The desire to get trials wrapped up more rapidly, and to accelerate the launch of new drugs as much as possible, is not new to life-sciences professionals. Pharmaceutical firms and their development partners are constantly looking for ways to increase the speed and efficiency of their work—and the recent pandemic has increased this pressure.
Rama Rao (RR), CEO of Bloqcube, spoke with Outsourcing-Pharma (OSP) about how blocktain technology can be put to work to accelerate clinical trials, and get pharmaceutical products to market faster.
OSP: Could you please share an ‘elevator description’ of blockchain technology, and how it’s been used to help pharma and clinical trial professionals?
RR: Blockchain technology is a secure way of having one single source of data, that is shared in multiple locations, in a ledger or transaction register, with an ability to record transactions as they happen, in order to provide a trustworthy and immutable record. This is done via cryptography that ensures that facts are reported consistently to those who need to have access it with speed and transparency
It's relatively new in terms of application in the pharma industry and has been primarily used for "tracking and tracing" medication through the supply chain. In addition to meeting regulatory requirements, such a digital identity would enable sifting between counterfeits and original medicines
We are amongst the pioneers to apply it for clinical trials. Currently some companies apply it for ensuring the quality of the scientific research, others are using it for ensuring patient data is well managed.
OSP: Tell us a bit about Bloqcube—who you are, what you do, how you got started and what makes your firm stand out among the crowd.
RR: Bloqcube is a three-year-old startup that has designed its solution, not from a technologist's perspective, but from a domain experts viewpoint, by first identifying the pain points in clinical trials operational processes,and then applying specific solutions. We use an Ipad to provide for ease of access and decentralization, a cloud based structure so we are not anchored to a site/web and the blockchain engine as a platform that is the foundation for governance and efficient processes.
We stand out from our peers in four ways:
- The data is available in real time across a unified platform giving end to end transparency
- The data flows into a financial module C2TA that checks for payment from the sponsor, pays using a peer to peer payment system, sends an accounting record to a system like SAP, and then brings the data back to make planning comparisons.
- The blockchain engine provides a foundation for multiple capabilities
- It's a fully decentralized system that can take the trials to the patient level.
It's a system that has won accolades for its ingenuity in crafting a next-gen software solution. Gartner Group has listed it in their Hype Cycle report for Life Sciences and Blockchains for 2019 and 2020. We got started because of my burning passion to find ways to accelerate clinical trials and take drugs to patients faster
OSP: You’ve got an impressive background, with nearly three decades of experience at high-profile companies like Novartis and Lilly. Could you please share how your work and experience with those firms helped drive you to found Bloqcube?
RR: Amongst the various leadership roles at Lilly and Novartis, two roles at Novartis stand out when I headed the Novartis Oncology Global Development Finance function and US Clinical development and Medical Affairs function. I was able to visit clinical trial sites and see at first hand some of the tactical and operational challenges faced by our partners in executing trials and that has stayed with me.
As an engineer familiar with Moore's Law I often wondered if there was a way to bring that into clinical trials operational processes. Some of those experiences were integral to my search for an appropriate solution
OSP: How does Bloqcube’s software system harness blockchain to help accelerate trials?
RR: Data that is captured as part of the case report forms is stored into blocks of the blockchain. As a transaction is completed it gets stored in the block and thus creating an immutable seal of successive blocks of data. Additionally, we have built a proprietary algorithm that runs of the blockchain to integrate our financial processes
As we have data in real time and data that is integrated at various levels or sites there is no need to reenter the data into multiple systems nor refer to multiple systems to understand what the correct data is.
OSP: Could you please tell us some of the reasons why speeding trials is a high-priority goal among pharma firms?
RR: The basic factor is that we need to move drugs faster to patients and that has been underscored by the COVID-19 pandemic in the search for the right vaccine to protect us. On a more financial level a day delayed can cost up to $8m according to some studies.
Commercially now there is more competition and may have been seen in the vaccines race some large well known companies were unable to bring their vaccine out in time. So the combination of humanitarian needs, with competitive pressures in addition to rising costs are some of the reasons
OSP: What are some of the key obstacles in achieving optimal trial speeds? How does tech like yours help break those barriers?
RR: The fact that there are multiple systems that are not unified is one factor; another is that there is a high degree of customer dissatisfaction with existing systems according to a study by a leading software company, and finally there are too many intermediaries involved in these processes that make it challenging to build a unified whole.
OSP: Do you have any anecdotes of a client putting your tech to use in their operation that you could share?
RR: At this stage this is confidential but they used our system in an observational diabetes study that was conducted in 150 homes in rural India with eye catching results
OSP: Where do you see blockchain headed in the coming months and years?
RR: The role of blockchain will improve and increase as people realize that it's wrong to conflate it with bitcoin. There are multiple areas of growth in the creation of digital assets and/or building up payment mechanisms for Central Bank Digital Currencies.