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What can we learn from a Pharmaceutical Leader? Ian Braithwaite Senior VP World Wide Clinical Trials
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After a Get Amplified break we're back with a flurry of exciting new guests. We kick off September by looking outside of the tech industry to see what we can learn from the Pharma industry.
Not only are both industries affected by high attrition, particularly through Covid, but both share the same challenges of time to market – of people being pulled in different directions, with too much workload and less people to do it.
Ian shares with us his fascinating experience particularly around decision making and the importance of bringing together a cross functional team of people to successfully manage projects.
With only 1 in 100 drugs making it through to a successful registration process and 1 in 4 making back the investment, it's a 7-12 year investment timeframe. A fascinating contrast to the speed of technology development and expected return.
Ian tells us how projects involve 3 key constraints which have to be managed effectively if you want a successful outcome. These are: time, quality, cost. If you reduce time, you increase cost.
It's a fascinating insight into managing a triangle of competing needs.
#podcast #pharma #leadership #projectmanagement #crossfunctional #team #clinicaltrials
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Hi, it's Vicky here. We've had a bit of a gap in series four. We had been scaling the business to plan, but over the last few months it has gone nuts. So we had to take a break whilst we just got resourcing sorted. But I'm glad to say now that we're back, we've got some great guests lined up and we've got resources sorted not only for looking after our growing list of clients but also to make sure that we can continue with our podcasts because we do love doing them and talking to amazing guests. And we've really got some amazing guests lined up for you. So hope you enjoy this one.
SamWelcome to Get Amplified from the Amplified Group, bringing you stories to help leaders in the tech industry execute at speed through the power of working together. It's gloriously sunny in Buckinghamshire today, so I'm shut up in my study. Vicky, how's the weather up in deepest, darkest Oxfordshire?
VicIt is also gloriously sunny. Thank you very much, Sam.
SamWonderful. So who have we got on the podcast today?
VicSo on the podcast today, we're going with a slightly different trait because what we thought would be really helpful for our listeners is we've recognised that in a lot of respects the pharmaceutical industry has been around for a lot longer than the tech industry. But actually, there are some real similarities in terms of the workforce. And so what we thought would be really helpful would be to get some leaders on from the pharma industry and just see what we can learn from them. So today we've got Ian Braithwaite, who Ian, you'll Cassie put me right on this, but your previous role was senior vice president of World Wild Clinical Trials, and hopefully you'll explain that some more for us.
SPEAKER_02Yes, uh, most certainly will do, yes.
VicWhat we're going to talk about, because Ian has significant responsibility if you think about clinical trials around risk and decision making. And we find a lot of the clients that we work with really struggle around how to make decisions to keep things more simple. So simplicity is a real challenge in the tech industry. Everyone is feeling like they're being pulled in different directions. There's too much to do, there's less people to do it, and yet they can't make decisions on how to prioritize. So we thought it would be really helpful to ask Ian to share some best practices with us on his experience. So over to you, Sam, to kick us off, please.
SamBrilliant. Well, welcome, Ian. Thanks for joining us. I you know how my brain works, Vicky. I love learning new stuff and hearing about new industries and things. So I'm really looking forward to this one. Ian, welcome. Perhaps you wouldn't mind by give starting by giving us a little bit of a potted career history, if you don't mind. Of course, Sam.
SPEAKER_02Uh, and just to say that the weather is glorious on the world this morning. Fantastic. That's good to hear. Yeah. The UK is bathed in sunshine. It certainly is, yes. So a little bit of a potted history. I've got a degree and PhD in pharmacology and therapeutics, postgraduate uh sort of diploma in clinical science. And 34 years ago, I made a decision not to become a lecturer at the Royal Mars, but to actually sort of move into the pharmaceutical industry uh as uh someone running clinical trials. And I said that I would do it for a couple of years and would make my mind up what I wanted to do for when I grew up. And 34 years later.
SamThat sounds familiar to me.
