Poorya Amini — Protocol AI, 800k Clinical Trials & Why Pharma Does It Wrong

Adam Walker:I\'m Adam Walker, a biometrics consultant, and this is the Pharma Prescribed Podcast where leaders, innovators, and hidden voices in healthcare open up, no sound bites, no spin, just raw insight, one prescription at a time. In an industry driven by data protocols and pressure, we rarely pause to ask the human questions.

Adam Walker:What drives us, what breaks us, and what truths live behind the titles we wear?

Adam Walker:Today I\'m joined by Poorya Amini, founder and CEO of Risklick A Swiss digital health company that\'s redefining how clinical trial protocols are designed Poorya\'s, journey spans veterinary medicine, a PhD in pharmacology. And hands-on experience managing trials at the University of Burn.

Adam Walker:In 2019, he launched Risklick to tackle one of pharma\'s biggest bottlenecks, protocol inefficiency. Risklicks. Flagship Product Protocol. AI draws on a database of over 800,000 clinical trials to cut protocol development time by 50%, reduce amendments by 20%. And shorten implementation by 40%.

Adam Walker:Poorya, welcome to Pharma Prescribed. For anyone who\'s not familiar with you, who are you and what is the mission that you\'ve been on?

Poorya Amini:Hello everybody. Thank you very much for inviting me to the podcast. That\'s a honor to be on your podcast.

Poorya Amini:And regarding myself, my name is Poorya Amini, as you mentioned, and my background is veterinarian and when I was working.

Poorya Amini:In the clinical trial unit, I was responsible to develop the protocol for the client or coordinate the protocol development for the client. And the way we were doing was the way that the industry was doing for the past 20 years, and I was complaining the way that we were doing because it was really inefficient, messy, and prone to error.

Poorya Amini:I was just trying to find a better way to do it and I searched that, almost interview most of the industry expert to see if they are doing differently or they have a better idea to do it. And what I was told that time, that, yeah, this is the way that industry is doing and we all do the same way.

Poorya Amini:But I was not convinced by the answer. I was not happy that, everybody just followed the way that we were doing in the past 20 years, and that time was the moment that I believe that there should be a better way to do that. I didn\'t have a clear idea. What\'s the better way to do that?

Poorya Amini:But I knew that the way that we are doing and the industry is doing is really not efficient. Most of the people were complaining and identify the problem actually. But I think nobody had a clear idea what would be the better way. That\'s why they continue doing the same way.

Adam Walker:So it sounds like what you\'re describing is that the pain of staying the same was greater than the change for you.

Adam Walker:And having been through that pain of redeveloping and starting protocol design time and time again, there was a drive in you that said, we must be able to do this better. I\'m wondering, where does that inner drive come from? Because as you say, the industry has always developed protocols in a certain way, and you slotted into that process yourself, but you weren\'t satisfied with that.

Poorya Amini:Yes, of course, because there were some mistake that was really easy to catch if you do it properly. But in that way, it was really prone to error, and I had a really bad experience with one trial. We spent 12 months with a lot of key opinion leader to develop the protocol, which I thought that moment that we are gonna change the guideline with this trial, that would be best trial, that we are gonna run and everything is ready.

Poorya Amini:Everybody were so excited to, start the trial and after 12 months development of the trial with the expert all around the world, then we started the study. What happened after five months, we had five amendments, meaning the first months even before they get to first patient in, we had to amend the protocols because we immediately realized the way that we designed the study cannot be run in the hospitals that we want to start.

Adam Walker:So it sounds like the issue is around having to effectively develop protocols on the fly and adapt it based upon the patient populations as they change, because you can\'t predict, presumably what kind of patients are gonna be available or not, particularly in complex clinical trials.

Poorya Amini:The issue was even simpler than that. The issue was that nobody realized that this patient will be discharged from the hospital after 72 hours and nobody basically investigate that, usually the standard of the care is that they will discharge after 72 hours.

Poorya Amini:That\'s why we put our primary endpoint in the 72 hours, and then immediately when we got the first patient in, we realized, okay, the patient discharged after 48 hours and will not come back to the hospital anymore because after the heavy surgery that they cannot even come back to the hospital to give us the blood to measure it.

