Most CDMO companies have been trying to establish more strategic partnerships with pharmaceutical companies for some time. To date though, biotechnology and pharmaceutical companies have dictated their terms and general approach to project-based when outsourcing to CDMOs, based on a transactional basis. The recent pandemic has completely changed this and created a huge opportunity for CDMO companies because now biotechnology and pharmaceutical companies can’t operate efficiently without them. The sheer volumes and speed required for drug development and distribution is now expected to become the norm. All parties, though, can benefit hugely from more strategic partnerships, not just the CDMO sector.
- 1 Strategic CDMO Relationships
- 2 Define CDMO Relationship Approach
- 3 Next Steps for Maximizing a CDMO Relationship
Setting up a strategic relationship means leveraging each company’s expertise to mitigate risks for a common goal. These have to be carefully defined although they could include any, or all, of the following steps when working with a Contract Development and Manufacturing Organization:
- Collaborative manufacturing network planning
- Technology transfer collaboration
- Leverage regulatory know-how
- Innovative contract structures
- Encourage manufacturing transparency
One of the first things to consider when partnering with a CDMO is how to review capacity planning, including how many sites are available. Together though, they can conduct scenario assessments and highlight the gaps that need to be filled. By doing this exercise together, the companies maximize both teams’ skills and expertise.
A collaborative project with a CDMO can speed up technology transfers to become a competitive advantage for both parties. This means being open about each other’s data and being willing to learn about their various approaches to manufacturing. Furthermore, the teams will need to communicate clear goals and comprehensive data.
Some CDMO businesses have exceptional regulatory teams and pharmaceutical companies need to be able to trust them and rely on them for new production processes. This alleviates the pharmaceutical company’s workload and increases the time to market.
Traditionally, a CDMO would charge pharmaceutical companies on a fee basis for their services. Today though, each business can propose various structures, for example, a reserved capacity model or a project based approach.
As mentioned, each business needs to be willing to be transparent, within the remit of competition law of course. Fundamentally, all teams need to be on the same page when it comes to capacity capabilities, quality issues, supplier delays, and throughput volumes.
Many strategic relationships fail because of a lack of leadership or a misaligned vision. It’s therefore critical for both the CDMO and pharmaceutical company to take the time upfront to plan and layout all the details, including rules of engagement. Unfortunately, it’s easy to jump into execution and forget the importance of the people aspect. Ultimately, a project is only as successful as its people and their mindset.
- Operate as ‘one team’
- Establish joint metrics
Key characteristics of a successful partnership are trust and respect. Of course, a business can’t just state this because trust and respect involves acting accordingly, at all levels. For example, having team members on each other’s sites shows that the businesses can trust each other. It also helps people to get to know each other on a personal basis. After all, getting to know each other as people, rather than just colleagues, is the first step of developing a true relationship that goes beyond transactional.
It almost goes without saying that communication is the basis for any successful relationship. Regardless, it’s important to know what that means in practice for both the CDMO and pharmaceutical business. For example, what mediums will be used to communicate, and how often will project updates occur? Another question to ask is who’s who and how can they be approached within the respective businesses?
Clearly, good project management involves setting clear and realistic metrics. As data is collected and shared though, the teams gain greater knowledge about each other’s capabilities and how to continuously improve together. The more shared metrics between a CDMO and a pharmaceutical company, the more likely the teams will collaborate.
Some businesses call this a playbook. Whatever terminology you want to use, it’s very helpful to detail processes, decision-making approaches, IP development best practice, and common techniques for the teams to use. Another good tactic is to review lessons learned together and to be open about how to work on those together as one team.
All successful relationships involve a shared vision with clear processes and expectations. There are many opportunities for a pharmaceutical company to partner with a CDMO. They simply need to remember that people are involved and need role-model leadership to establish trust and mutual respect. Then, choose the CDMO that has the right expertise and the willingness to adapt through mutual learning. With these foundations, a successful relationship is bound to develop.