Industry collaboration aims to advance the development of synthetic arms in clinical trials
Phesi, a data-driven provider of AI-powered clinical development analytics products and solutions, has announced it has entered into an exclusive strategic collaboration with clinical AI technology company, Sensyne Health, which is making an equity investment of $10 million in Phesi.
The investment will be used to accelerate Phesi’s and Sensyne’s product roadmap. For Phesi this means further development of its trial planning, protocol design and investigator site selection platform, featuring ClinSite. For Sensyne, this means the growth and ‘industrialisation’ of its data platform. The collaboration will see Sensyne anonymised real-world evidence data set of 6.1 million patients analysed alongside Phesi’s data, which today covers 30 million clinical trial subjects.
Together, the companies will provide an enhanced offering of clinical trial and real-world data predictive analytics, enabling life sciences organisations to quickly and safely determine the feasibility of replacing or supplementing a comparator or placebo arm with a synthetic arm.
‘For more than a decade, Phesi has been applying data to solve problems – helping clients to optimise clinical development and become data-driven organisations. This collaboration with Sensyne Health is the next step in our plan and underlines our commitment to transforming clinical development,’ commented Dr Gen Li, founder and president, Phesi. ‘COVID-19 has exposed long-standing issues in clinical development that our expertise in data and analytics help to solve. By collaborating with Sensyne Health, we can support clients even more comprehensively by delivering real-world data alongside our own trial data to optimise development planning and improve synthetic arm analysis. Data and analytics play a crucial role in designing and delivering urgent medicines in acute and chronic disease around the world, and I’m excited to see Phesi play a leading role.’
Rt. Hon. Lord Paul Drayson PhD, CEO and founder, Sensyne Health, commented, ‘Phesi was a natural partner for Sensyne Health because of its established track record in supporting leading life sciences companies. The collaboration creates a compelling offering aimed at accelerating the development of pharmaceutical products, fundamentally improving patient care, and enabling us to offer the global pharmaceutical industry a compelling combination of expertise and data across real-world and clinical data, at the forefront of innovation in clinical development.’
This collaboration with Sensyne Health is part of Phesi’s long-term aim to help clients take a data-driven approach to clinical development. This has become particularly critical given the challenges caused by COVID. Through ClinSite, clients can apply historical patient data accumulated over many decades to benefit clinical development programs, for example through developing optimised Target Patient Profiles (TPP). Through the joint offering with Sensyne Health, clients will also be able to identify opportunities to use a synthetic comparator arm. This includes minimising the sample size of a placebo arm or avoiding exposing patients to a placebo altogether. Pooling data from similar or identical trials using the same agent, with real-world patient data, will reduce patient and site burden, and the time and cost of conducting the trial.
‘Today, the pharmaceutical world is immersed in data, but it can’t yet make sense of it. It is imperative that the industry addresses this challenge – particularly when it comes to the use of synthetic comparator arms that reduce the burden of clinical trials on patients, and optimizing trial design,’ commented Dr Gen Li. ‘As the industry, including regulators, becomes more aware of the power of data, we must not miss this opportunity. Eliminating the ethically questionable placebo arm of a clinical trial is within reach. The sector has huge volumes of data available to it, that when analyzed via a synthetic comparator arm allow it to model precise outcomes. Together with Sensyne Health, we can help clients make safe and accurate synthetic comparator studies a reality, in addition to the existing use of analytics to streamline study design and accelerate trial conduct.’
The agreement between Phesi and Sensyne Health was completed on the XX January 2021; Dr Gen Li, Phesi’s CEO and Founder, also become a strategic advisor to the Board of Sensyne.