Driving Statistical Innovation – Barriers And Strategies Part 2

Transcript

Driving Statistical Innovation – Barriers And Strategies

PART 2

Alexander: Okay. So talking about all the barriers is maybe pretty frustrating. So let’s turn into some things that is a little bit more motivating and maybe, looking on the bright side what are strategies you, that you have seen being successful that, lead inventions to become innovations through successful commercialization?

[00:22:02] Kaspar: So maybe I can start, and one thing that also relates to what you just discussed, Alexander, is people see the risk and the price of changing something. We need to make clear to them, there is also a risk and the price of not changing something and that we need to emphasize just because something has worked for the last 10 years doesn’t mean it will continue to work for the next 10 years.

So make that transparent. And the, I dare say we sufficient that successfully commercialized a few things at Roche. And I can just draw on these experiences. I think what helped a lot is that early on, even if it’s maybe yet not fully clear, how things will evolve. So think about estimands. We have other examples at Roche, for example using open source software to plan clinical trial designs. So we, at Roche, we don’t have any commercial software to plan clinical trial designs. We exclusively rely on open source software.

So when I when I can, or when I should mention an example for estimands, for example, we started to collect examples where teams tried to implement that even before the draft addendum was issued, I believe, or just after that, where we all knew this is not perfect yet.

But we just collected all these examples and learned as an organization and it did, this is not the last call yet, but then you successfully or you continuously build on what you already have. So this is one thing, involve the organization early on. Share that even as the methods group, you don’t have the perfect solution yet. But we learn together. We are curious how things may be evolve. So that’s one thing.

So when we talk about replacing commercial software with open source software, you then use some r packages. You write markdown files, for the statisticians because they are under pressure in their projects. As you mentioned before. They’re overwhelmed.

Make sure the resources are available. Train people and admit that you don’t have the perfect solution yet. Case studies are very important. Of course, once you have a successful estimands implementation where a health authority was quite excited about what you proposed, make sure you share that.

And not just within the statistics function, but also with partner functions.

And there is a gap I perceive. And now with this advent of statistical engineering, that gap is closing where we have people who have a, an understanding of the statistical method, but they also have maybe a dedicated training in software development, in how you do things. And at Roche, we heavily invest in that and we see great benefits from that so that once you publish the invention, you already have high quality even validated software that goes with it.

So people, when they read the paper, they don’t need to wonder, how can I implement this? They can just go to GitHub, go to to try and have high quality software already available. What I experience can be useful is try to leverage external, ideally regulatory positions.

If regulators are excited about something and if they for your estimands, for example, there are papers out there from regulators where they talk positively about it. So make sure you spread that within the organization. Make sure that when people push back and say is FDA on board with this?

You have something ready that you can say yes they are, and here’s a paper where they publicly mentioned that, or or make sure you collect these quotes in webinars, at conferences where they talk about something enthusiastically. Because very often I dunno what the right kind of translation or literal translation is to English, but in German, we have to say the prophet in his own land doesn’t count anything.

Sometimes this is really what you experience. But then try to bring in external voices that leverage what you are saying. Anyway. Yeah. So these are some ways that have turned out to be successful in overcoming some of these hurdle.

[00:26:00] Alexander: Awesome. That is nearly exactly the playbook according to John Kota or part large parts of it. And I think. We talked about the book, our Iceberg is Melting which I can highly recommend great book about change management and also very entertaining and it only takes you 90 minutes to read it. Mouna, what are your experience from the Novartis side?

[00:26:25] Mouna: I think the aspects that Kaspar has casa, are pretty comprehensive and I would agree to all of them. I think we have similar experiences at Novartis. I would say maybe one thing to elaborate a bit on further, are maybe two aspects which would complement maybe what Kasper said. So the first one point, which I find critically important to create uptake for any innovative solution is to be crystal clear about which.

