Instant Genius - Inside the hunt for life-changing medicines

Episode Date: September 28, 2025

Chances are when we’re treated with medicines in hospital or pick up our prescriptions at the pharmacy, we don’t give much thought about how the drugs that are so vital for our health and wellbeing came to be. The fact is the journey that a new medicine takes from its beginnings in the laboratory to finally being administered to patients can be long and arduous. It typically takes the work of countless scientists, researchers and technologists toiling away behind the scenes for decades and is often fraught with failure. So exactly how does a new drug make the grade? In this episode, we’re joined by oncologist and drug researcher Dr William Pao to talk about his latest book, Breakthrough – The Quest for Life-Changing Medicines. He tells us how fundamental academic scientific lays down the bedrock for the development of a new drug, runs us through the vital importance that clinical trials play in the whole drug development process, and tells us the fascinating story of how the common everyday drug paracetamol was discovered by accident. Learn more about your ad choices. Visit podcastchoices.com/adchoices

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specialist focal, combine handcrafted tradition with cutting-edge innovation and high-end materials, delivering digital precision with analogue warmth. So you can experience exceptional sound at home. Music just as the artist intended. Visit name audio.com to learn more. Hello and welcome to Instant Genius, a bite-sized masterclass in podcast form. Every Monday and Friday, you'll hear world-leading scientists and experts talking about the most fascinating ideas in science and technology today. I'm Jason Goodyear, commissioning editor at BBC Science Focus. Chances are when we're treated with medicines in hospital or pick up our prescriptions at the pharmacy,

we don't give much thought to how the drugs that are so vital for our health and well-being came to be. The fact is the journey that a new medicine takes from its beginnings in the laboratory to finally being administered to patients can be long and arduous. It typically takes the work of countless scientists, researchers and technologists, toiling away behind the scenes for decades and is often fraught with failure. So how exactly does a new drug make the grade? In this episode, we're joined by oncologist and drug researcher Dr. William Powell to talk about his latest book, Breakthrough, The Quest for Life-Changing Medicines.

He tells us how fundamental academic science lays down the bedrock for the development of a new drug, runs us through the vital importance that clinical trials play in the whole drug development process, and tells us the fascinating story of how the common everyday drug paracetamol was discovered by accident. So welcome to the podcast. Thanks so much for joining us. Thanks, Jason. It's a pleasure to be here. So today we're talking about your book, Breakthrough the Quest for Life-Changing Medicines. So as the title states, we're going to be taking a sort of deep dive into the journey that new medicines go through as they move from being sort of ideas and experiments in the lab to fully-fledged treatments. that can be given to patients in the hospital or pharmacy or whatever.

So in the book, you go through several cases, sort of split into different case studies of different drugs, which we can talk about as we go through the process. But first off, I'd like to ask, as you make pretty clear, getting a drug through this process can be quite arduous. So roughly how many drugs can we say or actually get through this process, say, in a year?

In a year, yeah. Well, I can tell you that as of the end of December 22 when I sort of finished writing the book, there were officially about 1,800 what we call new molecular entities that had ever been approved by, for example, regulatory agencies in the U.S. So some people might say that's a large number. I think that's a pretty small number, if you think about the history of humankind, that only about 1,800 were ever approved. These are new molecular entities, not just copycat medicines, for example. So to me, the approval of a drug really should be celebrated as an achievement of human ingenuity. Because as you'll see from

the book and the chapters, I talk about eight different molecules from eight different companies, they really go an arduous path, a lot of ups and downs, a lot of failure actually. And so really, to me, it's actually a miracle that a drug ever gets approved. And I think most people probably don't appreciate when they take a pill, you know, who developed that, how long did it take to develop that, and so on. Yeah, so related to that. I think also, something that a lot of people perhaps won't think about, as you say, when they're taking their medicine, their prescription, is that drug discovery is truly a multidisciplinary process involving scientists and researchers from many different fields. So what can we say about that?

