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Business & Regulation Profession, Digital Technologies, Clinical Trials

Pharma and Fordism

Midway through 2022, we published an interview with Gen Li, CEO of Phesi, a company that uses data-driven AI tools to aid and accelerate clinical trials. The conversation focused on a report Phesi had produced on clinical trial disruption triggered by the invasion of Ukraine. Several months on, we sat down with Li once more to discuss the trajectory of his career and the ongoing effects of the war on clinical trials in Eastern Europe.

What formative events defined the early days of your career?

When I started my career at Bristol Myers Squibb, I was in charge of operations in a department called “Intercontinental.” The department’s responsibility was to conduct clinical trials in all of those “other” countries – many of which had very limited activities. One such region was South America, which had been neglected as a region for clinical trials because it had a reputation for running everything too slowly. Pharma had lost its patience with South America, and I had been tasked with doing something about it for my company – after all, the scale of the population being left out in the rain was huge. 

I deployed a pretty simple concept from operations management, called “critical path analysis.” In short, we look at all the segments and milestones in clinical trial activity within a given country, and then compare it with other countries that are running a large number of trials. Upon analysis, one problem became salient: the drug supply, which was often lagging months behind. Why? Because South America is the backdoor of the US, it has always suffered from illegal drug trafficking. Experimental medical drugs could end up contaminated with illegal drugs, which – understandably – demanded more scrutiny and was slowing the whole process down.

Once we’d recognized this one clear issue, everything else became (relatively) simple – in short, we got pharma companies directly involved in helping improve matters. And you can see the results today; South America is becoming an increasingly important place for clinical development.

Because South America is the backdoor of the US, it has always suffered from illegal drug trafficking. Experimental medical drugs could end up contaminated with illegal drugs.

I walked away from this project having learned an important lesson. Despite the pharmaceutical industry employing some of the brightest minds in the world, fundamental problems remain unsolved! And I am up for the challenge!

Why did you start your own company?

I set up Phesi for two reasons. The first is simple: I needed to support my family. The second is more glorious: I wanted to solve the major problem in clinical development – it is extremely expensive, with the industry burning around $100 billion per year. 

The industry is so primitive in how it plans and conducts clinical trials that it’s astonishing. A comparison with the history of the Ford Model T sheds some light on the problem. The company founder, Henry Ford, had the idea that every family should own a car. At the time, that was unimaginable. However, he had a management theory to back up his idea called “scientific management.” It was formulated by the mechanical engineer Frederick Winslow Taylor and applied with great effect by Ford in his assembly line manufacturing business.

The approach had such a great impact on history that we now call it “Fordism.” Given the scale, complexity, and diversity of nations involved, I think that pharma needs an equivalent of Fordism for clinical development. This is my motivation and my dream. We’re not here to patch and repair the field; we’re here to build a conceptual framework.

Our theory is based on the “balanced scorecard,” a concept whose fundamental principles I first articulated in publications in the mid-2000s (1). I first began implementing the concept at Pharmacia – now part of Pfizer. In brief, we must always remember to explore the relationships between different types of data; when you collect and structure your data at the most granular level, you afford yourself a great deal of extra freedom and utility.

Mao Zedong had died, and society was entering a new era.

Going back to my dream, it is not yet fulfilled – but we are getting close. We have now automated the framework in our Trial Accelerator Platform, which contains data from over 60 million patients, and almost half a million clinical trials. The platform has already helped one of our clients win an internal innovation competition, and it feels great to know that we have not only won their trust and helped them, but also influenced their thinking.

You say you’re an academic at heart – how did you get into business?

University was extremely important to me because I was in the first generation of students to attend China’s universities when they reopened after around a decade of closure during the Cultural Revolution. Mao Zedong had died, and society was entering a new era. I chose to pursue organic chemistry because I had long felt it was the most practical.

When my studies took me to the US, I managed to quickly overcome my culture shock and get a paper published in Science (2). Interestingly, the substance (agmatine) we discovered is now part of the mechanism for various new drug developments. It was a huge honor because it’s something many researchers will never achieve in their lifetime. However, at this time I was also thinking hard about myself, and whether I was best suited for academia. Eventually I decided that, given the nature of my personality, benchwork was not my future. I decided to go to business school, and there I got my MBA and completed my transformation.

How did being in China’s pivotal academic generation affect your experience as a student?