Which problem you are trying to solve. And I think that’s sometimes a bit lost in some of our discussion. So I experienced that a bit with estimands where admittedly, I think, yes, it is a success story overall. I think many of us, including myself and Kasper, have worked on this from day one. So we have our own experiences, in that field.

But at the same time, admittedly, I have to say that it is still I’m still facing, let’s say, situations where I’m talking to maybe clinical colleagues, non-statistical, but me, even statistical colleagues where you sense like a certain fatigue around the topic. And so what type of mentality where you think So what type of problems are we solving?

It’s, we are still doing exactly what we did before, right? So I think having a pitch ready, and maybe I had one person once saying that it’s very powerful to use metaphors in that context. I, and I would fully agree, right?

So for example, with estimands towards the beginning, I once had to give a presentation at an internal conference. So I tried to draw it in terms of a fairytale. So let me tell you a story and try to get people out of the box where they were sitting in and take them somewhere else to then actually give the pitch that you want to get, right?

Yeah. And I think having some strategies like that is sometimes helpful. Try to get them somewhere else in their mind so that they are not Stuck maybe in their way of thinking and then you can, maybe they are more open to maybe accept new ideas. I guess that’s one thing.

And Kaspar has alluded to that a bit. And I’ve made that experience around recurrent event data approaches for cardiovascular studies where very early on we started collaborating with other industry statistics, but also other academics and so on to try and push.

The change of the traditional endpoint. So the traditional endpoint in cardiovascular heart failure studies used to be a time to first composite event, which is not the most efficient way to capture the disease burden for patients who suffer from chronic heart failure. It’s a chronic disease. And so it was really a long sort of journey over, over years where we tried to yeah, collaborate with academics, but also regulators to see what are alternative approaches.

And that involved joint publications, joint short courses at conferences, the qualification opinion to the EMA so it’s like a multifaceted cross stakeholder collaboration that, in my opinion, is needed to drive uptake than also internally at our conferences. And then maybe the final point, of course, when you find partners in prime, you sometimes tend to choose people that think alike.

But when you really want to create uptake, so we need to have diverse opinion, but then not only to bring them into the team, but also to include them in the team. I sometimes feel we focus more on diversity than inclusion, but I think, yeah, so for these teams to drive uptake of innovation, it would be important to have diversity, but then also to really be inclusive of critical voices early on.

[00:30:20] Alexander: Awesome. Yeah, I think one kind of themes that goes through all these different things is communication. Yeah. Communication again and again. It’s communication about driving awareness, making it easy. Creating case studies the internal web portal using all kind of different channels for the communication.

Communicating within your organization, communicating outside organization, it’s an endless stream of communication. And very often people completely underestimate how much time and effort that takes. Yeah. I’ve seen it again and again where people say what, we talked about this 5, 6, 7 times already. Yeah. These are big organizations. Yeah. To get everybody to understand, have at least heard once about it. Yeah. You need to have lots of communication. Yeah. Think about, yeah, go ahead.

[00:31:23] Kaspar: Yeah, sorry. So yeah, it’s a marathon and yeah you might need to give the same talk 10 or 20 times and two different audiences, keep updating it.

Yeah that generates some frustration because we are, by nature I mean we are ,curious and we are impatient. And over time you learn that. Yeah, as I say, or I keep saying, it’s a marathon and you need to hang in there and try again and again. And if you have a few success stories in the past, that gives you the confidence that if you just hang in there, that you will change things at some point. But yeah it’s tough.

[00:31:55] Alexander: That brings us to the next point. There’s one skillset that you need to come up with great inventions. There’s another skillset and maybe a different kind of, Type of people that don’t gets frustrated so easily with doing the same talk again and again.

That is needed focus, the commercialization part. If you think about these two types of skillsets, what do you think about the skillsets that is needed to drive commercialization?

[00:32:27] Mouna: We talked about communication, right? I think that’s that’s the key part. Of course. I think it also takes someone who is not shy to reach out and network with people, right? So I think it needs people who appreciate the value of networking and outreach. It needs people who are.

