Transformation in Trials
A podcast about the transformations in clinical trial. As life science companies are pressured to deliver novel drugs faster, data, processes, applications, roles and change itself is changing. We speak to people in the industry that experience these transformations up close and make sense of how the pressure can become a catalyst for transformation.
Transformation in Trials
AI Won’t Replace Writers, But Writers Who Use AI Will Outpace The Rest with Bilal Bham
What if the documents behind a clinical trial were written with the patient’s voice in mind and delivered at the speed modern science deserves? We sit down with writer, consultant, and patient-advocate Bilal Bham to unpack how protocols, clinical trial applications, and clinical study reports actually get made, why structure beats chaos, and where AI genuinely shortens timelines without cutting corners. From first protocol outlines to final submissions, Bilal shares a process that blends proprietary AI with rigorous human review to turn dense source data into clear, regulator-ready narratives.
The conversation gets real about the craft. Bilal argues that new writers still need to learn documents end-to-end: where to find truth in source files, how to build arguments across sections, and how to keep stakeholders aligned from biostats to clinical operations. AI helps when you feed it the right ingredients, starting with comprehensive bullet-pointed outlines rather than instant prose. That discipline shaves weeks off delivery and keeps quality high, especially when regulators are exploring AI on their side of the table and expect traceability, accuracy, and transparent logic.
We also explore the power of inclusion. Living with Graves’ disease and thyroid eye disease, Bilal explains how patient experience sharpens trial design, consent language, and symptom reporting. Diversity is not a banner; it is better science. Recruiting across local communities in the UK, US, and Europe strengthens external validity and reveals gene-environment differences that change safety and efficacy. Pair that with plain-English patient summaries, fair compensation, and trusted community partners, and you get trials that are faster to run, easier to understand, and more likely to help the people who need them most.
If you care about clinical trials, regulatory writing, medical communications, AI in pharma, and building inclusive studies that actually work in the real world, this conversation is for you. Subscribe, share with a colleague, and leave a review with your take: where should inclusion start in clinical research?
Transformation in Trials is a podcast investigating how we can change life sciences to get treatment to patients faster.
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Welcome to another episode of Transformation and Trials. Today we're going to focus on the topic of clinical trials through the perspective of patient advocacy. And in this studio with me, I have Bilal Barne. Welcome Bilal.
SPEAKER_01:Hello, Ivana, nice to meet you. Thank you very much for inviting me onto your podcast.
SPEAKER_00:Very excited to have you. Now, Bilal, could you tell my listeners a little bit more about what you currently do?
SPEAKER_01:So I've been in the pharmaceutical industry since October 2006. This at this point, this being recorded on the 25th of July 2025. It's been nearly 19 years that I've been in the industry. I started my career in regulatory medical writing over in Germany for working for CRO. And then went to San Offi for three years and then came back to work for a biotech in Manchester. And then that closed, and then I went freelance back in 2000. And then I was happily freelancing, and then my company grew. And then I learned various other disciplines during that time. So medical communications, market access, patient advocacy, and also obviously leadership and understanding the regulatory landscape across the UK, EU, and America. And I now lead a small team and that's what we do. Consulting.
SPEAKER_00:Thank you. And when we're talking on the pre-call, what was amazing to me is both your broad understanding of how industry works, but also like your different perspectives on the industry, both as a patient yourself, but also as a professional and also kind of from within pharmaceutical companies from the outside. So I'm looking forward to getting into some of those things. And the first question: if some of my listeners do not know what medical writing or regulatory writing is, can you tell us more about what that entails?
