We covered the recent emergence of Blockchain technology as well as the challenges it presents to the validation activities, but can this technology transform a more “traditional” organization like a pharmaceutical company – and how? With many serialization and track & trace regulations in the compliance period, and others (e.g., EU FMD, US DSCSA) on the horizon, life sciences companies need to think beyond serialization as a core capability and prepare for the next generation of supply chain. Verifying the provenance of a medicine—from where its ingredients were made and where the drug was manufactured, to how the medicine was handled through the end-to-end supply chain and all the way to the patient in a trusted manner, is becoming an increasingly mandatory supply chain capability.

As we covered in our previous Insight – you can revisit it here – implementing a blockchain can offer significant advantages to an organization – as well as challenges to overcome. Pharmaceuticals, being one of the most “traditional” and highly regulated industries can reap most of the benefits out of utilizing an emerging technology such as blockchain.
Whether it's drug development, research and testing or delivery to pharmacies, the pharmaceutical sector is one of the fields that deals with a lot of data.
As a result, the solution may be able to assist the industry in overcoming some of its most pressing issues.

Implementation of Blockchain technologies in pharma covers a broad scope of applications, with new ones emerging all the time. Companies in the sector have already started to work on these challenges and transform their businesses. Here are a few examples on where Blockchain technology can be introduced and how it can improve them.

One of the primary problems for pharmaceutical businesses is the improvement of the supply chain. In this case, the solution can bring an advantage since it can ensure rapid and secure transactions/operations all over the world.
Pharmaceutical companies can also utilize this resource to develop auditable trials and pharmaceutical sources across the supply chain. This means that everyone from manufacturers to customers can check the drug's source, development process, quality, and delivery conditions in a secure setting.
Blockchain can help companies reduce – or even eliminate – the number of fraudulent products on the market, as the participants can control the process of medicine development completely from start to finish.

Blockchain has the potential to enhance the performance of clinical trials. The technology is secure and unchangeable by its nature, ensuring that clinical trials and protocols are strictly maintained and followed.
As the encrypted data is distributed across various parties, and it is almost impossible to decode block’s hash, the system stays secure. Even if a part of the architecture is compromised, the information will not change or disappear, as other parties contain it and can verify the truth.
Therefore, it can assure privacy and accuracy of clinical trial data. In addition to this, stakeholders can create public registries to access the results of clinical trials.

Businesses can have greater control and management of their inventory if blockchain technology is properly integrated into the supply chain. For example, it can be automated to send out requests for more in-demand drug goods.

Blockchain can also assist in overcoming roadblocks in the R&D process.
It has the potential to improve drug research and development by facilitating collaboration between industry and academic institutions, as well as philanthropic organizations.
Smart contracts, for example, will shorten the time it takes to market a new product because firms will not need to invest additional resources in the process (banks, lawyers, etc.).
Better data mining and analysis of current literature or patent applications will emerge from combining the technology with Artificial Intelligence, Machine Learning, and Natural Language Processing.

Blockchain technology is still in its infancy and we will continue to come across new use cases and ways where it may be applied and completely change the way of working for everyone.
Pharmaceutical businesses especially should think about all the benefits blockchain could bring and begin analyzing how it might help them enhance their workflow. Not only can this technology increase cost savings in the long term, but it can also allow them to become more compliant with the increasingly complex regulations being rolled out globally.
Here at i2b we employ a diverse team of consultants who can assist you in every step of the way – from initial inception and requirements definition to validation, testing and deployment of the solution for your organization. Reach out to us for a full assessment of your requirements and a full risk-based estimation of the impact to your business operations!

i(nsight)2b will bring you insights and news about implementation strategies, CSV methodologies and interesting insights around new technologies, platfroms and more. Here we will share our latest insights from within the Pharma, Biotech, and IT industries.