Training in launch and commercialisation​

Transcript:

Alexander: You’re listening to The Effective Statistician podcast, the weekly podcast with Alexander Schacht and Benjamin Piske, designed to help you reach your potential, lead great science and serve patients without becoming overwhelmed by work. Today, we are talking about the role of training in launch and commercialisation. And you may wonder what training is so special about. Well listen to this episode because it’s kind of a super weapon.

So how can training be a super weapon? Well, training helps you to connect with many many people and it helps you to build trust. It helps you to advertise for your services, it helps you to become known. And ultimately, it helps you to be in the room where the decisions are made and that is what we will talk about today. So stay tuned for this really, really good episode.

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. There’s also a launch and lifecycle special interest group within PSI and that is really, really helpful for every person that works in this space. So if you’re interested head over to the PSI website at PSIweb.org to learn more about PSI activities, other SIGs and become a PSI member today.

Jenny: Hello and welcome to another episode of The Effective Statistician. I’m Jenny Devonport and we’re going to do something different today. I’m going to be interviewing Alexander Schacht on the topic of developing and administering training for non-statisticians. We got to talking about this a lot through our work with the new SIG in the PSI organization. This SIG is dedicated to statisticians working in the environment of launch and life cycle. That is bringing a newly approved drug all the way to patients and what kinds of evidence generation and other activities statisticians can contribute to that are really valuable. And one of these is training so that everyone understands the data and the methods that were used to bring this beautiful product to life. So Alexander, would you like to say a few words to start? 

Alexander: Yeah, thanks so much for the introduction. It’s really nice to hear someone else saying all these words. Training I think is a really, really interesting topic. I always, you know, when I went into Pharma that, of course we’ll do some kind of stats training and I was always kind of thinking about that stats training that I would do at University kind of, what is a t-test? What is actually a test? What is the p-value? All these kinds of different things. And over time I realized, that’s surely not the best approach to just kind of copy and paste what I  did at University to the Pharma world. and I learnt that training not only helps the people in the audience, but it is an awesome tool for me to improve my influence in the field, build connections, build networks. So I leveraged training quite a lot, during my career in many different locations. And most of the time actually I didn’t call it training because training has this kind of bad connotation especially stats training, who wants to go to the stats training as if at least if you’re a non-statistician.

Jenny: Definitely. How did you get started providing training for non statisticians? Were you asked to do an offer? 

Alexander: Actually I don’t know, maybe both. There was some stats training anyway going on and so I participated in this and then there were also requests coming because people didn’t understand kind of the phase three data, they were asked to talk about. People came and asked, ‘Can you help me with these kinds of things? What does that mean? It has a ratio or gives us new methodologies that everybody talks about MMRM. MMRM at that time was kind of, you know, the big news thing and  we are not using LOCF anymore. We are now using MMRM. What’s the difference actually, these kinds of things were really kind of important at that time. It was a lot of one-on-one training, but then also, these were questions that everybody asked so let’s go into that. There was one specific thing that I got involved in that was Journal Club. I really loved this. It was a setup in the German affiliate of a big company and that company had a couple of different products in neuroscience. One of which was a huge blockbuster antipsychotic. There were about 12-15 medical scientific liaisons together with their lead physician. Whenever they had a meeting in the office,  a regular meeting every month or so, there would also be a one hour journal club, where they go through publications and talk about what it means for them, how they can talk about it with the key opinion leaders. And one of the MSL, else would give a kind of medical update on it and I would do a statistical methodological critique of it. And I loved it because it was very, very engaging, with lots of good discussions about these things. I learned quite a lot about how to communicate about statistics effectively. 

Jenny:  There’s a couple big topics that you introduced there and I’d like to break them down a little bit. The first is of course that usually the people that are going to be talking about the Phase 3 data and their implications are not statisticians. 

Alexander: Yes. 

Jenny: So can you talk a little bit more about what they’re interested in and why they need to understand the statistics. 

