Press release

BioCompute and WHISE-Embleema Launch Framework for FDA Drug Submissions

Sponsored by Businesswire

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.”


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
and on the GitHub project page:

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

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

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