Life Sciences & Research Institutions
Redefining the clinical trial process to save time, money and most importantly, lives.
It now takes up to 15 years and $2.8 billion to get a new drug launched.
We believe our technology saves 1 year & up to $250 million.
Pre-clinical Target Discovery
Currently, discovering targets in diseases such as immuno-oncology is a tedious and costly process because of the lack of NGS data.
Embleema integrates precision medicine –omics data, such as genomics, metabolomics, proteomics, glycomics. Data is collected from patients & ingested in Embleema’s HIVE (regulatory grade big data storage and analytics platform used by the FDA), which can be searched and analyzed to discover pre-clinical targets.
Currently FDA approvals for precision medicine drugs are delayed 3-6 months due to data quality issues & re-running analysis. These regulatory loops are postponing revenue generation for pharmas.
Before you submit, by using Embleema HIVE, the same platform the FDA uses for its precision medicine analysis during the regulatory review, you will identify & fix potential issues on data provenance and analytics that the FDA will challenge you on, thus significantly derisking the submission. Embleema HIVE will package your data submission using the appropriate data and analytics standards accepted by the FDA & potentially cut down the data evaluation process to 1 month, instead of 6 months.
Embleema can accelerate FDA approval by 2-5 months unlocking up to $100-200 million in delayed revenue.
What is HIVE (High-performance Integrated Virtual Environment)?
HIVE is the only commercial platform that mirrors FDA’s regulatory analytics for precision medicine and –omics data evidence evaluations, allowing pharmas to shorten their regulatory submissions.
Analytics code-base for NGS identical to that used by FDA for regulatory analytics.
Cost-Efficiency & Time to Market
Sharing FDA validated end points through trusted framework of BioCompute, rather than raw data, saves time & costs by avoiding data transfers & back-and-forth with the FDA.
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).
A framework for standardizing & sharing computations & analyses which eases the exchange of HTS workflows between the FDA, pharmaceutical companies, contract research organizations, bioinformatic platform providers & academic researchers.
Biomedical & healthcare statistics • NGS • Proteomics • Clinomics • Cancer genomics research • Viral genomics & vaccine development • Bacterial & parasitic pathogens • Microbiome analytics • Classication & clusterization
Dynamic Registries for Real World Evidence
Embleema’s technology builds dynamic registries that aggegrate all patient level data dimensions such as electronic medical records, patient reported outcomes, -omics or connected devices providing continuously richer data with fully informed patient consent.