By Luc Ruelens, senior director for external supply integration, Asia Pacific, Janssen Supply Chain
Historically, most of the chemical synthesis (execution of chemical reactions to obtain a product) for active pharmaceutical ingredients (APIs) at Janssen were done in-house. In the past decade, however, Janssen has increasingly sourced a substantial part of the early synthesis steps for new molecular entities (NMEs) from CMOs — mainly located in Asia.
Knowing what we want, Collaborating to Get It
In the early 2000s, Janssen was specifically looking for CMOs in Asia that had chemical synthesis and process development capabilities to make the chemical building blocks for complex NMEs. We were also looking for partners who could produce these building blocks in large volumes once the NME was approved. But most importantly, we needed to trust that we could develop the CMO into a reliable, flexible, and compliant partner for multiple products and under various business dynamics. We knew what we wanted, and we were ready and willing to collaborate to achieve it. The goal was to develop a few preferred partners for the early API synthesis steps in Asia.
Taking Collaboration to New Levels
One particular experience added a new dimension to how we at Janssen wanted to work with emerging CMOs in Asia. When we started working with Porton, a CMO located in Chongqing, China, it was for the supply of key building blocks for Janssen’s HIV protease inhibitor darunavir, launched in 2006. We put forward the objective for this NME to have a cost-effective, high-quality, reliable product that we could offer at affordable prices to HIV patients. There were ample challenges, but Porton was confident it could deliver.
Initially, Porton’s focus was on providing the supplies. However, both parties soon recognized the need to collaborate in multiple areas. Porton was looking at Janssen’s expertise at implementing quality and environmental, health, and safety systems, as well as its ability to design, retrofit, and build workshops. So, it made sense for Janssen to dedicate a full-time person to work with Porton to develop a multiyear milestone plan where Janssen experts acted as consultants. Porton took full ownership and hired dedicated resources to quickly translate the consultancy advice and reach the next level of excellence as a capable and mature CMO.
When I look back at Porton’s investments in capacity and capabilities, in attracting experienced leaders in multiple functional areas, as well as Janssen’s focus on systems integration, it’s clear that we came together as partners focused on a common goal. Our collaboration resulted in an integrated API supply chain with the upstream work being done by the CMO and the final API “assembly” steps being done by Janssen.
Carrying Learnings Forward via Customized Collaboration
More often than not, we’ve seen that partnerships with CMOs are strongest in the areas of technology transfer, building capacity, quality systems and cGMP deployment, environmental, health and safety support, and continuous improvement. But we have also observed that it can be challenging for Asian partners to interpret the best way to “create value beyond the contract” and proactively translate the knowledge into sustainable, effective, and autonomous actions.
As a result of our experience with Porton, which clearly demonstrated the value of strategic collaboration, Janssen is investing in the development of its CMOs to help strengthen their ability to strategically partner and collaborate. With the help of a consultant, Janssen has developed a program to aid our Asian partners to better understand and build specific organizational capabilities. The program includes a survey on how the partner perceives Janssen as a customer, a tool to define the partner’s capabilities in the area of strategy and leadership development, communication effectiveness, organization and talent development, financial health, and finally, deep-dive strategy workshops for information sharing. The next step in the program is the addition of a competency model that can be used by the CMO.
Having now completed this program with a few CMOs in China and India, we often see that companies are able to target their investment choices as well as their talent gaps. What’s more, company owners become more aware of their broader role as leaders and collaborators.