Introducing High Performance Virtual Integrated Environment (HIVE) Platform for Biopharma & Diagnostic Sponsors


The Embleema HIVE Platform is the only FDA-trusted -omics Big Data Platform for Regulatory Decisions

What is HIVE?

A comprehensive bioinformatics and regulatory analytics platform for all genomic and biomarker data.

HIVE has been used by the FDA for regulatory decisions and research projects since 2013.

Trusted Platform

HIVE is the only software with the Authorization to Operate (ATO) for analyzing genomic data in the FDA regulatory review environment.

Now Widely Available

Embleema’s HIVE platform, along with our regulatory expertise, is now offered to sponsors with the endorsement of the FDA.

We improve the speed and quality of genomic / biomarker submissions using identical standards and analytics currently used by the FDA.

Developed at the FDA by the Lead Scientist and Director of R&D, Bioinformatics, HIVE is now an Embleema Asset.


Since 2013, FDA HIVE Platform has Assessed Novel Therapies in Oncology, Anti-Viral, Diagnostic, Cellular and Gene Therapy Applications

Hive Regulatory Bioinformatics Framework


  • Small Molecules
    • TKIs, PARPi, Proteosomes
  • Cellular & Gene Therapies
    • CAR-T, DMD gene, SNM1 gene
  • Checkpoint Inhibitors
    • PD-1 & PDL-1
  • Antibody-Drug Conjugates
  • Monoclonal & Bi-specific Biomarkers
    • CYP2C9, CYP2D9, HbS
  • siRNA Therapeutics
  • Vaccines
    • Prevention & Treatment
  • Anti-virals
    • HIV, HEP C
  • Diagnostics
    • NGS, PCR, FISH

FDA has been using HIVE platform for over 150 new medicines and diagnostic tests since 2013

All approved drugs with any type of biomarker are reviewed in HIVE

In 2020, over 62 new oncology medicines and indications were reviewed by the FDA using HIVE

All diagnostic tests (NGS, PCR, FISH, etc.) have been evaluated by the FDA using the HIVE platform

In 2020, HIVE platform was used to approve 12 companion diagnostics test

FDA HIVE Platform ≡ Embleema HIVE Platform

Embleema has a research agreement with the FDA for HIVE to cross-share information, code bases, and pipelines

Scientific Leadership

The HIVE team is a co-author of the IEEE BioCompute standard, a framework for standardizing & sharing computations & analyses which eases the exchange of HTS workflows between the FDA, pharmaceutical companies, contract research organizations, providers & academic researchers. HIVE has published over 40 peer reviewed scientific articles.

The Most Comprehensive, Cloud-Based, Regulatory Analytics Platform in the Industry

Platform Features


Versatile Data Retrieval

Open APIs for third-party system integration

Extensive knowledgebases curated and shared in common with the FDA

BioCompute

Provenance & Standards

Full provenance of data and analytics using BioSample & BioCompute accepted by the FDA

Comprehensive data standardization and harmonization

Security

Sole platform with FDA authorization to operate (ATO) in a regulatory environment

NIST 800 compliant, FISMA-M compliant, HIPAA and GDPR-enabled

CFR21 Part 11

Federal Archive

Federally–approved archival system

Supports long-term storage of scientific data data, analytics, and methods to interpret it

Regulatory Analytics

Comprehensive data standardization and harmonization

Peer-reviewed algorithms and pipelines used by the FDA

Visualizations & Interpretation

Interactive visualizations of terabytes of multi-omics data

Present your data in easily analyzable format


Data that Sponsors and the FDA Can Trust

HIVE independently integrates and reviews your translational and bioinformatics data to develop robust, ready-to-file data packages (HIVE-packs) fully aligned with FDA standards for faster scientific reviews


Rapidly Address Biomedical Challenges to Accelerate Solutions

  • Deliver a faster, more precise assessment of product bioinformatics data in a secure environment
  • Speed up analytical reviews using proprietary HIVE tools
  • Save time and effort


Establish FDA Quality and Anticipate Regulatory Feedback

  • Avoid pitfalls that sponsors encounter, sometimes very late, in the development process
  • Generate high quality independently reviewed datasets
  • Ensure compliance to all existing data/ quality standards


Expert Consulting for Confidence in your Data

  • Interact with former FDA insiders who built the analytics platform currently used by the agency to evaluate new medicines and diagnostics
  • Learn how to tap into the most well published Healthcare IT platform
  • Get a virtual seat at the FDA table before your submission

Differentiated Research and Regulatory Bioinformatics for Life Sciences

Life sciences align with the FDA on their genomic data management, analytics and submission to accelerate NDAs, BLAs and INDs.

Use Case: Viral Vector Therapy Manufacturing Consistency

The FDA Office of Vaccines Research and Review (OVVR) uses HIVE to perform genomic analysis of viral vector product and vaccine batches, “making them significantly safer and more effective.” (*) HIVE detected a pathogenic mutation in a polio vaccine batch (**)

What is the current problem?

Non-comprehensive (miss revirulent genomic mutations of the attenuated virus)

Time consuming (~6 months)

Cost prohibitive

Raises ethical questions on level of animal testing


The Embleema Solution

HIVE performs a population analysis at genomic level (NGS) of batches of Viral Vector product, providing a significantly more sensitive and comprehensive comparison at molecular level with the reference sample and a less expensive solution for manufacturing consistency.

Comprehensive

Fast (1 week)

Analysis accepted by the FDA

Cut back on animal testing

Set-up a more accurate vaccine manufacturing consistency quality-control at genomic level, reducing your dependency on animal-based tests & saving you time and money.


Biomedical & healthcare statistics Real-World Data and Evidence Health Product Safety and Efficacy Monitoring Proteomics Next-Generation Sequencing Quality Control and Analytics Clinomics Genomic Analytics for Oncology, Immuno-Oncology, Cell Therapies, Rare Diseases, Neurology and Auto-Immune Diseases Viral genomics & vaccine development Bacterial & parasitic pathogens Microbiome analytics Classication & clusterization


Explore some of the use cases where HIVE is improving performance & impacting the market or contact us to request a demo.