Pierre Fabre today announced it will join the Embleema Health Blockchain Consortium, which brings together patient advocacy groups, life sciences companies and healthcare providers inside a decentralized blockchain network where digital health data is shared by patients to monitor the safety and efficacy of new drugs in development.
Embleemas blockchain network offers a novel way to put patients at the center of clinical research by letting them own their health data, disrupting the slow, costly and opaque process by which low quality health data is currently collected by pharmaceutical companies to monitor the efficacy of new investigational drugs. For Pierre Fabre, blockchain is an opportunity to set a new standard of transparency and engagement in its relationship with patients and regulators, via real-time monitoring of the effects of new drugs, and compensating patients for their active involvement in clinical research.
The emergence of digital health is forcing the life sciences industry to move away from the current linear process of drug approval, where regulators make decisions based on paper-based reports which synthesize data collected years before publication, to a new iterative model where digital health data is shared in real-time between patients, life sciences companies and regulators, said Frdric Duchesne, CEO, Pierre Fabre Pharmaceuticals. This means making the most of new technologies, to secure patient engagement, guarantee data integrity and ensure the safe transmission of data from patients to life sciences companies and regulators. Blockchain is the key to achieving this vision, and we chose Embleema because its technology platform was the most advanced.
Pierre Fabre will take part in building the decentralized Embleema Blockchain Network, hosting nodes to store and share data securely, and mining the network to guarantee the security of sensitive data. By design, the immutability of decentralized ledgers is particularly suited to safeguard the integrity of sensitive clinical data when shared from patients to researchers. It will offer the company a sandbox to interface its data with regulators as the industry moves toward tighter integration.
The 21st Century Cures Act (2016) has given the FDA a mandate to accelerate regulatory approval for new treatments that incorporate the perspectives of patients and the reporting of real world data. The European Medicine Agency has a similar approach with its adaptive pathways. This has led pharma to integrate real world evidence (RWE) into clinical studies. These include Electronic Health Records (EHR), patient reported outcomes and connected health sensors.
Embleema aims to improve a process which is currently costly, slow and inefficient. Contract research organizations (CROs) typically take more than one year to compile RWE manually from industry silos, often completing this with more studies. Per patient cost of trials is $36,500 on average & $16,500 for phase 4. Patients are not compensated when their aggregated data is sold, and do not give explicit consent. Finally, aggregated data does not have the quality of individual patient-level data, which is typically required. Blockchain is disrupting this process by securing patient consent to share individual patient level data.
Robert Chu, CEO of Embleema said: We are delighted to have Pierre Fabre join our Health Blockchain Consortium and partner with them to bring patient engagement and evidence generation to the next level using Blockchain technology.”
About Pierre Fabre
Laboratoires Pierre Fabre is a multinational pharmaceutical and cosmetics company founded in 1962 with a turnover exceeding $2Bn in 2017 and present in over 130 countries and with more than 10,000 employees. The company’s business activity is focused on research, development, manufacturing and marketing of cosmetics, family health products and prescription medicines, with a focus on oncology.
Embleema is the patient-driven healthcare blockchain network for secure sharing of personal health records. Hosted on a private Ethereum blockchain, Embleemas 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 patients data sovereignty.
CEO 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.