Alexander: Yes. If you think about the ratio of statisticians to non statisticians in Pharma companies that actually talked about his research, it’s probably something like 1 to 1000 or something like this. If you think of all of the sales rep, the marketing, the medical people in the affiliate in the regions in the global level and global app, you know, a few of all these. For big products or therapeutic areas these can be thousands of people. They have the challenge that they don’t usually have an access to a statistician but they need to talk about the data in the day-to-day job. An MSL talks with key opinion leaders and has long conversations with them, sometimes an hour or even longer, to talk about some new studies that are coming out and of course, they get challenged on anything that looks new or looks different or looks surprising or in some way shape or form, not in line with what we say genuinely expected. If they are not confident,they cannot really explain it in a good way and that doesn’t build trust between the different people.And imagine you would be going to a key opinion leader, world expert on x, y, z and your job is to talk about something that you don’t really feel comfortable talking about, this is miserable situation. These people really have an interest in understanding all the details in and out so that when they get challenged by customers they can confidently provide an answer. So they have a really, really big interest to understand all of these. Same way kind of, if you think about marketing people if they want to provide good marketing material or if they want to understand, what are the strengths and limitations of the studies from the competition. They also need to understand, why is that study different from our study? Is that a good thing? Is that a bad thing? What are the consequences for us? Do we need to write our claims differently? Will we get into trouble kind of, could we be accused legally for something like this or vice versa? Could we accuse or compete legally because they really overstate something. All these things depend very much on methodological, statistical questions and therefore it is really important for them to understand the ins and outs. 

Jenny: The other thing that I think would be great if you could touch on, is what these interactions between the statistician trainer and the non statisticians can teach us, statisticians, about what’s important? 

Alexander: Yes. Very good. The first is I learned quite a lot about what’s really on the mind of the people that are working in the fields and see customers every day. If you work in your global or kind of statistical ivory tower, you can very easily get detached from what is really happening? What are the real questions?  You may think that’s pretty clear and straightforward. It may not be that way. You may think like, ‘this analysis, where we interviewed everybody that has been missing as a non-responder, that cleared easily. No, it’s not very often.  And there’s lots of very, you know, minor details that can play a big role, kind of in exclusion criteria or study legs or things like that, that you might not actually see as a topic. Talking to these people first hand helps you to understand this. And then you can bring them back to and make sure that everybody understands it because if you have talked to three different MSLs and they all have the same issue, it’s probably a wider topic that you should address globally so that everybody understands it. The other point is I also get much more aware about the competition. What are they doing? You get to see kind of marketing promotional material from them and you better understand how our business actually works and operates. That’s one of the key things and finally I learned a lot about what works and what doesn’t work in terms of explaining statistics.

Jenny: Okay. So you talked a little bit in the beginning about people having questions about the phase 3 trial. So let’s say you’re a statistician that has just completed their phase three program and they’re in the heat of label negotiations and they know they need to give this training to the field. How do you decide what topics to cover? 

Alexander: I think that’s an excellent question. So first, I think it is important to have a look into, what is your overall strategy for your compound? What are the key strategic things in your data that need to come across really crisp and clean? Let’s say your compound is better in terms of a certain safety aspect. Then everything around the safety aspect needs to be very very clear and crisp and clearly described. Everything that is somehow controversial is really important and there you need to listen quite a lot. You need to listen about what this costs for example, at advisory boards and key opinion leaders? What are the challenges that MSLs have? What are the questions that the physicians that you’re working with have? What are the things that they find it difficult to explain? All these topics are good topics for training. And as I said, most of the time you wouldn’t call the training, you would call it kind of explaining the results or kind of getting to know how to use the data better or something like this. 

Jenny: Okay. And when you give a training like this, what kind of feedback do you usually get? And how can you then follow up on that? 