SPEAKER_01:Every clinical trial that happens has to be planned and then written. So there are documents that need to be written before a clinical trial commences. And some of you may have heard of a protocol. So that is the document that tells you exactly what is going to happen in a clinical trial for a particular indication. How the investigators or the physicians will treat patients throughout the clinical trial. And there's various documents that need to be written before then. There's things called the CTA, the clinical trial application that needs to be written, applied to regulatory audience to allow your clinical trial or ask for clinical trials to be performed in a particular jurisdiction. And then you write the protocol alongside a multidisciplinary team of various different stakeholders within a company. So it could be medical directors, high stats, clinical operations, regulatory affairs, what have you. And then once a clinical trial has been performed, it then has to be written up. And there are documents called clinical study reports, which write up clinical trial data. That's just one example, a couple of examples rather. There's other documents as well that have to be written as well. So regulatory medical writing entails a lot of documents that form part of what's called the electronic common technical document, which then is submitted to various regulatory authorities for a company to say we'd like to market our drug in this jurisdiction. And there's all sorts of other documents as well off the back of that. So you may have heard of journal articles, so they have to be written, people like us write them professionally, and various other documents as well. It could be sales, marketing, communications, it could be showing a particular country that their drug may be more expensive, but it's better because of the benefits that it brings versus the competitors, etc. There's also all that type of landscape analysis and documentation that we do. So in a nutshell, that's what we do. And there's other types as well. There's various different other types of medical actions. So that you've got healthcomms, which is more PR, more marketing, etc. But we stick in general more the core science, because that's where all the exciting stuff happens.
SPEAKER_00:It sounds like a very specific genre. So how does one become a medical or regulatory writer in pharma?
SPEAKER_01:Well, I'm I'm also a medical communications writer now, so I do everything because I've been in this industry for so long. I write all different types of documents. But essentially, you get a job if you can, and that's how I did it. And for me, working for a CRO was a really good step. I had really good people that I worked under who taught me a lot, and we had a structured process of learning. And then it was just up to me to go and understand the job. It took me, it usually takes on average around three years to understand what you're doing. It took me about three years to understand what I was doing. And then after five years, I really got it. There's always more to learn. Right now, AI is a big thing, so we're learning AI and we're developing our own AI tools as well to help deliver better for our clients.
SPEAKER_00:I am curious about that. How is AI changing the way that we write in the pharmaphree industry?
SPEAKER_01:Well, it's quicker and it gives you more insights than you would with your own one brain. And in some ways, it's actually a better writer than us. I back myself as a very good writer, I've been doing this long enough, but even I've been surprised at how good the copy comes out when you work with it. And you have to train it depending on what you're working with. You can work with the off-the-shelf ones like ChatGPT or Claude or whatever, but we have our own proprietary one as well, and it learns and it learns very quickly. When you're doing things that don't need, they're not under NDA, you can use AI, uh, like just off-the-shelf, like for example, ChatGPT or Claude. And it's surprising how many insights you get from a document and from how it in vertical commerce thinks and delivers to you. Because it has access to writing styles from all around the world and also lots of different types of knowledge. It doesn't always get it right. You have to make sure you check everything. There are errors that it makes, but then it's up to you as an experienced person to be able to understand what's right, what's wrong, and work with it.
SPEAKER_00:So it sounds like with AI, it could kind of give us a solid draft, which is how a new person in this industry would learn by making those early drafts and learn along the way. Do you think it would be different for new people starting with this as a career to start with AI also?
SPEAKER_01:I think for me it will be difficult if you are a new person coming into the industry, you still need to learn how to write the documents from scratch. So, for example, a clinical study report is a 150 to 100-page document. You need to know what goes where, where you're going to get the information from the source documents. Where does it go? How you're going to formulate it, how you're going to write it, how you're going to create the arguments. Creation of tables, policy control, cross-checking internally of both externally as well with the reference source documents. So all of that kind of thing is getting built into AI, but I it's not 100% yes. It's still important to learn how to write the documents, otherwise you lose the skill of writing. And it'd be really sad if we lose the skill of writing. Like most of us don't write with our pens anymore.
SPEAKER_00:True. Yeah.
SPEAKER_01:So for me, it's an important skill not just to be able to write, but also understand the context of the document that you're writing, whether it's a clinical study report or a manuscript, abstract posts, a slide deck, who your key stakeholders, who you are tailoring the documents for as well. AI can help with that, but in the end, you've got to know what's in there and what's missing as well, because it won't necessarily tell you, well no.
