Why the pandemic is enabling a data-driven approach in oncology

Cancer diagnoses and screenings dramatically dropped during the peak of the COVID-19 pandemic.

Recent data from tens of thousands of patients suggest that the U.S. is likely to see at least two years of increased cancer diagnosis rates and poorer outcomes, according to Jeff Elton, CEO of ConcertAI.

EHR data reflect a pronounced drop in pan tumor diagnoses and multiple myeloma (MM) diagnoses.

Against that backdrop, Elton recommends that the oncology field adopt a data-driven approach to optimize patient care in the wake of the pandemic.

On one level, the dip in diagnostic rates in the early days of the pandemic was not surprising, given how common lockdowns were in early 2021. At that time, it seemed likely that the situation would play a role in driving later-stage oncology diagnosis. The problem is especially evident in the hematological malignancy population.

“The early phase of the pandemic — before vaccination — really hit peop…

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Why research on hematologic malignancies is ramping up

Micrograph of a plasmacytoma, a hematological malignancy. [Image courtesy of Wikipedia]

Oncology has benefited from a wave of advances in recent decades. From 1991 to 2018, the age-adjusted overall cancer death rate dropped 31%, according to an analysis from American Association for Cancer Research (AACR). That death rate dropped 2.4% between 2017 and 2018, marking the most significant annual reduction.

The reasons for such improvements are multifaceted, including falling smoking rates, improved diagnosis and more effective drugs.

The popularity of immunotherapy has played a vital role in improving treatment outcomes of certain cancers. “It is amazing to think about how much immunotherapy has changed the practice of oncology,” recently wrote Dr. John M. Burke in Targeted Oncology. Burke, a hematologist and medical oncologist at Rocky Mountain Cancer Centers, said data from the past two decades…

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Ethics matter when deploying RWD and RWE

Image courtesy of FDA

Because adoption of real-world data (RWD) and real-world evidence (RWE) remains at an early stage, individual biopharma executives are likely to take on a central role in ensuring that such data — and the related use of AI — are handled ethically. It becomes imperative that drug developers using RWD ensure transparency, apply consistent rules, peer reviews and develop best practices when dealing with biased research data.

The ethical dimensions of RWD are poised to “become a much bigger topic of conversation,” said Jeff Elton, CEO of ConcertAI, which just hauled in $150 million in Series C funding.

That said, FDA has released a series of guidance documents related to RWD and RWE in recent years with some recommendations for dealing with incomplete data. In essence, the agency stressed studying the representativeness of RWD and, if it is not fully representative of a t…

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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…

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Why RWD and RWE are poised to continue gaining ground in 2022

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While the present adoption of real-world data (RWD) and real-world evidence (RWE) remains early, such data promise to accelerate regulatory decision-making and support the approval of new indications for drugs already on the market. 

“We’re now seeing real-world data being used and consulted almost 100% of the time to design a protocol for a study,” said Jeff Elton, CEO of ConcertAI. “That was not the case three or four years ago. That’s a pretty fast transition.” 

It also helps that the FDA has also sharpened its focus on RWD and RWE. For example, late last year, the agency published proposed guidance related to data standards for product submissions with RWD. The agency also weighed in on the use of RWD and RWE to support regulatory decision-making for drugs and biological products with specific advice for data from electronic h…

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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…

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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…

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