Rich Data Sets & Ontologies
HIVE stores and analyzes all kinds of health data: real-world data (EMRs, PROs, connected device data feeds), -omics data (genomics, proteomics, metabolomics raw data files), clinical trial results (STDM, AdAM) HIVE supports ontologies and standardized terms for diseases, diagnosis, treatments, medications and had integrated atlases for tissue, metabolic, cell and pathology HIVE support the NCBI BioSample standard for biological source materials used in experimental assays For NGS analysis, HIVE uses the same set of Quality Control and analytics tools used by the FDA for its regulatory reviews.
Scalability & Performance
HIVE massively parallel computing and storage architecture allow large scale analyses: Data Scale: +25 Petabytes of –omics, image, clinical, RWD raw data and computational results integrated into HIVE for the entirety of regulated lifesciences industry. Databases: +200 different databases on genomics, proteomics, images, PRO, adverse event reports, pathogens, registries for cancer, woman’s health, medical devices in a single secure system. Computations scale: +tens of thousands years worth of parallel computing conduced every year. More than 120 various high performance packages available +more are being integrated as per need. Science: many tens of publications in peer review journals by HIVE experts. +200 years of combined experience by physicists, chemists, biologists, computer scientists, and clinicians.
Compliance
HIVE security layers were developed in collaboration with the FDA & academia providing compliance to data privacy and security regulations such as HIPAA, GDPR, FDA Authorization to Operate & Federal Information Security Management Act (FISMA). HIVE applies the FAIR principles (findable, accessible, interoperable and reusable) for data storage and management. HIVE provides full auditability of data provenance, curation and analytics. Data is transported, stored and aggregated through secure data protocols. Archival and long term compressed storage using NCBI/NCI/EBI protocols.
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 been the subject of more than 40 peer reviewed publications.
Recognized in the Industry
HIVE has been the subject of more than 40 peer reviewed publications. Read them here here.
Differentiated Research and Regulatory Bioinformatics for Life Sciences
Lifesciences align with the FDA on their genomic data management, analytics and submission to accelerate NDAs, BLAs and INDs.
Case Study 4: 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.