SPEAKER_00:Exactly. So the expertise still needs to be there, but we also need to kind of keep the pipeline of experts coming. So it's not replaceable.
SPEAKER_01:No, but I do think that uh AI will, I think it's going to reduce the number of jobs for various various things because you just don't need them. And for me, I'm I used to hire Gen Z for various things, but now I don't need to hire Gen Z for very soon because AI does it and it's cheaper. Yeah.
SPEAKER_00:Yeah.
SPEAKER_01:So for me it's it's a case of work with it and learn with it, but also really understand what you're trying to do. So it's important that some documents are still written by hand, especially when you're in Ubi so you understand it, and then you work with AI to make it better.
SPEAKER_00:Yeah. Yeah, I'm curious for the AI drifts that that are possible to create, what kind of input does it need to be able to create that first drive?
SPEAKER_01:Well, with our proprietary one, what you can't do is just kind of put I always use a baking analogy. You're not just going to put you know eggs, flour, milk, a bit of sugar into a bowl and you know put it into an oven and then out comes a cake. It doesn't work like that. We've got to do various prep processes. So you can automate a lot of things, but you still have to work in a very methodical manner. So I'm autistic. So for me, I'm very process-driven. So it works for me because I know exactly what to ask the thing to give me what it wants, what I need from it. So here with our proprietary one, it we have portals where we put in all the source documents and then we give it time to digest and read it, and then we then ask it, let's get an extensive bullet pointed outline for this, for the introduction, for example. And there's other plugins that we have to other AIs, so they go into PubMed and what have you, and they source up the various relevant documents, and then we'll go, right, okay, what can we do with this? And then that's how I do it. So it's structured rather than just giving you pros straight away. You want to be able to look at the information and go, is this correct? Because then you've got when you go to source documents and go, right, is this correct? And to be fair, it is generally correct when it gets it, when you give it a specific instruction, but when you give it too many instructions or ask it to do too much, it doesn't get it right. So in a methodical manner, go through, for example, a manuscript, we create bully-pointed outlines, introduction methods, results of discussion. You bully point it out extensively and have all the references there and tables and figures as well, and then you review it and then you make corrections and then you send it to the client to have a look. That's how I work. I don't send them a prose draft first, I send them a fully pointed outline to ensure that they're happy with what's going to go into the first draft. Once that's done, then you turn that into a full draft, and it's much quicker and it's correct.
SPEAKER_00:Yeah, that that makes sense. One of the things that has been on my mind lately is how much should sponsor companies invest in AI versus rely on our collaboration partners to use AI in their process. The example that you're giving is that you as a service provider are investing in becoming better and more efficient with using new technology. And the sponsors that you collaborate with they benefit from your investments in this new technology.
SPEAKER_01:Yeah, so it's a competitive field. Everybody's got their own widget, everybody's got their own idea how they want to do things. Some people aren't using AI, and I think they're gonna fall behind very, very quickly. So we had to do something to be able to stay competitive. And more and more people are using AI, and I found the positives and I won't say negatives, but learning growth, growth areas for using AI. And I think it's important that when we do go to a client, we say, right, we're not just gonna use Chat GPT or one of these other generic ones, we have our own, but also we know how to use these existing ones when we don't when something's not under NDA, it's gonna go out to the public anyway, so it's not really confidential. May help speed things up. There's still we still need to understand what we're writing and making sure that it's correct and hits the marks of the client once. So there's still a cost to that, but that is for me a kind of a USP that we have because we have our own, and also we're developing it's not just it's it's according to different types of documents that we write. So it's not just we have one generic one, it's like right CSR manuscripts, different modules of the ECTD, various different pharmacovigilment safety documents, and we also go into the more many communications different type of manuscripts as well, manuscripts are reviewed, different types of reviews, but also writing the different types of slide decks as well. But again, for me, the way I work is I like to see an extensive bullet pointed outline. I don't want to see the final draft of as soon as I put everything in, what I want as a taster. I want to see if everything's correct. And yeah, of course it makes errors. If not, it doesn't make as many errors as it did about 14 months ago. It's still making a lot of errors. It makes errors now, but you've got to get it to understand what it needs to do. Uh and the more time and we spend on it and the more it learns, the more it improves, not just the hours, but also the generic ones that are out there. So for us to