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April Monthly Special 2023

Embleema – The regulatory-grade health data platform accelerating new drug discovery and release new treatments

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One of the biggest buzzwords being thrown around the field of medical technology is “blockchain.” This is for good reason. Simply put, blockchain holds the potential to revolutionize healthcare. With its full deployment, patients can be truly focused on at the center of all operations, which in turn will also be entirely overhauled with better security, privacy and accessibility. But how exactly does blockchain enable all this? How is the health industry fully utilizing this vastly capable cutting-edge technology?

Blockchain is a powerful technology for enabling secure data sharing and access between multiple parties. This is a major challenge in digital health, where the privacy and security of medical data is paramount, but where improving the quality of care cannot happen without more coordination in management of patient data across the healthcare system and the ability to apply analytics to population level medical data. In short, blockchain can help digital health by making it easier to share data securely, with patient consent, across very fragmented healthcare systems. Being open and highly secure means blockchain can be applied to the medical industry in a variety of ways, leading to immensely reduced costs and new ways for patients to access healthcare. Combined with the compounding nature of data and innovation, future proofing technologies can be further applied to foster an era of growth and innovation.  Already, pioneering companies are laying the foundations for a blockchain revolution.

Embleema is the patient-driven healthcare blockchain network for secure sharing of personal health records. Hosted on a private Ethereum blockchain, Embleema’s consolidated, highly-secure repository provides the healthcare ecosystem with an undisputed and holistic view of patients’ medical history; Embleema is creating a decentralized healthcare data economy by connecting the key stakeholders in the healthcare industry, directly with patients while maintaining the patient’s data sovereignty.

Embleema's software platform brings precision medicine sooner to patients by collecting and generating regulatory-grade evidence. The platform is used by the FDA for its regulatory evaluation of health products involving genomic datasets and is the basis for future CDISC standards for cell and gene therapies. When life sciences use HIVE, they align their bioinformatics submission with the FDA and accelerate the regulatory decision. The FDA also uses its platform to produce regulatory grade genomic sequences for SARS-CoV-2 and other microbial pathogens (project ARGOS). In addition to the FDA, their platform is used by leading pharmaceutical companies, biotechs, patient advocacy groups and clinical research centers.

HIVE Platform for Biopharma & Diagnostic Sponsors

HIVE is 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 and has been used by the FDA for regulatory decisions since 2013. By using HIVE and aligning to FDA bioinformatics standards and protocols, biopharma sponsors expedite their regulatory approvals by months. 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. 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. The FDA Office of Vaccines Research and Review (OVVR) uses HIVE platform 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.

Power Patient-driven Personalized Medical Research

An integrated software to rapidly design studies, collect patient consent and study data, track participant enrollment and progress and curate the study data as it is gathered. Create a study in days using Embleema state-of-the-art data collection tools for your therapeutic area. Define your informed consent, data collection and common data model in their study designer and invite participants to instantly collect consent and continuous Real-World Data.

About | Robert Chu

Robert Chu is the Founder and Chief Executive Officer of Embleema. Robert is the former SVP of Global Technology for IQVIA & has created & managed data networks in over 20 countries in the U.S., Asia & Europe.

Robert Chu left his role as Senior Vice President, Global Technology Solutions at IMS Health to found Embleema in June 2017 and is supported by a team of healthcare and technology executives from Harvard Medical School, T-Systems, the Pharmaceuticals Division of Pierre Fabre and iBionext and Nokia / Withings Digital Health.

"Embleema is the only end-to-end data platform for personalized medicine unifying clinical, real-world, molecular data, analytics and regulatory submissions."