Welcome to another episode of The Effective Statistician! Today, I sit down with Darko Medin to explore how artificial intelligence is transforming biostatistics.

Darko works as a biostatistician for companies worldwide and builds digital solutions that push AI’s boundaries. We dive into Bio AI Works, the platform he’s developing to improve AI reliability and eliminate issues like hallucinations in large language models. Darko explains how AI can enhance statistical accuracy, uncover hidden data patterns, and accelerate breakthroughs in oncology and precision medicine.

If you want to understand how AI can revolutionize biostatistics while maintaining scientific rigor, this episode is for you. Let’s get started!

Key Points:

  • AI Challenges: Hallucinations, Accuracy, Reliability
  • AI Solutions: Validation, Cross-checking, Domain-specific rules
  • Use Cases: Oncology, Precision Medicine, Drug Discovery
  • High-dimensional Data: Hidden patterns, Complex datasets
  • AI Agents: Semi-autonomous, Goal-driven, Multi-step processes
  • Interpretability vs. Explainability: Statistical rigor, Scientific validation
  • Future of AI: Scaling, Faster iteration, Reliable outputs

Artificial intelligence is rapidly transforming biostatistics, but ensuring its accuracy and reliability remains a critical challenge. In this episode, Darko Medin shares valuable insights into how Bio AI Works is tackling these issues, from reducing hallucinations in large language models to uncovering hidden patterns in complex datasets.

If you’re interested in how AI can enhance statistical rigor and drive innovation in fields like oncology and precision medicine, you won’t want to miss this conversation.

Tune in now, and if you found this episode insightful, share it with your friends and colleagues who would benefit from learning about AI’s role in biostatistics!


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Darko Medin

Clinical Biostatistician at Universitätsklinikum Jena

Health Data Scientist, Senior Biostatistics consultant helping Clinical Research organizations, academia and companies around the world achieve their goals with over 10 years of experience in the most innovative and advanced fields and projects. Expert in different Life Science domain specific Data Science and Statistics.

Expertise – Experienced and Specialized for Clinical Research domains ranging from Oncology and Cardiology to Endocrinology, Immunology Anthropometrics and many more Clinical Research areas.

Experienced in developing and maintaining Data Science and Biostatistics Digital products including those in various Machine Learning and AI fields.

Specialized for Life Science areas such as Biology and Medical Statistics.

Advanced in development of Machine Learning / Artificial intelligence model development for Healthcare and Biomedical research.

Performed 160+ Statistical analyses for top Research institutions and some of the top Meta-analyses in areas of Cardiology and Oncology. Experienced in Clinical Biostatistician in Preclinical, Clinical trial phase I, II, III and IV trials and HTA assessments.

Mentored thousands of Data Science, Biostatistics and Bioinformatics students around the world.
Educational program lead, Biostatistics Mentor, former Biology professor and a Life Science Researcher.

Developed multiple state of the art Artificial intelligence, Machine learning, Biostatistical algorithms and models for Life Science industry in Japan and Asia. Developed over 50 courses, tutorials and other forms of educational materials in Data Science, Biostatistics and Bioinformatics areas.

Expert in developing, customizing methods and using various programming languages for Statistical computing.

Meta Analysis expert (R, Revman5, Cochrane methodology)

Clinical Biostatistician – Domain specific

Clinical Biostatistician- Systematic Reviews

Researcher – Biology and Anthropometrics

Data Scientist / AI/Machine Learning developer (R, Python)

Bioinformatics and Data Science mentor (R and multiple platforms)

~Innovative Clinical Trial design

~Study protocol Design

~Frequentist Statistics

~Study Review from a Statistical Perspective

R~ Meta-analysis, Biostatistics implementation of 150+ statistical packages and Machine Learning expert

Python programmer ~Biostatistics, Meta-analysis, Machine Learning/Deep Learning/AI

Experience using Transformers, TensorFlow, Keras, XGboost and LGBM.

Data Analysis Consultant

MSc, Faculty of Mathematics and Natural Sciences. Clinical studies researcher and Biostatistics specialist.

Transcript

Taming AI for Biostatistics: Darko Medin on Bio AI Works & Reliable AI Models

Alexander: [00:00:00] Welcome to a new episode of The Effective Statistician, and today I have someone that is actually quite well known on LinkedIn. How are you doing?