Who are open to using new ways of communication, like social media that use internal other firms that are not shy. To not shy, not intimidated by senior folks, let’s say or other functions. What else does it need?

[00:33:05] Kaspar: Yeah, to reiterate that I think you need to be maybe a bit more proactive compared to the invention piece. You need to go out there. And, for invention, I think collaboration often primarily happens among statisticians. Maybe statisticians in other companies, with regulators, with academics. This is your breed. This is, these are the folks you know, and these are the folks who think alike.

Maybe often. I think for the commercialization piece, collaboration is needed. Outside of your kind of your community if you want. And these are people who think differently, who have different backgrounds, who you need to talk to differently. And I experience that sometimes for statisticians that is a little bit out of our comfort zone. But I think this is absolutely needed if you want to successfully commercialize.

[00:33:52] Mouna: May I just jump in there for question?

[00:33:53] Kaspar: Yeah, sure.

[00:33:53] Mouna: Because I think for the invention piece already, I think you need these other functions also if you want to make it customer centric, let’s say. So I think that’s at least from my experience, that’s a bit the danger, right?

That the invention piece is created only within, let’s say, the area of our area of expertise, let’s say quantitative scientists, people that we have the same terminology and the same language, and we talk about it and we start the invention, and then we think about the commercialization. But then, There’s already a challenge there to, to have that bridge, right? If we were to include these other functions and the customers, let’s say, and if the customers are regulators, clinicians, I don’t know. I think they should be in there early on.

[00:34:39] Kaspar: Fair enough. And also we, we have the ambition to invent things that help drug development and to get that inspiration, it, the interaction with other functions already during the invention piece is crucial.

I agree to, with respect to that. Maybe a few more things. And we discussed this before, so this persistence thing I think is very important for commercialization. This is also important for invention, but I think it remains very important.

Because for an invention, some, it’s much easier to say when it’s done. You’ve written the paper, you’ve developed the method, you have shown it’s better than what we do today. The commercialization piece, like we now experience with Estimands might be an endless story. This, that, this is fully embraced by the general enterprise of drug development may take another 10 years or so.

For safety. This is the same. I keep saying if we change something here until I retire, then I’m more than happy and I still have a few years to go. I think this persistence piece is very important. Some, one thing that I feel is underappreciated and but helps a lot is what I would call some degree of teamwork.

Because if you invent something, your name’s on the paper. If you start commercializing something, then you bring it to other functions. They may walk away and be their own advocates. And your name is not there anymore. And you need to be absolutely fine and happy with this. And this is very helpful in my opinion.

And yeah, sometimes I think organizations should incentivize this more. It’s the, maybe you generate some impact and your name is not directly tied to it anymore. But then you have your end of year appraisal and people ask, oh, where is your impact? I think we need to have a comprehensive view on that.

Yeah. And that helps commercialization a lot. And for me, this, for example, a good example for that is open source software. And this has really picked up over the last few years that in pharma industry, we are even, our whole reporting pipeline is now built in our, and our priority.

This is all open source. So that you generate an ecosystem. Of companies with regulators that then help develop this further and to have this mindset not oh, I invented this. I sit on this, I keep it within my own company. At some point I even want to make money with it. This is not our core business.

Our core business is developing molecules. Everything else are tools. And I am very supportive of sharing, of making things open source that goes hand in hand with collaboration. So this I think, is also crucial mindset piece that helps to be a good commercializer if you want.

[00:37:20] Mouna: And I think that’s a very important point. Also, the last example, right? Because I think by doing so, you are increasing the acceptability of those approaches implemented in that software, right? Because the more people, the easier you make it for them to be used, the more people will use it. The more people will include it in their submissions, let’s say.

The regulators will need to wrap their head around those things. So I think it also serves, let’s say, your own purposes, right? Your driving advocacy for something externally.

