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The pace of oncology drug development is moving at the speed of life. Approvals are trending up, giving cancer patients more treatment options to stay ahead in their fight and change course if they experience a setback.
A key factor behind this favorable trend is the systematic implementation of model informed drug development, or MIDD, and its advancement by regulators like the US FDA.
MIDD is a comprehensive approach to drug development that aims to cut clinical trial failure rates by fifty percent using both mechanistic models based on preclinical and literature data and statistical models derived from clinical data.
Among the many benefits it offers biopharma sponsors, MIDD informs better decisions at every phase and stage and increases the probability of success in clinical studies by selecting the right dose, the right treatment duration, and the right patient population.
With a broad portfolio of MIDD technology applications and services, as well as a cross section of scientific expertise, Certara can uniquely advise sponsors how and when to systematically integrate MIDD into their programs.
And our MIDD capabilities in oncology research span from preclinical through post marketing.
In early stage development analysis, our quantitative systems pharmacology tool, or QSP, helps answer vexing questions.
And in late stage development, MIDD offers capabilities that focus on efficacy and safety.
Certara is the industry’s leading practitioner of MIDD.
Across all therapeutic areas, we’ve helped our biopharma industry partners successfully bring more than two fifty new drugs to market with an integrated MIDD approach.
In oncology, our team includes twenty experienced clinical pharmacology scientists.
That experience translates into results as we support more than one hundred oncology programs with MIDD and help our partners navigate FDA Project Optimus requirements.
Increase confidence in your oncology drug development decisions from molecule to market. Find out how Certara’s model inform drug development dream team can help you systematically integrate MIDD into your oncology R and D programs.