Darko: Thank you for a fantastic introduction, Alexander, [00:00:15] and I’m doing great. Really happy to be the guest, your podcast, and really looking forward to discussing some interesting topics with you.

Alexander: Yeah. What have brought you to use the space where you are now? Maybe you can give a short [00:00:30] overview of your cv.

Darko: Of course. I’m someone who is working as a biostatistician for various companies around the world, but I’m also someone who enjoys building digital products, especially in a field of ai. [00:00:45] So that’s related to one of the topics that we will be discussing today, which is a specific platform called Bio AI Works.

I would say that the time we live in and the developments that are happening in ai, [00:01:00] everything is moving so quickly. So I would try to speak about different items which may be related to specific solutions for specific problems that exist today within different research domains. And [00:01:15] again, I would like to thank you for the chance to discuss this.

Alexander: Yeah, thanks so much. Before we dive into the content, I can highly recommend you to follow DA on LinkedIn. You can join lots of others that [00:01:30] are following him for his continuous other sharing and of first we’ll put the link to daco LinkedIn as well as to the tool we wanna talk about into the show notes.

So yeah, you mentioned already your [00:01:45] platform, bio AI works. Can you tell us a little bit about the problems that it solves?

Darko: Yeah. Bio AI Works is a platform that I started building, I think over two years [00:02:00] ago, and initially it was envisioned to create a connection between biostatistics and artificial intelligence.

The connection between biostatistics and artificial intelligence involves a lot of biological fields as [00:02:15] well. So that was my initial idea for Bio AI works. However, as the AI development and evolution started to become faster with much more dynamics, many new ideas came to my [00:02:30] mind. And right now the focus is on specific problems that AI models, which are, by the way, they’re fantastic.

So everything that we are seeing with. Large language models such as Pat, GPT, open AI models, other models [00:02:45] such as Lama Grok. It’s really a field where a lot of fantastic developments are happening. However, a large language models have a specific set of problems that are related to hallucinations and accuracy, even though large language [00:03:00] models can do a lot of fantastic, perform a lot of fantastic tasks, especially in the field of generative tasks, generative ai.

They have been struggling with that scientific, statistical accuracy [00:03:15] that us as statisticians usually want to have. The specific problem where Bio AI works is it’s a significant portion of Bio AI works, is focused today, is trying to be different in that [00:03:30] way so that AI models that are developed at Bio AI works.

We’ll have a higher level of reliability. So there will be a lot of different checks that AI models need to pass to produce a specific [00:03:45] out. So that’s one of the main problems that we are trying to solve today. When I say we for Bioworks, I’m partnering, even though I started building Bioworks a few years ago.

In development of certain AI models. I’m [00:04:00] partnering with a great company O Analytica, and we are looking to build a diverse set of AI models. So one approach I just mentioned, but there are other approaches that we are also looking to explore, such as precision [00:04:15] medicine research, precision drug discovery, using generative AI in drug discovery as well, and also AI models which would be able to solve one problem.

Which is often found in statistics and [00:04:30] data science, which is the hidden patterns that are in the data that we don’t see using the standard approaches. However we are now in the process of development of an AI model called the universal Constructor, [00:04:45] which main ability is to try to identify those difficult, to find patterns in the data.

Then produce entire data sets of hidden patterns of what we don’t see just [00:05:00] by looking into correlations, associations, and other standard statistical approaches such as linear istic, regression and so on. So we are trying to combine the foundation that we have in biostatistics and statistics [00:05:15] and the rigor that we have in those scientific fields with the capabilities.

Of artificial intelligence and try to improve artificial intelligence by making it more [00:05:30] accurate and more reliable.

Alexander: When you talk about reliability, can you expand a little bit on what that means to you?

Darko: Yes. There are actually multiple fields we are exploring when we speak about [00:05:45] reliability. So one of those fields is obviously statistics, basic domain, which is always needed in some way, the basic accuracy, the receiver, operative characteristic.

Other metrics that we have in [00:06:00] statistics. When we create outputs, we want to know that these outputs are statistically accurate and cross validated, which means that any output that is created. It’s validated in a certain way. It’s [00:06:15] not just generated as an output and produced. It needs to be validated in this process that we are trying to build at the core of AI models.

But of course, this is just one side of the story. There are other approaches that we are [00:06:30] experimenting with in improving the validity of outputs with the domain specific checks and balances partnering with. So Analytica we have. A whole team of scientists from different biological [00:06:45] spheres, including molecular biology biostatistics, statistical programming, other fields of life science.