go to a client and say, right, we are an AI-powered company where we can give you products or your documents that you acquire, whatever you need quicker, which means you end up saving time because if time is money for them, just because something can be done in a day doesn't mean it's going to be done in a day, it's going to be costing a day because we've put we've got experience to understand how long it's so you know we've all got to eat, so it's got to be a reasonable price. But at the same time, I also believe that once you shorten their timelines, because for example, if you do an NDA, a new drug application, you're talking up to six months of work. So the way we're looking at it, we can do it in probably one to two right now, maybe two, but I reckon we can do it once we've fine-tuned everything, we can do it in a month. Then the pressure's on them, the client, to then really internally deliver. But then imagine how much time you save. Not just that's one thing, and then all the other things you can speed up clinical trials. There's other software out there that mimics how a drug may work within it within the clinical trial population, shortening clinical trial times. Time to market is shortening. And that means that also biotechs that are bootstrapping don't have to spend so much money. And one of the worst things that happens for a biotech is they run out, run out of money, then they have to go back to investors again. And then from their perspective, they're diluting shares, and what they want to do is hold on to the shares. So this is another way of saving them time, money, and giving them the opportunity to make money properly when hopefully their product does well in the clinical trial and is approved for a prescription or whatever it may be.
SPEAKER_00:I also wonder how this will impact our regulatory approving bodies once they review this documentation. Because at least the FDA are working on figuring out how they can leverage AI for review processes also.
SPEAKER_01:Yeah.
SPEAKER_00:It'll be interesting to see how it kind of plugs into their evolution also.
SPEAKER_01:But I think initially there was a big pushback, we don't want to use AI, but everybody is going to use AI because we're human, we're lazy. We want the quickest way to do something. But you don't choose the hardest way to get somewhere. Right? Yes, it's about the journey whether, you know, if you're trying to improve your health and fitness, is you know, just injecting yourself with a Zenpic's not just going to make you healthy. But when it comes to this, we all find that that's the innovation of humans. We want to do things the quickest way possible. They have had to accept the fact that we will use AI, but then it's up to us whether you are a consultancy, a pharma, biotech, medical device company, to ensure that everything that you deliver is correct. And that's what you pay companies like us to do because we are then experienced enough to go through everything. We have our systems and processes, checks, and balances to make sure that everything is correct, then you're not going to come back to us and go, Oh, this is wrong, that's wrong, because we've written it by hand, so we know what to expect.
SPEAKER_00:You also build up the expertise for many different kinds of drug areas when you kind of really get into writing the documents.
SPEAKER_01:Yeah, I mean it it it helps. I think for me, it's more important to be able to write than it is to understand a therapeutic area. It helps, but if you're a good writer, you can take on any document, and now especially with AI, you can write and it looks like an expert's written it. And that's that was my way of writing things. I've always written it from a way of if I'm writing for a client, then it's their document. So their right the document has got to read in such a way that it's written by someone who understands the subject matter. Structured, yes, process-driven, yes, but also there's the nuance of delivering in such a manner that people who read it can absorb the information in a stepwise manner, whether they are new to the therapeutic area or are an expert in the field. My first document I ever wrote was a prostate cancer phase three clinical uh study report. So that was a baptism of fire. And then when I worked at Sanofi, I had three years of diabetes and then done lots of lots of oncology, uh, mucology, infectious diseases, vaccines, dermatology, lots of neurology as well, and psychology as well. And we touched on clinical trials in terms of being a patient. I'm a patient with thyroid eye disease and Graves' disease. And what Graves' disease does is you have an overactive thyroid and it impacts the immune system into attacking the back of the eyes. I had one, so it's unilateral, and it inflamed the tissue behind the eye, pushed the eye out, calling it causing what's called proptosis where the eye sticks out. And so for me it was very difficult to blink or rather shut my eye. And my eyelid retracted, so when your eye goes out, your eyelid retracts. And there are currently drugs under clinical trial, and there's one that's approved in America, and it's probably going to get approved here this year or next year. But there are other drugs being developed for thyroid eye disease, which reduce the inflammation, work with the immune system. I had eye decompression surgery, so the eye then settles back into the eye socket better, so it's in a better position. So my eyelid now shuts. When I'm tired, but after two, nearly three years at least it's all numb.
