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Product Update Marks Turning Point as L7 Informatics Targets Translational Research

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CHICAGO (GenomeWeb) – Last week's release of version 2.0 of its Enterprise Science Platform marked a turning point in the trajectory of L7 Informatics, signifying the company's desire to serve the translational research market.

The new version of ESP includes a new user interface, workflow chaining to support multivariable processes, as well as support for next-generation sequencing, translational research, and cell therapy applications. It also features a validated, pre-built connection to the Microsoft Genomics service so users can run bioinformatics pipelines on the Microsoft Azure cloud.

"Before, we had one single application called ESP. Now we have broken it up into a platform with about 10 applications," explained Vasudev Rangadass, CEO of L7 Informatics, the Austin, Texas-based company formerly known as Lab7 Systems. L7 announced the name change in May, in conjunction with its hiring of Rangadass.

"We completely overhauled the platform. It's a lot more scalable, it's a lot more fine-grained," Rangadass said. "We've taken this monolithic app and broken it up into several apps. It's got better UI, a much more modern UI that's easy to use."

These apps, he said, "can be mixed and matched to solve different types of problems," including those in next-generation sequencing, cell therapy, and translational research.

L7 now calls ESP a "scientific information management solution that enables life science and healthcare companies to connect people, processes, and systems to accelerate discoveries and drive precision healthcare." In some ways, this marks a return to the company's roots as much as an evolution, as Lab7 came out of a pharmaceutical incubator for translational research in late 2011, according to Rangadass.

"The core focus initially was to break down the walls between the wet labs and the genomic [world], which is mostly bioinformatics and analytics," Rangadass said. "Over the last year, we have been branching into two or three big markets." The new focus includes both translational research and neobiologic pharmaceuticals.

"I'm trying to expand the focus from just working on genomic research labs where they are today to these next-generation therapeutics because they all face the same problem," Rangadass said. "It's not that they are necessarily sequencing all the time, but they are editing the genome. They need a system to manage it because it's mostly a wet-lab process, but it's a wet-lab process followed by a logistics process where they have to shift."

Rangadass described ESP 2.0 as more than a laboratory information management system. "It's an integrated platform with all the applications that you need to manage translational research," he said. This includes sample management, inventory management, and retrieval management.

"The core LIMS, we've kind of blended it into the platform," Rangadass said. "We don't look at LIMS as a separate tool that you need to buy because we are building an integrated platform that allows you to manage translational research, all the way from samples to the insights of the knowledge that you gain from doing genomic analysis. It could be protein analysis. It could be any type of analysis."

For L7, the translational research market also includes health systems that are applying genomic data to diagnostic decision support.

"Pharma companies are using this platform to identify new biomarkers, while health systems are using the same, exact platform to do diagnostic decision support. One is looking into the future, one is looking at the present," Rangadass said. "The platform is designed to support both types of workflows."

The same platform also can help manage next-gen biologics, including gene therapies, cell therapies, and regenerative therapies, which Rangadass said "need a very sophisticated platform to manage the entire needle-to-needle value chain," including manufacturing processes and regulatory compliance. The L7 CEO previously worked in supply-chain management.

"It's for more than just genomics research," Rangadass said.

Biopharma research is not about only the genome, he added. "The genome encodes the protein, so anytime there is a drug that needs to be created, people are editing the genome or people are editing the cells, editing the RNA, editing the DNA. It's not sequencing, but at the end of the day, they are modifying the DNA," Rangadass said.

Within the next couple of years, L7 Informatics would like to become the "platform of choice" in both the next-generation therapeutic and translational research spheres, according to the CEO. "Both have very similar trajectories and our platform, we believe, can solve both their problems very effectively," Rangadass said.

"We believe that we can add a lot of value," said Rangadass. "We believe our platform will make existing genomic research labs more operationally efficient."

The company is trying to tailor its platform for heavily regulated environments. "We believe that eventually, the future of medicine is going to be a world of genomic-based, proteomic-based, metabolomic-based, all kinds of omic-based diagnostic decision support, and we're basically building the platform to support that," Rangadass said.

Rangadass said that L7 is in the process of getting regulatory clearance for its software because he believes that the market will demand such in the future. "Diagnostics will dictate that. Clinical trials will dictate that. The research doesn't dictate it, but ...the next phase of research is clinical trials, and the next phase of clinical trials is actual therapeutic usage, and clinical trials and therapeutic usage will definitely dictate regulatory compliance," Rangadass said.

Initially, L7 wants to support US Food and Drug Administration Part 11 compliance, as well as Good Manufacturing Practice compliance, as set out by the International Society for Pharmaceutical Engineering. Eventually, Rangadass would like to seek FDA 510(k) clearance and similar status in other countries for ESP.

L7 is looking globally, though most of its current customers are in the US. Rangadass said the company has a contract with Agriculture and Agri-Food Canada, a government-run food research lab that is using the platform for plant genomics. Rangadass said there are "discussions" underway regarding expansion to the UK, Taiwan, and Japan.

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