Tech-driven Services and Software
With more than 90 novel drugs that leveraged Simcyp for approval and scores of other drugs for which Simcyp answered key regulatory and development questions, a list of key applications include:
- Drug-drug interaction simulations – perpetrator and victim
- Absorption modelling – formulation effects/bioequivalence, food effect
- Dosing for special populations – pediatrics, elderly, organ impairment, disease conditions, ethnic differences
- Evaluation of drug performance from extrinsic factors – smoking, alcohol
- Novel routes of administration – dermal, inhalation, long-acting injectable
- Biologics – mAbs, ADCs, other proteins, cytokine mediated DDIs
- Virtual bioequivalence and formulations for complex generics
- Early PK prediction, FIH dosing
Immunogenicity (IG), the ability of a therapeutic product to trigger an immune response in the body can be ‘desired IG’ to support vaccine and allergen response or ‘undesired IG’ causing immunologically related adverse events. Certara’s QSP team has developed a regulatory-ready software platform (Simulator) for managing both wanted and unwanted IG, a pivotal tool to guide clinical and regulatory decision-making in drug development. QSP can provide insight early in the development process (for example, predicting IG from protein sequence alone or extrapolating from pre-clinical assays) and ultimately be used to leverage vast amounts of biological and pharmacological data to address larger challenges such as phase 2 failures.
In short, QSP enables the understanding of disease pathophysiology to identify and test therapeutic strategies in virtual trials with virtual patients.
Our Simcyp COVID-19 Vaccine Model has won an R&D 100 Award, which recognizes the top 100 “R&D pioneers and their revolutionary ideas in science and technology” in the past year. The model, which is incorporated in Certara’s Vaccine Simulator, has been used by major pharmaceutical companies and allows researchers to study how a vaccine is handled by the human body in computer-generated, virtual populations.
Piet van der Graaf, PharmD, PhD
With over 20 years of experience working in the pharmaceutical industry at Sanofi and Pfizer, Piet brings considerable skill and experience to QSP projects and contributes to the strategic development of Certara. He is also Editor-in-Chief of CPT.
Hannah Jones, PhD
Hannah has over 18 years experience in global pharmaceutical organizations, possessing a particularly strong background in PBPK and PKPD modelling, She has over 50 publications in PBPK/PKPD modelling and other DMPK related topics, and considerable experience influencing drug research and development programs through modelling and simulation.
Karen Rowland Yeo, PhD
Since 2002, Karen has led projects relating to the extrapolation of in vitro data to predict in vivo pharmacokinetics in humans. This has included development and implementation of the models into the Simcyp Simulator. Her specific research interests include physiologically based pharmacokinetic modeling and prediction of drug-drug interactions.