Newsletter today PYC FDA8 May 2024 15:01
FDA’s Center for Drug Evaluation and Research (CDER) announces new Quantitative Medicine Centre of Excellence
At Physiomics we have long understood the importance and application of quantitative medicine in the development of new therapeutic drugs. Over the years we have used this expertise to strengthen our clients’ evidence and understanding of their drugs’ behaviour, in both safety and efficacy, to de-risk their development journey.
By establishing the QM Centre of Excellence, an institute dedicated to application and development of quantitative modelling and simulation approaches, the FDA are recognising the need for this expertise in streamlining development of new therapeutic drugs.
The aim of the QM Center of Excellence is “to facilitate and coordinate the continuous evolution and consistent application of QM across CDER”.
Furthermore, this is another signal that the regulators are increasingly encouraging and expecting model-based evidence in regulatory applications and assessments. To learn more about Physiomics’ expertise in quantitative pharmacology and how this can be applied to de-risk decisions and make the development of your therapeutic pipeline more efficient, please get in touch!