Interview with Jenny Devenport
What is medical affairs? Launch and Lifecycle?
How has this area evolved over the last 2 decades?
What is the current state across the industry in terms of the role of statistics in this space?
This is a series of episodes and today’s content is the first episode. Join Jenny and I while we dive into her career and discuss important points about the following:
- What is Launch and Lifecycle
- How as it evolved in the last 2 decades with respect to
- Phase IV studies
- Observational studies
- Global vs local positions
- What is the relationship between HTA vs non-HTA areas and collaboration with stakeholders
- Collaboration with the regulatory side
- Involvement in strategic evidence generation
- Number of statisticians/programmers supporting this area
- Organization within or outside of statistics departments
- Outsourcing approaches (strategic parts, RWE and outcomes research, studies, NMA/health economics)
Listen to this episode and share this with your friends and colleagues!
Director, Biostatistics at Roche
Agile, results-driven, Biostatistics and Health Outcomes Leader with extensive experience in building/ developing teams, encouraging effective cross-functional collaboration, and championing scientific curiosity to improve patient care through rigorous analysis and effective communication. Adept in devising and delivering change management strategies and organizational training to maintain employee motivation and focus in an evolving marketplace. Proficient at articulating and measuring strategic impact of evidence generation and communication initiatives.
Alexander: You’re listening to The Effective Statistician podcasts, a weekly podcast with Alexander Schacht, Benjamin Piske and Sam Gardner, designed to help you reach your potential, lead great sciences and serve patients without becoming overwhelmed by work. Today, I’m talking with Jenny about what is the current state of launch and lifecycle and how will it evolve?
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. And we also have a special interest group within this community that is exactly about the topic of the episode today.
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. And of course, you’ll also get much more things around the business understanding and stuff like that through PSI. So head over to psiweb.org and become a PSI member today.
Welcome to another episode of The Effective Statistician. And this one is a special one because it will be the first one in this series of episodes that we are recording. And this one, I’m welcoming Jenny. Hi Jenny. How are you doing?
Jenny: I am great. Glad to be here. Thank you very much for having me.
Alexander: Okay, for this first one, let’s dive a little bit into your career a little bit and maybe that can be also a little bit tied to the topic actually today because the topic for today is really kind of what is the current state of medical affairs? And how has it evolved from, you know, over the last two decades. But let’s go into kind of your experiences first. How did you come into this area?
Jenny: So, I have to even take a step back and say, how did I even get into statistics? And the story is interesting. So when I was a student, what I learned was that I love solving problems and yet I was still a little bit unsure of how I would do in statistics. So I took graduate statistics as an undergrad, and it went fine. And so my advisor really pushed me to go into statistics and when I graduated, I had wanted to go into Pharma. I always knew I wanted to solve practical problems, but the Pharma company I wanted to join wasn’t hiring new graduates. So I got into public health as an analyst and I thought, well, you know, this is okay. I will solve problems that matter in the domain of Public Health and this will have an impact on the system and that was fantastic. And I learned a lot about programming and I’m not learned a lot about decision making, you know, within healthcare management. And then finally I had enough experience to get hired on with that first Pharma company as a clinical development statistician and I thought, this is great too. So now I will get to join a team to solve bigger problems. I did that for a long time and I was involved in a number of device and drug approvals. But then another company came calling and said, we’re starting a medical affairs organization. And your background seems to be really different. And this was, you know, the first time that I had heard that, that background, that different background would be appreciated and I thought, huh? Okay, well this fits in with my plan too, I’ll work more strategically to help teams make a difference. So I joined a medical affairs organization in the US. And worked my way up into management, got to solve a number of problems that really helped shape the healthcare ecosystem. So I’m not just, you know, answering questions about the product but really answering questions about the disease area and the domain and the way that care is delivered. And that was great fun. And then I came to Global Medical Affairs and really got an appreciation for the differences between the US and the Global Healthcare systems. And, you know, the similarities and the differences in the types of problems that they have to solve in order to provide really good care for their patients. So that’s a little bit of my career journey.
