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September 24, 2021

Managing timelines is a shared challenge for contract development and manufacturing organizations (CDMOs) and their clients, with important implications for both parties. For cell and gene therapy developers, delays mean lost time and resources that can negatively impact the pathway to commercialization for their products. For CDMOs, delays impact capacity and resource planning.

CDMOs and their clients must work to understand and mitigate timeline risks so that there is minimal impact on project success. A CDMO’s project management (PM) team will be the client’s main partner in developing and managing timelines and holding various internal and external stakeholders accountable. Where needed, the PM team also serves to facilitate an escalation path to help resolve challenges. In this post, we will outline how the PM team can help manage timelines and avoid delays.

 

Understanding Risk

When developing project timelines, there are many potential risks. However, the two broad types of risk that should be top of mind are technical risks and operational risks (Table 1).

Technical risks involve issues that can arise with the process and/or analytical testing, such as contamination, process deviations and failures. Technical risks make timelines one of the most unpredictable factors in Good Manufacturing Practices (GMP) production. Until the manufacturing teams have gained experience with the process, it is difficult to anticipate the exact challenges that may arise. Both the CDMO and the client need to be prepared to problem solve in real time. Given the developing nature of the field, many cell lines, processes, analytical controls, and other technical elements are not standardized or even well understood, and therefore technical risks are inherent in every project. By applying their expertise and knowledge (e.g. understanding of regulatory guidance, experience working with similar processes and test methods), the PM team at a CDMO can help clients manage technical risk. This is achieved by clearly laying out the risks, addressing worst-case scenarios, and developing mitigation strategies in a transparent and collaborative manner.

Operational risks involve issues that arise outside of the technical realm, such as documentation delays, supply chain issues, changes in client strategy and even staffing changes. The PM team will use their expertise and experience to identify operational risks and respond proactively. Here are key examples of how operational risks can be mitigated by the CDMO:

  •  Understanding documentation requirements and managing both parties’ expectations regarding document turnaround time will help the PM team design a framework to address requirements efficiently;
  • Assessing material requirements and ordering long lead-time items early can help remove them from the critical path and thus minimize project delays; and,
  • Cross-training amongst project team members will allow for the seamless progression of work and reduce the risk associated with unforeseen staffing changes.

Effective risk mitigation will stem from the application of core project management principles. Expect the project planning phase to include a clear definition of the critical path, the identification of dependencies, and a risk assessment.

Table 1: Broad risk categories and how to approach them

Risk Type Definition How To Approach It
Technical Issues that arise in the process (e.g. contamination, process failure)
  • Acknowledge that every project has risks
  • List all technical risks
  • Identify worst-case scenarios
  • Identify interventions
  • Involve clients early and often in the identification of risks and creation of mitigation plans
Operational Issues that arise outside of the process (e.g. documentation delays, supply chain issues)
  • Recognize risks early
  • Define their impact
  • Identify mitigations
  • Be proactive and transparent with clients

 

Clear, Timely and Transparent Communication

To build a strong working relationship between a CDMO and client, clear, timely and transparent communication is critical. This demonstrates a true desire and dedication to project success and is a value-add for many emerging biotechs that are navigating the challenges of bringing new cell and gene therapies to market.

The PM team should have a sufficiently strong technical background to clearly describe the reasons for a potential or actual delay, the associated risks, the mitigation plan, and impact to the project. Clarity on delays helps clients learn more about their process and develop mitigation strategies to avoid problems during future scale-up production.

In addition, timely and transparent communications are equally important. Although some communications will undoubtedly be challenging to both deliver and receive, clients appreciate knowing sooner rather than later and understanding how the CDMO plans to carry out next steps to get the project back on track.

Contact us (cdmo@ccrm.ca) to find out how our PM team can be a strong advocate for your success.

 

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