What is due diligence?
Why do you need a statistician in it?
What makes it very special?
In this episode, Benjamin and I share about how we did it our way and discuss the following points:
What makes it very special?
- Great experts to work with
- Exposure to senior management
- Intense work experience
- Secret project – not even allowed to tell where you go to
How did it work for me?
- Deep dive into the data
- Meeting with the other company
- Interviews with the experts
- Looking into further material
- Discussions with the other experts
- Conclusions and recommendations
Listen to this episode and share this with your friends and colleagues!
Alexander: You’re listening to the effective Statistician podcasts, a weekly podcast with Alexander Shacht, Benjamin Piske and Sam Gardner. Designed to help you reach your potential lead, great science and serve patients without becoming overwhelmed by work. Today, we are talking about my experience as a statistician in a due diligence project. And if you don’t know what that is, stay tuned, it’s really, really awesome and interesting and maybe a great opportunity. For you in the future as well.
Alexander: I’m producing this podcast in association with PSI, a community dedicated to leading and promoting the use of statistics within the healthcare industry for the benefit of patients. Join PSI today to further develop your statistical capabilities with access to the video on demand Content Library, free registration to all PSI webinars and much much more. The reduced rate is only £20 for non high-income countries and £95 for high-income countries. Head over to the PSI website at psiweb.org to learn more about PSI activities and become a PSI member today.
Alexander: Welcome to a new episode today. I’m talking again with my good friend Benjamin. How are you doing?
Benjamin: Thank you. Very well Alex. Yeah, it’s been a while. We’ve been chatting occasionally, but only the two of us, it’s been a while.
Alexander: Yeah, and today we talked about a really interesting experience I once had, and was very very special. It was the so-called due diligence project. And when I first heard about it I said “Due diligence? What’s due diligence?” It’s just kind of, well I’m always diligent, so special about it? And then I learned that this term is specially used when there is a new bigger business opportunity. Like when you buy a small company, or if you buy a product, or if you want a partner on a product or these types of things. Where you know there’s usually quite some money involved and you want to make sure for your business that it is the decision. So that’s why there are these due diligence projects. The company I was working in at that time had a two-step process, or at least two steps. The first was a kind of high level review, and that included a couple of people, and a couple of hours to look more generally, into the time compound. And then there was a deep dive to make sure there’s a really thorough review of everything around the product. And that’s where I got pulled in.
Benjamin: Yeah, that sounds interesting. It’s really like a project right? As it stands, diligence is something that we all know and it should be known, and it’s really like what we talk about a little bit like a bigger complex project. I mean, if it’s an easy task, obviously we probably wouldn’t need a special strategy. But when you said about buying a small company and so on. Is it then that the statisticians really need this process?
Alexander: Yeah, it was really interesting when you buy a product in a certain stage of development. I think at that time it was within phase 2. And you look into everything that I have, and of course, you also need a statistician to understand the data very well. Yeah, what is the quality of the data? What is the, you know, how confident are you? What is the whole see clinical plan looking? Like I said, something that is feasible. Other things that can be improved, changed is what the probability of success is that, well, well, estimated or of any kind of, you know, limitations or maybe also strengthens the data and the other features that makes these product really compelling, or other things in there where you think like that more looks like a dead horse. So that’s the part about it and it was an awesome experience because it was quite a big team. I think about 20 to 30 people involved from the buyer side across all the different areas. Yeah, so Safety, Medical, Pharmacology, all kinds of different functions. Led by the project manager that was coming from this Business Development area. All these people who are hand-picked and highly regarded experts in that field. So really kind of an A-Team, lots of awesome people. Yeah. So, you know, when you work in a usual kind of study team, yeah, you have some more experienced and less experienced people, some, old standing people, some mediocre people, you have all kinds of a wide mix. But in that sense, you only have people that really know their stuff. Where the Senior Management trusts them, okay. If Fred is saying that, then that’s right.
Benjamin: Usually I mean, people feel quite comfortable in the working environment and have people that they know how to deal with, cetera. But really having hand-picked experts to collaborate with on a quite important piece of work. It’s probably outstanding, that is for your experience, probably very special by, however, that’s not the standard, you know, the basis for due diligence. It’s more like when you describe how your experience was. But how did you guys then prepare? I mean, did everyone get a handout on the process of due diligence? Or was it that you guys sat together and discussed it and then figured out the way of getting to the problem and finding the solution or an answer together? So, how did it work then?
