BMS taps Concerto HealthAI to bolster protocol design

By Maggie Lynch

- Last updated on GMT

(Image: Getty/jirsak)
(Image: Getty/jirsak)

Related tags Bms Bristol-myers squibb Artificial intelligence Precision medicine RWE RWD

Bristol-Myers Squibb enters a multi-year strategic agreement with Concerto HealthAI to use machine learning to aid in protocol design for precision treatment and improved patient outcomes.

Concerto HealthAI focuses on using oncology-specific real-world data (RWD) and artificial intelligence (AI) enabled insight solutions to generate real-world evidence (RWE). The company will work with Bristol-Myers Squibb to apply AI to accelerate trials through the clinical development of synthetic control arm studies.

Per the agreement, Concerto HealthAI’s RWD and AI insights platform eurekaHealth will be used to explore RWE for regulatory purposes, validate clinical application for AI solutions, and execute clinical studies. 

Jeff Elton, CEO of Concerto HealthAI told us, “eurkeaHealth is the top, middle, and bottom of our insight generation and next best action capabilities – the bottom supports the integration of data from different sources and is centered around a patient-centric data model; the middle allows AI to accommodate the ‘missingness’ and messiness’ that is often found in real-world data while speeding insights through ‘intelligent models’; and the top allows insights to be translated into protocols, sites, and actions.”

With the increased use of RWD, there has been a “rapidly emerging”​ use of synthetic control arms to replace what has been a standard of care or placebo arm, according to Elton.

“We use AI, machine learning and other approaches to predict who may respond, making higher powered and lower cost studies,” ​he explained. “We can also use AI and machine learning approaches to identify super- and lower-responders, focusing studies and approaches on these populations to assure the best possible outcomes for all subpopulations no matter how small.”

Regulatory organizations push RWE use

Recently, the 21st Century Cures Act accelerated the adoption of RWE-based approaches to clinical trials and post-approval studies.

In December 2018, the US Food and Drug Administration (FDA) reinforced its commitment to expanding the use of RWD in studies by issuing a framework to assess RWE in regulatory decisions and approvals.

Elton explained that with an increased demand for RWD by the FDA, the size of RWD data sets, and the increasing power of deeply abstracted data and AI approaches, it is possible to deploy RWE centric clinical development and an outcomes research operating model. 

Related news

Show more

Related products

show more

Saama accelerates data review processes

Saama accelerates data review processes

Content provided by Saama | 25-Mar-2024 | Infographic

In this new infographic, learn how Saama accelerates data review processes. Only Saama has AI/ML models trained for life sciences on over 300 million data...

More Data, More Insights, More Progress

More Data, More Insights, More Progress

Content provided by Saama | 04-Mar-2024 | Case Study

The sponsor’s clinical development team needed a flexible solution to quickly visualize patient and site data in a single location

Using Define-XML to build more efficient studies

Using Define-XML to build more efficient studies

Content provided by Formedix | 14-Nov-2023 | White Paper

It is commonly thought that Define-XML is simply a dataset descriptor: a way to document what datasets look like, including the names and labels of datasets...

Related suppliers

Follow us


View more