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Part 7. What Nova's approach can be used for

TL;DR​

The model is updated progressively with the new information collected in answering the current question, which helps answer the next one. That creates a sequential process, a virtuous circle, guiding the development and marketing of future treatments.

Everything above (see Boxes 3, 4, 5, 6 and Figure 1) points to the same conclusion: Nova's approach can answer questions across the whole lifecycle of a new therapy, using the Absolute Benefit (AB) and the Number of Prevented Events (NPE), the events that matter to patients, as the outcome measures for the individual and for the population.

Two advantages come with those measures. Successive decisions during development are taken against the same yardstick, and at any point one or more comparators or future competitors can enter the process against the same criteria.

Box 10 lists the questions the approach can address, always aiming to maximize AB and NPE. And at every stage, the general one: do you go on or not?

Box 10: Questions addressed by the Nova approach during the R&D and translation to market​
  • The exploration of new therapeutic approaches
  • The search for a target or a combination of targets
  • The optimization of the mode of action, i.e. search for parameters of the drug-target interaction
  • Prior to starting to shift to human clinical trials, what is the predicted dose-response-effect relationship?
  • Once the PK is known, what is the refined dose-response relationship?
  • What is the mechanism of action (i.e. the systems and systems entities and functions) involved in the efficacy?
  • Should the drug be developed as a combination? With which other compound?
  • Demonstration of surrogacy
  • Responders
  • The optimal regimen
  • Interactions with the components of the standard of care
  • The design of clinical trials such that the cost is minimal for a contribution of new information and with a maximum chance of success
  • Virtual control arm(s): placebo, competitor(s)
  • Reduction of uncertainties of real-life application
  • Pricing
  • Time

The model built to answer the first question is updated progressively with the new information collected in answering it, and that helps answer the next one. The result is a sequential process, a virtuous circle (see Figure 1), guiding the development and marketing of future treatments.