Gary Patou (Class of 1976)

Gary is hosting a meet-up for all Old Citizens living on the West Coast of the US at his home in Los Altos Hills in the San Francisco Bay Area on 18 November 2023. To attend please complete the booking form here.

Gary Patou (Class of 1976) worked as a hospital doctor in London for nine years before moving into drug research, which has become his life’s work. Based in the US for over 20 years, Gary has worked as Chief Medical Officer for many biotech companies, managing the development of new treatments from lab research to patient care. Since 2000, he has overseen research and development that has led to the approval of five new drug applications.

If I met you at a wedding, how would you describe your career?
I am a doctor who does drug research. I develop new medicines for patients. So, a research physician more than a clinical doctor, to be precise. Can I just add, though -- what a fantastic career this is!  I’ve developed an array of drugs which have made tremendous contributions to medicine and on a much greater scale than anything I could have done had I stayed in clinical practice.

Pharmaceuticals and biotech are sometimes seen almost as dirty words because of high drugs prices and so on. There are relentless press articles about how bad the industry is. The industry is often viewed in the same light as the tobacco or oil industry!  People often joke with me at dinner parties: ‘You’re not a real doctor’ and so on..

 Anyone at school considering a career in drug development should consider the impact one can make in advancing modern medicine. All the advances in cancer treatment leading to cancer death rates declining and our being able to even cure cancers and provide a range of treatments for so many other diseases… come from our industry. Even when the original idea comes from a University, there are very few examples of drugs that tumbled onto the market without a lot of development work undertaken by biotech and pharmaceutical companies.

At what stage did you decide to specialise in research?
I was interested in medicine and medical research from the age of nine when my primary school teacher was talking about lung cancer and describing what a devastating disease it was. At the time, my father was a smoker and I thought, “Boy I’ve got to make sure he doesn’t get lung cancer.  I should be a doctor and find a cure for this disease”. I wanted to be a doctor from that time on. I never thought about anything else.

So, I qualified as a doctor. I then spent nine years in hospital practice as a clinical microbiologist and infectious disease physician. I also did laboratory research to obtain an Doctor of Medicine degree.  It was in the era of AIDS and I was approached to head up a vaccine effort for an AIDS vaccine at a biotech company. I joined the biotech industry with a very clear idea that I would lead this vaccine programme and then come back to my hospital practice in London.

I thought it would just be a couple of years.   Fast forwarding to the outcome, the vaccine we developed didn’t work. We tried everything we could. But from day one at the biotech company I enjoyed the whole drug research process tremendously. That was 1991 and I’ve been doing drug research ever since. I never looked back and never went back to hospital practice.

What does that involve day to day for you? You’re not in the laboratory with test tubes yourself, are you?
I did my lab stint when I was at University College, London and I haven’t done that since. But that experience helps me understand what is involved in discovering drugs in the laboratory.

In industry my role is: when the lab scientists come up with a drug candidate – something that has a potential use with patients – they come to me and ask me what disease we could use it for and how we could develop it. I assess the results of all the various pre-clinical tests we need to do to make sure the drug is safe to go into people.  I also assess whether the levels of the drug achievable in the blood of patients are going to be high enough for it to work. There are a whole gamut of data points that need to be assessed before the decision is made to progress the drug development process.

Then I shepherd the drug through the three phases of clinical development. We have phases 1, 2, and 3 which test the drug in increasing numbers of patients.  We start off in phase 1 with healthy volunteers and once we establish that the drug is safe for them, we invite patient groups into the phase 2 trials.  All along the way I am talking to the government’s drug regulators, the Food and Drug Administration in the US and the MHRA in the UK, making sure they are in agreement with our plans.

Later, as we get closer to getting approval for the drug, I start working with the company’s sales and marketing teams. At the end of the day, drugs are commercial products and we need to make sure we are providing the right information from the trials that the teams think will be important for widespread adoption of the drug and its ultimate success.

The process sounds relatively straightforward, but drugs always throw up surprises.  That is why it is necessary to test them in large numbers of people, before a drug is approved by the regulatory authorities, to ensure that safety and efficacy have been robustly demonstrated.

Could you tell us about a particular success where you have moved a drug through those phases and brought it to market?
I have a couple that are worth mentioning.

One drug is an antibiotic called Factive which combats multi-drug-resistant bacteria. This is an emerging problem from decades of inappropriate use of antibiotics: bacteria that are resistant to almost all antibiotics. At SmithKline Beecham, now GSK, we developed this drug. But unbeknown to us, it had a side effect for particular individuals after longer durations of therapy. We had studied Factive in 14,000 patients in clinical trials. At this point, I had left GSK and my team took the drug to the FDA.  They refused to approve it because of the side effect and because they perceived there were lots of other treatment options for patients.

