10 August 2020 - - US-based biosimulation specialist Certara has developed a new biosimulation platform for COVID-19 vaccines and launched major enhancements in its Immunogenicity and Immuno-oncology QSP platforms, the company said.

Certara has partnered with leading, global pharmaceutical companies on these advancements to help de-risk and speed up drug discovery and development.

Certara's QSP platforms have vast potential to improve biopharmaceutical research and development and inform decision-making, such as vaccine development for COVID-19.

With many COVID-19 vaccine candidates in the pipeline, determining which vaccines are best for various populations cannot be answered quickly enough through traditional vaccine development timelines.

Certara is developing a QSP platform for COVID-19 to test vaccine candidates across multiple patient populations.

By creating virtual patients and virtual trials, this new vaccine platform will facilitate dosing strategies for a range of patient cohorts impacted by COVID-19, such as the elderly and children.

Furthermore, Certara launched version 3.0 of its Immunogenicity QSP Simulator, which can integrate diverse inputs, including bioinformatics and in-vitro assays, enabling compound prioritization and informing go/no go decisions.

The IG QSP Simulator has been validated with 20 clinical case studies. Certara also launched version 2.0 of its Immuno-oncology QSP Simulator, which addresses solid tumors and will include blood cancers this year.

The QSP platforms contain robust regulatory-ready models that can be used and reused extensively to answer key questions that are difficult to study experimentally.

In addition to IG, IO and vaccines, Certara will be launching a new QSP program for neurodegenerative diseases later this year.

Certara optimises R and D productivity, commercial value and patient outcomes through its unique portfolio of model-informed drug development, regulatory science, and market access solutions.

In fact, 90+% of all novel drugs approved by the US FDA in the past six years were supported by Certara software or services. Its clients include 1,600 global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 60 countries.