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Although the cryptocurrency side of blockchain technology has dominated news headlines in the last year, technology has a real promise in biotechnology and life sciences. A recent survey (September 2018) of the Alleanza di Pistoia found that 60% of professionals in the pharmaceutical and life sciences sectors use or experiment with blockchain technologies in 2018, compared to 22% in 2017.
Blockchain technology offers three key features1 that are missing but are necessary for the life sciences industry to evolve to the next level:
- Ultra secure and immutable storage of information
- Decentralization and greater transparency of transactions
- Incentives of the main stakeholders
Key use cases for blockchain in biotechnology include:
- Fight counterfeit drugs
- Improve virtual clinical trials
- Efficient 3D printing of drugs
These problems are ordered based on the probable expiration of adoption for the use case.
Fight counterfeit drugs
The pharmaceutical companies spend billions of dollars and go through a difficult process to produce and market prescription drugs. With the global counterfeit drug market valued at $ 200 billion2 every year, there is a clear motivation in the pharmaceutical industry to combat counterfeiting. What is at stake are human lives too. Adverse reactions and effects due to false drugs can lead to death.
In emerging markets, 10-30% of prescription drugs2 they are usually counterfeit, with problems ranging from drugs with wrong ingredients to incorrect proportions of ingredients. Most counterfeit drugs are produced outside the United States and sold all over the world. Antibiotics and antimalarials are two of the most commonly counterfeit drug categories, yet many classes of drugs purchased online are at risk and account for almost 40% of all counterfeits. Counterfeit drugs are growing in the United States with the explosion of the opioid crisis. Recent reports have indicated that fake opioids related to fentanyl have caused deaths in 12 states in the United States.3
It is for this reason that the key members of the pharmaceutical industry have started MediLedger4 blockchain project in 2017. The MediLedger project focuses on providing track and trace capabilities to players in the pharmaceutical supply chain. Includes Genentech, AmerisourceBergen, McKesson, Pfizer and AbbVie teams. Initial pilot projects are positive and suggest that a blockchain-based solution will enable compliance with the Drug Supply Chain Security Act (DSCSA) by improving operations and reducing the supply of counterfeit drugs.
The lack of transparency of the supply chain and the authenticity of the product are the basis of global pharmaceutical fraud. Without transparency in the supply chain, it is very difficult to identify the origin of the fraud, to identify the bad actors who have committed the crime or to verify the authenticity of the product. What is needed is for the whole process, from production to quality assurance to distribution, to be protected in a database that is not accessible with each encrypted and signed and encrypted entry. Blockchain technology clearly provides these features and the resulting transparency.
Virtual clinical trials improved
Clinical trials are very expensive, laborious and inefficient parts of drug development. According to Journal of American Medicine (JAMA), the increasing costs for clinical trials are a serious concern for pharmaceutical companies, with costs ranging from tens of millions to hundreds of millions of dollars. These high costs are due to the difficulty of identifying and recruiting skilled participants, coping with high drop-out rates (30% +) and managing and administering a person-to-person process through thousands of participants over an extended period.
In-person process management increases costs due to the need to hire qualified full-time medical personnel and recruit participants from a localized region with access to specific clinical trial facilities. Currently, a clinical trial visit costs an average of $ 3000-7000 and participants must visit the facility 12-24 times a year. This geographical limitation limits the size and demographic characteristics of the pool of participants and frequent visits to the office create conservation problems. Virtual clinical trials can broaden the pool of participants, reduce the need for full-time medical staff and increase retention by providing patient-centered experience. Pharmaceutical companies such as Pfizer, Merck, Sanofi, GlaxoSmithKline, AOBiome and Novartis have implemented virtual approaches, particularly in non-intervention clinical trials, with mixed results.5
The results were mixed for a number of reasons, including data reliability and integrity issues, poor compliance, data security and privacy issues, and poor consensus management. Blockchain technology combined with wearable sensors and sensors based on the Internet of Things can provide the right mix of data integrity, data security and data privacy required by FDA (Food and Drug Administration) and HIPAA (Health Insurance Portability and Accountability) regulations Act).
Blockchain solutions also provide intelligent contract technology to automatically ensure that patient consent data is recorded, digitally signed and fully verifiable. Participants are allowed to offer paper prizes rather than current monetary incentives to improve compliance, increase engagement and loyalty, and create a much more patient-centered experience.
Identification and recruitment of participants could be greatly simplified if historical medical data were accessible via a personal blockchain-based health record (PHR). This type of PHR can assure stakeholders that their data will be protected without compromising the privacy and confidentiality of sensitive patient health data.
With the broader adoption of blockchain-based PHRs, pharmaceutical companies could scan populations around the world to quickly find the right set of patients different from global populations. Blockchain technology can create the right level of trust for patient data, dramatically increasing data sharing globally and dramatically reducing the costs, complexity, and burden of clinical trials.
Efficient 3D printing of drugs
In 2015, the FDA approved the first 3D printed drug, Spritam®, for epilepsy. At the end of 2017, the FDA also provided indications6 on the use of 3D printing for customized drugs that can be printed in non-traditional production facilities, such as a hospital or a medical clinic. For 3D printing to become an efficient engine for custom-made drug production, however, a huge step forward in patient data management is needed.
The ability to provide a personalized medicine is directly related to the quantity and quality of the patient's available medical data, as well as to data on people such as the patient. Patient data, particularly "omics" (such as genomics, epigenomics, proteomics, and metabolomics), as well as the patient's microbiome and allergy profile, are critical to selecting the right types and dosages of drugs for a certain set of symptoms. Long-term population health data are also important for understanding the range of potential results of different drugs, considering age, gender, ethnicity and other patient factors.
Today, unfortunately, it is difficult to access these specific types of data for a particular patient because the data is fragmented and silenced among many providers. Centralized systems have not proven effective because data stored with many patient records has a single point of failure and a rich profit for hackers. A blockchain-based PHR, associated with a person's biometrics, however, could allow such a foundation and an immutable blockchain register for registration transactions would minimize data tampering. Similarly, blockchain technology can allow the sharing of longitudinal data, creating useful data sets in different population pools.
With such a base, it becomes possible to use systems based on artificial intelligence (AI) and machine learning (ML) on data to quickly determine the best types of drugs and dosages of active ingredients tailored to the needs of the patient. When AI / ML output is integrated with a 3D drug printer, a patient's personalized medication can be printed at a doctor's office or pharmacy.
Conclusion
Blockchain technology has enormous potential to reduce drug counterfeiting, dramatically improve the cost of virtual clinical trials, and usher in a new era of personalized medicine. Many other use cases are possible and early adopters will develop a significant competitive advantage over those that will follow.
References
1. https://medium.com/crypto-oracle/blockchain-in-healthcare-a-data-centric-perspective-109e898d73f3
2. https://healthresearchfunding.org/20-shocking-counterfeit-drugs-statistics/
3. https://www.npr.org/sections/goatsandsoda/2017/11/29/567229552/bad-drugs-are-a-major-global-problem-who-reports
4. https://uploads-ssl.webflow.com/59f37d05831e85000160b9b4/5aaadbf85eb6cd21e9f0a73b_MediLedger%202017%20Progress%20Report.pdf
5. https://www.fastcompany.com/90229910/virtual-clinical-trials-are-bringing-drug-
home development
6. https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm587547.htm
Jordan Woods is managing partner and Radhika Iyengar-Emens is managing partner and founder of DoubleNova Group.