And we are trying to create a domain specific set of rule that AI model [00:07:00] needs to follow. So that the outputs that it creates are more valid, more accurate, and less prone to that. Very frequent problem with the daily AI models, which is hallucination. So that’s one issue that we want to avoid at [00:07:15] all costs, which is hallucination of AI models.

Well,

Alexander: what’s a hallucination? So I’m just thinking about kind of psychiatry and hallucinations, but if you’re talking about hallucinations, you probably mean something [00:07:30] different. What’s in the hallucination of an AI model?

Darko: Good point. So halluc in AI models is a completely. Different item, different research field compared to psychiatric and psychological terms.

So [00:07:45] in AI models, hallucinations are very frequent. Almost every AI model built today has some form of hallucinations when specific prompts are prompted towards that AI model. This is happening [00:08:00] mainly due to the fact that most AI models, at least today, are generative. Which means that at the core of their functionality is that they’re trying to generate new pattern and new [00:08:15] sequences from text.

But still trying to make sense of those sequences. So when we ask a question to an a AI LLM model, it’ll try to answer that question as accurately as possible given all the [00:08:30] knowledge that it has acquired during the training process. At the same time, it’ll try to be creative a little bit. It’ll try to be generative and try to generate potentially patterns that don’t exist in the original data.

Now, [00:08:45] this is from one angle, okay? Because generative AI models allow a lot of flexibility. That’s the foundational principle that enables those impressive answers that a lot of AI models can produce. [00:09:00] However, it has a downside. The downside is that given all that complexity, all the training data that is included in training those AI models combined with its creativity and [00:09:15] generative capabilities, trying to create some new patterns, sometimes actually very often I would say these new patterns are randomly created.

Well,

Alexander: it could be said, don’t know. It makes up. [00:09:30] Clinical trials that doesn’t exist. Yeah. Says one arm studies that are existing and there combine these in into a clinical trial and says, compares these kind of different things. [00:09:45] Something like this,

Darko: I think you, you made a great example. So a lot of times in AI model will try to combine the information that it has and in specific situation it doesn’t have this critical.

[00:10:00] Angle, maybe sometimes there is not enough information to make a specific conclusion, but an AI model will still try to use its generative capabilities to create a specific story for that answer. And [00:10:15] sometimes that may actually be just randomness, just as you said, her, a random hallucinated clinical trial, let’s call it that way.

And that would be one case example. However, there are many other examples [00:10:30] where generative AI model, this is especially the case for large language models because they are trained very often on large amounts of textual data. Most large language models today actually ingest majority of the text that exists on [00:10:45] the internet, and that’s how they’re trained.

We can just imagine how many possible combinations can those. Models create from that text. Sometimes that text is inaccurate. Sometimes it doesn’t resemble what we are [00:11:00] trying to find. Sometimes it doesn’t have a scientific foundation. Sometimes it has scientific foundation, but large language models really struggle from differentiating this.

If we take scientists can take a critical [00:11:15] perspective. When he or she reads literature, we can say, okay. This is just a blog post that someone wrote, or we can say, oh, this is a peer reviewed clinical trial study, which is very [00:11:30] rigorous. Then I will trust more that peer reviewed study. And there are so many nuances there.

So our human intelligence naturally has built in mechanisms to critically evaluate things. And AI models are still struggling there. [00:11:45] So to be able to prevent those hallucinations. We need these mechanisms that will critically evaluate data. Or anything that’s generated, anything that’s generated that novel to differentiate what could be [00:12:00] reality and what could be a hallucination for that model.

Alexander: Okay. So one thing said, by the way I want do is less hallucinations. The other thing you mentioned [00:12:15] is reliability. You mentioned like example, like receiver operating curves. In order to create a receive operating curve, you need to have something like a gold standard. Yeah. That you compare [00:12:30] against. How do you create a gold standard?

Is that based on simulations or something like this?

Darko: Yes, so this is one of the approaches that we are exploring. So using AI models to. [00:12:45] Identify causal patterns in the data and for this specific field, we are using a lot of simulations to simulate co causal associations, mathematically simulate them and then try to transpose this into a real [00:13:00] world situation.

