The clinical trial sector is experiencing a rapid influx of artificial intelligence (AI) and data science tools, as companies seek to improve efficiency and reduce high failure rates in drug development.
At Biomed Israel, taking place from 12-14 May, Ittai Harel, managing partner at Pitango Venture Capital, will lead a session on “Reinventing clinical trials: new models, technologies, and companies”.
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The discussion will focus on how advances in clinical trial design and execution, including digital platforms, decentralised trials, adaptive methodologies, and data-driven patient recruitment, are beginning to challenge established approaches to clinical development.
Dikla Shpangental, senior vice president and general manager for Switzerland, Israel, and South Asia at IQVIA, will deliver the keynote presentation, alongside presentations from companies including PhaseV, ImmunAI, QuantHealth, NucleAI, Leal Health and Yonalink/Veeva.
This interview has been edited for length and clarity.
Abigail Beaney (AB): What are some of the main innovations you are seeing in the clinical trial space?
Ittai Harel (IH): Over the years in pharma, some areas have seen a lot of change, and others have not. Clinical development is an area that has seen less change, but it is an area that sees at least $100bn spent each year, and a huge amount of this investment ends in failures. As a result, there is so much improvement that can be made here. In the last few years, there have been several innovations emerging that are going to have a huge impact.
Pharma is typically conservative and slow to adopt, and understandably so – when a company is spending millions to hundreds of millions on every study, they do not want to change things dramatically until it’s been proven.
When you consider the amount of information that is now available about patients from smart watches and other wearable devices, when you think about all the analysis that is being done today with single cell and genetics, all the data that’s finally being collected and amassed including unstructured data and how AI and large language models (LLMs) are able to better analyse it, I think we’re finally on the cusp of big changes in clinical trials.
AB: Which companies are currently showing the most promise?
IH: One standout company is QuantHealth, which is in the space of data science. There is also PhaseV, a high-quality start-up that is growing rapidly, and others in Israel that are deploying AI and data science in the space, but each has its own angle and own uniqueness.
QuantHealth has taken on what is probably the most difficult data science challenge – modelling and predicting, with accuracy, how patients could react to certain drugs and what would be the results of a clinical trial based on the choice of dosage, patient selection, claim and every other clinical trial design parameter.
They leverage massive datasets as to how molecules behave, and what we know about the chemistry, biology and genetics behind them, information from previous clinical trial data and de-identified patient records. They are asking whether we can predict how a group of patients or even a single patient will respond to a new drug or to an existing drug. After leveraging their platform for hundreds of clinical trials in recent years, they have proven this ability with ever-growing accuracy in several therapeutic areas and are seeing accelerating adoption by pharma and biotech, both for early-stage and later-stage clinical trials. For pharma and biotech, this will enable higher success rates in clinical trials, faster time to market, and optimisation of the market potential of novel therapies.
Immune AI is another company showing great promise – it is bringing unique biomarker information and is looking at single-cell analysis and AI. It can bring proprietary biological insight for pharma companies to understand much better which patient to dose and understand how the immune system will react at a single cell level. The company has attracted both massive investor interest and major partnerships with pharma.
Another company is NeuraLight, which is looking to establish diagnostics through the eyes using biomarkers found in our eyes. While developing their platform, they focused on their ability to be a key tool to facilitate clinical development of neurological drugs. As they can identify patient response very early and give continuous analytical feedback, giving the possibility for more efficient, accurate, data-driven endpoints for certain diseases, which are currently predominantly patient-reported outcomes.
When you think about companies like this, they are addressing exactly the major value chain of bringing drugs to the market. If they are successful a few years from now, the whole drug development industry could be so much more efficient, and that can result in lower prices on drugs, on drugs that are much more customised to each patient.
AB: Other than AI and technology, what are some of the best ways that challenges in clinical trials are being addressed?
IH: There are challenges like diversity of patient populations for which drugs are developed, and it is also valuable to have all the biological and behavioural data and real-world evidence for the sake of optimal fit of therapy to the patient, but while it is easy to talk about, it is challenging to do. In Israel, we’re having a lot of discussions, even at the infrastructure and government support level, about what we can do to facilitate this and enhance the environment to attract more global players for clinical development locally, given the high quality of medical facilities and care.
There’s also the economics of clinical trials – Australia did a phenomenal program, which has near enough result in a queue at the border of Australia, to run studies there ever since they created economic incentives. That suggests there is a lot to be thought about from a clinical trial business model perspective, as well as from the efficiency and effectiveness of running clinical trials in other regions.
Another key aspect is on the regulatory side. It remains very conservative, and I think technology and information are moving so much more quickly, and there needs to be a catch-up.
The FDA and other regulatory bodies have established work groups and have been taking initiatives, and this is set to accelerate, driven by capabilities enabled by innovators.
The world has changed in so many ways. Even considering access to patients, we’re able to run clinical trials remotely much easier than before, utilising all sorts of monitoring and diagnostics that are brought to the home to be done there. It’s a new world out there in terms of capabilities, and it’s about to get even stronger with the influence of some of the companies we’re talking about and what they’re bringing on board – everything from quantum computing to implanted chips, to the ability to predict drug reaction from single cells.
There’s been so little change in such a structured discipline, and the people running trials are incredibly intelligent. When we speak to some of the most senior people, to drive adoption of innovation, we many times hear pushback: “We know this stuff, we trust ourselves, our analysis, our guts, we’ve been doing this for 30 years. We’re great at it”.
But the reality is that despite the very high degree of professionalism, it’s a space that has remained stagnant, in comparison to other areas of drug development. So, the opportunity for innovators and pharma and biotech companies to differentiate themselves is tremendous.
You look at industries that were stuck like this for a while, and there’s a breaking point usually, like a dam, that sees the first cracks and then breaks open – and I think we’re getting there.
Whether it’s two years from now or five years from now, everyone in the industry can feel it.
As always, this change is starting with those early adopters, but it’s also up to the innovators to show data that substantiates what they do and create belief and trust in these new systems. The reason we are seeing investor interest from funds such as Pitango HealthTech and others is that it’s an area we believe is going to see very significant changes and opportunities in the next decade.
