Intro to Pharma of the Future?
Why is it so hard to incorporate modeling and simulation into drug development? Why do these powerful tools so often fail to provide satisfactory outcomes?
Many companies have implemented “model-supported drug development,” rather than model-based drug development. These companies have tried simple solutions, such as hiring more scientists and support staff. However, simply increasing demands on existing processes and technology is unlikely to be successful. A rigorous effort is needed to identify the strategic, operational, methodological, and educational changes required to establish model-based drug development. Only then can pharmacometrics be fully integrated into the entire drug discovery/development/commercialization life-cycle.
Enterprise transformation is never easy. Interactions among stakeholders involved in generating, interpreting, and applying modeling and simulation results are highly complex. An effective operational process must achieve the following goals:
- Reduce flow times for performing modeling and simulation activities.
- Increase quality and consistency of modeling and simulation work products.
- Ensure the relevance and timeliness of modeling and simulation results.
- Improve effectiveness of communicating modeling and simulation results to development teams.
- Provide tools to enhance pharmacometrics productivity.
Cognigen Corporation has instituted a Pharma of the Future? (PoF) program as an ongoing research initiative to support this important enterprise transformation. The concepts, technics, and services that we will describe in future blog entries will help the pharma industry implement a pharmacometric process that functions more effectively in the short term while laying the groundwork for future initiatives to further the transition to model-based development.
Cognigen Corporation is well placed to lead the transformation to model-based drug development. In the past 5 years alone, Cognigen scientists have successfully completed more than 100 modeling and simulation projects. We provide pharmacometric services for approximately 20 to 30 drugs per year. Our experience includes most therapeutic areas and spans all phases of drug development from pre-clinical to clinical development, from discovery to commercialization to post-marketing surveillance. Our work has a well-deserved reputation for credibility, and we have successful track record for using pharmacokinetic and pharmacodynamic modeling and simulations to influence regulatory and clinical decision-making. In fact, roughly 25% of NDAs submitted to the FDA incorporate our work as a basis for dose selection and justification.
All this experience in building complicated models has given us the raw material that’s needed for a disciplined examination of the essential elements required to successfully generate timely and relevant modeling and simulation results. The research performed in this “laboratory” has enabled us to develop, test, and implement innovations that reduce costs, increase productivity, and raise the standards of quality and effectiveness of modeling and simulation work products.
Are you hooked? Don’t worry, there’s more where that came from. Read the next entry in the Pharma of the Future? blog: Origins of Pharma of the Future?. If you need to get caught up, peruse the previous post: An Uncommon Vignette?