Stephanie Wilburn
Senior CMC Project Manager | BrevisRefero
In a perfect biologics manufacturing world, a Sponsor would be able to sign a contract with an experienced CDMO and voilà, a product meeting all specifications would be ready to ship in a few months’ time. But life, and science, unfortunately doesn’t work that way. Instead, engaging with a newly signed CDMO is a complex process that involves detailed planning, on-the-fly technical and operational problem-solving, and constant teamwork and collaboration between Sponsor, CDMO, consultants, suppliers, vendors, shipment couriers, etc. Having strong Chemistry, Manufacturing, and Controls (CMC) technical project management expertise on the team is an integral part of managing this process to keep activities on-track, and to mitigate impact to timeline, budget, and resources, all the while maintaining a strong working relationship between the parties involved. Effective project management is not just about Gantt charts and action trackers, but dynamically utilizing a wide kit of tools with expertise, while developing many other tools ad-hoc to meet the distinct requirements of the program and critically solve problems real-time. In the end, experienced CMC technical project management ensures that all the many puzzle pieces fit in your biologics development and manufacturing, no matter how challenging the puzzle, to drive forward a successful project.
"Effective project management is not just about Gantt charts and action trackers, but dynamically utilizing a wide kit of tools with expertise..."
Contract Generation, Budgeting, & Timelines
Contract generation is not only about legal terms, but there are critical considerations required at this stage on the program’s technical requirements, transfer of information, and impact to timelines and budget. In this stage, it is essential that there is a clear technical understanding from the Sponsor on the requirements of the defined CDMO work, driven by the end requirements of the product and upcoming clinical trial. During contract generation, without adequate review, required activities can often be missed and adding these activities later in the process can result in significant financial and timeline repercussions. Detailed technical review of the contract content is paramount, where technical project management and review can help identify key gaps and initiate essential discussions with the CDMO. It can identify whether both budget and timeline are reasonable given the required scope, and with respect to budget this review can identify areas of significant cost savings or identify an underrepresented budget that would have inaccurately influenced future budgeting and financial decisions. For timelines, a critical review can identify areas to streamline activities, which could significantly reduce overall program timelines, or can identify unrealistic timelines that would have inaccurately influenced the planning of future activities and estimated timing to reach the clinic.
"Detailed technical review of the contract content is paramount, where technical project management and review can help identify key gaps and initiate essential discussions with the CDMO."
Project Execution & Tracking
Throughout project execution, adept technical CMC project management is paramount to drive forward activities, through facilitating proactive problem-solving between all parties with use of standard and novel project management tools. The workflows of CDMO activities feed into the many critical future program activities (i.e. Formulation Development, GLP Tox studies, Stability studies, QC testing, Fill/Finish, Clinical studies etc.), so it is essential that the CDMO activities are well-managed and tracked to ensure successful hand-offs between stakeholders. Well defined tracking tools help to identify project gaps and clearly determine if CDMO activities are steering off-track, and if so, their overall impact to timelines, budget, and resources. It is critical that these tools are dynamic, and constantly reviewed and updated, to ensure that their use most effectively represents the current project status.
Templated project management tools can be helpful as a starting point for creating a comprehensive project plan; these, combined with a technical project management lead with CDMO experience, are crucial in customizing the tools to the specific program requirements. These tools include Gantt charts and trackers for action items, budgets, and invoices, but there are requirements for more CMC-specific applications to closely track, including:
· Pre- (and post-) manufacturing batch record reviews
· Bill of materials and ordering status
· Exception documents such as deviations and out-of-specifications
· Risk mitigation plans
· Shipment status
· Release and stability testing
It is important to critically define the tools that are most important for the program, based on scope and involved parties, and then to adapt them as required. When gaps in tracking are identified during project execution, more innovative tools may need to be proactively created. This constant evaluation of project requirements is essential to ensure all aspects of the program are being tracked, and to minimize any surprises from missed risks. The overall result? Reduced impact on timelines, enhanced timing of key hand-offs, and greater certainty on budgets and resources, which are all critical components to a program’s success.
"It is important to critically define the tools that are most important for the program, based on scope and involved parties, and then to adapt them as required."
Project Close-Out & Reconciliation
Once a manufacturing campaign has been successfully completed, close-out and reconciliation are important activities that require attention to detail to meet clinical material supply timelines. This includes batch and testing documentation being obtained from the CDMO to ensure full traceability and backup documentation is available to the Sponsor. It is important that this is completed throughout the course of manufacturing and wrapped up soon after manufacturing completion. Effective project management tracking of document/file structure and document naming convention plays an important role in identifying any missing elements.
Going back to a CDMO well after batch release to request missing documentation significantly increases risk that required documents are not able to be located in a timely manner. As well, detailed project management final budget review and reconciliation prior to full project closure helps mitigate risks of unexpected charges down the line.
Overall, strong technical CMC project management of CDMO activities is essential to the success of a biologics development and manufacturing program. Project management, and its associated tracking and monitoring activities, should be driven by the Sponsor, either through internal experienced resources, or by consultation with a technical CMC project management professional. This support is essential at each stage of project progression and can ensure that your biologics development and manufacturing program successfully reaches clinical trials to the benefit of the patients in need…on time and within budget!
If you would like a free, no-obligation consultation to talk about your biologic drug development outsourcing, planning, budgeting, or execution then please reach out to us at:
contact@brevisrefero.com or call us at (905) 636 - 6559.
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Stephanie Wilburn
Senior CMC Project Manager | BrevisRefero
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