Yeah, so we often think about scientists as epitomized by the Nobel Prize, for example, where basically only two or three people went a prize and get attributed for an entire field for discovery. However, with drugs and developing new medicines, there are often hundreds, if not thousands of people actually involved. So it's very difficult to point to just one person and say that one person was responsible for, you know, the drug ever making it all the way. And the reason is that drug discovery actually happens over decades. And one of the stories that I write about, actually it's about a hundred year journey.

Actually, a couple of those stories. There's a hundred year journey from the first time, for example, a clinical disease was described all the way till the medicine was approved. and that's because over decades, it just takes a long time to figure out, oh, there's this disease, oh, what's making that disease happen in the body, oh, how do I actually then figure out how to drug that, oh, how do I develop a drug to target that? How do I develop a drug to make it safe and not hurt the person who has that disease and so on? And sometimes, even though we like to think that drug development might be a linear process, meaning we go from A to B and then B to C and C to D and it's

very logical, actually it can be going from A to E and then back to B and so on and so forth. And that happens over decades. And the scientists and the clinicians and the other people trying to develop those drugs actually pass the baton on. And some of them may not even know the previous generation that worked on them. So let's have a look then at this process. So say we've identified a disease or something which needs treatment. So where does a new drug actually start its life? You know, How do we choose which molecules to study in the first place? Yeah, so that's a real fundamental question. The way I like to think about it is written about in the last chapter of the book, actually,

about insights of drug development. But every drug that's ever developed, you think about it has to get to the intersection of three circles in a Venn diagram. So one circle is biological understanding, another circle is clinical understanding, and then the third circle is technological advancement. So imagine these three circles and then them interlocking in a Venn diagram. And then in the center is the intersection among biological understanding,

clinical understanding, and technological advancement. Now let me explain that in a little bit more detail. So say you have a disease and you really want to understand, you know, is there something that I can do to intervene in that disease, like cancer, for example. Well, first of all, you need to understand, you know, there's lung cancer or pancreatic cancer or prostate cancer and so on and so forth, and where can you potentially make a difference already if there's medicines out there? Then the second is you need to understand, well, if I want to make a difference, what's a good target? Well, a target is something inside a cell,

inside the body, inside the cancer that is making that cancer cell grow. And so you need to understand from a biological standpoint that that target, for example, Target X, is really important to the cancer growing, and that if you actually affect that target, that the cancer would stop growing. But more importantly, you also need to understand what the biology of that target is in normal tissues. So if you actually make a medicine to target that X target, then it's not going to hurt the patient or harm them or make them even worse than they were with the cancer already. And then finally, you have to think about, well, hey, I want to hit target X. Well, how do I hit target X? I need some kind of drug. Now, there are like to be.

a lot of targets out there that are so-called undruggable, meaning currently the technology that we have, we can't actually hit that target at all because we just scientifically and intellectually haven't figured out how to do that and do it in a safe way. So first, you need some technology that makes the undruggable drugable. And then once you figured out how to make that undruggable drugable, then again, since you're going into the human body, you need to make sure that that drug is actually safe and effective hitting the target and then not having a lot of side effects that are going to make the patient worse. So really you need to get to the intersection of all three of those, and that can take a very, very long process. Yeah, sort of continuing with this idea. I think

something that's really interesting that also a lot of people overlook, which is a bit strange when you think about it, is that we need this bedrock of fundamental research, fundamental research science in the first place, which wasn't necessarily even aimed at searching for new drug discovery. A classic example is we can't treat genetic conditions without first figuring out what the structure of DNA is and how that works. So, you know, how much do we lean on this bedrock? Oh yeah, Jason. So that's an incredibly important point. So there's a lot of fundamental research that goes into drug discovery, but that can take decades to form the knowledge from which we can then even start to think about making drugs. So you give a great example. For example, if you want to

target a genetic disease such as sickle cell disease, you know, sickle cell disease is a disease that gives patients anemia. They have a mutation that they're born with, which amaze them have a different form of hemoglobin, which is the protein that carries oxygen in the blood. And instead of having nice round red blood cells. They have sickled red blood cells, which then causes a lot of problems. They get clogged in the blood's arteries and veins. They cause a lot of pain. They can cause premature death and so on and so forth. But to understand all of that, yeah, you need to understand, first of all, what is a mutation? And what does that mutation mean in DNA? And so you can even trace the origins of knowledge about that back all the way to Watson and Crick, who discovered,