Adam Walker:Goodness, that\'s pretty challenging.

Adam Walker:So what is it that risk click is doing that reduces the friction in that protocol design, particularly around developing and changing protocols, but also more importantly, I think, more closely aligning to the expectations of a clinical trial.

Poorya Amini:Yeah. First of all, we try to bring the data to the design and the way we want to bring the data is not the selected data.

Poorya Amini:We want to have a comprehensive data analysis before they even design the study and give all this data to the expert to know what worked, what didn\'t work, and what is the routine practice here and there. And then when the expert have the comprehensive analysis of all historical data, which traditionally, if now you want to do it manually, it takes three to six months only to do the systematic analysis of all the.

Poorya Amini:Historical evidence to find out, yes, this patient, they only stay 40 hours in the hospital, not the 72 hours. And this is the routine practice and the clinical practice in. Almost all the countries. That\'s why you can integrate it in your study design. And on the other hand, we bring all the stakeholder to work on one unified process and one unified platform there.

Poorya Amini:That means this issue can identify very fast while when you work in the silos that. It\'s really hard to identify even this simple issue that cause a huge problem or amendment to the protocol.

Adam Walker:So I\'d just like to dig into that a little bit further because as you were describing that, I was thinking about my own experiences in early phase clinical trials, and I used to sit alongside one of the PIs who was a medical writer, and I would build the databases based upon his protocol design.

Adam Walker:So it. If I\'m understanding it correctly, it\'s the other way round where you\'ve got a funnel of data that\'s driving your protocol design that then takes you forward, but subsequently you\'re able to pull out data directly from the protocol design. Have I understood that correctly?

Poorya Amini:Correct. Basically, we want that the expert designed the study based on the comprehensive analysis of. All available evidence around the world to better understand. And then by connecting the protocol design to the operational system, then we bring also the feedback of the operation directly to the.

Poorya Amini:Study designer and then they can integrate all this feedback early enough. They can proactively address the challenges and the issues that might slow down the trial or stop the trial.

Adam Walker:Okay. Thank you for explaining that.

Adam Walker:So that means therefore that time to final protocol and first patient in presumably is reduced.

Adam Walker:What other metrics are there that you are measuring as key performance indicators that differ from anything else that\'s currently out there in the marketplace?

Poorya Amini:The main factor is that reduction of the time in the protocol development and also the startup time of the study.

Poorya Amini:This is what we are trying to do, and the other factor is the quality. Of the protocols, quality of the data, because now the other challenge we have it in the industry, and I can tell you this is across most of the pharma companies, is that they have a lot of data, but from the protocol, from the past documents, but they\'re all in the PDF and cannot be used even to use the insight for their own.

Poorya Amini:New design protocol because they are all in a non-standardized way and they\'re all sitting in the PDF. And I was talking to one large pharma company and they told me the way that they write only the name of disease, they write it in eight different ways. Now just imagine that you want to reuse this information for your prospective study or for any analysis across the organization.

Poorya Amini:First of all, there\'s a huge effort that to normalize the name of. Disease that understands systematically all these eight disease with a different name are referring exactly to the same disease. And now if you go to patient population, if you go to more detail, it gets even worse.

Adam Walker:So was there a sweet spot in 2019 when you came up with this idea, when technology was adjusted in place, where you could adapt to getting that information into?

Adam Walker:Large language models pre what we know to be in the palm of our hands. With regards to chat, GPT, open AI and various other tools what was it that enabled you to be able to do this at that time?

Poorya Amini:That time? The initial idea was that data-driven design, how to systematically collect the data. Pull the data together and analyze the data automatically to inform a decision for the trial design. And that time we were using it for that, we were using the natural language processing model, the machine learning model. Of course still we are using some of those technology because the LLM models, they\'re really strong, but.

Poorya Amini:The use case might be different than our use case because what we try to do from 2019 for the first three to four years is just to clean the data. And then create a database which is automatically updated on the weekly basis, and then can link all this data, most of them, were publicly available, but they were scattered in so many sources.

Poorya Amini:Give you an example. If you take an example of a trial, you have the. Summary of a trial in the registries, like clinical trial.gov. You have a publication of those trial in other platform, PubMed journals, conferences and company, website and so on. Then if you go to FDA, you have all related to the regulatory FDA approval.