[00:37:52] Alexander: Yeah. This’s. Maybe one thing that I would like to add. So when we think about communication, we often think about, doing a presentation, sending emails, putting things on the web portal, putting something on social media, and that is one part of it where, it’s one to many communication.

I think another aspect that is really important are these more one-to-one situations. One to few situations where it’s not so much about, presentation and things like this. It’s really negotiation. Yeah. You negotiate with the other people and convince them to, to adopt the new part.

And I think the negotiation skills are something that we are typically not very trained on. Yeah. It even goes into sales activity. Yeah. Of course. He has no kind of, usually no financial transaction involved. So it’s not really sales. Yeah. Because you don’t ask, to be paid or something like this.

But the negotiation aspect is very similar to what happens in, in a good sales process. And I’m not talking about kind of the, It’s a bad kind of view on sales that, these are the people that you go to, they sell you something and afterwards you feel bad about it. No, it’s the negotiation convincing and the influencing that the other person really sees the value in it and wants to adopt it, wants to share about it, and you really build an ally and there’s one piece, see communications as is, at a conference, it’s to get another piece where you have these negotiation topics.

[00:39:48] Mouna: Yeah, no, I would agree influencing and I guess I wouldn’t, or I didn’t in the past use the word negotiation. I would use influencing. So it would be interesting. To think whether there’s a key difference. But I think, of course, like both Kaspar as well as I, we work in groups that are also involved in consultations on our drug development projects.

And of course, that’s a key aspect of it, right? So it is about consulting. So first of all, of course listening, understanding the problem, and then trying to support and help. And that often then also requires influencing the team into a certain direction. I think it’s important to then, still, always keep in mind that, the complex or innovative solution is not always the better one, let’s say, right?

So sometimes being. Pragmatic and yeah, finding a compromise is useful. And, but I guess that’s also underlying paradigms of negotiation discussions.

[00:40:48] Kaspar: Yeah. And I like what you mentioned both. I like this kind of convincing, influencing, inspiring piece. A lot. And Alexander, I think we need to be careful in order not to sell too much. Because if you try to sell something, people can decide not to buy it. And I think we, yeah, we, it’s more it really, and you mentioned that it works through one-to-one conversations or maybe also targeting small groups. Try to influence them, convince them, and even inspire them that if they use this new thing their project will look better, they will make better decisions. All these kind of things. Yeah.

[00:41:25] Mouna: Yeah. And I think sometimes it takes small steps, right? So one strategy that we found useful is you may not want to shoot for the main analysis, let’s say in a, yeah. In a project with something new, right?

And so you start building up experience. People get more confident. They, you keep communicating around it. So it takes time. It takes small steps. Sometimes it takes resilience. I think some of these points we have already discussed. But yeah, so I think influencing advocacy and so on are very important.

And interestingly, I think these skills are needed within our groups, right? So when we look for new candidates, we certainly look at, of course, being very strong with theologically, but we also of course then look at being interested in the drug development problems. Having a certain healthy level of pragmatism, being good at communicating, but also having influencing skills, right? Yeah. That, so it’s a whole package, let’s say.

[00:42:24] Kaspar: And and maybe I can add to that one piece that is, that appears important to me or is dear to my heart. So far we have discussed what do individuals need to bring. But for me, there is also the question, and here I’m talking to management folks who built these organizations.

How can you build an organization that is innovative? So that kind of has the invention and commercialization piece.

Another thing I find very important is if you have statisticians who are very efficient, who have their projects in order, don’t just give them more of the same. Leave them alone for a while and give them the freedom to be inventive and to be innovative at the end when they can also commercialize things.

Because I think there is a risk. And at some point, this is also a question of fairness, because if you are efficient in your work why should you get more of the same and then do more stuff than other people?

At some point, I think make sure you keep the freedom, a certain portion of freedom for people.

[00:43:28] Alexander: Yeah. Yeah.