you know, the structure of DNA and how DNA then ultimately is the genetic basis of life. Then you need to understand also, you know, how did that mutation in a particular gene lead to sickle cell disease in the first place and sick of red blood cells and so on. And then ultimately you need to understand how can I even manipulate and change that mutation of the genetic level such that I can improve a patient's life. So the great thing, or maybe the underappreciated thing, is that a lot of this basic science knowledge is the foundation for future drug discovery. And so it's really important that we continue to support as a society basic science research. And so I'm a big advocate of basic science research. If you go

through the chapters in the book, virtually all of them start with some basic science fundamental discovery. And this was led by scientists who were not really setting out to make a drug, but really just were curious about nature. In another example, you know, I have two chapters about cancer drugs. And in cancer, really all of the research started with people just trying to understand how do cancer cells grow in the first place, you know, or even fundamentally, even more than that is how do cells grow in the first place? How does a cell know when to grow and when to stop growing? The basis of that was discovered by Rita Levi-Montalcini and Stanley Cohen in the 1950s. They were just trying to understand how do cells grow, and they ultimately discovered what we call

today growth factors. These are proteins that stimulate cells to grow, and that led to a whole area of, well, if you have factors that lead to cells growing, then how do cells know how to detect that factor? That ultimately led to the discovery of, for example, growth factor receptors, and then the growth factor receptor discovery led to, oh, growth factor receptors are altered in cancer and so on and so forth, and this happened over decades. So it's really important that we invest in basic science research and particularly in people who are just curious about nature. And it may not even be in human model systems. It may be in flies.

It may be in worms. It may be in other kinds of species. The breakthroughs come from those and then lead to ultimate breakthroughs in human biology and medicine. Yeah. So we've mentioned that you mentioned cancer and certain genetic diseases. I mean, you talk about spinal muscular atrophy in the book, for example. and also viruses such as HIV and the recent COVID pandemic.

So do the approach is to developing treatments for these different diseases vary in anyway, or do they have the sort of same universal sort of method? Oh, well, that's an interesting question. I mean, I think every medicine that's ever developed has to be fit for purpose exactly for the problem that it's trying to solve. So, for example, yes, the first chapter is about spinal muscular atrophy, which is unfortunately a common rare disease that can be fatal in people with the worst form of it. It's a genetic disease, autosomal receptive, meaning that there's a mutation in both parents

that ultimately lead to loss of this particular protein SMN1, survival of motor neuron one, which then leads to defects in musculoskeletal areas where then patients who can't, the babies that are born then can't breathe and ultimately can't sit up and then may die before the first age, a year of life. So in that sense, the first you have to understand that's a genetic disease. And then once you understand that, then you have to understand, oh, how do I actually potentially make a difference in patients with that particular mutation? And those you need to understand then, oh, well, different forms of medicines can happen. For example, I could use gene therapy. I could use, I'm going to get esoteric here. You could use an antisance oligoneucleotide

therapy, which is a different way of altering the particular genetic basis of that disease. And then ultimately, you could have an oral pill, a small molecule that alters the disease in the way that you want. I'm glossing over a little bit because it's a little bit technically more sophisticated than that. But it is really fascinating and it's really amazing that there are three drugs approved now for spinal muscular atrophy. But each came in a different way with the deep understanding of the biology and then how to potentially alter the disease in the way that could make patients' lives better. Now, if you move on to infectious diseases, you know, then you really need to understand, oh, what is the particular virus or bacteria that I'm trying to impact?

In that case, for example, there's a chapter about Lena Capovir, which is a new anti-HIV medicine, and that's a really novel medicine. It was actually the 2024 science magazine breakthrough of the year because of the really novel mechanism of action that it has. It's what's called a capsid inhibitor. I can go into more detail about that if we want. But there, you know, people already knew, for example, in HIV, human immunodeficiency virus, which causes AIDS or required immunodeficiency syndrome. There were already a number of ways to tackle that virus. But at Guilead, the scientists thought about a different way. Could they make a capsid inhibitor? And that was again based on fundamental biological understanding, but then ultimately led to the approval of this medicine.