Alexander: Feedback is really important. I think you get a couple of different kinds of clusters of feedback. The first is you get feedback on your material itself. Was it clear? Was it crisp? You get feedback on what is missing. You will get questions about, ‘yeah you talked about XYZ but our computation did it a different way. Why did they do it that way and we did not’? So that helps you to kind of add to these things. You will also get overtime, you know, these kinds of things are not completely stable. There’s always new evidence coming, there’s always new challenges coming and so you’ll get an update on what are further topics that you need to talkvabout. You’ll also get that different areas in the world will need different things. For example, it could be that your label in the US looks different to the label in Europe. And that may have consequences in terms of what you can actually speak about, what you can even train people about. There are all kinds of different local regulations around the world in terms of how you can talk about different things. If you think, for example, how you can train sales reps in Canada, there are very specific kinds of rules. And you need to know about these rules or at least know someone that knows about these so that you’re staying compliant. So you learn a lot about these kinds of things as well. 

Jenny: So what I’m hearing is these trainings really need to consider the audience’s perspective, the competitive environment, sometimes even the legal environment if there are differences anticipated in different jurisdictions. That’s a lot to think about. 

Alexander: Yeah. And then the overall strategy of your compound. I think for me training is part of an overall communication strategy. You communicate and communicate here, I really mean in two ways, you talk and send information but you also receive a lot of information. And training is part of that. Training is, you know, when we think about communication we mostly very often think about just publications or just abstracts papers. That is much more to it. There’s key opinion leader engagements, there is training and training in all kinds of different forms like FAQs, videos, short kind of write ups, in person events, Journal clubs. You can even think about new mediums like podcasts or something like this? There’s a lot of what happens in terms of communication and also kind of listening, what are all the needs from the different affiliates from the regions, what is happening in the competitive space? You need to have a good communication kind of speaking and listening process overall and training is one of the key factors there. 

Jenny: So what I’m hearing is that just publishing a methods paper to explain your trials, may not be enough.

Alexander: Yes.

Jenny: Can you talk a little bit more about that and why a multi-channel approach is really needed sometimes?

Alexander: To have really good robust communication, you need to understand that kind of series of communication. What you think is not what you say, what you say is not what is heard, what is heard is not what is understood, and what is understood is not what is acted upon. So, there’s this whole chain where each step, it can go wrong. And so, you need to make your communication channel really robust to make sure that everybody gets a message. And not just once, many times. If you think about change management within your company, there’s this rule of thumb that says you need to talk about something important seven times before everybody hears it at least once. So just because you published a method paper, doesn’t ensure anything. It gives you credit to your CV but it’s a nice basis for further kinds of things. But to be honest, by the time you have published it, it’s probably already too late. So think about all the different audiences. Think about how you will reach them. And lots of them you will not reach directly. You’ll reach through the trains a train approaches for example, or through synchronous communication like video clips or slide sets or documents or all kinds of different things. So think about the whole kind of communication cascade from you as a statistician, let’s say in a global team up to the local sales rep, increase or wherever. How do you reach all of them? What do they need to know? And also the and the other way back, how do you listen to all of them? And how do you get the information so that you can adjust it? And so for me, I think whenever you do something in terms of, for example of publication, not just think about the publication itself and here I’m thinking of kind of let’s say a primary paypal of your phase three study think also about all the training and communication that goes together with it said sure together with it. If you present, let’s say your phase three data at a conference for the first time. And for me, that is an absolutely critical time in the launch because this is where you give the competitions the opportunity to critique you. You should be really, really well prepared for that. At that moment, you publish this data, you should have the cool kind of communication cascade in place so that everybody up to the well, probably at a time, not sales rep, but at every MSL, everybody in the organization has access to all different questions they might ask. Very often you’ll have this kind of press release that gets out and unfortunately lots of people will only hear about this data through this press release. Lots of people in your competition will not know about the data, then  the people in your own company.

Jenny: It’s a real shame. 

