CMC Project Plans: A Critical Tool for Early-Stage Biopharma

The Challenge for CMC Teams

CMC activities are critical to early-stage biopharma companies preparing for commercialization. Growth of the company depends on the CMC team achieving milestones, which are technical and cross-functional. They also typically require capital investments. CMC teams operate in environments of significant uncertainty with changes triggered by evolving clinical, regulatory, and even business strategy decisions. Success requires efficient internal and external coordination and communication, and the company may stumble if it does not appropriately address the impact of these changes on CMC operations.

CMC project plans are part of strategic planning.
Ashutosh Pandit is passionate about leveraging data to support informed management decisions. With his experience in financial modeling, research, consulting and data analytics, he provides project management and coordination support for major CMC, Quality and Supply Chain initiatives with a focus on bridging the gap between technical and business perspectives.

CMC needs to work closely with counterparts in preclinical, clinical, quality, and regulatory groups. Each deal with uncertainties such as results from studies and feedback from the agencies. Uncertainty increases the complexity of managing projects across functional areas. It makes it more difficult for CMC leaders to monitor and complete the hundreds of tasks on schedule.

In fact, many of our clients face situations where delayed activities on the critical path can trigger program-level delays years down the road. Simple tasks such as report completion/approval in the near-term can avoid delays in later BLA/NDA submission.

In this uncertain and investment-intensive environment, effective project planning and management is vital. Most companies we work with use CMC project plans to navigate activities, milestones, and turbulence across Process Development, Analytical Development, and MSAT sub-teams. Depending on management preferences, CMC teams may build simple project plans capturing broad milestones and key activities. In other situations, they may build out a more comprehensive plan that captures activities in detail. Either way, good CMC project plans create connections within tasks and across sub-teams, define durations and deadlines, allocate resources, and identify the magnitude and timing of significant costs.

Without project plans, CMC leaders tend to focus on core operations and immediate risks, ignoring the downstream impact of secondary activities.

One Highly Effective Approach to Project Planning & Management

In our work, we try to ensure clients have the ability to make sound decisions before a potential crisis arises.  To do this, we help them align and link required resources (both people and money) to project plan tasks. This provides functional leaders with more data-driven information and an understanding of the implications of activities, risks, and decisions.  It also enables more informed budget discussion and decision-making with finance and senior management, particularly in high investment areas including contracting with CMOs and test labs, ordering key materials with long lead times, and increasing headcount.

In one recent engagement, Converge helped a client use the project plan to demonstrate resource constraints in their Analytical Development team. The team was overworked and stressed to deliver on expectations. They were developing and qualifying methods, overseeing analysis of batch samples, supporting process development, and investigating out-of-specification events. By outlining activities, effort levels needed, and resources available, they showed how they needed additional resources to achieve the desired time frame. It also indicated that the current state would delay critical activities that could risk important company milestones.

Key Takeaways

  • CMC projects in development-stage companies are complex, expensive, cross-functional and they involve a high degree of uncertainty. Managing these projects is very challenging.
  • Effective project plans help CMC leaders focus. They spend time on key and at-risk items that require immediate attention rather than trying to attend to everything.
  • CMC project plans should not only capture key activities, but also designate associated connections, resources, and costs.
  • Appropriately managed project plans provide the basis for sound budgeting and resource planning. They also allow management to quickly measure and evaluate the impact of strategic changes.

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