I was extremely motivated, but not only because of my place in that generation. I left home and traveled to Peking University – the best higher education institution in the country – at the age of just 14. Can you imagine? To say that I felt intimidated would be an understatement!

Then and now, Chinese university students live in dormitories. In my dorm, there were eight of us – the oldest being twice my age, which was fortuitous. We all know that a 14-year-old kid is not even close to being a fully-rounded adult and I’d say it was my dorm mates, my chemistry teachers, and the public who helped raise me. That 28-year old was especially important – I call him my “older brother” and we still keep in touch.

Right now, I can see that some pretty chaotic ideas are being sold – and they will damage the playing field.

Despite all the pressure, I felt so blessed that I had been given the opportunity to attend university. Thinking about it now still makes me emotional. It is something I will always appreciate. 

What changes have you seen in the role of data in pharma over the years?

Not so many years ago, data in pharma was good for little more than producing pleasing animations – as with many other fields. So if we compare the early days with today, we can see that data is getting better and better at describing real human beings and real actions. The pharmaceutical industry is riding the revolution in our capabilities to run calculations and store information.

That said, I would also advise caution regarding expansive claims about data science and its possible applications within pharma. This industry has seen similar surges in hype. For example, there was the hype around high throughput screening strategies, in which pharma hoped to use automated technology to produce large numbers of compounds which could be turned into new medicines. Another was called OSB – Opportunity Seeking Blockbuster strategy – by which, somehow, a pharma company becomes able to focus only on drugs able to generate annual sales of more than US$1 billion annually. None of these hype trains ended up going anywhere. Right now, I can see that some pretty chaotic ideas are being sold – and they will damage the playing field. We all need to make sure that we can deliver on our promises.

Does pharma suffer from a deficit of computer science expertise?

If Einstein’s theories can be taught to kids in high school, we should be able to take on new knowledge at any level of complexity. Phesi is no exception. Our Chief Information Officer was a 20-year Microsoft veteran with no background in bioscience; now, he is fully equipped with the level of knowledge necessary to work with us. The trick is for different employees to leverage each other’s strengths. I predict that pharma will be taking on more and more computer scientists in the years to come, and that these people will help us resolve some of the field’s fundamental problems. I would say the greatest dangers concerning skills are not the deficits but the silos. When someone truly believes they are the smartest and that they can solve everything alone – that is the real danger.

Tell us how your attention has recently turned to Ukraine…

As individuals, we have career responsibilities and we have social responsibilities. As a company, Phesi has commercial responsibilities and social responsibilities too. To me, these are the same. Paying attention to serious issues and finding opportunities to shed light on them is one way to attend to one’s social responsibilities. When COVID-19 hit, we reported extensively on how it was impacting clinical trials, and our reporting on the effects of the war in Ukraine is essentially a continuation of this effort to shed light and help people.

At the affected investigative sites, many people’s livelihoods are at stake. Many of these sites are very small businesses with very limited financial capabilities. If we don’t pay attention to their struggle, they will die out and the wider ecosystem will be hurt. Ukraine was an important country for clinical trials in breast cancer, so harm to that ecosystem will have a longer-term knock-on impact.

For all these reasons, we want to help by raising awareness and spreading the word.

As the war drags on, how is it affecting trials?

Given the severity of the situation – from bombings and mass exodus to economic devastation and risk of escalation – we might well have expected to see a “no man’s land” from which trials would not emerge intact. But as we examined the data, I was stunned to find that many activities remain ongoing. I have heard people relate many stories about the exceptional efforts they have made, doing everything humanly possible to bring in people from outside or to try and relocate patients to Germany and other neighboring countries. At first, I thought these were isolated situations, but actually they’re not. This sort of heroism has been much more widespread. In both Ukraine and also in Russia, we are seeing that roughly half of all prewar clinical trials are still ongoing. We have seen that clinical trial activities have increased significantly in Poland and, given the scale of the relocation efforts being made, I would say that this comes as no surprise at all.

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About the Author
Angus Stewart

Associate Editor of The Medicine Maker

Between studying for my English undergrad and Publishing master's degrees I was out in Shanghai, teaching, learning, and getting extremely lost. Now I'm expanding my mind down a rather different rabbit hole: the pharmaceutical industry. Outside of this job I read mountains of fiction and philosophy, and I must say, it's very hard to tell who's sharper: the literati, or the medicine makers.

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