Poorya Amini:The drug label this information in another platform, and then you have a clinical guideline in another platform and all, there is a lot of platforms that this expert need to search and find the data. And what we did in the first three to four years is just try. To automatically collect the data from all these sources, unify the format and link this data to understand this trial, this publication is related to this trial, and this FDA approval is related to this trial and so on.

Adam Walker:That must have been an enormous, heavy lift and my immediate reaction to you explaining that. Over the course of a three to four year period, I\'m just wondering how on earth that was financially viable to be able to put all that effort in. It is clearly paying back for you now, and we can talk about that, but at that particular point, you must have been very solid in your conviction that this was going to reap dividends for you because not many people, myself included, would invest three or four years in.

Adam Walker:An idea that was at that point, unproven. I\'m wondering what\'s in your inner psyche or what was in your inner psyche at that time that gave you the confidence that it would play forward positively for you?

Poorya Amini:I mean we, before we start doing that in the large scale, we did it some sort of the MVP, and we realized in the MVP that works perfectly, and then we could present that MVP.

Poorya Amini:With the, small inter user interface to potential users to see the power. That\'s how the system can work. If we link all this data and then we use this data to inform a decision, that was the point that we could convince the people, yes, that would be the future.

Adam Walker:That\'s really remarkable and really impressive.

Adam Walker:And for those of our audience who aren\'t familiar with MVPs, I think you are referring to minimum viable product. Yes. Namely the central focus around. Developing a tool, what it looks like, what it feels like. And you talked about user experience and testing of that in a small hotbed of interested people, I gather you have now an awful lot of collaborators in big pharma in the tech space.

Adam Walker:Perhaps you wouldn\'t mind just elaborating around that a little bit more.

Poorya Amini:Yeah, the way, we developed the tool. It was really a customer centric approach because I believe we need to develop a practical tool that solve a problem. We don\'t want to have just a luxury tool that do things. We need to be practical and need to work in the complex environment of the.

Poorya Amini:Pharmaceutical or an organization. That\'s why even from the beginning when we had the MVP, we just presented to the end user and try to ask end user to work with it and start providing the feedback. And still we are. Doing the same loop and still we are improving still. We are constantly collecting the feedback of the end user, what worked, what doesn\'t work, what is the way that they think that should work, and then we try to basically improve it.

Poorya Amini:Exactly. Based on that. The customer need not to build a solution behind the carton, and then we think, okay, this is gonna work, and suddenly open the carton and then present it to the end user.

Adam Walker:I love that it sounds like you are describing a very transparent development involving your end users, where effectively they can see the value of their input.

Adam Walker:I\'m wondering if it was very difficult to get that in front of people in the first instance because. Clearly you\'re a highly qualified academic scientist and medically qualified, but also you\'re a very strong sales person as well. If I may make that point, you are entirely believable and I can understand why people would have taken that on board, but I\'d love to hear it from your point of view.

Poorya Amini:I think the fact was that I really strongly believed in my idea that was the fact, and then I could transfer the message to the people who I was talking to, and that I really believe that\'s the way it should work in the future. And also try to show them and explain the reason behind. And I think since, I was talking mainly to the scientists.

Poorya Amini:And I knew how to work and talk to scientists. With a scientists, you always need to work with evidence. You cannot say, yes, this gonna work. I believe it. No, why? I believe it. And then I could basically put my reason behind why. I think that\'s lead. And then what? It helped me a lot.

Poorya Amini:It.

Poorya Amini:Could relate with the pain. Said yes. Today, I just spent the whole day to find one publication. Then say, yes, that\'s what I\'m talking about. You shouldn\'t spend your time, you shouldn\'t spend your expertise, your a highly expert person, brain of the company almost, and then you shouldn\'t spend your time to find the evidence to search for publication to understand.

Poorya Amini:How to design the query to get the best result and then start a screening that the publication to find your publication is not you. It\'s not your task. Your task is to understand the inside of this publication and how you can use it for your scientific design and scientific work. That\'s why I think one point that.