So that’s one of the approaches. The other approach that we are exploring is, even though we are developing a lot of advanced, they. Technologies because these are more technologies today than just saying, oh, this is a [00:13:15] model. We know from statistics and from data science that a model is not very useful unless it’s a part of a specific product that can productionalize that model and bring real value to its user.[00:13:30]

We’re exploring approaches that we know from previous experiments that were. Reliable and accurate. And when we create something generative, when we try to explore another advanced tap, [00:13:45] we always step back and compare to that specific approach that we knew had large sensitivity, specificity area under the curve.

So all those statistical metrics that we typically use in statistics. [00:14:00] I would use this dance to mention how important statistics and biostatistics is in AI development. Practically, all AI models are at the end analyzed using some form of statistics. And even the modeling itself is something that comes [00:14:15] from statistics.

We use a lot of statistical approaches there, but we still try to combine them with. Advanced approaches that come from other fields, such as being able to generate text, being able to generate AI agents that can perform [00:14:30] a specific task, which are not usually used in statistics or any similar field.

Alexander: You mentioned the words AI agent, but what’s that?

Darko: AI [00:14:45] agent is actually an entity. That can utilize that AI model to perform a specific task. AI agent can actually has a level of [00:15:00] autonomy, right? It’s not fully autonomous yet. There may be some companies around the world that are trying to develop fully autonomous agent, but most of them are actually semi-autonomous, which means that we can set a specific goal to that agent.

That [00:15:15] agent, AI agent will try to find various solutions on its own. We don’t have to write all the prompts, so an AI model, which is not an agent, we would need to provide practically all instructions [00:15:30] on our own. For example, we want an AI model to perform task one and then to perform task two, task three, task four, and so on.

So we have to provide inputs all the time. AI agent is an entity [00:15:45] which is just given with a goal, and it’ll figure out all the tasks that it needs to perform and it can perform them on its own. As such, AI agents are very useful for Bio AI Works [00:16:00] platform because biological AI models are always very complicated and.

This makes sense because biological systems are complicated. So if we take a look at how D-N-A-R-N-A [00:16:15] molecular biology works, if you look at how clinical trials work, how biomarkers work, there’s huge complexity there. We are talking about thousands, tens of thousands of different variables. And as such, AI model dealing with [00:16:30] all these variables and with all this complexity.

Usually involves a multi-step process where an AI model needs, for example, first to pre-process the data, then to connect a specific data to its biological [00:16:45] domain, then to create a specific predictive model, and then to test and validate that SP predictive model, and then to create a specific outputs for the user.

So an AI agent would be able to do all this just with setting [00:17:00] up the goal. Setting up what’s your goal? And if an AI agent is well optimized, it’ll perform all these tasks on its own.

Alexander: Okay. So it’s basically, yeah. I like the approach that you say connects lots of different [00:17:15] prompts into one, somehow a meta prompt.

What does typical question or specific use case that you foresee for your bio AI work platform? [00:17:30]

Darko: That’s a great question. So the first use case is obviously related to one of the fields, what I was working for a significant portion of my career, which is oncology research. [00:17:45] There are a variety of use cases that we are exploring right now, but one of those use cases is related to creating AI agents that can accurately predict how.

These molecules called [00:18:00] antigens. Neoantigens on the surface of cancer cells can be recognized by immune system. So it has potential application in many fields, from immunology [00:18:15] to cancer vaccine research, mRNA vaccine research. It’s still in developmental phase research phase. However, that’s one of the use cases that we foresee.

And again, our [00:18:30] focus is not just to create a model that can produce fancy outputs that look impressive. Our goal is to create a model and integrate that model into digital products that can provide as accurate as [00:18:45] possible outputs. From that reliability foundation, we want to build on other advanced features of this model.

That, that’s one of the models that we are developing a peptide predicting model for cancer research. And another [00:19:00] model is more general. I already mentioned it before, which is the universal constructor. So it’s very general. It would enable people to potentially find patterns in the data that previously could not be found.

Again, we have a lot of [00:19:15] use cases that we are envisioning here. Some of them. Are again, related to finding maybe biological targets that could not be found before because of all the complexity in the data or [00:19:30] uncovering biomarkers that could not be uncovered before. Of course precision medicine research is another field that all these models could be potentially associated with.

So we are trying to target [00:19:45] specific problems that exist there. Specific problems in the data and the data science that revolves around all data in life science and try to iterate this much better, much faster. When I say iterate [00:20:00] better and faster, I mean about the scale. A lot of data is generated today on a daily basis in life science and significant improvement are very often dependent on how fast [00:20:15] and how well.