SPEAKER_02And 34 years later, right? Uh I've uh had what I would consider to uh have been um a reasonably successful career in clinical development within the pharma world and also working within clinical research organizations. Now, the so-called CROs are basically organizations which are dedicated to running clinical trials. The major pharmaceutical companies and biotech companies, uh, they uh sort of contract out the conduct of many of their clinical trials to organizations which have global footprints. And I spent probably the past 20 years working within this sector. Now, uh, the last formal job I had uh was as senior vice president for general medicine and rare diseases um at worldwide clinical trials. I left there in March to sort of move on to a couple of charitable endeavors as I sort of hit my retirement. But that job at Worldwide and the previous jobs I had at Cynios and PPD and AstraZeneca and Fuji Sour were all global roles looking at the development of drugs. And everyone says that it's a very, very lucrative uh sort of environment in which to work. The fact of the matter is that only one in a hundred drugs that are given to humans in the first instance actually get through to a successful registration process, and of those one in one hundred, only one in four make back the investment that goes into them. And the data from Tufts University say that it typically costs us$2.3 billion to have a successful drug. No small undertaking. Not a small undertaking, and when you think about it, you know, sort of the development uh sort of time spans are between seven and twelve years, which is far longer than anything within the tech sector, although I still struggle to get Excel to work sort of reliably for me. And I think that could be a user rather than a maker issue, but there you go, right?
SamYou know, so I think that's well they should make it easier for you in reality.
SPEAKER_02Oh, absolutely. Yes, most controlled. But anyway, so um you know I've been working within the global environment, and I have to take on board the rules and regulations that are mandated by the FDA in America, by the European Medicines Agency in Europe, Japanese, uh, PMDA, and also uh, sort of Chinese authorities and any other uh sort of uh drug regulatory authority that we go to will have a say on how they want those trials conducted. And uh we have to factor that into all of our plans. And I think that this is one of the challenges uh you know that we have is to actually sort of come up with a drug development program that's fit for all for many, many years, and they have one or two assets that they are banking the pension on to be successful, and we frequently have to sort of explain to them the constraints within the area in which we work to address all of those rules and regulations, and this is actually sort of a big part of the work that we do with our risk assessment and risk management. Typically, one of the things that I will do is actually sort of bring my team together with the client organization to talk about their drug development. What is it that they want to achieve and why? Because whilst I'm a project or program manager of the highest level, I work to time, quality, and cost constraints like all other project managers, be we within construction or tech or clinical development or whatever, right? You know, those are the three cornerstones of what we do. All projects have to run on the basis of quality, cost, and timeliness. And at times we are called upon to actually make compromises to make the project work. If we want to go quicker, do we increase the cost? If we want to go quicker, do we want to affect the quality, to reduce the quality in some way, shape, or form? But as I've said, right, yeah, I am being monitored by drug regulatory agencies worldwide to ensure compliance to their standards. So sometimes this triangle of competing needs is skewed in terms of quality. So I have to affect either timeliness or cost. Yeah. But there's a fourth constraint within the work that I do, which is an absolutely fundamental aspect of uh sort of drug development, is that the safety of the patient is paramount. And by safety, I mean to say that we cannot sort of negatively impact their health and well-being, be it physically or psychologically. So at the end of the day, everything that I do is governed by the focus upon patient safety and also the quality of the data we're able to generate from clinical trials.
VicSo, Ian, I just wanted, I mean, just listening to what you were talking about there just really makes me think why I'm so pleased that we're doing this podcast. Because quite honestly, it feels like the tech industry is child's play in comparison with the pharmaceutical industry and what you have to go through and the seriousness of it.
SamYeah, I think we use the phrase it's not a matter of life or death too easily. Whereas actually, you know, uh in its most extreme point, it is a matter of life or death with what you're you're talking about here.
SPEAKER_02Yes, it it is, and and this is you know at the forefront of everything we do. Working within the CRO side of things, it's a business. I'm with her to me.
SPEAKER_00Can you just explain what CRO is, Ian? Because CRO in the tech industry is chief revenue officer.