But they really had to understand what was the target and then develop particular small molecules to try to inhibit the target in the way that they want to do. And then finally, you know, there's a molecule about Paxloid or Numerrelvir, retonovir, which is the small molecule antiviral pill for COVID-19, which was developed in record time by Pfizer. And there, you might say, well, how did they develop it in a record time? It was literally less than two years. Well, it was based on a lot of prior knowledge, particularly from the first time there was a SARS virus in the mid-2000s. So there was already knowledge and even chemicals that could potentially inhibit the virus. But still, people had to understand, oh, what is the virus that's causing this horrible disease?

You know, why are people dying so much? Then in the virus, where's there vulnerability such that I can kill that virus. That turned out to be an enzyme called the 3CL protease. And then, you know, how do I get a molecule to hit that particular enzyme and kill the virus? And then how do I make it effective and safe to give to millions of people across the globe? So yeah, every medicine that's ever developed really has to be fit for purpose for the particular target for the disease. And then it has to use the right technology so that it can be given to the right patient at the right time. Ambition comes in all shapes and sizes. At First Citizens Bank, we roll with your goals,

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unforgettable listening experiences at home. Try it for yourself at a focal powered by name boutique. Visit focal powered by name.com for more information. In the book, you relate a fascinating story about paracetamol. So I would venture not many people have heard how we actually came to, not necessarily discovered, but find the common use for paracetamol. So can you run us through that? Yeah, so paracetamol, at least in the U.S. is called Tylenol. It's a very common anti-fever, anti-pain medicine given around the globe. It's been around for decades now. But yeah, maybe most people don't appreciate that it was completely discovered by accident. So basically in the late 1800s, there was a patient with intestinal worms in Strasbourg who went

to his doctors and was prescribed basically naphthalene. So nowadays, we don't take naphthalene. we think of naphthalene associated with mothballs, actually. But I guess it was given in the late 1800s for intestinal worms. And so he ended up seeing these two physicians, and they prescribed nathylene. The patient got the prescription and went to the local pharmacy and got the prescription and then took the medicine. And basically his intestinal worms didn't go away, but he had a fever. And the fever went away.

So he went back to the doctors and told them that, hey, you know, I had this fever and it went away, and the doctors were like, wow, basically we've never seen a medicine that relieves fever. Now, this was the late 1800s, right? So nowadays, we take it for granted that we can relieve fever. But back then, it was not given. So the two physicians recognized that that was maybe something really novel. So they went to the pharmacist, and it turned out that the pharmacist had actually given the wrong prescription, hadn't even given naphthalene, but given prescription for acetanolide, which is a coltar derivative. It's a back. then there were a lot of new dyes being developed originally from coal tar, originally from

benzene and oil and things like that. And so not only did it turn out that the patient accidentally had the fever go away, but actually had been giving the wrong medicine. Now, today, obviously, that would be malpractice that pharmacy would be shut down. But I guess what was important is those two physicians realized that, oh, there might be something here, and they ended up starting to test acetanolide, and eventually that became the first anti-feverment called antifbrin, which was then marketed for basically relieving fever. So that was incredible. And then paracetamol wasn't even discovered for another, what, 60 years later or so?

But it turned out that antifference was very, very effective, but it actually had a lot of side effects. So something called methemoglobinemia occurred, where basically the chemical was affecting red blood cells in a bad way and causing patients to turn blue, which is not something you want to have done to your patients. But it wasn't appreciated until the 1940s, essentially that it was a breakdown product of acetanolide that was more effective at inhibiting fever, but didn't have those side effects, and that ended up being parasitamol. So let's move on to sort of another stage in the process. So you mentioned earlier there, sort of animal models with flies and mice and things. And often researchers

has published these studies in animal models. And some people, especially I've noticed on social media, they get sort of really sniffy about it and they say, well, yeah, it works in flies, it works in mice. So what? How can we make them, you know, think differently in this way? Yeah, so one of the main challenges right now in drug discovery is we have no perfect human model systems or what I call human model systems. So there's no particular system right now where we can test the drug in a human discovery.

