Six Benefits a Biotech Company Should Expect from Their CDMO Program Team

When an emerging biotech company collaborates with a contract development and manufacturing organization (CDMO), the dedicated program team plays a pivotal role. The program team often includes representatives from analytical services, R&D, engineering, operations, and quality, with technical and regulatory support available if needed. Here are six important benefits a biotech company should expect from their CDMO interactions:

1. Effective Communication and Coordination - A well-run program team ensures responsive and transparent communication. Deliverables are clearly understood by all stakeholders, and project milestones are met in a timely fashion. This coordination is crucial for the smooth progression of the project.
2. Comprehensive Support - This includes technical guidance from analytical services, R&D, engineering, operations, and quality, with regulatory support available as needed – often a critical need for pharmaceutical startups. All relevant departments are represented on the dedicated program team, with the program manager responsible for monitoring progress of the project and ensuring the scope of work is executed as planned. Having a regulatory team available to consult is beneficial to support the sponsor from early-stage clinical milestones through new drug application filings.
3. Direct Interaction with Technical Experts - By having representatives from each important subject matter departments on the team, the client can interact directly with the technical personnel working on the project.
   
   Megan Kuikstra, program manager at Grace, notes, “I think it’s extremely valuable that we facilitate direct communication between our subject matter experts and our sponsors—between people with the same technical expertise. We foster those relationships, which often continue outside the meetings. It allows for even better collaboration and trust.”
4. Regular and Flexible Meetings - A strong relationship grows through transparency and ongoing communication. Regular weekly or biweekly calls keep the client informed of progress, while the program manager acts as the single point of contact to address questions or concerns.
   
   Kuikstra explains, “In addition to our team calls, I set up regular one-on-one meetings with my direct contact on the customer side. Those calls could be once or twice a month, or if we’re in a stage where the timeline is very tight, we might have a quick daily touchpoint. We’re very flexible in our approach, which enables us to modify the meeting frequency depending on the stage of the project.”
5. Adaptability to Changing Needs - A customer-focused program team is ready and willing to adjust to changes in the sponsor’s needs. Whether it’s accelerating the project following positive results, increasing product volumes, or responding to regulatory requests, the team is flexible and accommodating to ensure the project's success.
   
   Kuikstra emphasizes, “We really try to be as flexible as we can, because we understand that changes happen when products are in clinical development. That's one of the things that we pride ourselves on—adjusting for and accommodating our customers when changes are needed. We really want to build a partnership with our customers.”
6. Experienced and Consistent Team Members - The expertise and experience of the program team members in areas such as process and analytical development, quality, and good manufacturing practices (GMP) are invaluable. A veteran team can leverage its process development history to effectively solve any problems that might arise, mitigate risks early on in the process, and ensure quality with cost-effective solutions that accelerate project timelines. Maintaining the same team members throughout the project lifecycle ensures that critical knowledge is retained, which is particularly beneficial when there are staff changes on the customer’s side.
   
   Kuikstra adds, “The team’s direct knowledge of the project history can really help move a program forward more smoothly. It’s particularly relevant when the customer’s program team undergoes staff changes. In those situations, we provide that historical context and background knowledge for them.”

Addressing the Needs of Emerging Biotechs

A young biotech company, especially one bringing its first compounds to market, needs a CDMO program team that acts as a trusted partner and collaborator. The team provides tailored guidance on regulatory pathways, phase-appropriate development, and detailed support for regulatory filings, such as preparing chemistry, manufacturing, and controls (CMC) documentation for an investigational new drug (IND) application. They can also assist with technology transfer, guiding the startup through the transition from laboratory-scale production to larger-scale manufacturing.

Whether a biotech company is emerging or established, a dedicated CDMO program team offers invaluable support through effective communication, technical and regulatory guidance, and adaptability to changing needs. By fostering strong relationships and maintaining consistent team members, the CDMO program team ensures that biotech companies at any stage of the API lifecycle can navigate the complexities of drug development and bring their products to market successfully.