Emerging Disruptive Technologies in the Pharmaceutical Industry: An Interview with Frank Leu, Novapeutics

Revolutionary technologies, from AI to machine learning to blockchain, are becoming increasingly relevant as they move from hype to reality. Still, their take-up is slow as many stick to legacy systems that have served well in the past. PharmaFeatures spoke to Frank Leu, CEO of Novapeutics and BioPharMatrix, about the benefits of these disruptive technologies and how companies can implement them successfully.  

PharmaFeatures: Tell us about yourself, your experience, and your work with disruptive technologies such as blockchain.

Frank Leu: My background is mainly in pharmaceutical sciences, with a PhD in pharmacology. I worked ten years in antibody therapeutics development for neuroendocrine cancer at a specialized biopharma. Soon after, University of Pennsylvania’s UpStart program and professor Xianxin Hua who is also an inventor of the technology, and I co-founded Novapeutics in pursuit of a cure for diabetes. Here, I worked on planning and developing all aspects of the company – from research on outsourced vendors to drug development, clinical trials and supply chain. Working with vendors and third parties, and through research of the materials in the advisory capacity through BioPharMatrix, I discovered there was a significant amount of redundancy and lack of integration between their programs. 

PF: How well has the pharmaceutical industry taken up innovative technologies such as blockchain?

FL: The pharma industry has come a long way in the last few years, evolving quickly and improving in technologies like the Cloud and Internet of Things, but the pace is still slow when compared with places like Walmart. This is in part due to the regulatory overhang in drug development and research, as well as clinical operations, but also because pharma companies are not doing enough to push the technology forward and adopt it in drug development.

A few years ago, large pilot studies were implemented by the US government, with one successful pilot run by the FDA alongside IBM, Merck, Walmart and KPMG. They proved that there was value in blockchain for clinical development. 

But despite that, it is clear to me that the conversation around new technologies is suffering from a lack of leadership. After these initial pilots the US government has not followed up on its potential. We need more work from the FDA, due to the heavy regulation around drug development by the government. A blockchain-oriented system must be created to drive this process. 

Big pharma companies are still investing in understanding how blockchain works and can help to create a system that utilizes blockchain architecture. But too many companies are approaching the problem in isolation, looking to be the first to develop a working system in order to maximize their profits, in order to offset the average $1 to $2 billion cost of developing a product through to market. But this gets in the way of making drug development more efficient and streamlined, while cutting costs in the process. Technology can drive the cutting down of this expense, make it simpler and cheaper. In blockchain, AI and data mining, there is currently a lack of prioritization. 

Blockchain technology has the ability to create and embed trust in a system, and ensure that data cannot be changed. You can find out who input a mistake, where in the chain it was made etc., and trace it back. This can be anything from a mislabeled product to a specific batch of product that has been contaminated. Whereas otherwise the entire supply would need to be halted while investigations were undergone to isolate the problem, with blockchain there is great value in automating accountability and ensuring immutable trust in the system. 

There are certainly some issues remaining – the need for humans to input the data, leading to potential errors or problems – but these are minimized compared with alternatives. 

The pharma field needs to focus on devoting its resources to devising a common platform that can be adopted and used without the need for an intermediary to connect the varied systems. Not that it will put anyone out of a job – you will always need vendors to come in and consult on running the system better. 

PF: How will technologies such as the blockchain change the pharmaceutical landscape?

FL: The world is changing. In five to ten years, the way we use internet information today will no longer be a thing. Blockchain is set to change the whole data and information paradigm. Because right now there is a very real problem with platforms such as YouTube, Facebook and Google. They control all your information mostly in a centralized fashion. This centralized data can cause a liability problem for companies if it was hacked, which is why they are often under scrutiny by the regulatory bodies. They are liable for this centralized information in case of hacking and/or misuse.  

The second problem present at the moment is one for consumers. We no longer own our information. Videos and contents we create are owned by the platform they are on, because they profit significantly from the content. They incentivise the individuals with a very small fraction of the payment for providing contents, but it is nothing to what the company earns from it. In a blockchain data architecture, the content creator has much more control and ability to profit proportionally to their contribution. Such as the latest craze in the NFT (Non-Fungible Token) art and music. A piece of digital art with NFT embedded created by Beeple has sold as high as 69 million dollars in a Christie’s auction. And when this piece of art exchanges hands in the future, the artist will benefit 5% to 10% of the exchange value as specified in the embedded smart contract.   

