real-world data Archives - Medical Design Sourcing

AI oncology startup ConcertAI raises $150M in Series C funding

Real-world data (RWD) specialist ConcertAI has closed a $150 million Series C funding from the investment firm Sixth Street.

The Cambridge, Massachusetts–based startup has achieved a $1.9 billion valuation.

“Our Series C represents another milestone in our emergence as the leader in accelerating biomedical innovations through AI SaaS clinical trial solutions and improved patient outcomes through the generation of real-world evidence for peer-review publications, regulatory decisions, and clinical interpretation,” said ConcertAI CEO Jeff Elton in a news release.

ConcertAI specializes in analyzing clinical and genomic data as well as conducting RWD analyses for regulatory purposes to inform clinical trial design.

The company has extensive, independent, deep datasets linked to claims data.

The company has alliances with biopharma companies, including Janssen and Bristol Myers Squibb (BMS).

In September 2021, Janssen and ConcertAI deepen…

Harnessing the power of real-world data requires careful consideration

Image courtesy of Pixabay

The use of real-world data (RWD) has boomed during the pandemic, but the pharmaceutical industry has only scratched the surface in terms of tapping its potential.

The use of such data, however, is set to grow, given the FDA’s recent release of new guidance concerning the use of electronic health records and medical claims data for regulatory decision-making for drugs and biologics.

Two years ago, some people in the industry questioned “whether RWD would have any application in the world of clinical development,” said Jeff Elton, CEO of ConcertAI. Those days are over. It is now clear that RWD is important, given the FDA guidance and the surge in use in RWD during the pandemic.

The level of rigor concerning RWD is set to grow, given FDA’s feedback concerning the use of such data in clinical trial designs, trial interpretation. “The expectati…

ConcertAI and Janssen deepen data-science collaboration

A multi-year partnership between Janssen Research & Development (NYSE: JNJ) and ConcertAI (Cambridge, Mass.) will focus on using real-world data and AI for oncology applications involving multiple cancer types.

ConcertAI will work “almost an extension of [Janssen’s] R&D development process,” said Jeff Elton, CEO of the company. The two companies’ teams will work closely together with ConcertAI providing data, technology and clinical data scientists.

The two companies began working together in late 2019 and have since partnered on a number of programs, some of which progressed to the clinic, regulatory submissions and regulatory approvals.

Elton said that the recent collaboration is “a major expansion of what we first put into place in 2019.”

ConcertAI and Janssen are also working together to support clinical trial diversity. “We’ve been using some specialized data sets to ensure that clinical trials didn’t unwittingly exclude certain racia…