The Benefits of Modeling and Simulation in Drug Development
Modeling and simulation, also known as “model-informed drug development,” has already had a profound impact on drug development, yet its full impact is just now coming to light.
Modeling and simulation (M&S) has the proven ability to influence every phase of the drug development process, including the commercial decisions around the benefits of even bringing a specific drug to market. One of the most important elements of biosimulation is that it allows you to carry over the knowledge and the wisdom from one phase to the next, and from one indication to the next, both in terms of successes and failures. M&S transforms data into information and information into knowledge.
M&S Delivers Scientific and Commercial Benefits
- Ability to make data-driven decisions at all stages of drug development through a quantitative framework;
- Leverage all available data on the drug in development, as well as public data on competitors, to achieve the target product profile;
- Design safer, targeted and more efficient trials;
- In some cases, eliminate the need for clinical trials;
- Select the right dose for the right patients, the first time;
- Simulate virtual patients in hard to recruit or test patient populations, such as pediatric, pregnant women, elderly and/or organ impaired;
- Maximize the probability of commercial success.
Certara is a global leader in M&S, providing technology, services and solutions to the biopharm industry. As the leader, the organization is committed to developing, integrating and delivering the most current scientific knowledge into our portfolio. To that end, we recognize the criticality of modeling not only in informing key decisions, but as valuable strategic currency with regulators in bringing new therapies to patients quicker and more efficiently. M&S delivers enormous power when systematically integrated across the drug development process. Certara works with its clients to connect model outcomes and strategy to regulatory writing and submittal.