Translating R&D concepts into confident decisions

QSP has enormous potential to improve biopharmaceutical R&D and inform decision-making across the drug development process. QSP combines computational modeling and experimental data to examine the relationships between a drug, the biological system, and the disease process.  With the ability to leverage vast amounts of biological and pharmacological data, QSP enables the understanding of disease pathophysiology, to identify and test therapeutic strategies in virtual trials with virtual patients.

Certara has differentiated its approach to QSP by building robust, regulatory-ready software platforms for reproducible model development.  Today, those platforms are available for immunogenicity, immuno-oncology, and next, neurodegenerative diseases.  The software is available in proprietary and proven editor tool, with an easy-to-use interface, that delivers models and model results that are reproducible.  This unique approach has been shared with US, EU and Japanese regulators, all committed to advancing the use of QSP in drug discovery, development and regulatory review.

Growing value of QSP

Tackling the most complex challenges

In its July 2020 workshop, the US FDA described this modeling & simulation technology as shifting from “justifying the value of QSP”—to “best practices” implementation. QSP can help answer questions about the most novel compounds and modalities, combination therapy, initial dosing for first-of-its kind therapies, and other vexing development situations:

  • In a given biological pathway, what is the best target and modality for pharmacological intervention to treat a given disease
  • How can we improve the therapeutic effectiveness of an existing drug through combination therapy
  • Can we predict human response (dose) to a novel mechanism based on preclinical data
  • How can we better understand the underlying pathophysiology to identify druggable pathways?
  • Can we predict the effect of a drug in a special population/other indication
  • How can QSP support translation, product differentiation and utility of biomarkers
  • Can we individualize dosing regimen based on patient characteristics
  • How can we optimize clinical trials by accounting for pharmacodynamics interactions with comedications and genotypes

Certara is currently providing QSP consulting services and regulatory support to address the above questions, in therapeutic areas including oncology, vaccines, neurology, CNS, hematology, autoimmune disorders, rare disease, dermatology and gene therapy.

Browse our library of QSP papers
Tackling the most complex challenges
Understanding the Impact of Immunogenicity

Understanding the Impact of Immunogenicity

Innovation in biologic development has led to a marked increase in the approvals of protein-based therapeutics for a range of diseases. Despite the success of biologics, immunogenicity (IG) or the tendency to trigger an unwanted immune response remains an inherent and major challenge. As a result, Certara developed a QSP software platform with support from the seven members of its QSP IG Consortium to predict the IG of biologics and its impact on efficacy and safety in diverse patient populations.

Certara’s IG Simulator, built in a unique regulatory-ready platform supports decision-making from discovery through clinical.  It can take FIH data to design Phase II/III trials, predict impact of disease and co-medication, extrapolate to new populations, and predict if IG can be managed by dosing.  The robustness of this groundbreaking model will facilitate compound prioritization and informing go/no decisions for biologics developers.

Based on our work in IG, we have developed a new QSP platform for vaccines.  The Certara QSP Vaccine Simulator is used to provide dosing recommendations across multiple patient populations for COVID-19, oncology and RSV.

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Advancing Immuno-oncology Therapy

While Immuno-oncology has delivered on its promise for treating a wide range of cancers in targeted populations, the expansion of that success through combination therapy has been more elusive.  QSP is well suited to address this challenge, by understanding and integrating the complex dynamic factors determining efficacy that can lead to better combinations and dosing regimens for a wider group of patients.

Working with a consortium of six leading pharmaceutical companies, Certara has developed a QSP IO Simulator that will enable exploration of different therapeutic combinations, even drugs using different modalities, within virtual populations. The Simulator incorporates compounds’ pharmacokinetics, target binding, and mechanisms of action as well as existing knowledge on the underlying tumor and immune system biology to predict clinical results for novel combinations, and complex biologics such as bi-specifics. The Certara IO QSP platform is actively being leveraged for sponsor-specific projects.

Read our blog on leveraging virtual patients
Advancing Immuno-oncology Therapy
Neurodegenerative Disease Development

Neurodegenerative Disease Development

QSP biosimulation facilitates the understanding of the pharmacological effects of drugs on biological systems—in the case of NDD, the integration of complex interactions of different brain circuits across multiple biophysical scales. We can begin as early as the discovery phase, building from literature data, ‘learn and confirm’ the model via the addition of in vitro and animal data to inform first dose for IND submittal. As we gain further in vivo data, we advance the model to integrate diverse factors including biomarkers and the interaction of different misfolded proteins with neuroinflammation, providing a framework for predicting clinical outcomes.

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The Promise of Gene Therapy has Arrived

Considered personalized medicine, each ‘therapy’ is based on individual patient data detail to repair or enhance faulty genes. Too low a dose might exclude that patient from any future benefit, while too high a dose can be very dangerous, since any immunogenic side effects may be irreversible and could last for years. Threading this needle requires a novel development approach.

Certara’s Virtual Twin-QSP platform has demonstrated success in multiple rare disease gene therapies in predicting and informing Phase I/II and III studies. We create a computer-simulated model of each patient (virtual twin), replicating the patient’s various attributes, including morphology that affect a drug’s fate in their body and hence its effects. Hundreds of virtual twins are simulated in virtual trials to evaluate the impact of different drug doses, schedules, and combinations so that we can predict an optimal dosing regimen for each patient.  Using this proven approach, we are working on AAV-based gene therapy; ex-vivo, in vivo and in situ; lysosomal storage; LNP-based RNA; gene editing; CRISPR/Cas9; and CAR-T technologies.

Download gene therapy brochure
The Promise of Gene Therapy has Arrived
Bio Pic PietGraaf
Piet van der Graaf, PharmD, PhD Senior Vice President, Quantitative Systems Pharmacology

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.

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