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Saama-Led Consortium Seeks Data-Driven Answers to COVID-19

CHICAGO – A group of life sciences and bioinformatics companies have banded together in the race to find treatments, vaccines, and a cure for COVID-19.

The fledgling EndPandemic National Data Consortium said last week that seven firms have signed on to the group within two weeks of its formation to work toward data-driven responses to SARS-CoV-2 and related COVID-19 disease. They plan on integrating and analyzing data from current and future clinical trials and clinical records to accelerate research.

Clinical analytics firm Saama Technologies launched the EndPandemic National Data Consortium with a call for partners on March 30. By April 14, they had signed up six others: Andaman7, producer of a multilingual COVID-19 patient symptom survey that integrates with many electronic health records and medical devices; immune monitoring and biomarker development firm Caprion Biosciences; epidemiology analytics platform developer Clineron; multiomics data integrator Indx Technology; and digital health and life sciences consulting firm Zaylan Associates, in partnership with strategic consultants Chrysalis Biomedical Advisors.

Ken Massey, chief life sciences officer of Saama Technologies, based in Campbell, California, said that company Founder and CEO Suresh Katta has a long history in developing data aggregation and visualization technologies and in philanthrophy, so he decided that he wanted to help the COVID-19 response in any way possible.

"Our concept was, let's make available for public use our platform," Massey said.

Former US Department of Veterans Affairs Secretary David Shulkin has been a special advisor to Katta for about a year.

"We won't find rapid solutions for the SARS-CoV-2 pandemic with our data remaining so fragmented," Shulkin said in a statement. "In order to adequately address this pandemic, we must share data from clinical studies across the research, healthcare, and pharma communities. By having comprehensive datasets and deep data analytics, we will have the opportunity to make great progress."

Saama's Life Science Analytics Cloud technology platform is scalable to handle different types of data and dataset sizes.

Massey said that the Life Science Analytics Cloud can serve as a hub to integrate data for COVID-19 and other virus-related research. "Then we would make that information available back to everyone who contributed so that their scientists could do cross-trial analyses, subset analyses, meta-analyses, look at placebo arms, for example, across multiple trials, but use that really as a decision tool," he explained.

That concept quickly got other companies interested.

"This is an unprecedented time and we need different ways to accelerate. EndPandemic is one way where we can bring the whole industry together and accelerate finding the cure for COVID," said Mohan Uttarwar, founder and CEO of Cupertino, California-based Indx Technology, which does business as Indx.AI.

Uttarwar called the group a "willing coalition of like-minded companies," where the whole is greater than the sum of the parts because each partner brings unique strengths to the consortium.

The EndPandemic group, of course, is not alone in the worldwide response to COVID-19.

The TransCelerate BioPharma coalition of 21 major biopharmaceutical companies announced last week that it would use its own information platform to allow members to share control-arm data from COVID-19 clinical studies. The organization said that it would "immediately investigate" opening up this data to nonmembers as well.

In context of the EndPandemic consortium, Indx.AI, maker of an artificial intelligence-based platform called iCore to help pharmaceutical companies aggregate and manage multiomics data, is adapting its iCore technology to accelerate the discovery of COVID-19 biomarkers. Uttarwar said that the company hopes to have these modifications ready for COVID-19 by the end of the month.

Similarly, Saama's Massey wants to be able to offer a "demo-able" product with real COVID-related data in it within a couple of weeks.

The Indx.AI iCore platform ingests and organizes genomic, proteomic, flow cytometry, and both in vivo and in vitro imaging data. A proprietary data ontology and AI engine helps users manage, visualize, interrogate, and correlate information "We can predict the outcomes, whether it's the outcome for efficacy or for toxicity or for interferons," Uttarwar said.

While IndxAI started in oncology, Uttarwar said that the same principles of immunology apply to vaccine development in terms of stratifying patients, providing researchers and drug developers with insights, such as which combination therapies might best work with specific clinical pathways.

"The idea is to create a master trial command-and-control center like a launch pad. ICode would be that container that brings [together] all the different [informatics] tools," Uttarwar said.

Other participants are contributing patient research and clinical data, including electronic clinical outcomes assessment data and electronic patient-reported outcomes.

Uttarwar noted that it is difficult for researchers to access and understand all the new data being created in trying to understand SARS-CoV-2 and COVID-19. "What we're trying to do is organize it in a way that is easily accessible," he said.