SPEAKER_00:How did it change your relationship with sponsor companies now that you also are a patient and an advocate?
SPEAKER_01:Well, for us, it was it was it was having a conversation to understand, look, you need to be inclusive. Who what kind of people are you including in your clinical trials? Because in in the West here in the UK, I'm not born in U born and raised in the UK, but my family's from India. So I'm considered diverse because we're the we're a minority here. And there's a lot of people who whether with, for example, my background where we're not generally including clinical trials, it's always white males, or when it's uh uh healthy, healthy volunteers, but when you are trying a clinical trial in humans, yes, there's a lot of women that have a lot more women seem to have thyroid eye disease than men, but having a diverse group of volunteers, or patients if you want to call them, or participants, will increase the richness of your clinical trial, because sometimes drugs don't necessarily translate to different cultures and different genes. Because as a geneticist, the gene is a wonderful, very complex and enigmatic thing that controls how your body responds to different types of drugs and stimuli. And sometimes it doesn't because of how your body's made up, how your genes have created different types of proteins and why these.
SPEAKER_00:And that's an excellent point. I wonder when you're a part of creating the documents needed to create a new clinical trial, if having experience to being a patient kind of covers like, wait a minute, we should also be thinking about the patient perspective in this.
SPEAKER_01:You do. It's about stakeholder management. So uh it's kind of one of the buzzwords in our industry. It's understanding that they're not going to understand all the technical stuff. So patient-layed summaries are very important, or simplifying things just so they understand what's going to happen. They'd have to know all the ins and outs, the intricate things that you can't necessarily explain unless you are a somebody who works in the industry or a scientist or a physician or healthcare professional. But in general, we're writing things in such a way that they could they will understand what their role is going to be in the clinical trial, how the drug may or may not impact them, that may get placebo, what a placebo is, and what their rights are in terms of sticking with a trial, not sticking with a trial, what is considered an adverse event and how they need to report it. Everybody's got apps now. So, you know, you're not feeling great, you put that down as this. And that's all that all adds to the richness of a of the results of a clinical trial. So I think that's been a big part of it. But then also working with patient advocacy groups as well, who are professionals very dedicated to the patient voice rather than pharma and biotech, which come on, let's face it, it's all about making money. Brutally honest, it is. But for me, it's about, yeah, of course, we all need to eat, but for me it's about doing something that's going to be, first of all, from our perspective, from a selfish perspective, working on cutting-edge clinical research, because that excites me, working with new drugs that other people haven't, but also from a patient perspective, delivering something that's going to actually help them. So I'm not, I've never been a fantastic scientist in the lab, but I'm fantastic on abuse of doing what I need to do. That's my strength, that's what I'm good at. So being able to contribute somehow to the patient journey and helping them and working with them as well. So, you know, before we'd have patient focus groups, and it's important to do that. But now one of the things I can do is I can give my opinion, give my experience as well, benefit of my experience of being a patient, about how patients think, feel, and also ask certain questions that only people like me who have been patients or are patients can ask other patients rather than just oh well, we're a company or a consultancy and we can ask you this, this, and this. Great, we're done. But then you don't get beyond the first layer.
SPEAKER_00:Yeah. That's making sense.
SPEAKER_01:Yeah, you can you can get you can get more depth now. I can ask questions that I would never have thought of because I've been through the process. I know what the healthcare process here and the treatment but the pathway in the UK is. And then have learned in terms of thyroiditis and groteses how it works across Europe and also in America.
SPEAKER_00:So how did you initially find your way into the life sciences industry?