Alexander: It’s a complete shame. And imagine this poor MSL  from your company that two weeks later goes to a key opinion leader and wants to talk about this data but unfortunately, the MSL from the competition was two days before and already, critiqued it. What a bad situation, wasn’t just a wasted opportunity. So if you have this kind of opportunity to have the first mover in terms of sharing your data, capitalize on it. Make sure that everybody in your organization understands all this data that you have, you know, all your training communication laid out so that you can explain the data, all the strength, all the limitations, what it means in comparison to the competition, what they might come up with? Anticipate all these kinds of things and have this cascade completely kind of planned out and ready to go at the time of phase three publication. So we really see phase three date release. 

Jenny: For review, when you’re developing a training, who should attend? Should you target a bigger audience all at once or should you grow it over time? What is the reason maybe to pick one strategy over another? 

Alexander: I think I would probably go with some kind of combined strategy. Probably you will have something like a much bigger kind of, let’s say, Ibex, Google meet, whatever your company uses,  where everybody around the world gets to know about the data. And that probably is a very short call because you’ll have lots of people around the world that not just work on this compound but lots of compounds. Think about a person in some marketing in Italy or Greece or Spain, they may be responsible for this compound but for five others as well they don’t have the time to spend hours and hours in training on it because they have lots of other things. There you need to be short and very, very kind of to the point of communication. Then you have other people like, let’s say certain physicians or marketing people, people that work on reimbursement that are much more kind of fully dedicated, for these you can have additional kinds of meetings where you have you know more content, more in-depth, you have maybe you know Q&A and things like this. These will be people that will be in a way multipliers. These are the people then the local sales rep can go to and ask, ‘I heard this half hour presentation, I have a question’ because you will not be able to answer all these questions. Think about the ratio that I gave you earlier 1 to 1000. If 1000, so the reps will knock on your door, you’ll be quite busy. So think about how we can enable others to talk about it effectively and you know Jenny you mentioned in an earlier discussion we had it’s kind of you need to be ready to pass on the baton to others. You need to give us these keys to the statistical kingdom and let them go with it and equip them as good as possible so they can explain it to others. 

Jenny: Yeah. It’s a really important point because we need to remember as statisticians, we typically spent the majority of our time, say, 80% 90% of our time within the confines of our company accepting congress’s where we may go out and present data and so the people that are going to be interacting directly with customers the most need to have access to the most important information about the trials. And so when we say,  we’re giving you the keys, really are giving them over a lot of the rigorous control that we’ve had to date on that study to somebody else to do their job, to help make sure that people can make the decisions in the field about when and how to use these new medicines. So it’s a really interesting thing. What we should talk a little bit about you know, kind of tactics in training and what works, you know, do you do a lot of video training? Do you make slides? How do you go about making sure that people understand the methods and their implications for the data?

Alexander: So I think the first is you need to be whenever you give training, understand first about what do you want to achieve? What are your goals and they have two sides, what are your goals for yourself? What is a networking opportunity? What is the influencing opportunity? How do you want to come across? And then the second thing is, what are the goals for the audience? Then second, where’s the audience? Is that an audience like a small group of expert physicians at a global level? Or is that very heterogeneous group of people from global affiliate regions from different functions that you train maybe at a conference. Think about where they are and think about what exactly they need to know. How do you get to that? One of my key tactics is to co-create. I love it. Instead of you doing all the work, pick someone from the audience and do the training together. So maybe if you go give it to a group of global physicians, pick your favorite one and ask, whether you want to do it together. Or you give it at a conference, pick one of the MSLs that you like to work with and ask whether you do it together. That way you, while preparing it, can make sure it’s appropriate for them. And the other thing is you get so much more credibility. It’s one thing if a statistician talks it’s a completely other thing if a peer talks. 

Jenny: Absolutely. It’s also a great way to make sure that the appropriate message is getting through. If anyone can explain it, you know you’ve succeeded if only the statistician can explain something correctly, you haven’t really done a good job of training, you haven’t succeeded in passing over the keys.