[00:43:29] Kaspar: In your work. So I think this is something that’s really good to hard. And then I see this at the risk of often not being done. I think very often people tend to ask immediately if you try to inspire them and say, oh, here is a topic, maybe that it will be big in the future, maybe not, we don’t know yet. Then you often get the question back, so what’s in it for me? We don’t know yet. This is because it’s new. And when I started to look into estimands, a lot of people said this is nothing.

This will not go anywhere. And I looked into many topics that didn’t went anywhere. I keep saying people have no clue how many unfinished papers I have on my hard drive. You need to have this mindset of curiosity because if this doesn’t explode, at least you have learned something.

At least you have maybe built some connections with people and then maybe three years later that pays off as well. And then also across companies with academics, regulators because. Yeah, our former CEO kept saying, 99.9% of innovation is happening outside of Roche. And of course that’s true. And that really speaks to the necessity of collaboration.

[00:44:34] Alexander: Awesome. Very good. And that leads us very nicely to the last point of our discussion, which is a really great initiative that you and others kicked off to make sure that across the industry we become better in terms of driving inventions to become innovations.

Let’s talk a little bit about the new groups that you’re forming. Wants to start speaking about this?

[00:45:06] Mouna: So maybe I take a start. So thanks very much Alexander, for giving us opportunity to share some of these news. Yeah, so last year some of us got together and had similar discussions around statistical innovation. What does it take, what are the challenges, but also the opportunities that that you are facing. And in those discussions, I think all of us benefited a lot from that. And we thought, how about creating a community of statistical methodology leaders in drug development so that we can have those discussions a bit broader than maybe just the three, let’s say, companies that were at the table at the time.

So I think some of us are talking to each other and co collaborating already. A lot of that is happening on a very opportunistic sort of in a very opportunistic matter. So we mean in meet the conferences, some of us are based Basel. But I think there is a lot to learn and a lot of exchange with other statistical methodology leaders.

And by leaders we don’t mean those that are leading that certain team, but we talk about individuals that are driving methodology strategy within their respective organizations or companies. So we pitched this idea to create such a community and such a group to the EFSPI a couple of months ago. They were very supportive and the idea is now to kick this off relatively soon. We think there will be communication in the next EFSPI by newsletter as far as we are informed. And yeah, we are looking forward to then exchange and meet with these methodology leaders. And we hope to follow up maybe been some of the discussions that we shared here today, but also we hope to build synergies. So I think one thing that we have realized is many of us are working on similar things, right? Not surprisingly, many of us, for example, are developing certain internal trainings on certain topics such as causal inference.

And this backs the question, is it really necessary that all of us do our own thing? Or could we collaborate on a few of these things? Then also could we give some of these trainings externally at conferences and so on. And I think that’s just one small example of where we could build synergies and collaborate further.

Kasper. Anything to add?

[00:47:26] Kaspar: Yeah we work on similar things and I think we also realized we struggle with the same things. Sure. So we can share experiences and best practices. And I think what is important from our perspective, and I think also what is very very much supported by EFSPI is, I mean we Mouna, I, myself we work for Novartis and Roche.

And then with that also helping uptake, for example, by regulators and the community. So I think this is also an an important piece. Another important piece is to discuss. We do this routinely at conferences, but as Mouna said, this is very opportunistic and we can maybe do it in more structured way.

What are future trends? What do we need to watch out for? Where is the statistics profession maybe going or where should we, what should we take care of in the future? We hope this group will form a forum where all these things can be discussed.

[00:48:13] Alexander: That’s very good. How is that different to the EFSPI Leaders Group?

[00:48:20] Kaspar: So our understanding is the EFSPI leaders they look into how to build a successful organization, how to maintain that, how to develop the statistician or data scientist profile further and share experiences with in that respect. For us, it’s more about real we call this the statistical methodology leader, so it’s more like methodology.

We typically sit in our organizations and drive the methodology forward. We are maybe not, so I don’t supervise anyone. I have enough difficulty supervising myself, so I’m really interested in driving the methodological part of it. And we also envisage that we can support the EFSPI6, for example.

