually more effective in these cases.