Poorya Amini:Helped me a lot that the scientists really don\'t like to do all this administrative work or find what they need. And then they saw a tool as a potential assistant, let\'s say, that can do all this they are scientific but not related to their job for them.

Adam Walker:It\'s that reduction of burden, isn\'t it?

Adam Walker:It\'s that friction, it\'s that daily friction, the pain that you described. I can understand why expert to expert conversations really do resonate so loudly because it\'s one thing having a business person be in front of scientists and sell them a service is quite another to say, I feel your pain.

Adam Walker:I\'ve lived that pain. Here\'s a tool that I think might reduce that ultimate burden for you and for your company. So it\'s incredibly impressive. And when we met in person at the conference recently, I was so impressed by, not just by you, but the tool itself. And it was really imperative for me to make sure that we had this conversation because.

Adam Walker:As I said to you in person, I think the tool is remarkable. I\'ve not seen anything like it. I have felt that pain myself, so I understand it and I know that plenty of people that I\'ve worked alongside who are in the position of developing protocols themselves would also really value the input of your tools.

Adam Walker:So that really is central to, this conversation as much as anything else. I\'d like to just circle back. You had a background in veterinary science and now you are all about making sure that patients are at the heart of everything that risk click\'s doing. How is that looking for the company now?

Adam Walker:You are six, nearly seven years on the go. What is the success of the company looking like for you now?

Poorya Amini:I think we spent enough time to develop a robust solution. At the beginning we had a mission to make a data-driven end-to-end solution because I think now is a new normal.

Poorya Amini:But that time I also believe that. Any solution in the pharma industry should be end to end because they are already using a lot of solution which are not talking to each other. And then basically make. The effect of this silo even bigger because there is one department that is using this solution, which the other department doesn\'t know this solution at all, and just receive the output of that solution and now may need to figure it out how to work it, output of this solution to continue the process.

Poorya Amini:And so that\'s why, we wanted to have it. The reason that took us long time, but in, the tool is one year almost in the market and in this one year I see that we are currently working with several large pharma out of top 20 and several biotech. And I see now the reason, now the traction goes very fast because then they are convinced on the product side. Before launching the product, we focused again on developing a good. Solution by working with the end user rather than directly go and talk to the business people and try to do the business development. Of course, it was a hard journey because as the investors, everybody wants to sell faster.

Poorya Amini:And then everybody expect that you go to. The sales as fast as you can, and it was really hard to convince the people, Hey guys, first we need to have a good product and build on the good product. If we just rush to the market and then we try to sell it fast. The people might not appreciate.

Adam Walker:I understand. And just for our audience\'s, understanding how large is the company and how many people do you employ behind the scenes? \'cause I\'m sensing that you must have an awful lot of very smart people running very hard behind the scenes.

Poorya Amini:A lot of leader opinion, the future is not a big companies. The future are the. Small or medium sized company, which are very efficient and agile because as soon as you become a big company, this process gets heavier and heavier. You cannot avoid that because to manage a big size, you need a, more complex process in place, let\'s put it this way. And currently we are around 25 people in the company, but at the moment we are growing very fast and we aim to be 45 by Q2 next year.

Adam Walker:I looked on your website and I can see that you are advertising for roles at the moment.

Adam Walker:It\'s very interesting as well as you say, because when companies do get to a certain size, certainly beyond 50, I think is when you know you need a lot more external administration. There\'s a lot more management and. I\'m sensing that you want to be involved in the day-to-day of the activities rather than be an administrator of people, because that\'s not what got you into this in the first place, and it\'s certainly not what seems to be driving you going forward.

Adam Walker:Is it?

Poorya Amini:It is. I\'m going to most of the client conversation as well because still I want to listen to them. I want to learn from them and we want to develop with them and we want to grow with them. Yeah, that\'s what drive us. That\'s why the way that we work with our client, we call it partnership.

Poorya Amini:And in those partnership that we want, we have a mission together. What is the best solution for you? What is the best solution for your organization? Of course, we have a out of the shelf solution. This is most of the parties ready. You can use it, but. How we can make it better for you. And this is what we do.