SPEAKER_01:One of my friends over in Switz neighboring Switzerland now. He used to live in Manchester, worked for a big agency. And his name's Gareth Worthington. He was one of my customers. I used to work in a men's fashion shop as a part-time job during my masters, and um got talking to him and he I said to him, I didn't want to do a PhD, I'd done it, I was doing the master's, and then said, What can you do? I said, Well, I can write. I said, That's interesting. I'm a writer. And he's now published author as well. He's still in the farm industry, but he's waiting for it for it to hit big and then he can leave. But that's how I got introduced to it, and then I started applying for jobs, and they all said I haven't got enough experience. I'm like, I literally am coming out of university. So, what experience took me to have? I did have an article under my belt from working during my placement year where I worked for the European Molecular Biology Organisation reports, Ember Reports, and I had an article published in the Science and Society section. That was 2003. So that I had one piece of work behind me, other than that, nothing. So I started applying, but and because I'd lived in Germany during that time, I eventually got an opportunity opportunity to work for a CRO in Frankfurt in 2006. So that's kind of how it happened, and then it took off from there.
SPEAKER_00:Yeah, yeah. Now it's always interesting to me how people find this industry because not many people uh while doing their studies find on you know what I'm gonna be in life scientists.
SPEAKER_01:We all went into university thinking we're going to be the next this scientist, that scientist, then reality dawns you actually, your brain isn't cut out with that. I love science, but I'm more artist. So I kind of like I get to at least paint pictures with words and uh running my own company. I can I have control over the creative process of number one our marketing, but number two, how we work with clients as well.
SPEAKER_00:You you do get to create. You get to create like the experience.
SPEAKER_01:Yeah, make it fun and interesting rather than just doing run of the mill being boring and not innovate. Gotta innovate.
SPEAKER_00:Yeah, that's that's very cool. Well, we are about to round off, and I always ask my guests the same question towards the end. And that is if I gave you the transformation trial of magic wand that can change one thing in the lifetime's industry, what would you wish to change?
SPEAKER_01:Inclusivity. Inclusivity in terms of different genders and male, male, female, or however you choose to identify yourself, and also different ethnicities. Living here in the West, we have different ethnicities, and also reaching out to people in certain areas. So where my family lives, where my mum lives in my city of Preston, it's a predominantly Indian Asian area, it's Indian Pakistani, and there's a lot of different types of health issues within the community which are very similar to each other. So targeting communities where certain drugs would be more impactful rather than just going for the tried and tested white people thing, that would be really good because it adds to the richness. You don't have to necessarily have a clinical trial in India or various other places of Pakistan. You can do them here. But there is obviously there is stigma with pharma. I mean, if I find when I introduce myself as a pharma person, there's always that kind of oh, you work in pharma, blah blah blah. Yes, if a couple of people have not done good things in our industry, but that doesn't represent the rest of us, millions who work in the industry. And because there are millions of us who work in the industry doing a good job and we just want to do good things and progress science. For me, it's inclusivity if you're going to hold a clinical trial in the West, especially for things that impact general populations as well as specific minorities. So it might be depression. Depression is a big thing in our community, type 2 diabetes, there's education as well in terms of how you can live a better lifestyle, and then the various different types of systemic disorders as well. Targeting here in kind of Europe, America, North America, where you've got diverse communities, working with them to ensure that they're part clinical trials, so then you get a richness of data.
SPEAKER_00:That's actually a really good point. Using the diversity that we have right around the corner, it's not necessarily thinking about well, how can we get into those countries? That's a really good point. Thank you so much.
SPEAKER_01:Pleasure.
SPEAKER_00:And Bilal, it's been an absolute pleasure having you on the show. If uh my listeners would like to reach out to you and learn more about yourself or your company, where can they find you?
SPEAKER_01:Well, find me on LinkedIn. Very, very easy. Uh my name is Bilal B I L A L. Surname is Baum B H A M. So Bilal Baam B I L A L B H A M. Find me on LinkedIn. Feel free to send me a connection request and tell me that you heard me speaking to you, Ivana. And yeah, let's have a conversation. Love to speak with you and see if we can do some wonderful things.
SPEAKER_00:Awesome. Thank you so much.
SPEAKER_01:Pleasure.
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