Model-informed precision dosing gains scientific support

Certara has published four new papers to provide the necessary evidence to bring model-informed precision dosing to clinics

Certara, the company behind the modelling of 90% of FDA approvals in 2018, has announced its latest push to bring model-informed precision dosing (MIPD) to the point of care. The company has published four new MIPD papers in recent months, outlining the path to making individualised dosing a reality.

MIPD uses computer modelling and simulation to predict the drug dose for a given patient that, based on their individual characteristics, is most likely to improve efficacy and/or lower toxicity compared with traditional dosing. MIPD is particularly useful when dosing patients who belong to a vulnerable population, who are at increased risk of drug-related harm, so improved dosing will likely enhance their care.

This is not only a problem for individual patients, it is also a significant societal problem because drug-related harm is estimated to cost about US$42 billion a year globally.

Professor Amin Rostami, Certara CSO, said: “We believe that MIPD will enable the healthcare industry to complete the transition from the traditional ‘one size fits all’ drug dosing through the current ‘stratified/average population’ dosing to reach the goal of ‘individualised’ dosing.”

MIPD's path so far

The knowledge behind the push comes from Certara’s experience in model-informed drug development (MIDD), which uses similar modelling methods to predict how a new drug in development will affect patients. To determine how to apply MIDD advances to MIDP for adoption in clinics, Certara collaborated with colleagues in pharma, academia and global regulatory agencies.

The results of Certara’s 2016 Health Care Summit on MIPD, published in 2017, concluded three main future areas of focus:

  • Computer models exist that can assess individualised dosing but more data are required to feed them.
  • Further consideration needs to be given to the implications of using MIPD tools from both a regulatory policy and pharmaceutical development standpoint.
  • Getting clinicians to adopt MIPD will require evidence-based efficacy and cost-benefit analyses.

Certara has since been working to address these points, conducting research to add to the data in their models, collaborating with regulators and publishing evidence in the form of papers.

Future mainstream adoption of MIPD

The US FDA approved its first companion MIPD tool for octocog alfa, which is used for the treatment and prevention of bleeding in patients with hemophilia A. Based on this milestone and the momentum of MIPD, it is anticipated that MIPD adoption will follow a similar path to MIDD, which would result in it becoming a required element in clinical practice within a few years.

Tom Polasek, Medical Director of MIPD at Certara and lead author on three of the new MIPD papers, said: “Certara is proud to be collaborating with MIPD pioneers and conducting scientific research to generate the data needed to advance this field and improve patient care. We believe that the co-development of companion MIPD devices and/or apps during drug development will help drive adoption and we are strongly supporting those.”

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