The company was going to bin Factive. But I in-licensed it to my next company.  I was confident that I could justify its use to the FDA, why it was important to approve it and how we would manage the risk. In the end the FDA referred Factive to what is called an FDA advisory committee.  This is a committee of experts who spent a whole day reviewing the drug, acting like a jury being presented evidence by both the FDA and my colleagues and I. In the end they gave a unanimous vote for its approval. This ended up as a front page article in the Wall Street Journal, with a cartoon of me taking this product across the finish line!

So that’s an extreme example – it’s not straightforward, it’s about risk-benefit, unmet need and safety, and judgement.

The one I am most proud of is a drug called EXPAREL.   This is a painkiller given to patients at the end of surgery to provide post surgery analgesia.  The cool thing about it is that it’s a non-opioid – so it’s not addictive unlike many of the drugs that are usually given after surgery. One injection will give pain relief for three days. This drug is approved and has been in millions of patients in the United States and is also now approved in the UK.  The history here is that the drug had been through extensive phase 3 clinical trials, before I joined the company, and all the trials failed.  The company was close to bankruptcy.  I observed there was a design flaw in the way the trials were set up and would account for the trial failures.  I reran the trials with a modified design and we were successful, the trials were now positive. The approval of this drug will hopefully lead the way to a decline in the use of opioids and reduce drug addiction --  so I am particularly proud of this one.

There seems to be an infinite number of things you could be researching, so what makes you decide to pursue a particular project?
Only 20 per cent of drugs that get to being trialled on humans make it to the finish line. The aggregate cost of developing a drug is about £1.5 billion. That includes all the cost of the 80 per cent of failed drugs plus all the ones that don’t even make it into human trials. If you just take the costs specifically of a drug that succeeds, that would still be £150-200m. Either way it’s a lot of money.

So, you can only develop drugs where there is going to be a return on that investment. There needs to be a commercial opportunity, and there needs to be an unmet medical need. The starting point may come from within the company or from a university that has published research. Everything we do at my current company is homegrown – we use our own in-house research from the start.  But at other companies we have paid to bring in research programs from Academia.

What would make the process simpler? More detailed knowledge of the health of the population as a whole?

The challenges we face are not in the selection of the targets to work towards or the basics of science. The challenge is in the time and cost of the clinical trials.  There is an international rule is that if you are looking at a drug for chronic use, you need to have trialled it in a minimum of 1500 patients.  This costs between £150-200mm.  And the question might be: can you identify predictive markers that, in a trial of a much smaller number of patients, will give confidence that the drug is safe and efficacious, before committing to a full 1500 patients? Alternatively, can the drug be developed for a rare and devastating disease that drug regulators would be willing to suspend that rule because currently there’s nothing to treat those patients? Like Motor Neurone Disease: is there a case for doing a smaller study to try and help those people more quickly?

Another  issue is there’s a lot of discussion about the duration of patent life. There have been moves to shorten patent terms and allow drugs to become generic [ie to be manufactured by companies other than the original developer]. That would be the death knell for the biotech and pharmaceutical  industries. We rely on the ability to sell our drugs for a reasonable period of time to recoup our R & D costs and provide a return to our investors. 

Are you working in America because it’s the centre of the industry – or do you just enjoy living in America?
I never planned to move to the USA. But it is the epicentre of biotech and most of the research is there now. The UK does great research but on a much smaller scale. The US is really the place to be for biotech.

What makes it so expensive? Is it the sheer scale?
If you’re an investor – and anyone with a pension fund for example is likely to be invested in this sector – you need to have a reasonable return on your investment that justify the risks in the industry.  It typically takes 7- 12 years to take a drug through development  and to approval, with a lot of investment in the process and likely many failures along the way.  Therefore, over time, the drugs need to be sold for relatively high prices in order to get back the costs of development and then pay the investors who have funded it. Investors could put their money in Apple or Google and get a great return. So, to be competitive, drugs have to be sold at high prices to compete with the investment returns offered by other industries, especially with the heightened risk that at drug will fail.

Investment returns drive drug development. For example, nobody in biotech is developing antibiotics at the moment. Historically, antibiotics were sold at low prices and it’s hard to break out of that mould once the precedent price has been established. So the returns for investors don’t work – and now nobody is developing antibiotics. Thus  there are no new antibiotics, despite the unmet need.

The great scientists of the past, like Alexander Fleming for example, are well known, but this work is now carried out as an industry. Do you see yourself in that tradition of innovators, though?
Well, Fleming never developed penicillin, he only discovered it. It was moved forward by Ernst Chain, whose name you may not know – so the drug developer was not so well known as the drug discoverer. But I do see people like Fleming as my heroes. I don’t claim to be at anything like that level of sophistication and I am not researching in the lab like he was – but there have been occasions where ideas have come to me and I have suggested whole new areas where a drug could be utilised successfully. There is a lot of opportunity to think creatively in drug development.  I also describe it as a team sport. Beware of anyone who takes too much individual credit. It’s always a team activity with a lot of people involved.

