In the rapidly evolving field of biotech/pharma drug development, the success of a therapeutic program highly depends on a robust chemistry, manufacturing, and controls (CMC) strategy. Successful R&D project proposals in the area of drug development often include CMC tasks as central elements of development plans. So, what should you consider to safeguarding your CMC strategy?
1. Adequately timing the integration of your CMC program
- The later you start with your CMC plan, the higher the possibility that your product development will be delayed due to missing data and repetition of experiments. As a result, your development costs and time-to-market will increase, which may have a serious negative impact on the return on investment (ROI) for your investors.
Early integration of a strong CMC strategy in your R&D project will undoubtedly strengthen your development plan and will increase the chance to secure the best funding schemes for your innovation. Ideally, this integration already takes place at the early preclinical phase. You can hardly start too early with designing your CMC plan.
- Early integration allows you to anticipate the identification of critical CMC parameters, including:
- Designing and refining manufacturing processes to ensure efficiency, reproducibility, and quality.
- Optimally defining your drug substance (DS) and drug product (DP) formulations.
- Adequately assessing appropriate analytical methods for process control.
- Allocate sufficient time and budgetary resources to set-up the right strategy and to execute the activities. This is something we often see underestimated in the design and financial planning of R&D projects.
Adequately designing a feasible and thoroughly planned CMC strategy and obtaining quotes to make a good cost estimation is critical for success. By ensuring to have these details worked out, funding agencies and investors are also more likely to emit a positive assessment, generating confidence in your development plan. Most importantly, by investing in a credible CMC strategy and cost structure, you will pave the path to successfully completing the full product development path on time.
2. Understanding Regulatory Requirements
- Ensure that you thoroughly understand and comply with the specific and rapidly evolving guidelines for CMC implementation that regulatory authorities (e.g., EMA, FDA) impose on drug developers. This is essential to ensure successful navigation towards receiving investigational new drug (IND) / new drug application (NDA) authorization(s).
- Include a strategy for early engagement with regulatory agencies in your R&D project plan. This is crucial to obtain first-hand information for a solid CMC strategy and to anticipate critical challenges, such as:
- Staying up to date with the regulatory landscape to avoid delays.
- Timely identifying pathways towards accelerated review and approval, reducing time-to-market, and unlocking commercial opportunities sooner.
Early engagement with regulatory authorities as a central part of your R&D project planning is usually highly appreciated by funding agencies and investors, as it demonstrates that you adequately assess critical stakeholders to guarantee your project’s success.
To conclude, when developing a novel therapeutic product, setting-up a sound CMC strategy and obtaining the right input from regulatory agencies should be part of your first actions to plan for success. By doing this, you increase the chance to secure the required financing / raise the right amount of funding and accelerate your product development towards making your new treatment available to patients as soon as possible.