Alexander: Yeah, that’s good and it’s really great that you have these insights from the US, you have the insights from a global perspective because I’ve never worked in the US, you know, specifically on the kind of so to say local level in the US. But I’ve worked in all the countries outside of the US and of course, kind of, when you look from a global perspective, you know, there’s in the end, there is no, you know, global sales there’s always local sales. And kind of the global means you need to make sure that you support all the different markets around the world and appreciate their variability and you need to take that into account. Okay, let’s dive into a little bit of the topic today. And that is how we got to where we are now? We both started in medical affairs quite some time ago. And when I first kind of stepped into this area, I changed from a global clinical trials statistician into a local medical affairs statistician. And some people said, this is kind of a demotion or something kind of a very very unusual thing to do, but I really wanted to have much more freedom of what I could do. And the landscape at that time was kind of two decades ago in the early 2000’s and in hindsight I knew that this was the same for lots of other companies for that all the different affiliates around the world were running lots of lots of affiliate studies. Yeah. So you would see big companies that come with a new product and during the launch of the product, you know, Germany will run some studies, UK will run some studies, the US will run some studies. Everybody will, you know, run some studies that, you know, they fund locally, run locally and they’ll report locally. And very often kind of these studies you know, the global headquarter would say, okay here’s some kind of rough guidelines. Yeah. What you need to take care of everything else, just do it. What was your perception at the time?
Jenny: Yes, I would say it was very similar. I think, you know, when you first enter medical affairs and you look at it from a purely, rigid development statisticians point of view. You think, why do you even need all of these studies and what’s going on in those local markets and in those local healthcare ecosystems that are demanding different evidence than you know, what’s been provided in our beautiful label. And then of course as soon as you start talking to people that are a part of that ecosystem, whether it’s the country manager or whether it’s the business managers or physicians or patient groups, you learn that, you know, there does need to be this bridge between development and clinical practice, that there’s additional evidence, that is needed locally and appropriate communication. And so then as you dig deeper and learn more about what exactly is needed, you realize that by addressing some of these local needs and taking a more holistic view of health outcomes and their impact on patients and society, you can have a bigger impact on that. And so it’s again a little bit beyond the product and thinking more about the outcome that you want to achieve.
Alexander: Yeah. But there’s also some other aspects in terms of studies that were important from a commercial perspective. Yeah, so getting evidence is one thing. Yeah and but running studies has a couple of other aspects as well that is important for phase 4 studies, but it’s also important for phase 3 studies. These are also tools to engage with your target audience. Yeah, so lots of the physicians that are investigators in studies get experience with the product. They get experience with your company and building these relationships is really really important. And then that’s another aspect here. Yeah, that if all physicians have, you know, seen firsthand, how your treatment works, what kind of side effects occur, how is it were able to cope with these kind of things that gives them much more kind of trust in prescribing this treatment later on because, well, they have already some experience in it and very often in some kind of safe environment. Yeah. Where there’s a protocol, they get a lot of guidance, there’s a lot of support from the companies in terms of, you know, whenever anything is happening, let’s say an adverse event is happening, you know, they have someone to talk to, yeah, to manage these things. And so that gives them a lot of, yeah, experience.
Jenny: Absolutely. I think the other important aspect of that is that it goes both ways, right?
Jenny: Is that, you know, we’re very used to running studies and running things according to a particular protocol and being, you know, again, rigorously trained scientists who think very carefully about those protocols. And sometimes there’s a gap between what is written in the protocol, and what is usually done in clinical practice. And so learning to listen to these investigators and partner with them, and make sure that we’re answering the right questions, and working within a system that is implementable later on is really important then. So I think this is one of the aspects of medical affairs that is unique is that, you know, we think a little bit differently about what the patient population that is potentially exposed could be and whether or not we need to study, whether it was adequately studied in the development program, and whether we need to consider looking at that a little bit more closely again, based on this position feedback, again based on the realities of the local treatment environment. What other questions do we need to address?
Alexander: Yeah, and there’s lots of different questions I was at the time working, quite a lot in deep psychiatry space. And if you go back to the time you will see there were blockbusters at the time where entity presence, entity narcotics, yeah and I was exactly working in these spaces at the time. And many of the usual studies would be short-term studies. Yeah, like eight weeks or something like this. But, of course, these patients are not treated for only eight weeks, of schizophrenia for life. Yeah, so they get treatment over years and it was really, really important to understand what happens over a longer period of time.
Alexander: And the other thing is in a real life setting you wouldn’t have the luxury of capturing all these extensive, you know, questionnaires where you need to have, you know, highly skilled physicians with specific training to even write these questionnaires. And of course you need to have a much closer look into this or more vulnerable subgroups. Yeah, so we have published quite extensively about substance abuse in schizophrenia. All these are patients that usually are not included in phase 3 studies. Yeah, because they’re much harder to manage. And one interesting thing in observational study actually at the time was we had three outcomes or three baseline characteristics. No substance abuse, substance abuse and not reported. Guess which one was the most difficult one? The not reported. And yeah, these kinds of areas have an impact and you need to understand them.
