FDA Partners with COTA Inc. to Embrace Real-World Evidence for Breast Cancer Insights

Jul 10, 2019 | Breast Cancer, Cures Act, FDA, Oncology, Real-world data, Real-World Evidence, RWD, RWE

Breast Cancer Insights

COTA, Inc. positions itself as a leading precision medicine technology company utilizing real-world evidence to bring clarity to cancer care, recently announced it has signed a two-year Research Collaboration Agreement (RCA) with the U.S. Food and Drug Administration (FDA) Information Exchange and Data Transformation (INFORMED) Program, the agency’s data science and technology and incubator supporting regulatory science research. The RCA will establish a study protocol with an initial focus on breast cancer, and will provide the FDA with information on the evolving treatment landscape, including insight on treatment variation within defined subpopulations of patients.

We live in exciting times when it comes to the merger of technology, science and innovative new approaches and processes.  There is a lot going on just with the FDA alone.  With such a fast general pace, we will slow things down for a basic question and answer breakdown of this deal and the players.

The Federal Authority

A reminder that the 21st Century Cures Act spurs the idea of “Real-world evidence” in clinical research. This act brings a compelling prospect: that the drug and health companies can include data from electronic health records, claims data and other data sources to augment the more time consuming and expensive gold standard of controlled, interventional clinical trials. The federal law encourages the executive branch enforcement agency, the Food and Drug Administration, to embrace the emerging paradigm.

What is the Issue FDA is Trying to Resolve?

Only 3 to 5% of all adult cancer patients participate in clinical trials.  This represents an unacceptably low number given the enormous number of cancer trials that could help those in need today.  This deal, it is hoped, will help the FDA better understand the broader treatment of cancer through the application of real-world evidence (RWE) under the INFORMED Program.

Hopefully, the RWE generated through this collaboration will be enriched using the COTA Nodal Address® (CAN) patient classification system, allowing for deeper insights and greater understanding of the variance of patient treatment and outcomes.

More on the Issue

Sean Khozin, MD, MPH, Director of the INFORMED Program for the FDA, reports that “Traditional clinical trials typically have very strict eligibility criteria and don’t always reflect the range of characteristics of patients in the real world.”  Dr. Khozin continued, “Real-world data provides an opportunity to improve our understanding of the experience of a broader patient population in support of developing tailored treatment decisions at the point of routine care.”  Note for our readers, Dr. Khozin’s position generally dovetails with our recent perspective on RWE v. RCT.

Real-World Breast Cancer

With 332,630 new breast cancer cases just in 2018 alone, further data is required to understand how such drugs can impact patients outside of clinical trials. The RCA provides a growing real-world observational database for the FDA, allowing for an improved understanding of treatment and outcome differences among the general population of patients with breast cancer.

The FDA and COTA Partnership

The two plan on being on the front lines of where oncology and precision medicine are rapidly unfolding and evolving; the two seek to develop “a strong understanding of the functions of RWE and improving the lives of cancer patients everywhere,” reported Mark Doyle, CEO of COTA.

Who is COTA Inc.?

Formed in 2011, COTA is private start-up that has raised $65 million from strategic VC investors, including some big corporate players in the clinical trials space such as IQVIA, Celgene and Novartis.   Other investors include Memorial Sloan Kettering Cancer Center, Boston Millennia Partners, Horizon Blue Cross Blue Shield of New Jersey, Hackensack Meridian Health and Atoc Holdings. Founded by doctors, engineers and data scientists, COTA brings a patient first approach to cancer care through the use of real-world evidence.

COTA’s patented CNA system can provide fragmented, often hidden data from the real world to provide clarity in cancer care. Combining clinical expertise in cancer with proprietary technology and advanced analytics, COTA’s platform helps inform decisions and action in oncology. They partner with providers, payers and life science companies to ensure everyone touched by cancer has a clear path to the right care.

COTA Finance and Business

We estimate COTA to employ about 100 employees with a cost structure estimated at $12m to $15m per year. As Cota Inc. is private, it is difficult to determine revenue and P&L but we have general estimates.  One thing is clear, they have a line up of elite industry sponsor, academic medical center and venture capital participants.

What is the COTA Nodal Address™(CNA) System?

As reported during their 2018 $40 million capital raise, this platform is a powerful and unique precision disease classification system built on its comprehensive real-world data set.

What does this platform do? First, it connects to electronic medical records systems. Thereafter, the technology pulls out the key structured and unstructured data elements from the record. The system then organizes the data in a usable, harmonized format for data analytics.  Then, the COTA Nodal Address System allows an analyst to group the patient data using what they claim is a patented technology called the COTA Nodal Address.  It is essentially a “role up” of all the key clinical features that any oncologist would agree are the ones that are needed in order to reasonably forecast prognosis and to select optimal treatment choices.

One of the real challenges associated with healthcare data analytics is that analysts often rely on the ICD codes for analytical purposes; however, ICD10 codes were developed primarily for billing.  The codes simply lack the level of clinical granularity that a physician, a care team or a population health team needs to make important decision.

Once CNA secures and organizes all of the data, advanced visualization tools can be configured for superior data visualization.  This helps oncologists make the best possible decisions about patient treatment options.


INORMED is an incubator for collaborative regulatory science research focused on supporting innovations that enhance the FDA’s mission of promotion and protection of public health. The research portfolio of INFORMED is focused on data science and health technology applications such as the use of real world-data for clinical evidence generation, the utility of biosensors and the internet to quantify intrinsic factors, including the patient’s experience.

FDA scholars covered INFORMED in an academic journal Nature.


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