Dr Gen Li is President and Founder of Phesi – a clinical development data and analytics company using AI and predictive data analytics to support the clinical development industry in streamlining workflows, reducing amendments and getting therapies to patients faster.
Health Tech World speaks to Dr Li about the ongoing challenges and opportunities for companies aiming to transform the clinical trials space.
What are the major challenges facing clinical trials today?
When we started on this journey, we soon realised that things could not be looked at in isolation.
Even if you have the best sites, they may not be able to recruit as you expect them to.
You have to get to the root cause of the problem, which is the design of the trial.
Dr Gen Li
But if you are not looking at the right patient, no matter how good the site is, you’re not going to be able to do the job.
The patient is at the centre of what we do and the data from 95 million patients from around the world enables us to do great things.
How does the sheer volume of data enable you to be patient-centric?
One of our clients is currently working on an acute stroke trial.
If you look at a clinical development database, many of the patients will not actually relate to the onset of the disease.
But we can focus specifically on acute ischemic stroke and physicians working in that phase, allowing us to find the right site for the trial.
We can look at many variables and relate everything back to the target population, allowing us to be very patient-centric.
How are you making it easier to recruit more patients?
We have four different module units. Patient view, trial view, investigator view and country view.
They are all closely linked together.
When things work in concert, you can actually maximise and accelerate the clinical development process.
Have you faced any particular challenges in trying to reform this area?
The challenge is always about coming from the old world approach to doing things.
The fatal part of the problem is that the industry has not been very good at looking at the views in an integrated fashion.
In a clinical development organisation, you compartmentalise people in different places. You have operations, regulation, quality and so on.
All those elements are working inside their own space surrounded by walls.
The most exciting part of what we do is bringing different people together, because the data has no borders, no boundaries. We help people to work together.
Are there other companies trying to transform clinical trials in a similar way to you? What makes you different?
There are different approaches and they’re all trying to bring their own wisdom and capabilities to improve the industry.
At the end of the day, we’re all trying to accelerate the process of bringing innovative medicine to patients.
Many of the companies are themselves very much segmented. There are some doing site selection, there are others working on patient data…
And all of them are doing good things.
But we are the only one making all of the connections to bring everything together.
That’s because we have the largest volume of the data in the world, contextualised, to be able to solve the problems.
We are also future-proof because we can leverage that data to build a digital twin, and then eventually lead to external control arms.
We’re making very good progress in this area.
Have there been any major success stories from drugs you’ve helped to get to market?
One of our big successes was cancer drug Keytruda, developed by Merck, Sharp and Dohme.
We helped to improve the design protocol and shortened the enrolment cycle time from 28 months to 21 months.
And then Eli Lilly’s donanemab is probably the best Alzheimer’s drug on the market.
Yes, it’s been getting a lot of media attention in the UK
And rightfully so.
We have built a disease model around it and helped them to get the design right and shortened the treatment duration.
They are now targeting younger patients in the earliest stage of the disease.
How do you plan to build on your success in 2024?
We are a relatively small company of around 30 people. So we are collaborating with major consulting firms to leverage their infrastructure..
We are currently being shortlisted from 80 different candidates in one of the top five pharma companies to provide a strategic solution in the product design space.
We’re also working with another top five company in revamping their clinical trial feasibility function.
We are really looking forward to the months ahead and there is no doubt in my mind that we will become much larger, stronger and better-known by our colleagues in the industry.