Much of the information comes from rapidly expanding public data sources. "How can we help pharma companies that have jumped on to the clinical trials, make [data] easily accessible, easily available, so that they can really speed up?" Uttarwar said.

Montreal-based Caprion's role in the consortium will be in vaccine development and tracing of convalescents.

The company, which now has nine laboratories in six countries, can isolate peripheral blood mononuclear cells and analyze serum and plasma of those who have survived COVID-19. As vaccine development progresses, Caprion will be able to contribute to immune monitoring those who have received an inoculation by studying potential reductions in cytokine. The company is also conducting reverse transcriptase PCR testing on samples to build out profiles.

"We are very much interested in using our proteomics technologies and genomics profiling technologies to better understand what might be going on," President and CEO Martin LeBlanc said.

The firm has added capabilities in the last two years thanks to a series of mergers and acquisitions. Caprion merged with HistoGeneX last year, adding immunohistochemistry and genomics capabilities to a firm already focused on multiparametric flow cytometry and proteomics for biomarker development. That deal came just months after Caprion acquired immune monitoring firm Serametrix.

Caprion also bought Primity Bio in 2018, adding mass cytometry capabilities as well as software for analyzing flow data and immunophenotyping pathway analysis.

"I think the world is learning very fast how lack of preparedness and lack of ability to turn around and mount a relatively more rapid and coherent response is going to be the biggest challenge when we come out of this crisis of solving coronavirus-related issues," LeBlanc said.

According to LeBlanc, the new EndPandemic consortium is looking at pandemic and epidemic response from more than just the perspective of the current COVID-19 crisis.

"This is only phase one," he said. "I think phase two will be to make sure that we are more and better prepared such that any variation or evolution of such pandemics doesn't cause the kind of economic disturbance we're facing now."

That means examining every level of the scientific and data chains to glean biological insights into how the technology these companies offer can address the many ways viruses can present and spread.

"I think there is a need for more fundamental science. I think there's a need for better insights even on the trials that are happening," LeBlanc said. "Wherever those needs are, we, I think, can offer a solution to generate and make more sense of the data."

The consortium, or at least some of its members, are looking long-term to the post-COVID world.

LeBlanc said that initiatives formed during past infectious disease outbreaks have disappeared once the initial crisis passed due to lack of funding and waning interest.

"I think what is need is a much more stable, ongoing, longer-term source of funding," he said.

"This can be a catalyst," Uttarwar said. "Hopefully, this will become a new norm. This [provides] an opportunity to learn and collaborate to accelerate translational research."

Canada learned from the 2003 SARS outbreak that in particular gripped the Toronto area and strained resources in the province of Ontario. While it may not have led to much immediate drug development, LeBlanc noted that the experience led to greater preparedness, particularly with the 2004 foundation of the Public Health Agency of Canada, which absorbed the National Microbiology Laboratory in Winnipeg, Manitoba.

That agency and lab led Canada to be prepared for the Ebola epidemic that began in 2014. "When the Ebola crisis came along, we already had some vaccine leads that eventually led to the to the Merck vaccine for Ebola," LeBlanc noted.

There will be a second wave of COVID-19 response, particularly after a vaccine is developed and approved for use. LeBlanc is concerned that the global health infrastructure may not be ready to scale up vaccine administration on a scale of millions or billions of people.

"We should be much further along with alternative ways to scale production of vaccines using alternative plant-based methods and we should know by now a whole lot more about the potential of RNA and the safety of RNA vaccines," he said.

However, that cannot happen without a sustainable source of funding as well as a trusted third party, in the form of a public-sector or other noncommercial sponsor, such as the US National Institutes of Health, the Centers for Disease Control and Prevention, or the US government's Biomedical Advanced Research and Development Authority. The sponsor is the "wild card," Massey said.

"We ultimately need a noncommercial sponsor to take this on as a sort of ownership position," Massey said. That also would allow the consortium to provide a degree of trust to participants that data they share would be secure and used only for the intended purpose of finding treatments and a cure for COVID-19.

Massey did note that every other similar group out there is trying to reach the same key decision-makers in pharma companies and government who might be able to sponsor the effort. But he said that the consortium was taking a purely noncommercial view of its activities.

"This is our contribution to this worldwide crisis that we all collectively need to wrestle down as soon as we can," he said.