The $1 trillion per annum pharma industry is facing numerous challenges, and many believe that blockchain technologies and artificial intelligence (AI) might provide the solutions it so desperately needs.
According to the most recent estimates from the Tufts Center for the Study of Drug Development, it currently costs in excess of $2.7 billion to bring a new drug from the drawing board to pharmacy shelves, and it has been observed that this number doubles every nine years as drug discovery becomes more difficult and expensive.
To compensate for the rising R&D costs, pharmaceutical companies often grossly overprice their successes, such as Sovaldi, a highly effective medication for the treatment of hepatitis C, which costs between $45,000 and $84,000 for a basic 12-week treatment course.
A New Hope for Pharmaceutical Companies
At the 2017 Blockchain Summit in Taipei, TaiwanChain, a Baltimore-based next-generation artificial intelligence company specializing in the application of deep learning for drug discovery, Insilico Medicine, presented its recent work in converging the blockchain and next-generation AI technologies to accelerate biomedical research.
“Blockchain and AI have the potential to reduce the gap between the rich and the poor, reduce human biases, and democratize the health economy. I am very happy to see our research presented at TaiwanChain … Learning these new technologies is a key to reducing the global suffering and maximizing happiness,” said Lucy Ojomoko, PhD, a senior scientist at Insilico Medicine and an author of a research paper titled “Converging blockchain and next-generation artificial intelligence technologies to decentralize and accelerate biomedical research and healthcare,” which was published in the peer-reviewed journal Oncotarget.
Many people are aware of blockchain as the technology behind the popular cryptocurrency Bitcoin. Blockchain can be described as a distributed database that stores records inside cryptographically secured blocks, which are linked together, forming an immutable chain of records that is inherently resistant to modification of the data.
While Bitcoin uses a blockchain to record transaction data, the technology can be used to store any type of data, with no need for a trusted third party or intermediary to serve as a validator. Because most blockchains are open and distributed, they guarantee transparency and very high availability.
Furthermore, blockchain technology supports smart contracts, which are self-executing contracts with the terms of the agreement between buyer and seller written directly into lines of code. Smart contracts make it possible to perform credible transactions without third parties while rendering transactions traceable, transparent, and irreversible.
As such, blockchain and smart contracts provide a foundational layer for storing and transferring data from a wide variety of sources and for a large number of different purposes. This alone would be enough to address several issues pharmaceutical companies are currently facing, but the possibilities grow exponentially larger when artificial intelligence is added to the mix.
For many years, there has not been a shortage of health-associated data, but integrative analysis of this data has always been problematic. Complex and computationally expensive techniques are necessary to make sense of the available data. Machine learning techniques utilizing Deep Neural Networks (DNNs) are proving to be exceptionally effective thanks to their ability to automatically extract meaningful features from available data, as explained in the aforementioned research paper.
Blockchain and AI in Pharma
In 2016, Merck associate director for applied technology, Nishan Kulatilaka, noted at the MedCity Converge conference in Philadelphia that healthcare could be the second-largest sector to adopt blockchain technology, after financial services.
The convergence of blockchain and artificial intelligence into a single “blockchain-based system will enable unprecedented collaboration, bolstering innovation in medical research and the execution of larger healthcare concepts such as precision medicine and population health management,” explained Transformational Health Industry Analyst Kamaljit Behera.
While most agree that blockchain and artificial intelligence are unlikely to be the panacea to solve all challenges of the healthcare industry, there is little doubt that they can help pharmaceutical companies drive their costs down by optimizing current workflows and removing many high-cost gatekeepers.
The World Health Organization estimated that global fake drug sales had reached $75 billion in 2010, a 90 percent increase over five years. Despite the occasional successful effort to combat counterfeit medicines, such as Interpol’s operation Pangea VIII in the summer of 2015, which seized 23.5 million units of counterfeit and illicit medicines at an estimated value of $75,322,485, arrested more than 150 people, and removed nearly 2,500 fraudulent websites from the web, counterfeit medicines still comprise up to 30 percent of the total medicines on sales in many developing countries in Asia, Africa, and South America.
