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.
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
- Prevention & Treatment
- HIV, HEP C
- 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
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
Versatile Data Retrieval
Open APIs for third-party system integration
Extensive knowledgebases curated and shared in common with the FDA
Provenance & Standards
Full provenance of data and analytics using BioSample & BioCompute accepted by the FDA
Comprehensive data standardization and harmonization
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
Federally–approved archival system
Supports long-term storage of scientific data data, analytics, and methods to interpret it
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)
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.
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.