What would happen if innovations in the life sciences chain were updated with innovations in drugs and treatments?
With many standards of serialization and traceability in the compliance period, and others (for example, FMD UE, US DSCSA) at the horizon, life sciences companies need to think beyond serialization as basic skills and prepare for the next generation of supply chain. The verification of the origin of a medicine – from where its ingredients were produced and where the drug was manufactured, how the drug was managed through the end-to-end supply chain and to the trustworthy patient, is becoming an increasingly mandatory capacity in the supply chain. This scenario is now possible using blockchain technology.
Blockchain (sometimes referred to as Distributed Ledger Technology or DLT) is protected by cryptography, which allows a network of nodes to collectively hold a ledger of information without the need for complete trust between nodes. Blockchain is essentially a chain of timeline events based on an agreed consent mechanism. The mechanism ensures that, as long as most of the network validates the entries (ie the "blocks") posted in the ledger (ie the "chain") as established by the governance rules, the information stored on the blockchain can be considered reliable as reliable. Investors and companies from different sectors and functions have taken note of the potential for blockchain.
In one example, patients with acute lymphoblastic leukemia are now benefiting from a type of immunotherapy called T-cell therapy of the chimeric antigen receptor (CAR-T). The approach pioneered by the University of Pennsylvania provides for the extraction of immune cells from a patient modified with cancer target proteins and returned to the patient. These cells are "living drugs" in the patient's body with autologous therapies tailored to each patient. Other influencers of macro life science are driving a change in the products arriving on the market specifically within oncology, central nervous system and systemic anti-infectives. These innovative therapies challenge the traditional supply chain of life sciences, increasing the need for safe and authenticated drugs, delivered without delay and maintained at a verifiable temperature. The right treatment must be delivered to the right patient at the right time, through a secure supply chain.
Even today in the clinical trial phase, test data / results are not easily accessible to the patient for either sharing purposes with their physicians or sharing through clinical trials depending on the therapeutic area. With the use of blockchain, patients can gain access and control their data to whom they want to share and which data they want to share, while ensuring full information security.
Looking beyond practical applications in the life sciences chain, the blockchain has applicability in all aspects of the supply chain. However, it can address in particular some unique aspects of the life sciences chain as supply chain requirements evolve with the mix of products and therapies.
provenance: One of the most complex challenges of the supply chain of life sciences has been the ability to effectively trace the origin of a product (or therapy) from raw materials to the finished product. Despite the various efforts of the complete chain custody systems that exist today, the fragmentation of systems between trading partners opens the risk of fraud. Blockchain technology is an ideal solution, since no organization is responsible for the origin. Organizations across the life sciences ecosystem benefit from having an authentic product in the supply chain, ensuring brand integrity and improved patient outcomes by offering the patient an authentic product. Blockchain allows the idea of a "digital passport" for a product, containing all relevant information for each component or ingredient, including instructions and patient adherence information contained in the pack.
Serialization and trace trackOver the last twenty years, regulators around the world have implemented the requirements for identifying a single product in order to ensure greater safety of finished products along the supply chain. These requirements have the aspiration to eliminate counterfeit and diverted products, ultimately contributing to increasing patient safety. As provenance, one of the major challenges with track and trace is the effective exchange of data through the partner ecosystem, from pharmaceutical manufacturers, to wholesale distributors, to distributors. With the use of blockchain, supply chain partners can more effectively and securely share data across the supply chain and ultimately with the final patient. There is an important business opportunity in the use of blockchain with serialization capabilities for the recall process. The recall notification, once injected into the blockchain, can initiate communications and alarm messages to all interested parties (manufacturers, distributors, distributors and finally patients). All parties can monitor and verify the recalled product, minimizing the time needed to dispose of the withdrawn products, reducing risks and costs.
Specialist logistics: In one aspect of the life sciences chain, the cold chain logistics is at the center of attention. This series of uninterrupted controlled temperature, refrigeration, production, storage and distribution of products is complicated and expensive. The pharmaceutical industry expects to spend nearly $ 17 billion by 2020 for cold chain management.4 When applied to the cold chain, blockchain combined with technologies such as IIoT (Industrial Internet of Things) can create a secure documentation of storage temperatures at any point in the path of a product. This allows supply chain managers and managers to identify potential temperature ranges and other efficiencies throughout the end-to-end supply chain and represents an opportunity for the challenges posed by CAR-T, as mentioned earlier . There are further opportunities to integrate blockchains with artificial intelligence (eg machine learning) to detect potential problems of specialized logistics.
Recent industry statistics have found that blockchain-based technology investments and spending have exceeded the $ 1 billion threshold and continue to accelerate. Current Accenture projections for the blockchain services market alone estimate a CAGR of over 60%, reaching nearly $ 7 billion by 2021. Within the natural sciences, blockchain technology could provide a & # 39; opportunity of $ 3 billion by 2025.
Even today, drug discovery continues to be a very long and cumbersome process and, in most cases, duplicates of research have occurred or occur simultaneously. With the use of blockchain, researchers can share preliminary research results and potentially fund research to help simplify time and cost for drug discovery.
But looking beyond the supply chain until the last patient, Accenture's research finds that only 38% of patients feel informed about new products coming soon that could benefit from their health and less than half of the patients believe that Doctors talk about the whole spectrum of therapies, which often lead to therapeutic decisions without the general picture being understood. Once all product data is stored in the blockchain supply chain, life science organizations will be able to address patients with much more relevant information, such as product availability, detailed product information, and product-specific history . The ability to bind the patient to the product will not only increase patient satisfaction, but ultimately his ability to manage his health for better results. Inevitably, blockchain will more effectively distribute personalized medicines to patients in the right setting at the right time, with the right dose.
Compared to financial markets, for example, the participation of the life sciences sector in technology is still in its infancy. But Accenture's research shows that within the next three years, about 30% of life science companies plan to use blockchain, opening up new business opportunities and addressing the challenges of the past.
However, the following represents the key barriers that technology must overcome to get a legitimate place in the life sciences:
Network effect: To get full value from the blockchain, many partners in the ecosystem must participate. Interoperability between blockchain and other technology solutions must be addressed to achieve full participation of the ecosystem.
Governance: Smart contracts require agreement on permitted transactions between the ecosystem partners and is an ongoing exercise, which requires strong ecosystem participation and purchases.
Regulation and legal: Because blockchain technologies offer a new sociopolitical paradigm for businesses, few legal and regulatory frameworks are available to govern their use. From the standpoint of life sciences, strong regulatory frameworks can guarantee the integration of blockchain technology to avoid challenges in terms of regulatory reporting, HIPAA compliance, etc. Regulators also need a thorough understanding of how to operate in a blockchain environment.
Performance: Being the blockchain of data and the number of nodes, the time needed to verify the transaction could increase causing a potential delay in standard corporate actions.
Blockchain supply chain applications are endless for life sciences companies, given the requirements for specialized medicines and therapies. Those who start now, who are willing to experiment, fail quickly and innovate based on that experience, will be the organizations that gain competitive advantage and improve patient outcomes.
Carly Guenther is managing director at Accenture Life Sciences.