Poorya Amini:And still getting a lot of, because, this is a really new area we are trying to make it even better by bringing the collective knowledge of the company and industry to one solution that everybody can benefit. Of course there are some data which are belonged to a client. Of course, that should be there and that the IP goes there, but the collective knowledge the industry is generating should be shared.

Adam Walker:I wholeheartedly agree with that, and actually in that manner, retaining the fact that. Patients are essential to everything that we do. Patient safety and patient wellbeing. It reverts back to that white glove service that I think you\'re describing on a by client basis that effectively every one of them feels like they are the most important person in the room and like they should, of course.

Adam Walker:More importantly that you are learning from all of those different settings, being the person in the room that\'s able to have those conversations as well. It\'s absolutely impressive and so fascinating to hear you describe that, if you don\'t mind me asking as well. I wonder, are there people that you looked up to before you came into this industry that gave you that inner spark and that inner drive that you could be a success in doing this for yourself?

Poorya Amini:There was a lot of resistance when I started to do that and wherever, I was presenting basically the idea and the potential solution. Most of the time I. Got negative feedback for a different reason. One reason was that everybody believed, yes, the solution should be made either by a large pharma company or by one of the big player.

Poorya Amini:Of the market that they have a technology and they can gain the business knowledge, which I didn\'t agree because I said, yeah, innovation, especially in that level, need to be in a very agile setting and small setting. If you become big. It\'s really difficult to innovate. The other pushback from was that, it\'s hard to change in the pharma industry.

Poorya Amini:The reason that still they are doing the same way that they were doing in the past 20 years because it was hard to change. But I said, yes, I agree. It\'s really hard. The change management is difficult in this industry, but now is a. Because of the technology, because of the acceptance of the technology, because we need to be more efficient.

Poorya Amini:We cannot do the same things that we are doing and just say the change management is difficult, if we can prove that we create more efficiency. For the company, more value for the company. I think they can take the pain of the change management and they will go for that. But yeah, they had at the beginning, very difficult conversation.

Adam Walker:Building on that particular point, change management, I would imagine is absolutely pivotal to run alongside any implementation of software solution in a big pharma, in a biotech, in any organization. You\'re effectively having to sell it to the people whose daily roles are changing, that they are reassured that in the future state, they\'re still gonna have a role and their job is still relevant and they\'re not gonna be put out to pasture or indeed redundancy.

Adam Walker:That\'s a pretty hard sell at the moment, isn\'t it? Because AI has a flip side to it, on the positives, we\'ve got efficiency. We\'ve got. Large language models. We\'ve got all sorts of capabilities that we didn\'t have in a heartbeat ago to today where we are now looking at the future in the next three to five years that we can\'t even imagine because of the exponential improvements that are happening.

Adam Walker:I\'d love you just to elaborate around that particular point how you see. Tools that are currently available, and perhaps the future of those AI tools might play out for companies like Risk Click, but certainly the companies that you\'re supporting.

Poorya Amini:Yeah, I agree. The change management is a big part of.

Poorya Amini:Being a successful solution in the large pharma industry because as, we all know, it\'s not only about the technology is just one part is a process and people involved need to come alongside the technology if you want to implement a solution successfully in the complex environment of the pharma.

Poorya Amini:And then if you want to. See the impact I think we are lucky now the people are more open to the technology in general, especially the ai. I think it\'s becoming the new. Normal of our life that we all are using some sort of the AI technology to do our task, either even the personal task or the professional task we\'re all using.

Poorya Amini:That\'s why we. Are more open to AI technology compared to the past because if I compare my conversation now to 2019 is completely different. Conversation because that time was really hard, first of all, to convince the people and then the technology at that time was not that strong, especially on the generative ai. They were really strong model, like a transformers and so on, but regenerative, but now the people. Are more acceptance because they feel it. They understand how powerful it is, and they somehow expect that they use it in their routine practice.

Poorya Amini:But on the other hand, since we are talking to the scientists need to be skeptical ago. They need to. See the hard evidence. You cannot just go with a commercial claim and buy it because they need to see the evidence. And this is the way we try to generate the evidence.

Poorya Amini:We try to give the confidence to the scientists. You can test it you can see how it works in your hand. And then you can get a sense, and you can get a feeling of that. And then if that\'s, for you or not. I think that help us in the conversation to sell the product.

