CAMBRIDGE, Mass., January 10, 2023 / PR Newswire / – ConcertAI, LLC (ConcertAI), a leader in AI Software-as-a-Service (SaaS) technology and Real-world Evidence (RWE) solutions for life sciences and healthcare, presented at the JP Morgan Healthcare Conference (JPM) today. The overall theme of the session was the tremendous progress the company has made in the past twelve months in deploying new platform approaches at scale for biopharmaceutical company research and development, including a joint translational platform with Caris Life Sciences, Digitally Accelerated Clinical Trials initially deployed collaboratively with Bristol Myers Squibb, and the broad adoption of the company’s reference research data solution, Patient360^TM.

“While 2022 was a challenging year for the industry overall, for ConcertAI it is was a positive period that saw the introduction of two key product platforms for R&D and the emergence of our real-world data (RWD) solutions as the de facto reference standard for the industry,” said Jeff Elton, PhD, CEO of ConcertAI.

In late 2022, ConcertAI and Caris Life Sciences launched a broadscale reference platform for Translational Sciences, announced publicly on January 9, 2023. The collaboration creates the leading, and most comprehensive, oncology translational and clinical development multi-modal research data platform aimed at supporting and accelerating biopharmaceutical drug development and novel therapeutic research. “Caris was the first in the industry to provide Whole Exome Sequencing DNA coverage and Whole Transcriptome Sequencing RNA coverage (WES / WTS) for every patient, which includes mutations, copy number variations, insertions and deletions, fusions and variant transcripts, as well as genomic signatures for gLOH, MSI, HRD, TMB, Caris FOLFIRSTai™, and Caris GPSai™, said Dr. Elton. “The combination of these data and ConcertAI’s collection of research-grade clinical data in oncology, representing the treatment and outcomes of almost seven million patients, provides an entirely new solution for all biopharma Translational Sciences organizations. Among only two significant use-cases, it can guide the design of first-in-human studies and generate insights for approaches patient populations non-responsive to current therapeutics.”

The Caris Life Sciences and ConcertAI collaboration includes unprecedented multi-modal datasets at scale, e.g., whole transcriptomes, whole exomes, digital pathology, clinical, imaging, and medical claims, combined with advanced technologies and scientific expertise. In a statement made on January 9^th, David Spetzler, MS, PhD, MBA, Caris’ President and Chief Scientific Officer, said, “As precision oncology continues to evolve, Caris’ cutting-edge work on tumor biology and molecular biomarkers combined with ConcertAI’s definitive clinical data at scale will have broad implications in the discovery and development of novel signatures and therapeutic options for patients across a range of tumor types.”

Complementing this Translational Platform is ConcertAI’s Digitally Accelerated Clinical Trials solution for oncology, developed in close working association with Bristol Myers Squibb, the world’s largest oncology company with a leading clinical-phase portfolio. The solution is in full production, having advanced the first consented and randomized patients in Phase 2 and Phase 3 trials in August of 2022. The solution is integrated into the research workflows of the clinical research sites such that clinical trials and research become no more complicated than practicing medicine according to the current standard of care. Commenting on the collaborative approach, BMS’ Venkat Sethuraman, Senior Vice President – Global Biometrics & Data Sciences said, “The Digital Trial Solution will allow us to accelerate access to innovative, lifesaving cancer medicines to patients. And we anticipate this approach will become BMS’ gold standard for oncology studies in the future.”

The Digital Trial Solution is specific to the rather unique requirements of oncology clinical trials, where clinical, genomic, imaging and other data types need to be accessed and integrated. Our goals were to lower the burden on clinical sites and patients so that clinical trials could become more accessible in the community settings where majority of patients receive their care. This is also consistent with the FDA’s goals of assuring that trial populations more closely represent those ultimately receiving approved medicines. Marisa Co, BMS VP, R&D Business Insights & Analytics, further noted, “Achieving our first participant enrolled through the Digitally Accelerated Clinical Trial (DACT) model has been a tremendous cross-functional effort and demonstrates BMS’ commitment to use data and technology to simplify and accelerate the clinical research process.”

In 2023, ConcertAI is expanding its trial network across the U.S. in partnership with leading providers, clinical networks, and others. It is also implementing advanced solutions for patient matching to clinical trials, increasing automation tools to lower the support requirements for, or altogether eliminating the need to conduct, activities such as Source Data Verification (SDV).

ConcertAI also reported on the continued progress of the company’s Patient360^TM real-world data solution. In an industry first, Patient360^TM will now include a combination of Structured Clinical Data; Abstracted Clinical Data processed in ConcertAI’s cloud software by cancer-specific Centers of Excellence; medical claims data to allow a broader view of prior history of disease, co-morbidities, oral medications, and use of health resources away from the cancer setting; and Social Determinants of Health to aid in Health Equity and Trial Diversity analyses. This data solution is the foundation to the company’s collaboration with the U.S. FDA that has been in place for a little over a year. Catherine Richards, ConcertAI Chief Data Officer, noted, “We’ve seen an increase in use of our data products of 96% since late 2019, in part because of the close working relationship with have with the biopharma RWE communities. We want to assure that Patient360^TM meets current and future biopharma research requirements by aligning it to the standard of care, capturing data associated with new guidelines, and standardizing key terminologies and concepts for complex areas, like line-of-therapy rules. The approach is working as publications in peer reviewed journals and presentations at medical society meetings based on our data have increased 72% over the last three years.”

In the past two years, ConcertAI has provided support to multiple biopharma companies using Patient360^TM as part of their submissions, providing a valuable view on the current standard of care outcomes, especially for clinical programs targeting rare and non-responsive cancers.

The company also provided a unique view on its business strategy, one founded on high value innovations in DaaS and SaaS solutions. But where the company’s ability to invest at, or ahead of peers, comes from superior financial performance. Dr. Elton noted, “Some of our businesses today are already EBITDA positive and, as we close 2022, we expect they all will be, doing this while we increase our product investments.” As part of that, investment in operations and internal automation are key. As an example of where new product technologies may drive efficiencies, while sustaining quality, ConcertAI noted in June of 2022, at the American Society of Clinical Oncology meeting, that it had achieved accuracy and recall in advanced Natural Language Processing (NLP) solutions in oncology comparable to the company’s clinical human curation levels. This a first in a production solution for commercially available products in the industry.

The company also announced two months ago the appointment of Ronan Brown, PhD, as Life Science Chief Operating officer. And, more recently, Jitendra Gupta joined in a new role as Managing Director of ConcertAI’s India subsidiary, where a new Clinical Development Center of Excellent and other advanced capabilities are being put into place.

“Over the past two years I’ve had the opportunity to witness the impressive impact of ConcertAI’s technologies and data solutions in improving cancer patients’ outcomes,” said Claudio D’Ambrosio, PhD., ConcertAI Chief Revenue Officer. He went on to note, “ConcertAI leadership and colleagues arrive with deep domain expertise and a passion for addressing the greatest unmet medical needs of cancer patients. This leadership teams’ experience and depth of expertise in research, services, and oncology technologies is unprecedented in the industry.”

About ConcertAI

ConcertAI is a leader in Real-World Evidence (RWE) and AI technology solutions for life sciences and healthcare. Our mission is to accelerate insights and outcomes for patients through leading real-world data, AI technologies, and scientific expertise in partnership with the leading biomedical innovators, healthcare providers, and medical societies. For more information, visit us at http://www.concertai.com and LinkedIn.