Modeling and simulation can help guide critical decisions around dosing and toxicity, efficacy and mechanism of action, clinical trial design and cohort selection, and commercial probability of success as compared with existing therapies or others in development.
QSP models are inherently complex and difficult to use in a clinical setting. Rigorous model reduction methods alleviate the complexity, bolster the use of QSP models for valuable gains, resulting in the extraction of a practical useable model from biological understandings.
Mounting healthcare and R&D costs, high drug attrition rates leading to decreased numbers of new molecular entity approvals, and growing demands from regulators and payers indicate that a paradigm shift is needed to improve efficiency and productivity across the drug development continuum.
Certara’s Phoenix Technology Services team helped Arvinas integrate D360 Express with McNeil’s Assay Capture and Analysis System to facilitate structure-activity relationship analysis and save time.
Quantitative systems pharmacology models were used to help identify potential drug development risks for inhibitors of the enzyme fatty acid amide hydrolase (FAAH) as a treatment for pain and suggest hypotheses to address these risks.
The Certara team helped develop a quantitative framework that bridges the disciplines of pharmacology, epidemiology, and health economics to support meaningful dialogue between industry, regulators, and payers.
Scientists from Certara’s Strategic Consulting division helped Alios Biopharma develop a novel drug to treat respiratory syncytial virus (RSV) infection in infants.
Certara’s due diligence/asset evaluation teams are comprised of drug development and commercialization experts who advise on acquiring or investing in emerging biopharma companies.
Certara performed scientific and commercial due diligence of an investment opportunity (Rivipansel for Vaso-Occulisive Crisis in Sickle Cell Disease) for a private equity firm.