CTO and co-founder
Dr. Dan Nicolau
Physician and mathematician. Director, AI for Science, KCL.
About Pre.sentient
A trial must stay blinded. It should not have to run blind.
Pre.sentient exists to give clinical development its sight back without sacrificing the integrity that makes blinding essential.
A Phase 3 trial can cost over a million dollars a week, and for almost all of it everyone is flying blind. Failing trials keep enrolling patients, uncertainty around success leads to delayed preparations for it, and established options for improving probability of success are left on the table. Conventional interim analyses were meant to solve this, but they come with an operational burden, have suboptimal performance and are underused.
This has been accepted as the cost of doing business. It does not have to be.
Our mission at Pre.sentient is to bring real-time analysis to trials everywhere.
How it began
Pre.sentient’s origins
Co-founder and CTO. Physician and mathematician, MD and PhD from Oxford.
Having hypothesized the effectiveness of inhaled steroids as a treatment for COVID-19, Dr. Dan Nicolau was Co-PI for the STOIC trial, which tested the efficacy of budesonide for COVID-19 patients recruited from the community. This was an open-label trial due to the ethical and practical difficulties involved in devising and delivering placebo inhalers.
Early in the course of the STOIC trial, a strong efficacy signal became clear and Dr. Nicolau developed an ad hoc, novel method of empirical projection of p-value trend. Together with computer modeling data, this provided a sufficient basis (a p-value of 0.02 before a third of the way in) to justify stopping the trial early. Use of inhaled budesonide to prevent hospitalization in COVID-19 was subsequently adopted into guidance in a number of countries around the world and may have positively impacted thousands of lives. This laid the foundation for our patent-pending rolling outcome prediction algorithm.
Inspired by this, Dr. Nicolau and Dr. Coates founded Pre.sentient Technologies to explore technological solutions that fulfil the priorities of investigators, sponsors and regulators to stop and adapt studies in a robust way at the optimal time. To generalize beyond open-label trials and enable real-time unblinded comparative data to be evaluated without degrading trial integrity, Dr. Coates’ answer was to delineate where a human in the loop was necessary and where it would be inappropriate. This laid the foundation for our patent-pending enclave technology.
Patients in a failing trial carry all of the risk and none of the benefit. Every week that trial continues is a week they could have been offered something better.
Leadership
Built by physicians and mathematicians
CEO and co-founder
Dr. Tom Coates
Physician and former Chief Medical Officer.
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COO
James Merrick
Operations, compliance and commercial partnerships.
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Head of Engineering
Fergus Nelson
Secure product delivery.
Advisers
Reviewed by the people who set the standards
The methodology is guided by leaders who have directed regulatory statistics, shaped global guidance, founded clinical trial technology companies, and advised hundreds of development programs.
Regulatory science
Lisa LaVange
Former Director of the Office of Biostatistics at the FDA's Center for Drug Evaluation and Research, and President of the American Statistical Association in 2018.
Clinical trial software innovation
Dr. Paul Bleicher
Founder of Phase Forward, the clinical trial software company acquired by Oracle, and former Chief Executive of OptumLabs.
Clinical trial statistics software
Yannis Jemiai
Former CSO of Cytel. Statistician.
Healthcare innovation
Dr. Alex Oshmyansky
Radiology physician, co-founder and Chief Executive of Mark Cuban Cost Plus Drugs, named to the TIME100 Health list.
Follow the science as it develops.
Stay current with Pre.sentient’s latest thinking, research, and progress through our publications, perspectives, and industry events.