The US Congress urges the FDA to engage with drug sponsors to explore greater use, where appropriate, of in silico trials for advancing new drug therapy applications.

"FDA FY 2017 - Significant Items - Senate Appropriations Committees Significant Items" - Click here for more details

in silico clinical trials Best-in-class clinical trial simulation and disease modeling platform

NOVA’s unique positioning relies mainly on being able to simulate in silico clinical trials in the same conditions as in vivo (same endpoints, clinical outcomes, patient population) and offering a tool that breaks the internal silo between modeling experts and R&D teams. Providing our sponsors with a very high degree of quality and validation, with a fully whitebox approach for in-depth auditing.

Each model component is seamlessly traceable from the model documentation back to each primary source of information to ensure full auditability.

Our team of expert biomodelers apply standard operating procedures, from knowledge curation to computational model calibration and validation, which have been refined over the past decade through multiple projects in various therapeutic areas.

JINKO

Problem formulation

Project Plan

Systemic knowledge review

Knowledge Model

Computational Models

Computational models of disease & treatment

Virtual population

Inter / intra-patient variability

Model validation

Validation report and in silico study protocol

Simulation

Research report

US FDA selected NOVA for the Model-informed Drug Development (MIDD) pilot program in 2019 to present its approach to model design and validation.

FDA
nova
applications

Mechanistic models of disease and virtual patients are aimed at helping drug developers generate new insights and manage the complexity of human biology.

NOVA’s methodology enables users to predict a target or drug candidate’s clinical benefit on virtual patient subgroups potentially years before pivotal trials can be conducted, by combining disease models, drug candidate submodels and virtual patients.
The range of applications from early research through to market access for a single disease model is described below:

  • Discovery

    Streamline target identification & secure proof of concept
    • Explore efficacy of various targets & combinations treatments
    • Explore transability from animal models to humans
    • Prioritize compounds into clinic
  • Clinical Development

    Optimize trial design & capture best responders
    • Explore various regimens dose, number of administration(s) per day, time between administrations, duration of treatment
    • Identify subgroups of optimal responders /theranostics biomarkers
  • Market Access

    Demonstrate value to payers
    • Transpose Phase 3 trial results into a virtual population representative of specific geographies and context
    • Benchmark competing treatments

NOVA’s modeling expertise combines mathematical models of disease and treatments with virtual patients into an integrated clinical trial simulation platform called JINKO.

in silico

In a nutshell, disease and treatment computational models are built based on knowledge extracted from literature and data.

Then, to simulate a trial, these models are run on virtual patients to predict the clinical efficacy of new drugs at the population level before trials on human subjects take place.

in silico How do in silico clinical trials work?

The disease model itself is a combination of various interrelated pathophysiological sub-models.

They are constructed by mapping all the biological phenomenon known to be involved in the corresponding processes and characterizing the functional relationships (mostly biochemical reactions) linking these phenomenon.

In practice

First the normal biology is modeled, then the perturbations leading to the disease state are introduced, and finally the treatment model is plugged into the disease model to simulate the action of a drug candidate on the system.

content Do you want to learn more about in silico clinical trials ?

Take a look at our white book

Go to download page
In Silico white book

Therapeutic areas of expertise

NOVA has developed expertise in various therapeutic areas: oncology, rare diseases, metabolic diseases, immune-based diseases, cardiovascular diseases, infectious diseases.

We are a trusted partner

  • Enyo
  • Takeda
  • Janssen
  • Innate
  • OM Pharma
  • Theratech
  • op2
  • Erytech
  • Elsalys
  • Shire

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