Budgeting for New and Unusual Processes
With the promise of finding cures for many, often life-threatening, diseases, gene and cellular therapies have exploded in the last few years, with hundreds of active clinical trials and thousands of pre-clinical research programs. Since Comprehensive Cell Solutions (CCS) provides specialty research products, cell collection, processing and GMP manufacturing, we are often involved from the very beginning in some of these efforts.
The first step is to make a preliminary assessment of the technical requirements and the project’s feasibility. If the customer is a known entity, and the project involves established products or services, most of the work is done and there are little or no variables that may affect pricing. However, if it is research that will venture into unexplored or unproven areas, it will result in a multi-step process aimed to determine the feasibility and cost of the undertaking.
If the initial assessment is positive, we perform due diligence on the organization requesting our services, especially if it is not a large and established company. A more in-depth analysis of the project is started, including review of legal ramifications, regulatory constraints and compliance, operational requirements, timeline, capital expenses, if any, and how to prioritize the potential project within our existing or other pending projects.
At this stage we begin building a financial model and a very detailed analysis of the protocol with the help of the technical team. Using financial models developed for this purpose, costing - of general and dedicated supplies, materials, reagents, equipment, outsourced services, if any, clean room use, if needed, and necessary labor component – is determined. How much training is needed? How will the technology transfer occur? This process is often iterative, as many brilliant ideas conceived and developed in a research lab don’t transfer easily to a clinical setting. In cases like this we need to work with the customer to conform their process to regulatory compliance, operational realities and, occasionally, to realistic business models. In fact, the amount of work to be done at this stage is sometimes so intense that we will enter first into a consulting agreement, before moving to a service or manufacturing agreement.
Final considerations before completing the budget and pricing accordingly include the nature of the work relationship; is it fee for service, research/manufacturing partnership, potential for future, high volume engagement or even a Joint Venture?
These critical components should be considered when implementing a successful research program. Developing, streamlining, managing and optimizing your program does not have to be cost burdening. CCS is one of the few organiztions that can provide in-depth expertise and support in each of these areas, either to those who are in early-stage development or are already established.