Alexander:  Exactly, exactly. However, that might not always be possible. Maybe you are asked to give a presentation or training this afternoon. In these kinds of circumstances, I’m usually doing something more kind of flexible. So I would walk into the training and first capture what are all the things you would like to get to know from this training? And then I go around the room, best is to start with the most junior person in the room and then ask all the others. What would you like to get out of this training? What are your main questions? And you can write them all down on a flip chart or if it’s a virtual, on a screen and then cluster them. You’ll see what are the main topics that people want to talk about and then go from there and explain them one by one. 

Jenny: That’s a really good point in terms of appreciating the scope as if you have a thousand people, they’re not going to have a thousand different questions.  

Alexander: Exactly. And then the other thing is in terms of tactics, always follow up on things. Maybe there is an open question that you didn’t have time to answer or you don’t have data to answer or it was about something like, ‘how is that compared to this study from the competition you have never heard about’. Follow up on these things, that helps you to build credibility. That is where kind of afterwards, people say, ‘yeah, that training by Jenny was really, really great. I absolutely can recommend it’. That’s where you get all the benefits for yourself because after the training you want to be in a situation where you haven’t just trained the people, but you also have increased your influence while building trust, while showing you’re caring for the people, you’re showing that someone that can actually explain things someone that has competence and someone that has character in terms of following up on things being reliable. All of these things will help you to build trust and this hot will help you to follow up on other things. I’ve been in lots of situations where this kind of training has opened me new doors to new opportunities to maybe be invited to local key opinion leader meetings or to, you know, behind the doors discussions that we weren’t even aware of happening. Or maybe there’s a  market here in the room that says, ‘hey, he really knows all the data, let’s bring him into this meeting where we talk about one of its promotional campaigns so he can explain to us what data is best to use and what are the other things that are possible. So there’s a lot of positive things that can happen to you personally as well, not just kind of nice things for the audience. 

Jenny: Yeah. I think that’s a really important point is that this does help build your brand potentially more than just having your name on the analysis plan. Well, that this is really an opportunity to bring the data to life in a way that the people who struggle to read the analysis plans may not otherwise see and that’s really important because they will remember you. The field people tend to be on those products for a very long time. 

Alexander:Yes. 

Jenny: Whereas the medics that led the development program may move on to the next product very rapidly and so they won’t be there to say, ‘Alexander did a great job, you should bring him in again’, whereas these MSLs will remember you and ask for you by name.

Alexander: And I would say 99.5 % of the people in your audience this year will actually have never seen an analysis plan.

Jenny: Exactly. So I think it’s really important to broaden the audience of people that are aware of what has gone into being able to substantiate this evidence. Is there anything else that we haven’t covered that you wanted to highlight in terms of training for non statisticians? 

Alexander: I think the key for you as a listener is to think about, ‘what would make it possible if you do this really, really well?  What will you personally get from it? And think about all these different things, that way you will see, training is not just an addition to do, it is one of the ways, how you can massively increase your influence. And also massively increase your exposure. Imagine you have very, very senior people in these audiences. I once gave training at a European key opinion leader meeting and the president of the whole European organization of the company was in that room. That helped me to build a really, really good relationship there. He would, you know, I once was standing in the lobby of the German affiliate and he was there coming from a meeting, entering the airport. And he saw me in the lobby and he stopped, came over to me and we had a 15 minute chat. While his taxi was waiting outside. Imagine these kinds of people to talk to, they may be higher in the organizations than your  VP of statistics. They can help you to open doors that your VP of statistics can never do. So, there are a lot of opportunities in these trainings, think about them.

Jenny: Definitely. I think that was very well said. Thank you Alexander for being open to this different role in this podcast and I really hope that listeners will consider what they can do to seize the opportunity to train non-statisticians on their phase 3 data or on other data problems to help them do their jobs better. And of course to help the statistician raise their credibility. Thank you very much. 

Alexander: Thank you so much. This show was created in association with PSI. Thanks to Reine, who helps the show in the background, and thank you for listening. Reach your potential, lead great sciences, serve patients. Just be an effective statistician.