This serious supply chain issue forces many pharmaceutical companies to increase the prices of their products to offset the resulting financial losses, which, in turn, affects the most vulnerable members of society, who may not be able to afford to pay for cures against many life-threatening diseases. In response, governments around the world are putting pharmaceutical companies under serious pressure to provide a more rigorous level of track and trace for the entire pharmaceutical supply chain, with the 2015 Drug Supply Chain Security Act (DSCSA) in the United States and the Falsified Medicines Directive (FDM) in the European Union.
As demonstrated during the Life Science Meets IT hackathon in Germany by a team of researchers advised by Manuela Maria Schöner and Dr Philipp Sandner of the Frankfurt School Blockchain Center, blockchain technology could significantly improve the visibility in the pharmaceutical supply chain, producing immutable records of drug movement through the supply chain.
The researchers developed a blockchain-based prototype system for tracking medical products called LifeCrypter to increase supply chain security for the pharmaceutical industry. “Each item of medicine is attached with an unambiguous identification tag, which allows for virtual and physical ownerships to be transferred from the upstream suppliers to the downstream consumers, in parallel, through a trusted network verified by smart contracts on a blockchain and the global drug supply chain at the same time,” the researchers explained in their paper.
A group of researchers from Moscow has recently proposed in their publication entitled “The cornucopia of meaningful leads: Applying deep adversarial autoencoders for new molecule development in oncology” to generate new drugs against cancer by using Generative Adversarial Networks (GANs), which are a class of artificial intelligence algorithms used in unsupervised machine learning.
The researchers have successfully trained an artificial intelligence network with known anti-cancer molecules, programmed it to generate new anti-cancer molecules, and compared the results with existing anti-cancer drugs.
“We found 69 unique molecules that were absent in the training sample. According to The PubChem Project database, about half of the molecules are already being used against cancer or have a proven effect against cancer. We expect that the remaining half of the molecules can also potentially be used to fight cancer. Thus, a fairly naive approach having relatively few input data allowed us to obtain good results. We expect that many tasks of bioinformatics can be solved using similar methods,” one of the researchers commented on his blog.
Clinical trials are essential for pharmaceutical development. The data they generate have far-reaching consequences, so it is of the utmost importance to ensure security, shareability, historicity, and fine-grained control of the data.
“Blockchain technology is a major opportunity for clinical research: it can help in structuring more transparent checkable methodology and, provided a set of core metadata is defined, can help check clinical trial integrity, transparently and partly algorithmically,” conclude Mehdi Benchoufi and Philippe Ravaud in their publication “Blockchain technology for improving clinical research quality.”
Clinical data stored on a blockchain would be private and secure by design, and the sharing of anonymized data could be made effortless with the use of smart contracts. Clinical trial participants could be instantly and automatically rewarded for their participation, and smart contracts could verify that the designed methodology has been followed.
Data from Internet-enabled medical devices used during clinical trials could be included with other research data and analyzed by an artificial intelligence neural network to reveal hidden correlations.
Digital Record Keeping and Processing
To provide patients with better care, it is necessary to facilitate seamless access to electronic health records without impairing the security of the data. Blockchain technology can be used to bring together trusted collaborators in the healthcare industry, including the primary care provider, the hospital, and even the pharmaceutical company manufacturing the medicine the patient needs, offering enhanced security, data integrity, and more control over who can access the data.
“A permissioned blockchain brings together trusted collaborators. Each of them can join the chain, or run their own chains, and the distributed ledger will keep track of all the events that are of importance for that particular iteration of providers within a patient’s care team for whatever task they’re trying to accomplish,” explained IBM Watson Health Chief Science Officer Shahram Ebadollahi. And with an added layer of artificial intelligence, patient data could be analyzed to suggest diagnoses or help pharmaceutical companies produce medicine based on current demand and feedback from patients.
Estonia is currently leading the way with its nationwide Electronic Health Record (e-Health Record) system for integrating data from Estonia’s different healthcare providers to create a common record every patient can access online. The system stands on KSI Blockchain technology to ensure data integrity and mitigate internal threats to the data.
Blockchain and artificial intelligence can help pharmaceutical companies lower their research and product development costs, solve many pressing supply chain issues, and help to better collaborate with other members of the healthcare sector. There are already a number of practical solutions based on these technologies, and it is only a matter of time before they become commonplace.