Can a model scale on using a lot of data at the same time and uncovering a lot of patterns at the same time and performing a lot of tasks very quickly. So that’s [00:20:30] another item that we are discussing very often.

Alexander: So one of the things that you would look into, for example, is high dimensional data.

For example, if. I am [00:20:45] collecting continuously blood levels and several variables around my body because I have diabetes, and that creates lots of data because on a per second basis, you create data [00:21:00] over days, one weeks, maybe years, and for potentially lots of patients that use this monitor. That is both high dimensional in terms of the number of patients as [00:21:15] well as the number of data points that you collect.

But is that is some kind of use case that you would foresee?

Darko: Yes. I think that’s a very specific concrete use case and I can definitely foresee [00:21:30] that item because a lot of the problems, as you probably know, and I think we actually discussed this, a lot of the problems. In statistics, in data science and in research in general, come from the high imaginality and high [00:21:45] complexity of the data.

And there are so many, not just so many variables, but also so many study designs, so many contextual information, so many differences that exist in the real world that we maybe don’t see in a [00:22:00] clinical trial, in a clinical trial. We have a very rigorous, specific setting, very specific inclusion criteria.

We have randomization, so all those things that try to correct the bias that could come externally [00:22:15] towards the study. However, in the real world, things are very often more complicated. That’s one difference that we see in the real world. Evidence that we don’t see in clinical trials. Usually comes from that complexity and high dimensionality.

So high dimensionality, [00:22:30] very difficult to resolve, and AI is definitely one of the potential solutions. So that’s another item that we are also exploring and a lot of updates will be in bio AI works regarding this specific field [00:22:45] which is the high complexity, high dimensionality of the data. People usually tend to favor simpler models settings because they’re just easier to work with and they’re more explainable. Yeah. However, when we take a neural [00:23:00] network that has 10 billion parameters, it very difficult to explain to any human how those 10 billion parameters work, how the model actually works.

What are. Specific weight on those, between those neurons and so [00:23:15] on. However, if that specific approach will produce a result that will solve a specific problem in the real world, then it has its use case even though we can’t fully claim it.

Alexander: So it doesn’t need to be, from my [00:23:30] point of view, it doesn’t need to be explainable.

As long it’s interpretable. Yeah, so there’s a lot of work on interpretable machine learning and interpretable ai, and so I would refer to that. I [00:23:45] actually recorded a podcast about exactly that topic sometime ago. So just call back in your podcast.

Darko: Will this, and I think the item that you explained is a very important that there is a [00:24:00] debate about this, how to think about explainability and predictive performance. However, there is another angle which is interpretability. If we know where the data comes from, how is that data potentially related to the outcome that [00:24:15] we’re trying to predict?

Even though we can’t explain, we could potentially explain, but it just would make sense to explain a billion parameter model. However, we can explain the data, if we can explain the context around the data, if we can make it interpretable [00:24:30] towards the outcome, then we resolve most of the problems that exist in that field.

And on the other hand, we get the power of AI models as a big plus in that specific use case.

Alexander: So thanks so much for [00:24:45] diving into this. I certainly learned quite a lot about ai, its limitations, its use cases, its opportunities, and how we can team it from a statistical point of view a little bit. [00:25:00] If people want work with you on these kind of different topics, how can they best reach you and where can they learn more about the bio AI works?

Darko: So the Bio AI works is a project that’s in development [00:25:15] and it’ll be productionalized very soon. Anyone can find more information on the website, bio ai works.com. However, I can also be contacted directly on LinkedIn so I can be easily found on LinkedIn by searching for [00:25:30] comin. Any questions, any interest related to Bio Air Works is most welcome also.

Any suggestions. Any potential use cases that we haven’t explored so far will be very welcome. And again, I want [00:25:45] to thank you for the opportunity to speak at the Effective Statistician podcast. And I also want to recommend everyone to follow the podcast. It’s really a golden source of very valuable [00:26:00] information for statisticians, but also for anyone.

In many different scientific fields, and I would also recommend everyone to follow Alexander Sha, who is someone who I learned from a lot. I’ve known [00:26:15] Alexander for a while and I learned a lot from Alexander. So definitely recommend following his content. Thank so much.

Alexander: Thank you for coming on the show and see you again and most likely on [00:26:30] LinkedIn.

Darko: Thank you very much, Alexander. Special thanks to you for this chance and looking forward to speaking with you again.

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