CPhI 2014 Experts Statements:Dr. Rudolf Hanko, CEO, Siegfried
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?
There are numerous challenges to the industry that make investments for captive production capabilities increasingly unattractive: growing demands on clinical development, increased competition between innovators and generic companies, and a lower risk appetite among investors. This is a growing trend, which renders development offerings of the CMO industry increasingly attractive. The discovery process, however, will remain the home turf for captive activities of innovators.
2. How have the requirements by pharma companies changed over the years, and how can suppliers manage to live up to them?
Integration of the value chain, especially between drug substance and drug product, becomes increasingly important. That's why our unique selling proposition as a company with expertise in both primary and secondary production and our excellent compliance track record are key. The corporate strategy focuses on the continued development of these strengths. Our acquisition of Alliance Medical Products (AMP) in the USA gives us outstanding skills in the field of sterile fillings, and we've also invested in a high-potency suite in Zofingen - these steps broaden our technology base. At the same time, our new manufacturing facility for APIs and intermediates in Nantong (near Shanghai, China) is nearing completion and will begin operations this year - further enabling us to improve our offer to the market.
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?
Value-based outsourcing on the basis of long-term strategic partnerships is and will be an attractive trend.
4. The establishment of shared risk/shared reward partnerships has increased significantly. Can these partnerships accelerate drug discovery and fill up the innovation pipelines?
Risk sharing, as stated above, will benefit both sides in development and launch as CMOs have an attractive offering to leverage such risk. On the discovery side, those risk-leverage sharing opportunities are much less pronounced. As a conclusion, we don't see an increased fill of the pipeline but a better management of pipeline failure and leakage.