Jenny: Absolutely. And if a treatment in that environment is going to have an impact, not just on that patient, but on the system as a whole, you need to crack that code. I think another interesting point in that area, that I wonder if you could speak about, is the realities of dosing. In our clinical trials, you know, we’ll go forward with particular doses and with a particular regimen and it’s very compliant within the context of those pivotal studies.
Alexander: Yeah. In real life, it looks completely different. I was working on one study where kind of, you know, on the global level people wanted to say let’s make it really easy. Yeah, instead of having all this up titration. Yeah, just directly start with the target dose. Yeah. And yes, it will have a little bit more side effects, but we don’t care, we make it much easier for Physicians if we start directly with the target dose. But that was not really listening well to the actual physicians. They, you are used to titrating these types of medications. It was not really a hurdle for them. And they did the same who use your drug. Because they knew they would have more side effects. And they rather titrate and have an effect a little bit later. Tell the patient, but don’t have the side effects. Yeah, rather than making it perceived easier for them to directly start with the protos. And these kinds of things are really valuable to know.
Jenny: Yes, and so, I would say that, you know, while that two-way communication occurs in all phases of research, it is really essential when you’re thinking of launching a drug. To remember that, you know, you’re going to have to launch a drug under less restrictive conditions than you did in your pivotal settings. And so you need to understand all of the constraints and limitations and potential pitfalls and that circumstance so that you can get the best outcome for patients and that means some study.
Alexander: Yeah. Another example about those things is in ED actually. And there was an observational study that looked into this and there were two different doses. And when they compared the doses, interestingly, the lower dose was more effective than the higher dose.
But of course, the higher dose had more older patients, had more comorbid patients, and had more heavyweight patients. Had lots of other kinds of prognostic factors, bad prognostic factors. Yeah, and so it was really interesting to learn that Physicians were able to tailor at the right dose to the right patients. Yeah, and it was really kind of when a physician first reported about this, she said, I don’t know really why we don’t see this stuff responses that we always see in clinical studies and you know, that digging into this, helped much better understand how the drug is actually used. And that helped to send feedback to the Physicians, who were treating the patients, who were taking it. They actually pay for it as well, you know, when they need to, you know, use a high dose and when to use a low dose. And these kinds of things are really, really valuable to understand. However, there’s also a little bit of a dark side there as well. Because, you know, with this experience and these kinds of things. There’s also this seeding studies. Yeah, where studies are predominantly done, not for generating evidence, but for generating sales. Yeah, and there have been a couple of, you know, really really bad examples where companies would you know recruit tens of thousands, sometimes more than 100,000 patients. Yeah, in observational studies and only on their compound. And then have very minimal documentation. But based on the documentation would be able to pay the physician for it. Yeah. And that’s kind of a really dark chapter of observational research. There’s a lot of bad press about this, of course, and lots of different Pharma companies were accusing us of these practices. Specifically also because these studies usually didn’t even end up in any publications or anything like this. So it’s also let’s say the dark side that we surely need to mention. And that is something that the industry I think has evolved from. But here and there these kinds of studies pop up again and again, interestingly still.
Jenny: Yeah. When I think it’s really important that it takes a lot of time and energy and money to run a clinical trial. Even a prospective observational study is still going to cost a lot of money. You should try to answer a question right? And you should try to answer a question of because when you think of the broader ecosystem, they’re waiting for more information to base guideline decisions on, to base individual patient treatment decisions on and so, you know, we should be really mindful of how we’re spending our research efforts to ensure that we’re contributing positively to those decisions.
Alexander: Yeah. Well these you know, the financial side of that, sometimes kind of that we spend, you know, for each dollar we spend investing here we get $3 back in terms of sales. And yeah, these kinds of calculations, of course, sometimes make you do the wrong things. Yeah, but I think there’s a lot of companies that have put restrictions in place. Yeah, there’s also, between companies, a kind of code of conduct. There’s lots of local regulations in different markets that make it much harder to do these things. Not that federally, making it impossible, because there’s always, you know, it’s not that black and white usually yeah. What does it mean that you have done it predominantly for financial reasons? Yeah. What you know, evidence is relevant. All these things are, of course, very subjective. Yeah.
Alexander: Whole scientific is this the question that you are answering in this study.
But of course, it has a certain kind of practice that directly questions it. So I had one study that recruited a kind of don’t know 100,000 patients and they actually entered only 20% into the database, then you can think, that’s a pretty clear signal that this was not done for scientific purpose. But I just wanted to save money by running the study. Yeah. Because at that time, of course, everything was paper-based.
