applications Why most drug programs fail ?

Whether pushing the boundaries of science with highly innovative therapies (gene editing), struggling with a small number of patients to confirm therapeutic hypotheses (rare diseases) or having to choose between thousands of options (target combinations in immuno-oncology), most drug programs fail to secure approval either because of safety risks or lack of efficacy.

While leading the world in spending on R&D, the pharmaceutical industry is lagging behind in applying computer simulation to increase its innovation potential.

in silico

In silico clinical trials - the computational modeling of diseases, drugs and patients, have become a strategic priority for regulators worldwide.

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.
application

Mechanistic models of diseases and virtual patients aim at helping drug developers generate new insights and manage the complexity of human biology.

In silico serves to explore and de-risk a large number of hypotheses in order to optimize in vitro and in vivo explorations and ultimately deliver better drugs to patients faster.

  • Discovery

    • Select the right target
    • Explore combinations of target/treatments
    • Support the translation from animal to man
  • Clinical development

    • Explore various regimens (dose, number of administrations per day, time between administrations, duration of treatment)
    • Identify subgroups of optimal responders / theranostic biomarkers
    • Leverage real-world data to inform clinical trial design
  • Market access

    • Demonstrate value to payers
    • Transpose Phase 3 trial results into an estimation of the drug’s public health impact
    • Benchmark against competing treatments

nova has applied its unique expertise in the past in NASH, COPD, Hepatitis B, immuno-oncology and cardiovascular diseases.

Julie

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