How Model-informed drug development rescue projects from a risky situation​

VP, Certara Drug Development Solutions

A Japanese client required urgent support in clinical pharmacology and pharmacometrics expertise for preparing NDA query responses that would be submitted to the PMDA. Certara worked closely with the client team to perform the simulation analysis and prepare response documents addressing concerns raised by the PMDA. Certara supported this client continuously and contributed to achieving their key milestone by utilizing Certara’s expertise in modelling and simulation exercises, as well as regulatory acceptance. Deep engagement with this client enabled us to advance their path to approval together.

Associate Principal Scientist, Certara Drug Development Solutions

A Chinese client in the drug discovery space urgently needed support to address development concerns expressed by potential investors. Certara formed a multidisciplinary team comprising experts in nonclinical, toxicology, CMC, regulatory, and clinical pharmacology, with support from PBPK modelling for first-in-human (FIH) predictions. The Certara team conducted an independent review of the data package and developed a plan to identify strengths, gaps, and potential risks, providing de-risking recommendations to strengthen the clinic-enabling program. Shortly thereafter, the client signed a co-development collaboration with a large pharmaceutical company.

Associate Principal Scientist, Certara Drug Development Solutions

A French client was seeking urgent assistance with conducting indirect treatment comparisons for their NICE submission. Later, they required intensive support for preparing CADTH pharmaceutical reviews and INFARMED query responses in their submission of a Marketing Authorization Application (MAA). The Certara consulting team worked cross-functionally in the most efficient manner, from data extraction to indirect treatment comparison modelling, health economics, and clinical writing. All of our experts were committed to providing high-quality work despite short notice. Through the quality of the teamwork, we gained the trust of the client and continued this collaboration for more than eight years, during which we successfully supported two generations of their drug for its submission and approval in different countries.

Sr. Director, Certara Drug Development Solutions

A US client required assistance to justify being taken off clinical hold for a drug being developed in oncology. Certara’s clinical pharmacology team was assigned as a member of the project team. Modelling analyses were designed and performed at Certara to understand exposure-response for efficacy, safety, QTc, and biomarkers. Additionally, analyses were performed to support the translation of doses in mouse TGI studies to clinic. The analyses contributed to the briefing book, justifying the restart of the trial. The trial has now resumed in the clinic.