News | May 14, 2019

BioCompute And WHISE-Embleema Launch Framework For FDA Drug Submissions

WASHINGTON--(BUSINESS WIRE)--

BioCompute, a collaboration between The George Washington University and the FDA to improve communication of bioinformatics pipelines, today announced a new guidance for life sciences companies using next generation sequencing (NGS) analysis as part of the regulatory approval process.

The United States Food and Drug Administration (FDA), together with the George Washington University, co-sponsored the 2019 BioCompute Workshop, entitled "BioCompute Objects: Tools for Communicating Next Generation Sequencing Data and Analysis." This goal of this workshop is to engage more life sciences organizations to use BioCompute for NGS and other bioinformatics data analysis communications with the FDA. Specifically, the workshop will highlight real-world case examples, and live demonstrations of new tools that leverage BioCompute.

A new Precision FDA-BioCompute Challenge will also be launched at the event to generate more BioCompute Objects (BCOs), and to integrate the BioCompute standard into more genome analysis tools.

In 2013, the FDA's Genomics Working Group outlined specific goals for a mechanism to resolve complications in submitting next generation sequencing (NGS) data to a regulatory body like the FDA. The BioCompute specification was developed conceptually to address the tremendous need for clearly articulating bioinformatic workflows in a manner that was transparent and allowed for reproducibility and verification. A BCO is an instance of a workflow written in a way that adheres to the BioCompute specification.

Led by Dr. Raja Mazumder and Dr. Vahan Simonyan, former R&D Director of Bioinformatics at the FDA, the BioCompute project developed a human and computer readable format to handle NGS data to address FDA needs for reproducibility of genomic analyses. An individual analysis is stored as a BCO, which can represent anything from ancestry, cancer, microbiome analysis, disease detection, and other applications.

“There is an urgent need to standardize the way genomics analysis steps are communicated, as we witness the emergence of different platforms and different scripts,” said Dr. Mazumder. “The more steps in the analysis process, the greater the need for standardized communication. The BioCompute standard aims to bring clarity and reproducibility to this process. This will allow regulators to save time and make decisions based on the data analysis rather than re-running the analysis on full datasets. Ultimately, this will enable drugs to reach patients faster.”

With the release of the new standards, the next step for the organization is to form public-private partnerships to ensure wide use of this standard. The WHISE-Embleema Exchange will be the first organization to implement the standard on its platform, dedicated to accelerating the exchange of health information from patients to accelerate clinical research.

“To drive personalized medicine and leverage the tremendous insights of genomic data, we must guarantee the integrity of the data supply chain,” said Robert Chu, CEO and Founder of Embleema. “The hundreds of millions of reads that come from a gene sequencer represent small, nearly random fragments of the genome sequenced, and there are countless ways in which that data can be transformed to yield insights into cancer, ancestry, microbiome dynamics, metagenomics, and other areas of interest. To make such analyses trustworthy, it became obvious to our organization that we needed to implement the BioCompute standard, and streamline information sharing from patients and life sciences companies to regulators for new drug approvals. Rather than exchanging a fully sequenced genome with a research team on our Exchange, patients, life sciences companies and regulators, will share a BCO. This will result in stronger privacy protections for patients, more affordable, lower volume data for researchers, and quicker analysis time for regulators, to bring new innovative medicines to patients faster.”

About BioComputeObjects.org

The BioCompute project seeks to set a common standard for communicating bioinformatic analysis pipelines. The BioCompute project has become a model of collaborative communication and has grown to include participants from many institutions in both the public and private sectors, including biotech, pharmaceutical, government agencies, and academia, as well as other related standards like Common Workflow Language. The Workshop builds on nearly 5 years of collaborative work to help streamline the way that bioinformatics analyses are communicated. More information about BioCompute can be found on the website https://www.biocomputeobject.org/ and on the GitHub project page: https://github.com/biocompute-objects/BCO_Specification/tree/IEEE-vote

About WHISE-Embleema Consortium

The WHISE-Embleema Consortium is on a mission to transfer ownership of health data to patients, accelerate information exchange, and incentivize patients to opt-in to research. Patient owned data can transform biomedical research, allowing information generated in the process of care to generate reliable, continuous real-world data on a medical product's benefit and risk profiles pre and post FDA market approval. Faster, standard real-world data and evidence will accelerate the availability of new treatments and improve the safety and the discovery of new therapeutic indications for existing FDA approved products on the market. WHISE compliance to FDA regulatory analytics follows from its reliance on a distributed network of HIVE deployment instances and BioCompute driven standardization architecture.

About Embleema

Embleema helps patients and pharma accelerate the availability of new treatments, by fast-forwarding the exchange of data from the real world. It provides a patient-driven healthcare blockchain network to allow patients to share their consolidate health records securely. Hosted on a private blockchain, Embleema’s consolidated, highly-secure repository provides the healthcare ecosystem with an undisputed and holistic view of patients’ medical history, while maintaining the patient’s data sovereignty.

For more information, please visit www.embleema.com and follow Embleema on Twitter @Embleema, Telegram, LinkedIn, and Facebook.

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