human outside of a human, if you know what I mean. So obviously, if we're going to go into human beings to test new molecules, we need to have some assurance that they're going to be reasonably safe and also do no harm, so to speak, and then potentially impact the patient's disease. So to get to that point, we really do need to do a lot of research outside of human beings, and the current ways to do that are in the laboratory in what we call preclinical experiments, and those preclinical experiments can involve manipulation of cells, for example, in the petri dish, or going into different animal species that we have designed to have what we think could be the simple form of the disease in humans. What that means is then, you know, because those human model systems or those systems that we put in the petri dish or in animals are simplified,

then they're not as complicated as the true human disease. And so, yes, it is true that we can often cure, for example, cancer in animals. And we've probably cured many, many cancers in animals that ultimately that research doesn't translate into human beings. But that's really because, as I mentioned at the beginning, we don't have human model systems that completely replicate humans. And that's also important not only in terms of the disease, but also in terms of the side effects.

So, you know, when you're developing or when we're developing a small molecule against the target X, We try to have that small molecule be as specific against target X as possible. But in life, it's virtually impossible to have no off-target effects. And so then we have to understand, well, if we have some off-target effects, is that going to lead to some toxicity in human beings? Now, the way we try to anticipate that is we test it in animals, but animals aren't human beings.

And also, so then the animals can sometimes have side effects that we don't see in human beings. We try to do a lot of this all to make sure that we develop safe and effective medicines for patients. But until we have complete human model systems, that's always going to be a challenge. Yeah, so we'll come back to that in a moment. But I'd like to talk about clinical trials now. So a lot of people will have heard, oh, this has gone through a clinical trial. But they might not realize actually how complicated and long the processes and how it's divided into stages. Can you briefly run us through that?

Sure. So first of all, I want to give a shout out to all of the patients who participate in clinical trials because they're really volunteering to test new medicines and new therapies. And, you know, they may be effective for them, but they also may not be effective for them. But building on a theme that we talked about before, you know, building upon the knowledge of even if it's not effective, that's going to be helpful to the next set of medicines that may come along that could be even more effective. Yeah. So as you mentioned, you know, so every new medicine, that gets approved, actually has to go through clinical trials. And there's a very rigorous process with regulatory agencies and also different institutions to make sure that all these trials are done ethically and with patients consent, meaning that patients know that they're getting experimental therapies and that nothing is happening, you know, sort of behind their back. The process involves what we call phase one, phase two, and phase three testing. Phase one is basically the very first time a new medicine ever goes into human beings. And there the goal of a phase one trial is really to test the safety and then also to find a reasonable what we call dose in schedule. You know, if you get

a medicine and you're told to take it once a day for five days, how do you think that came about? Somebody actually had to figure out in a human trial, hey, you should take this once a day for five days, not twice a day, not three times a day, not for 10 days, not for 20 days, but once a day for five days. That all happens because of a clinical trial. Then in a phase two trial, basically you try to establish, does this medicine actually have effectiveness against the disease that I'm trying to treat? Now, sometimes there might be what we call two arms of that trial. You might have one arm where you get the experimental medicine, and then you might have one arm where you get the standard treatment, but it's not a huge comparison in the sense that you're not trying to get this medicine approved.

but you're just trying to see, hey, does this medicine actually do what I wanted to in terms of improving the disease? And is it potentially better than what's out there already? And then finally, phase three trials are the ones that are the largest. You know, phase one trials can have maybe only up to 100 patients, phase two trials may be up to 200, 300, 300 patients. Some phase three trials may have thousands of patients. And that's really where patients are randomized to the new medicine versus the complete standard of care. And there, then after the whole trial is done, if the new medicine is superior, then you can file for regulatory approval.