How did you come to be a pupil at CLS?
I started off at my local Comprehensive – my parents were very committed to egalitarian education. But the school had only recently changed from being a Grammar School.  The Grammar School teachers were ill equipped to deal with the diversity of pupils in a Comprehensive environment.  Among the pupils there was a huge range in the level of interest in studying and much disruptive unruly behaviour.  Many  were from very troubled backgrounds.  Maintaining discipline was a problem for the teachers.

It was impossible to study in this environment and I was keen to study. I ended up being threatened with a knife on a bus by another boy from the school.  The headmaster indicated there was nothing he could do to change the dynamics at the school and suggested my parents consider a public school as an alternative. My father visited several public schools, basically begging them to offer me a place in the middle of the school term.

It was only at City of London that the headmaster offered to set up a one-off entrance exam just for me and then offer me a place if the scores worked. The headmaster James Boyes was the most wonderful man to give me that opportunity. I joined the school in the spring term, aged 11 going on 12. It was a remarkable thing the school did for me and made a huge difference in my life. I credit CLS with changing the trajectory of my life and future career.

Which other teachers inspired you?
The school has always had the most wonderful teachers. Aiden Tolhurst was a new biology teacher when I joined the school. Many years later he became Second Master. He was enormous fun and made science so interesting. I was fortunate that I ended up having him for four years as my biology teacher.

Peter Coulson, who sadly died last summer, was head of English. He was a really inspirational teacher. His methods were quite revolutionary.  We didn’t have desks in the class; we would sit round in a circle discussing poetry, literature and plays. I always tell my children it was like the film Dead Poets Society with Robin Williams – in terms of stretching the kids and doing unusual things. He was in that mould. An amazing English teacher.

I loved biology and chemistry. But I was also very interested in politics and current affairs. And I was (and still am) a history buff… so I will also single out Lionel Knight, a history teacher who was an old boy himself. He was always wanting us to think about things in different ways. We talked a lot about Marxism, what-if scenarios in history and so on. I really enjoyed history and he was a great teacher.

What was your first experience of work?
My dad had a chain of menswear stores and I used to go and sell men’s clothing on a Saturday morning. I knew nothing about clothing. I’m colour blind as well. But I would go and sell clothing and I was on commission like everyone else.  Probably it would not have been a good career fit long-term.

Which extra-curricular activities did you enjoy?
I loved debate. I ended up as president of the debating society. Myself and my partner won the debate competition two years in a row.

Did you defend the indefensible?
I did! At the time defending the indefensible was part of the exercise. To put yourself in the shoes of the other person. We did that all the time. There were lots of debates about staying in the European Union, even in the 1970s. We had to have the ability to argue both sides. You take whatever side, on a coin flip. That’s a fantastic way to learning that there’s two sides to every argument and allows one to understand the other person’s point of view.  A great life skill.

I think City had – has – a wonderful culture. It wasn’t about where you came from or your background.  It was about you as an individual and how you interacted with the other pupils and with the teachers. There were pupils from all walks of life and a tremendous diversity of opinion of politics and religion. It was a melting pot of different ideas and we were challenged intellectually. It was just wonderful -- that open-mindedness to ideas and giving kids the broadest educational experience it was feasible to do.

What are some personal qualities that a teenager might need to follow in your footsteps, career-wise?
Perseverance, optimism, teamship and, one of the things that City helped develop for me -- thanks to the educational breadth -- is learning how to think out of the box.

When you have a big team of people you do end up with a bit of group-think which may not always lead to the best decision in the end. It is vital to be able to think about things differently, broadly, without assuming norms, how you can do something in a different way.  In drug development, it’s all about problem solving and working out how to get to the finish line and have the best outcome for the drug and the patients…Out of the box thinking has really helped me in my career. I often credit CLS with nurturing in me that way of thinking.

What do you enjoy about living and working in America?
I’ve lived here since 1998. I love the open-mindedness to ideas in science and in business. In the US, no-one cares about your background.  If you have a good idea it’ll be backed and if it’s a bad idea, it won’t be. It’s all a meritocracy. It’s not about your history. It’s incredibly refreshing. Even after 25 years, I am in awe of that culture.

Is Britain still held back by not having that culture?
It’s gotten better. And that march towards a merit-based culture is really important. I come at this as a quasi-American – I do think those things have held back the UK. All the attention to your past and your accent have held the country back.

 

School Photo:1975/76, Gary is back row, third from the right.