SPEAKER_02Oh, right, yeah. I I think I'm I I did mention it before. It's um a sort of clinical research organization, and we're entrusted by the pharmaceutical companies and the biotechs to actually sort of run the studies for them. Right now, now they will maintain governance and oversight because that's mandated by something called sort of good clinical practice. They need to assure themselves that we're doing it right, but they can't afford to have the infrastructure in all of the countries to actually sort of do things on a day-to-day basis. So, for example, if I was a biotech of maybe three or four people, right, you know, with an asset and wanting to run a study in six or seven countries, I would need someone to uh act for you know, uh sort of as our representative there, someone to look at regulatory authority submissions, ethics committee submissions, someone to go out and look at and scrutinize patient data, right? And it may well only actually sort of um cost you know, sort of 20% of someone's time every month to do this for those different roles. But you can't afford to pay someone full time for that, you know, sort of one day a week that you expect them to do the job. So it's it's not sustainable. So they contract out, but they actually have a transfer of regulatory obligations. So we have a tick list, you must do this, you must do that, you must do the other. Right? Do you want this? Do you want that? Yeah, and you know, we literally sort of go through and sort of say, hey, we can do this, and we can provide the point to of a regulatory affairs associate, a clinical research associate who goes out to the sites. You know, we can have physicians who are multilingual who can support patient safety, right? But it comes at a cost, but nowhere near the cost of employing five bodies, yeah, right, you know, to sort of do that work, which in effect is only one full-time equivalent every month.
unknownYeah.
SamI guess you know, it's the it's the equivalent argument of you know, with regards to outsourcing IT infrastructure in in our industry, in that the important thing for the company that you're working with is to concentrate on the development of the drug, not necessarily the regulatory stuff. In IT, it's important for a business to concentrate on the stuff that's going to differentiate them and not raw boring infrastructure, I suppose. So similar kind of scenario. Outsource the stuff that doesn't necessarily make the boat go faster, as they say.
SPEAKER_02Well, what I would say is that the boat goes faster, right? Yeah, because it's a well-oiled machine. Yes, yeah, good point. As much as yeah, uh, it's one of those things where you know you can say that it's almost like the sausage factory, right? You know, because we're doing this all of the time, right? You know, we we just add some more meat into the machine and we produce more sausages, right? Yeah, and um, you know, and we do it sort of uh more efficiently. But the fact of the matter is that you actually sort of have to have really good plans, a strategy, right, you know, which is distilled down to the operational team so that they know what they're doing and why they're doing things, so that they can actually sort of you know implement in the appropriate way. And I think that this is one of the things that we probably need to talk about in terms of risk, because uh we spend a lot of time uh sitting down and identifying sort of potential uh sort of risks, and we do the what's what's the incidence and what's the potential impact, and we produce a risk matrix and some things right, you know, which could be devastating, right? Things like the Ukrainian war was devastating for patient recruitment because all of a sudden the infrastructure within that country for conducting clinical research was taken out of commission, right? That sort of derailed many drug developments because a huge amount of patient recruitment came from the Ukraine and also Russia. But it's been really interesting to sort of see the resilience of the Ukrainians that in the midst of war, that they've actually sort of managed to complete their recruitment, monitoring the safety of patients and actually sort of getting good quality clinical data out, even though they've been running the trials, not necessarily in hospitals, but in bomb shelters. Wow. That's seriously impressive. I have to say, I was uh astounded. Yeah, and the clients keep on saying, can we go back to the Ukraine? And we're saying, can we just wait until after the spring or summer offensive is complete before we go back? Yeah, yeah.
SamThat makes sense. Have we have we learned anything from or changed anything in the wake of the COVID experience and the sort of the the rapidity of getting the vaccines into service? Now I know I know that the you know the underlying technology for the vaccines was was already there to some extent, and I gather that rather than doing stuff in series, we did stuff in parallel, and that enabled us to get the drugs to market sooner. But do you think your industry has been influenced by that experience? Will that speed things up in the future, or was that a really a sort of a hit the big red button moment?
