Major platform advancements demonstrate applicability of biosimulation to accelerate drug discovery and development
PRINCETON, NJ – Aug 10, 2020 – Certara®, the global leader in biosimulation, today announced the development of a new biosimulation platform for COVID-19 vaccines and major enhancements in its Immunogenicity and Immuno-oncology QSP platforms. 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.
“Our QSP program has reached a state of development that can be scaled and leveraged across many development programs and therapeutic areas,” said Piet van der Graaf, PharmD, PhD, senior vice president of QSP at Certara. “The models can be used extensively to answer ‘what-if’ scenarios with virtual patients throughout the drug development process. Immunogenicity and immuno-oncology are our lead platforms, but now we are rapidly advancing a new platform for COVID-19 vaccines.”
Furthermore, Certara launched version 3.0 of its Immunogenicity (IG) 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 (IO) 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.
“We are proud to bring these updates to our users and look forward to continuing to optimize QSP models for drug discovery and development. By collaborating with industry leaders, we have been able to tackle major challenges impeding drug discovery and development, including new modalities, target selection, and combination therapies, working closely with our QSP partners. We all share a common goal of developing promising treatments for those who need them the most,” said Rob Aspbury, president of Certara’s Simcyp Division.
For more information about Certara’s QSP program, please visit https://www.certara.com/services/quantitative-systems-pharmacology/.
Certara optimizes R&D productivity, commercial value and patient outcomes through its unique portfolio of model-informed drug development, regulatory science, and market access solutions. 实际上，在过去六年，美国食品药品监督管理局 (FDA) 批准的所有新药中有 90％ 以上都是由 Certara 软件或服务提供支持的。Its clients include 1,600 global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 60 countries. For more information, visit https://www.certara.com/.