And that's ultimately when a medicine can get launched. Now, that whole process can take years and years. And you can imagine there can be setbacks to many molecules actually die in phase one, meaning that, you know, they may have not had an unacceptable safety. They actually were not effective at all. and their pharmacokinetic properties are not predictable, meaning like if I took the pill, the dosage level might be all over the place

rather than predictable and so on and so forth. So there are many, many reasons why a drug might fail. But along the way, even in phase one, phase two, and phase three, they may fail. And that's, again, because we don't have great human model systems right now to ultimately predict what's going to happen once we get into humans. So quite a lot of certain medicines are only effective in a certain proportion

of patients, you know, based on all sorts of different variabilities. So what are some of the reasons for that? And how can we make more efficacious drugs? Yeah. So, I mean, that's a challenge in the fact that there's eight and a half billion people of something like that now on the planet. And each one of is genetically different. So coming back to the animals topic, you know, often when we use animals,

we use genetically identical animals. And so, you know, we try to simplify again the experiments that we do. And so we use, for example, mice that could be all genetically the same. Obviously, human beings are not like that. So once we get into human beings, then you can have lots of variability in terms of how a particular drug is metabolized, particularly how the disease is occurring. You know, a disease may be due to just one mutation in a gene, but there could be other factors in the humans that affect how that particular mutation.

then leads to the disease. And then in cancer, it's even more complicated. So, you know, we like to think of cancer as a lung cancer or prostate cancer or breast cancer. You know, we classify by where it comes from in the body. But in truth, the research over the last 30 years has shown that every cancer is actually genetically different as well. Cancer usually arise because you have a mutation in a set of genes that then leads ultimately to uncontrolled cell growth. And in each individual, it's actually different. And so you can imagine if you make a cancer drug, it can be effective, but then depending upon that particular cancer's mutations, it may be less effective or it may be more effective or resistance may develop faster. So some of these are just

due to the complicated nature of human beings where, you know, it's just there's so much variability once you get into humans in the first place. You know, one of the quotes that I have in the book there is from Art Levinson, who was the CEO of Genentech and is currently CEO of another biotech. He's a super successful drug developer, and he says that, you know, drug development is not chess. And when he said that, I was really thinking about that, I mean, chess is a pretty complicated game. It's got 10 to the 40th moves for something like that. But, you know, chess has a limited number of pieces. We know what the pieces do. There's a chess board, so we have to play within that board and so on and so forth. But once you're talking about human biology, we don't know all the

players. We don't know what all the players do. You know, unlike chess, where we move one piece at a time, obviously in the human body, things are moving in parallel all the time, and so on and so forth. So think about chess and then think about how much more complicated drug development is. So the book's title, Breakthrough. So let's look into the future then. What are some of the kind of headline breakthroughs in drug discovery that you'd like to see in the next say five, 10 years? Yeah. So I think, you know, I'm really excited by the potential of what's going to happen.

I would call this the biological century, meaning that really, you know, the understanding that we have now of biology, I just said that we don't have a great understanding, but in truth, compared to our knowledge, even, you know, 20, 30, 40, 50 years ago, our knowledge is much greater. we have the tools and technologies now to really be able to do a lot of things. We have a clinical trial infrastructure, you know, to develop these drugs through phase one, phase two, phase three trials and so on. And so I do think the pace of drug discovery will continue to accelerate.

And I'm really excited about the future breakthroughs that are coming. You know, one of the reasons I wrote the book was to inspire the next generation to make breakthroughs. And those breakthroughs will probably come in, you know, new diseases that we can't conquer right now, like Alzheimer's disease, which is devastating, affects many, many people on the planet, you know, Parkinson's disease. Cancer is still killing lots of people worldwide. Unfortunately, the number of cases is still expected to double by 2050. Surprisingly, even though we have more effective medicines. You know, mental health disorders are really a huge unmet medical need.

So there's really a lot of areas that I think will be able to hopefully make breakthroughs on in the future. Thank you for listening to this episode of Instant Genius, brought to you from the team behind BBC Science Focus. That was Dr. William Powell. To discover more about the topics we've just discussed, check out his book, Breakthrough, The Quest for Life-Changing Medicines. If you liked what you just heard, then please do consider subscribing to Instant Genius on your preferred podcast platform. If you'd like to see our guests and hosts in person, then please also check out our YouTube channel at Science Focus. The current issue of BBC Science Focus magazine is out now.

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