So there’s a lot of invention and innovation is happening in the six, and that there is absolutely no ambition to interfere with that. But maybe we can connect one or the other, stick with each other or connect them to academic partners that we are very well connected to. Maybe connect them to regulatory partners where we have a lot of connections and and serve as a catalyst or as a link. For the six as well. That’s also a role that we envisage for this group. So it’s really like complimenting this statistics leaders forum that already exists with EFSPI.

[00:49:37] Alexander: I like this term of being a catalyst. Yeah, that’s exactly what came to my mind when I heard about your group. It compliments the six that are very, a lot of invention is happening there and they are focused on the specific topic or benefit risk or data visualization or estimands or whatsoever.

And your group is different because it focuses on people that are methodically savvy and Don’t necessarily have, line reportings. Whereas I think in the EFSPI leaders group it’s much more the vp, the directors, these kind of roles which is a lot more associated with people management and organization set up.

So I think it’s very nicely complement. These other organizations. How many people do you envision to be in this group?

[00:50:36] Mouna: Good question. We are foreseeing that several people will be interested in joining us and we are welcoming yeah. Anyone who considers him or herself as a statistical methodology leader to join us. And at the same time, I think one thing that we were very clear about when we went to the EFSPI Council is that we want a committed team, right? So a team that really will dedicate a certain amount of time to help, let’s say to help us with our objectives, so I think our expectation is that several people in industry will be interested in joining. We are also open for people in academia to join, right? So very inclusive let’s say. At the same time, all of us have experience, of course, in working in work streams and in initiatives.

And we also believe that it’s important to have an agile and not huge team, let’s say. So one very important aspect is that we want a committed team. We want only one individual per company. So if several people within a company are interested, then ideally they should nominate one of those and connect internally as needed.

We will certainly create a platform to share the outcome of our discussions more broadly.

[00:51:59] Kaspar: The first thing I’d like to mention is it’s not just Mouna myself who started this.

So go Kunz from Bohrer Ingelheim is also involved, and he also were supported by Frank Fleischer and Alun Bedding from Boehringer and Roche respectively in putting this together and we envisaged that hopefully people in many companies will be interested. However, there is a trade off between having lots of people and remain functional.

I’ve been involved in cross-industry working groups quite a few times in the past, and I have seen that striking this trade off is not so easy. So we envisaged that. Per company, we have one member. So if you ask how many members do we expect it’ll be likely very proportional to the number of companies who are interested.

But then we also envisage that we can build like subgroups who take care of certain aspects. And, but we, our main focus and a good outcome is if we can keep this functional. So it should not just be a chatty forum where we meet every two months for a two hour tc and then nothing comes out of it.

We really want to move things. Let’s see. That’s the ambition. Let’s keep fingers crossed that we are able to to meet that long term.

[00:53:11] Alexander: Awesome. I think such an initiative is very much needed and I wish you all success with moving forward. And I’m pretty sure this will not be the last time. We talk about this initiative here on the podcast, and probably next year when things are up and running, we can, talk about it again. That was a lot of discussion about change and driving innovations forward. Mouna, Kaspar, if you wanna give one thing home to the listener, what would that be?

[00:53:51] Mouna: Guess I would start with saying that innovation requires invention as well as commercialization, and that we shouldn’t underestimate the importance and value of commercialization even for the methodologically minded of us.

[00:54:07] Kaspar: And I would add to that, be curious. Don’t always ask what’s in it for me. Read that paper. Maybe it’s not useful immediately, but maybe it’ll be useful three years later. Talk to that stakeholder in another function, in another company. And and just be curious to hear and maybe they have something for you that leads to an invention where you can ultimately help improve. Be curious.

[00:54:31] Alexander: Thanks so much. See you again.

[00:54:33] Mouna: Thank you very much. Bye.

[00:54:34] Kaspar: Thanks, Alexander.