SPEAKER_02Um okay, I was actually going to use this as one of the examples of opportunities that come from uh sort of risk management. But at the time of the pandemic, a number of us who work in infectious diseases were aware that something was coming. And yeah, part of the initial alert, right, you know, you know, to me was an escalation through to my leadership that this was coming and we need to do something about it. And they they looked closer, right, and thought, well, what can we do, right? You know, to sort of ensure you know that the business is able to address and respond to the impending pandemic. And one of the first things they did was to sort of ensure that everyone was equipped with a laptop and a cell phone and the wherewithal to work from home. This was before any lockdowns or anything else, this was something that was done, right? Yeah, and the more we we got thinking about things was thinking, well, are we going to be able to go to the hospitals and monitor data within an intensive care environment? That's challenging enough underneath the best of circumstances, but within something which was so deadly and so infectious, would they really want our staff going on to an intensive care unit, monitoring data, distracting people from what they were doing, right, when they were supposed to be looking after seriously ill patients, and then those individuals would move to the next intensive care unit, collecting data and monitoring data, uh, ending up in a situation whereby they were actually a vector of transmission. We were also uh sort of looking back at some of the work that was being done with Ebola, right? Yeah, and traditionally paper records have been the mainstay of sort of clinical research. Over the years, we've moved to remote data capture, right? Yeah, but in things like informed consent forms, were always right, you know, sort of written on paper, and you'd receive a copy of it, right? You know, if you go in for an operation within the NHS at the present time, you get a paper consent form and you get an NCR sort of copy of your signature to the procedure that you've consented. You really don't want paper hanging around in an infectious disease sort of environment. Also, we were thinking uh how on earth can data be captured? So we actually sort of moved to something called a decentralized clinical trial model. So we managed to get our informed consent forms onto um you know sort of uh tablets, primarily iPads, right? You know, we also had the data capture on those iPads, we also had the uh randomization to treatment or you know, to sort of standard of care on those sort of systems. So we were able to actually access the patient data completely anonymized remotely to actually sort of look for you know sort of obvious mistakes or inconsistencies and you know to do this uh sort of quickly. You know, so for years we talked about the concept of decentralized clinical trials, but this pandemic pushed us forward. So we're actually sort of seeing you know, sort of a carryover effect. There's a lot of people who want to go back to face-to-face, right? But the fact of the matter is that the text there, right, you know, it's been proven to work, and the results are reproducible. Now, there are things that we do definitely need to sort of do on site, things like drug reconciliation. You know, did patient A receive the correct doses and quantities and measurement of drug, right? You know, can we count up the pills? Can we count up the infusion bags that we used, etc.? And that's also possible, right? Yeah, yeah. Some stuff you has to be done physically. Yeah, so I think I think at worst we're looking at something which is hybrid as opposed to completely decentralized, but the tech platforms have improved significantly, right? Yeah, and I also have to sort of say that we're indebted to many of those tech organizations for actually sort of coming in with reasonable fees for the use of their technology. And I think that they have benefits as a consequence because people have seen the utility of moving away from face-to-face sort of day-to-day work into something which is using the platform, collecting the data that way, and then looking at critical variables that have to be checked on site, maybe once every three or six months, as opposed to once every month.
SamYeah, that makes sense. Do you think the COVID thing gave your industry a renewed sense of purpose? We talk a lot about the importance of purpose and you know, getting a team behind the reason for doing something. Do you think that the COVID gave you that?
SPEAKER_02One of the things that we always do within clinical development is to actually sit down with our team and explain to them. Why this particular study is being done, the type of comparisons that are involved, and the potential upsides to patients. Okay, so when we come into work, you know, we're not looking at it thinking I can get an extra sort of two hours overtime uh out of this, right? Because we tend to be salaried, right? Yeah, um, and uh it's a matter of the financial aspects are covered, but what is it that actually sort of gets me out of bed every morning to come in? Not just clocking on and clocking off, it's actually sort of the work that I'm involved with, and the ability to have a positive impact upon patients' uh sort of health and lifestyles is critically important. Now, my background is oncology and rare diseases, right? And I've been very, very fortunate over the years to sort of work with a couple of uh really successful oncology drugs. I've actually sort of seen the impact of a uh antihormonal treatment on ladies with breast cancer. Previously, they were exposed to uh indiscriminate chemotherapy with all sorts of you know, sort of toxic side effects, etc. Right. Uh when I was at um sort of Zeneca, I uh worked on a drug called Zolodex in the sort of treatment of adjuvant breast cancer. And what this drug does is that it takes away the estrogen and the progesterogen that actually sort of drives many of these hormonely mediated um you know, sort of uh breast cancers. And it was remarkable. I came back from ASCO, right, you know, with the full data set, sat down off the bus, and he said, Do you realize you've actually sort of given women a treatment option, which, whilst not sort of uh sort of free from side effects, is considerably better than the chemotherapy they would have received. And and this is a long uh you know, sort of way of actually sort of answering the question about sort of did COVID reinvigorate us? Boy, did it reinvigorate us.
unknownRight.