Alexander: So actually it started with training on the process and especially all the protection along with it, so these projects are highly confidential. So my supervisor, for example, only knew that I’m working on a due diligence project, but he had no clue what that project specifically entails. Yeah, which companies would that be? Which products would that be? All these will be completely secret. Yeah, and also my step supervisor didn’t know. It was only the VP who knew about that and the details. And all the details, discussions were only with the VP. It was so secret that there was even an incident when our aide booked a flight, and it leaked where I’m flying to. So my supervisor saw it for approval reasons. That shouldn’t have happened and things like that. Yeah, so there’s really a lot of secrecy around it because, of course you don’t want to have any leaks that you’re interested in this product or this compound in this company to have any others jump on set.
Benjamin: But also, I think for the project itself. I mean, for your diligence project. It’s more than also, if you find out any, if there’s leaking any information through, you know, that will potentially spread information, that might lead to incorrect conclusions. So, in whatever way it is. If it’s by accident, or if it’s just aimed for failing.
Alexander: Yeah, and so we first got a lot of documents. Yeah, there was an Internal Special storage, where all these documents were put and then we could review them, put comments into it. Had a couple of discussion rounds virtually because the people included were from all over the globe. And then we had a meeting with the company, and that lasted over about a week. So every day we would usually kind of start a meeting with everybody together, then also including the other counterparts from the company. Then we would have interviews with various people in the company and would get together again, to kind of speak about our findings, to share what we saw, any news, collaborate with each other, and sort of if there’s these findings and we also note need to look into that one. If there’s that strength, and you need to check on a couple of other things. Because, everything is kind of connected to everything. Yes, if the upper dose looks promising from an efficacy side point. And someone else will say, “Is it safe?” How would it have an impact on the formulation? Is that possible? Or, if then the pill may be too big or whatsoever. All kinds of different connections. So, we were constantly looking into these and moving around backwards, forwards, documenting all of our findings. Yeah, and also doing kind of alternative calculations. Yeah, looking into the data seeing if we put a difference is something, how well, how would that look like? Yeah, is the sample size calculation for the next study? Does that make sense? Yeah, or should it be bigger? Or does it conform with the data that we need for an approval? Yeah, so we were also checking against regulatory guidelines, whether that makes sense.
Benjamin: So until now it sounds more interesting because of the, you know, especially the secret, the boundaries that you have from the protection side, but also more like a very deep project with a lot of experts but like a general project. So I mean, you meet you do the, you know, preparation and then to discuss, you ask questions, go back and forth. It could have been the FDA rather than the different company. So what is it then in this case of due diligence? What is it that made this approach to that project so different?
Alexander: First things first, is that you get a really intense view on all the data in a very short period of time.
Benjamin: So how do you manage this? I mean there must be something.
Alexander: Basically, everybody blocked off time at all. Every other project was kind of pushed aside. You need to delegate things, there was not anything like yeah, but I have this meeting. No, you don’t. I need to go to that meeting. No, you don’t just have top priority, there’s nothing else that is more important. And having that feels really really cool because you are not distracted by anything else. Yeah, of course, you could check your emails in the morning and in the hotel or things like that, but during the day, there’s only one thing that you’re working on. And that made it a lot fun. Working with experts, diving deep into this, then also the close collaboration with very senior people. Yeah, so everybody was asked to the networks of findings with, with their most senior people, and then up the chain. Yeah, so you had discussions with very, very senior people in the company. Okay, what are his pros and cons? What could be done differently? How big is your opportunity? How big is the uncertainty? That also gave you a lot of exposure to these people. And of course, this exposure is immensely helpful when it comes to maybe getting a new opportunity at work. Or getting the next promotion, or things like that. Yeah, these types of projects give you a huge opportunity to shine. And so if you ever have the opportunity to get into something like this, jump on it. At first it’s a recognition for what you have done. For your expertise, and see what you’ve done. And also see it as a huge opportunity for further growth. If you deliver here very well and just lots of good feedback, and your VP is a thin crust and even maybe potentially the supervisor of your VP, maybe even the CEO is included, then it can only be good if you perform well.
Benjamin: That’s true. I think that’s something you always should. We discussed this in regards to other topics like networking, etc. So this is like, next-level opportunity to shine as you said.
Alexander: Yeah. So we talked today about the due diligence project, and what it actually is. Looking into this business development, and maybe if you’re working for a smaller company, maybe you’re sitting on the other side. Yeah, and you’re trying to sell your product or you trying to make it look attractive. Either side, it’s an awesome opportunity. That’s a lot of fun, it’s really intense but it’s a lot of fun because you work with great people. They know their stuff, they are all experts, and because everybody knows everybody here. Instead of other people. That’s not a lot of ego involved because both give and take and it’s a really great opportunity to shine and to fill the progress.
Benjamin: Excellent, sounds very good.
Alexander: The show was created in association with PSI. Thanks to Reine, who helps with the show in the background and thank you for listening. Head over to the effective statistician.com to find the show notes and learn more about our podcast, boost your career as a statistician in the health sector. Reach your potential, lead great signs and serve patients. Just be an effective statistician.