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How Blockchain Can Support FDA’s Agenda


Pharmaceutical Executive

The digitization of healthcare is paving the way to accelerate drug development in the industry, and the FDA is doing its best to support industry.

Our healthcare data is our most valuable digital asset. It can save our life in an emergency situation and provides critical decision-making information for the providers to offer us the best care. Researchers and regulators go to great lengths to collect data to assess the safety and efficacy of marketed and investigational drugs in development. However, our health records are held captive in protected silos for fear of being singled out, for fear of seeing our right to care violated. As a result, a wealth of digital data is lost to personalized medicine.

Data silos come at a great cost, and hurt patients the most.

We already know that pharma and biotech spend around $2 billion in R&D before a new drug is marketed, but will better data and transparency decrease the cost? Orphan drugs have a mean cost of $147,000 per patient, versus $30,000 for non-orphan drugs, and it’s no argument that the current model of drug development is unsustainable.

That’s why the FDA is exploring supplementary sources of data to assess new drugs, including that which is collected in the process of care, as opposed to the “controlled environment” of clinical trials. As the now departed FDA Commissioner, Scott Gottlieb once said earlier this year: “We are expanding the opportunities for digital health tools to become a part of drug review, to couple these capabilities to drug delivery to form a drug delivery system.”

The digitization of healthcare is paving the way to accelerate drug development in the industry, and the FDA is doing its best to support industry. Blockchain combined with “in silico trials”-an individualized computer simulation used in the development or regulatory evaluation of a medicinal product, device or intervention, could accelerate the agency’s work. The FDA has openly discussed the potential for modeling and simulation technologies to improve drug delivery and development. This is a paradigm shift.

Despite all these advancements, current privacy laws, software integration issues, and lack of interoperability are still creating major bottlenecks in the system. The vast amounts of disparate data being generated, from patient-level data, electronic medical records, clinical trials, to wearables data, have created challenges for the FDA in terms of data security and patient privacy. Enter, blockchain.


What is blockchain?

In simplest terms, blockchain is a distributed system that records and stores transaction records. More specifically, it is a shared, immutable record of peer-to-peer transactions built from linked transaction blocks and stored in a digital ledger. There is no central authority, and transaction records are stored and distributed across all network participants, which is why a blockchain powered health information exchange could unlock the true value of interoperability. Blockchain is ideally suited to addressing the challenge of decentralization of medical data, but lack of expertise in using this technology is still a major barrier.  

What does the FDA think of all of this?

In 2017, the FDA announced its formal intent to study blockchain technology. In particular, the agency partnered with IBM Watson Health, to explore how data from electronic medical records, clinical trials, and wearables could be better shared and stored. In 2018, under a pilot project with four major hospitals, the Food and Drug Administration’s Office of Translational Sciences decided to work with consulting firm, Booz Allen Hamilton, to evaluate how blockchain technology could be implemented to facilitate the secure sharing of information among the FDA, health care providers, and hospitals.

Previously, our team has presented at industry gatherings on our work involving blockchain in healthcare, and views we have regarding patient ownership of health data to opt-in to medical research through a decentralized marketplace, and the platforms we developed, to representatives of the Office of the National Coordinator (ONC) for Health IT, HHS Office of the Secretary and HHS, and members of the FDA, who have been encouraged by the work we have done. As we left those meetings, my feeling was that the ONC encouraged actively tech and pharma companies to leverage the gateways the agency opened, to enable the flow of new data into research.

Dr. Vahan Simonyan, former FDA R&D Director of Bioinformatics, who, full disclosure, is on our advisory board, has helped us form a Health Blockchain Consortium to push for new industry standards, such as a new legal framework. We had our first official meeting in Boston last month, under the patronage of Dr. John Halamka, the chief information officer at Beth Israel, and Harvard Medical School professor, who has spent the last decade of his life dedicated to the technology and policy that enables information exchange among clinical, educations, and administrative stakeholders. The meeting was attended by regulators, academics, industry pharma partners, and patient advocacy groups.


From conversation to action

In my conversations with officials, we were excited to hear how interested regulators are in taking the next step to utilize blockchain technology to facilitate better collaboration and increased transparency between key stakeholders in our industry. From experimenting with blockchain technology to share oncology-related health care data, to launching a pilot program last year to explore using blockchain to track drug supplies, we need to give the FDA more credit in terms of their willingness to adopt new technologies. In fact, we see a path where a path regulator, alongside industry and patients, could test out blockchain technology in favor of patient data ownership and transparency as to how this data is used.

A recent survey from Deloitte in 2018, found that over the year prior, healthcare leaders have come to see blockchain as a practical, tangible solution instead of a theoretical one. Additionally, Deloitte found that 55% of health IT executives strongly believe blockchain would become a disruptive force in healthcare. But not all companies will benefit. Slow movers may lose out to companies that use blockchain technology to cut costs and increase efficiencies.


Looking forward to the future

Our team recently presented our work in blockchain to the Innovation Showcase held by the Health Care Innovation Caucus on March 7th, where our startup was selected out of 110 applications to be alongside a group of healthcare and tech companies like Abbott, Fitbit, Spark Therapeutics, Uber Health, and a few others. The goal of this meeting was to give Members of Congress and their staff exposure to the latest innovations happening in the healthcare industry and featured a diverse group of products and ideas that seek to transform or disrupt different segments of the health care industry.

It was a humbling moment, since we were one of the few, if not only startup companies there, and the only company presenting on blockchain technology. We spoke about how our key focus is to leverage the wealth of digital health data generated to flow into pharmacovigilance and drug assessment, and how blockchain can help empower patients to own their health data under their own terms, so third parties cannot sell their data without their own consent. I believe that blockchain technology has the potential to transform health care, by truly placing the patient at the center of the health care ecosystem and increase the security, privacy, and interoperability of health data.


Alexis Normand is head of Embleema Blockchain for Health Consortium.

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