SamSounds like you were fairly fairly invigorated to say.
SPEAKER_02So we talked about the decentralized approach, the use of technology platforms, right? You know, and could we get the teams? And you know, Vicky was mentioning earlier on about the great resignation and the attrition, you know, sort of within you know, sort of pharma, tech, contract research organization uh sort of sector. We actually sort of um sort of spoke to our workforce and said, folks, we don't know what's going to happen, we don't know what's gonna hit us, but we know that we have to do something about it. So we asked for people who had experience with the uh decentralized technology, with infectious disease experience across all of our therapeutic areas and asked them to volunteer to be part of our team. We called it the COVID task force, right? Yeah, and basically we were inundated with people. Right, yeah, people who were fearing uh sort of being put on furlough, um, yeah, sort of also sort of applied, right, yeah, and we were saying, why do you want to do this? Right, yeah, and and and their view was I would do this even if I wasn't being paid. And we sat them down, taught them the decentralized technology, taught them the infectious diseases, and we deployed them. We went from working our typical 10 hours a day to 16. Wow.
VicDo you think that's a good mindset for any role of because I joke about it, but actually, you know, I know we have to have money to live, but I love my job and I do it. I'd say I do it, I struggle to ask for the money because I love what I do, and it gives me real job satisfaction knowing the difference that we can make with the teams we work with. So you saying we would do this even if we weren't getting paid. Do you think that's a good mentality to have people that are motivated to motivate them? Yes.
SPEAKER_02Well, you see, the thing is that um we have highly motivated sort of individuals. They they start with this discussion about why are we doing this? How are we doing it? What's the benefit for patients? And the vast majority uh of my staff, you know, the physicians, they've come from healthcare. The the uh the project managers, invariably a paramedical sort of background. The contract clinical research associates, a lot of them from nursing background, right, you know, or scientific backgrounds, right? Yeah, sort of um, and yeah, so they'd already sort of have the mindset of wanting to do good, right? You know, wanting to do something that makes a difference. And yes, they will go to the ends of the earth, right, you know, to actually sort of do what's in the patient's best possible interest. Now, sometimes that best possible interest is not to sort of include them in trials or provide them with sort of particular sort of treatments. But the fact of the matter is that you've got the right mindset, you know, you've got someone who's hopeful committed um you know to actually sort of uh you know delivering upon the task. Many years ago, I worked in an organization that was running a trial for a rare disease, and uh these patients sort of you know, sort of were in uh a dreadful state, and the drug um you know was brought in, and it wasn't a big company, and you know, they didn't have much sway, right? You know, but we were worried about how we would actually sort of ensure uh that we got the recruitment and that we got the data collection in the right way. And what we did is we actually sort of sat down and went through the critical importance of everyone's role and what they were doing on a day-to-day basis for the success of that sort of particular study. Now, success would have been uh um you know data which said, yes, it does what it says it does and is well tolerated, or it doesn't do what we hoped it would do, or it's not well tolerated, right? So there would be a clear decision. But it was as simple as the people working in the archive. We have these case record forms and we have a mountain of them, and if you process them quickly, this actually enable and put and put them into the archive. This means to say that uh the data can be you know sort of inputted, it can be uh you know, sort of sort of statistically analyzed, and we get the numbers out. Right, yeah, and this was for the filing clocks, in effect. And all of a sudden they went, ah, that's why I do it. And these patients will get an answer sooner rather than later as to whether or not the drug will work for them or won't work for them. And similarly, you know, there were a lot of uh adverse events because it was a new therapy, and anytime anything new occurred, it was different, so it was reported. So there were mountains of adverse events, and those had to be processed within statutory timelines. And strangely enough, by actually sort of explaining this to people, productivity went through the roof, it was already high, but basically, we needed to build new roofs.
VicWow, that's a good one.
SamThere's there's so many new building new roofs. There's the title for the podcast.
VicYeah, there's so many snippets in what you just talked about there, Ian. I was busy scribbling notes about you know a lot of the work that we're doing at the moment, it seems to be people don't understand what good looks like other than hitting a number. It's not enough. What does good look like? What is success?
