The world faces massive health challenges in the form of multi-resistant bacteria, pandemic viruses, dementia, heart disease and issues associated with an ageing population among many other. The pharmaceutical industry will play a significant role in solving these problems.
This is the theme of this year’s UCD Michael Smurfit Graduate Business School Laurence Crowley Lecture, which will be delivered by Dr Paul Stoffels, chief executive of Belgian biopharmaceutical company Galapagos. Stoffels is uniquely well placed to address the topic, having been at the forefront of the battle against some of the world’s most serious diseases for more than three decades.
Having qualified in medicine in the late 1980s, Stoffels moved to Africa in the middle of the HIV epidemic. “I had studied infectious diseases and tropical medicine and I wanted to make a difference,” he says. “HIV was such an overwhelming problem. Huge numbers of people were dying within years of contracting the disease. I spent three years in the Democratic Republic of Congo and another year in Rwanda. I learned about the disease to see what could be done with old drugs and later worked with new drugs.”
The drugs in use at the time didn’t work because we didn’t understand the virus
Following the outbreak of war in Rwanda in 1991, Stoffels returned to Europe. He was asked by Janssen Pharmaceuticals founder Paul Janssen to work with him on the development of anti-viral drugs for HIV. “The drugs in use at the time didn’t work because we didn’t understand the virus,” he notes.
The difficulty lay in a problem with which the world has become all too familiar – the ability of a virus to mutate. The HIV virus is particularly adept at mutating in ways that make it resistant to drugs.
“We were the first to put a diagnostic test for resistance on the market,” says Stoffels.
That led to the pharmaceutical equivalent of a detective story, with Stoffels and his colleagues collecting more than 400 different strains of the virus from around the world to map its resistance to different drugs. Over a period of 15 years that work eventually led to the development of a combination treatment that would suppress and control multidrug-resistant HIV.
But that treatment was complex and expensive to deliver, with patients typically having to take 18 pills twice a day. “The life expectancy of people living with HIV is now close to that of the general population,” he says. “But it is a huge burden if you have to take medicine every day for the next 40 years. You have to make transformational treatments like this more available and accessible and to do that you need to simplify them.”
It has taken us 25 years to get there, but the original combination drug is still the cornerstone of HIV treatment
Great advances have been made since then. “We went from 18 pills twice a day to six pills a day and then to one pill a day. And we now have injectable treatments which are delivered every two months and soon we will have one that is twice yearly. It has taken us 25 years to get there, but the original combination drug is still the cornerstone of HIV treatment. The fight is not yet done. We need a HIV vaccine. Prevention is the most important thing.”
More recently, in his previous role as chief scientific officer with Johnson & Johnson, Stoffels spearheaded the development of the company’s single shot Covid-19 vaccine, which became the first to be approved for use anywhere in the world in early 2021.
He describes the effort involved as an example of extreme collaboration.
“We started work in January 2020 when the genetic code was provided by Chinese scientists,” he recalls. “That meant that people could create the virus in labs and begin developing vaccines. Within 13 months we had a vaccine approved by the FDA. In the first quarter of 2020 we had 11 or 12 potential vaccines at the pre-clinical stage. We tested them for potency, durability and safety. In the second quarter we looked at upscaling production, did the regulatory work, and prepared for clinical trials.”
July saw the vaccine tested in a human for the first time and September saw the beginning of a massive phase-three clinical trial involving 300,000 people in 200 centres around the world. Data from the trial was collated and supplied to the FDA for approval in January 2021.
The industry can do the technical side and make the vaccines, but governments and agencies have to make it happen
“It was a case of extreme collaboration between all the players,” Stoffels says, “including governments, the European Commission, the regulators, the European Medicines Agency, the FDA, the pharma industry and academic research institutions. The industry can do the technical side and make the vaccines, but governments and agencies have to make it happen. We were able to deliver a file to the FDA at 3pm on a Saturday and they were ready to work on it by 4pm that day.
“Society had a mission to beat the virus. I have never seen that type of incredible collaboration between partners before. We had a vaccine in just over 12 months where it would normally take between eight and 10 years.”
Having an approved and effective vaccine was just the beginning. “In the meantime, we had to build the infrastructure to produce it. We started to develop a new manufacturing plant in April and six months later it was producing the vaccine. That was a fantastic achievement.
“Covid has shown us what we can do when we work together to solve problems. We already saw that collaboration with HIV treatments, and we are now seeing similar collaborations in areas like oncology, orphan diseases, diabetes and geriatric diseases.”
In his current role with Galapagos, Stoffels is overseeing the development of transformational chimeric antigen receptor T-cell (CAR-T) therapies for cancer. This involves taking the patient’s own immune cells and altering them in a way that enables them to find and destroy cancer cells.
That brings him back to his central message around accessibility and simplification. “At present, the T-cells have to be frozen and taken to a lab to be programmed. We are working on a system in which it can be done in the hospital where the treatment is being carried out. We are using technology to make it simple and accessible.”
Billions of dollars have been mobilised for the fight against HIV
Simplification will also be key to making transformational treatments available to patients around the world regardless of their means. “When we were working on the HIV therapies we collaborated with organisations like the NIH, Gates Foundation, Wellcome Trust and the WHO to fund the development of the drugs and make them available to patients in the developing world. Billions of dollars have been mobilised for the fight against HIV.”
That needs to be replicated for other transformational therapies, he says.
“It can be easy to make new treatments available in the West with well-developed health systems, but when you are working in a country with a $10 to $20 per patient per year healthcare budget, it is much more challenging. These treatments have a massive impact on people’s lifespan and on their quality of life and we need to make them available to people around the world regardless of their ability to pay for them. We need to simplify them to make them as accessible as possible.
“That’s the challenge, and it motivates people like me enormously to be part of such an endeavour.”
The 2022 UCD Smurfit School Laurence Crowley Lecture Series will take place at 6:30 pm on Monday, January 23rd. This event is free and open to the public. To register, please click here