That’s the first layer of problems – security. The second is a problem for consumers – we don’t own our info any more. Create a viral video? It’s on youtube, tiktok etc. They own it. Blockchain will let you remain in control of material. Blockchain would end this by giving control to the individual. I think it is important for the blockchain platforms to still make some profit from their work, but the discrepancy would be nowhere near as big. 

Another way blockchain will change everything is through personalization of medicine. This does not just mean traditional personalized medicine, for example CAR-T treatments and therapies, but also how you organize patient info. When an individual moves location or country, their information is often not retrieved and given to their new clinic – it becomes fragmented between a number of physicians, with no-one having full access to a patient’s data. 

Blockchain would unify this information chronologically, with no way to fragment it. The patient would be the only one with the key to open this information, allowing physicians to see it as they choose. Should he transfer to another institution, he could close it for his ex-physician.

This idea is also very important for clinical trials when recruiting patients. With no humans filling in this data for every trial – potentially forgetting symptoms or important dates that would affect their selection – the AI is able to dive into a patient’s holistic record and find the right patients for each trial. With every piece of an individual’s record in one place, the AI could identify subtle patterns or phenotypes that human beings would miss. And all this would be done entirely with the patient’s control and oversight. 

This would also improve the clinical trial itself in terms of efficacy and oversight. For example, were two patients to die without clear reason, an inspection of the blockchain ledger could perhaps show that both were from the same region which saw a previous infection that increased mortality. 

Finally, patients would be empowered when identifying medical facilities for them. Should there be three potential facilities offering a patient treatment, blockchain would enable these facilities to analyze the patient’s information and bid to provide care based on their increased knowledge of treatability and specificity. This allows patients to better shop around for the best price. 

PF: How can life science companies separate disruptive technology from hype?

FL: Senior management, particularly the C-suite, must open the door and be humble to be educated to this new data architecture. Many smartest and most established businesses in the history of the world were disrupted to their irrelevance due to ignorance to technology adoptions. Such as IBM in the 1980s, Blockbuster, Tower Records, Kodak, and the list goes on.  Use cases of success are out there, but at C-level it is often still hard to tell which platform to invest in. Education must come first to convince yourself and define an accurate sense of understanding, so that you can come up with a suitable strategy for your organization on how to integrate the platform that is right for your company as the world moves forward.

Instead, some companies suggest simply starting a blockchain project to see if it works. That’s wrong, and they should understand their architecture and how new ideas would integrate first, so as to customize their architecture in such a way that they can adopt and integrate immediately. This requires advisors that have an in-depth understanding of the overall novel blockchain projects existing and developing. Separating fictions from realities, and constantly making small pivots to get it just right.    

Large companies that can work with big data companies are likely to come out with their own platforms, on the basis that if they build it, people will use it, due to the size of the company and the money they have to invest. This has been seen with vaccines, to an extent: companies like Moderna and Pfizer were all winners at the end of the day, as they had the money and ability to develop a product that worked. The same thing goes with technological development and implementation. Several large companies take leadership before governments are lobbied to allow use of these new systems. 

With smaller companies, it is more important to start to develop a hybrid system that relies heavier on using the legacy systems while the blockchain technologies easing into full adoption during this stage. Small companies should not worry about developing and adopting early blockchain technologies themselves, because the cost of being wrong could easily bankrupt them. Instead a careful plan based on a comprehensive understanding of the technology for quick adoption should be in place – again, education is very important. Senior management should work on determining at which point they can make a bet on the reliability and utility of a technology, and then transfer over. The earlier a company moves into a new, inevitable technology, the better off they are. 

The take home message here is that blockchain adoption for different sizes and various stakeholders in the drug development needed to be taking place already as of last year. Blockchain is not a technology of the future, it is a technology of last year and the need now is to understand where we are with it and how to implement it in each organizations in order to enhance the efficiency of cooperation for the entire drug development ecosystem.

Charlotte Di Salvo, Editor & Lead Medical Writer
PharmaFeatures