SPEAKER_02Well, I think success actually sort of uh looks at the successful adoption of a technology or a product, something where people say that's actually made my life easier.
VicIt's the end impact.
SPEAKER_02It's the impact, right? Yeah, one of the things which um uh sort of would hope that the tech industry do is to actually sort of sit down with their development teams, right? Yeah, and uh you know, sort of just don't do a uh okay, so it's developed, it now goes into marketing, and then that's it. You never hear anything more, right? You know, what you need to hear is the feedback from the customer, which will be you know sort of sometimes positive, sometimes negative, but always hopefully constructive, so that you can go back and you can actually sort of either uh come up with a with an improved uh sort of you know sort of version 1.1 or 1.2, but it can also inform the way that you actually sort of design your process for the production right here of uh your sort of products as such.
VicIt's it's not just the the production and the the developers, I don't think. It's also so the tech industry is very much moving into a SaaS or a subscription model. And previously a salesperson would sell into a customer and then move on to the next customer.
SamDrive by selling.
VicYeah, yeah, drive by selling, it's not that anymore. If you want them to stay on that subscription, you need to really understand that customer and really get close to that customer. But we found certainly in my experience, if you went and did a case study with a customer, you did the case study about the initial implementation. So, how did that go? Versus actually going back two years later and going, what's this done for the business? What is actually the impact of what we've done here? And there's a real missing link there from in my experience.
SamSo, Ian, it's it feels like we've covered a huge amount of ground there and uh an awful lot of stuff for people to get their heads around. Perhaps we could, as we bring the podcast to a conclusion, perhaps you could help us by summarizing, give us three takeaways for our listeners.
SPEAKER_02Yeah, thanks, Sam. Um, what I would like to say is that I've always found that decisions taken in haste invariably have downstream sort of consequences. So, what I would suggest that people who are facing you know emerging data, which affects uh you know uh the project plans that they have, is that they actually sort of convene the experts and the stakeholders and have a thorough discussion of uh what's happened, what they would like to do, and why. And you will come out with uh sort of possibly sort of three options, two of which are impractical, right, you know, or uh sort of pie in the sky. Then you will have uh a realistic option, and that's what you need to focus in upon, right? You know, you know, once you've made the decision, put in place an implementation plan, which involves an awful lot of communication at different levels to different stakeholders, right, you know, to people who are affected as to why you're going to do that. That creates the buy-in. And even if it's uh you know for a uh sort of successful outcome, you know, um that buy-in is necessary so that people will um you know sort of uh progress uh you know, sort of uh you know at speed, right? You know, um, but if it's actually sort of something which is negative, you know, in my world, you know, a sort of a safety concern is um you know sort of something that needs to be addressed uh sort of promptly, in a timely fashion, and in a consistent way, so that we can actually move patients over to alternative uh sort of therapies, alternative managements, right? You know, but explain why. There's nothing more frustrating than being told what to do without an explanation. I think we all uh sort of come to work, right? Yeah, we all come to work, right? You know, sort of uh to understand what we're doing so that we can be fully committed to the delivery of what we're asked to do.
SamAnd because I said so is not a good enough reason, as my daughter would have told me many, many, many, many times. Found out the rationale, yeah, communication. Um, and just before we wrap up, do you have a book recommendation for us?
SPEAKER_02Oh, yes, Simon Cynet book. Start with why. Why are we doing what we're doing?
VicYeah, yeah.
SPEAKER_02And every time I read it, I I think, oh, I hadn't realized that sort of thing. And it's it's a well-thumbed copy. Um uh, you know, but the fact of the matter is every time I read it, I find another level of depth.
SamYeah, yeah. You know, I think the more people that read that and the more people that have a why in their life, the better, would be my observation. Yeah. So thank you, Ian. That was uh magnificent. Really appreciate it. Um, nice to have a candid through a different industry. I I love to learn about different stuff. So that was really fascinating for me personally, and I'm sure for our listeners. So it just remains for me to say thanks for listening to Get Amplified from the Amplified Group. As always, your comments, your likes, and your subscriptions are gratefully received.
VicSuper, thank you.