Poorya Amini:But on the other hand, I think the difficult part is that learning a new solution, learning a new software, learning a new technology at the beginning sounds. Difficult and heavy. But we try also not to impose everything to user for the learning, and then we try to onboard them step by step and take their hand step by step be alongside.

Poorya Amini:Them and then support them at the beginning to show them, okay, look, there is a value for you of course it\'s on the organization level, but for your job there is a value

Adam Walker:Thank you for elaborating on that. So if I\'m hearing you correctly, that support follows through, how do you think AI is gonna improve?

Adam Walker:The tools that we are currently using today, because you mentioned about the conservatism within which we work around clinical research, drug trials, medicine more generally. How do you think that will play out in the next couple of years?

Poorya Amini:I think in medicine and in the clinical trial, first of all, there would be a limitation on AI or any technology has pros and cons and some limitation.

Poorya Amini:We need to understand the limitation and we need to transparently communicate this limitation to the users to understand, okay, it\'s not magic. That I just press a button and AI agent can do all the job for me and then do that. No, they can assist you to do the job more efficiently or some job.

Poorya Amini:They can do it even automatically, but there is a limitation and then you need to understand the limitation and then you need to be careful with that limitation. Even for our tool, we have a. AI agent that support the user onboard the system, meaning that the AI agents and the first line support can take the hand of the user and show them, how you can do it. You just do this, you press a button here and here is the manual that you can read, and then you can find more information. If this is not enough, I would be happy to connect you with the human agent to have a call, and then this is the way that we try to onboard the users.

Poorya Amini:Successfully.

Adam Walker:That\'s very reassuring. So you\'re retaining the human in the loop at all times. You\'re keeping that oversight and you\'re making sure that the quality is maintained all the way through by the sounds of it. Yeah, that\'s wonderful.

Adam Walker:At this point in the conversation, Poorya, I always like to finish with a quick fire round.

Adam Walker:So I\'m wondering what is the one piece of advice you would give to your younger self?

Poorya Amini:Don\'t give up on your dreams.

Adam Walker:I think it\'s fair to say you haven\'t, and you have shown unbelievable resilience in those dreams. What are the top three qualities you value most when building a team?

Poorya Amini:You mean if you want to hire somebody in the team? What are the qualification we value? Team player, player problem solver and fast learner.

Adam Walker:Okay. I like that. I hope you\'re all of those by the way. I\'m sure you are. What is your favorite thing that you do outside of work, sports, anything in particular?

Poorya Amini:Skiing paddle tennis, not paddling, but the paddle tennis we go usually with the team to work at least one or twice per week. That\'s some sort of the team activity as well. And yeah. And football, soccer.

Adam Walker:Don\'t start me on that one. What\'s your team? Are you a local fan?

Poorya Amini:Yeah, in, we have a team in Burn that\'s a young boys, and we were in the Champion league several times.

Adam Walker:My team hasn\'t been in the Champions League yet. My team is Brighton and Ho Albian, just for information. They\'re top half for the Premier League. But they\'ve not been in the Champions League yet. I\'m hoping for that one day. And finally, what is your number one golden rule in life and in business per.

Poorya Amini:Have discipline and respect your discipline.

Adam Walker:Yeah. That\'s fantastic.

Adam Walker:I really want to thank you so much for taking the time to explain the background of risk Click. The resilience and the drive and determination that you\'ve explained in your backstory is remarkable. And having had the opportunity to dig deeper into that today, I think our audience will really understand what it is to take an idea.

Adam Walker:Stick with it for the length of time that you have to produce something. So game changing for our rare industry, it really is as good as it\'s sounds for all of our audience. It is remarkable, and I said that to you when I met you in person. I reinforced that point again today, Poorya. It\'s remarkable Risklicks protocol ai from what I\'ve seen and in challenging the status quo within the industry within WeWork.

Adam Walker:It really is a game changer. Unbelievable applaud it and congratulations for everything that you\'re doing and you continue to do. And I just wanna thank you once again for being on Pharma Prescribed Today. It\'s been an absolute delight and a pleasure to welcome you. Thank you.

Poorya Amini:Thank you very much for the invitation and a nice conversation.