Jenny: So to the comments I wanted to pick up on. So, you know, on the bright side of observational studies and real-world data, you know, I think it really is important to understand how a product is being used and understand how other products are being used in the real world and sometimes you know, the existing data sources, you know, the obvious ones like claims data don’t have the same end points. If you’re really interested in learning about, to understand patient benefit, you know, they do have some financial information that’s relevant to the healthcare ecosystem, but not necessarily a lot about patient benefits. So going ahead and collecting those additional data points can help, you know, kind of inform that cost benefit ratio analysis, I think the other and that’s a big one.
Alexander: Yeah. I think it’s really important to understand how your patients are treated and who is treated within the patient segment? Yeah, because it could be that and it’s very often that, you know, when you enter a new area. First, a specific part of the population is treated, maybe those with more severe diseases. Yeah, or maybe those in the second, third line of treatment because Physicians say, okay this is a new drug, I don’t know so much about it. So I use it when I don’t have another choice. Yeah, also the patients as physicians actually using it first, a different Physician. These some more the early adopters, the more kind of risk taking physicians, may be physicians that have participated in your clinical trials. So maybe more academic centers, all these things play a role there and understanding that will help you to also understand kind of first, maybe first, safety signals coming in. Yeah, safety is another kind of thing that you can’t really answer, usually with claims data. Yeah. And if there are specific things that you really would like to monitor that are not that severe like, you know, things leading to hospitalization or things like that, but maybe just a nasty side effect that is nasty enough to be disturbing but not, you know, severe enough to be a public health issue. Yeah. I don’t know about pitching or a little bit of diarrhea, or these kinds of things. Yeah. Or some pain from your injection site reaction. Yeah, these things might be actually quite good to know but you don’t find some in claims data bases.
Jenny: Absolutely. I think the other point that we all went to school on during the pandemic was what data do you absolutely have to collect? You know, when all of these observational and clinical trials were being conducted during the pandemic, we heard all about an exhausted frontline healthcare worker situation. And the reality is that charting does not occur in real time nor does entering CRF data. And so, you better be very pragmatic about what needs to be collected. Understanding that not every single question is going to be answered by every single study. But what can we really collect that would be a value. That a physician is going to fill out in their last 30 minutes in the locker room.
Alexander: Exactly. Exactly. Yeah. How observational studies are run is very different to how our clinical trials are run in many, many different aspects, you know, it kind of, it starts with how you do data monitoring, it starts with which Physicians actually take part? Yeah, you may have, you know, many Physicians that will take part in an observational study that will never be eligible for clinical trials. Because it’s as if they don’t have the patient’s throughput, you know, because I can’t reach any recruitment targets, or maybe they don’t have, you know, the infrastructure with maybe a study nurse and things like this, or maybe they have, you know, certain training they don’t have. Yeah, I treat CPA and what have you said and they just don’t want to do it. Yeah, and so but still these, you know, maybe these are the Physicians that predominantly will prescribe your medication. So it’s really important to you know, learn from these parts as well.
Jenny: Absolutely. Absolutely.
Alexander: There’s another area that when I look back over the last 20 years, has dramatically changed and that is anything to do with reimbursement the healthcare systems and HTA. When I first entered space, there was hardly any HTA body in place around the world. There were some, you know, first thoughts about these kinds of things. And here’s a little bit kind of, you know, discussions, but it was pretty much kind of, you know, very unstructured approach across the world and bad roads were rising for healthcare and some of, you know, cost of drugs that were really, really big. Yeah, politicians became much more aware about, ahm, we need to put in some breaks here, including some systems here. And in the last 20 years, you know, lots of lots of laws have changed in different countries and your bodies like so nice in UK or specifically England or the Equator and Germany, French system, Canadian, Australian, Korean, all these different countries around the world have adopted and have applied multiple changes in terms of layer translation in these areas. And so this kind of, you know, payer topic wasn’t a big topic 20 years ago. Yeah, and we need more sales, that’s all. We need more sales. Let’s, you know, increase the price. That was a very, very common, kind of thing to do to reach your target, in terms of your financial targets as a Pharma company. Yeah, when there wasn’t enough volume, well, let’s increase the price, which is not that easy anymore.
Jenny: It is not. No, and I think it’s really interesting that you see it manifest differently in different parts of the world. But, you know, there is an appreciation for we have a whole population to take care of and so if we have this new gene therapy coming in, that’s going to have a very high price tag because presumably, it’s a cure. How is that going to impact the other diseases that we need to treat? And how are we going to be able to add this to our portfolio? Understanding that our health care budget may not increase enough. And so these really are interesting decisions that need to be made. That we don’t always see in the development space. Certainly, they’re thinking about access questions with respect to the design of their trials and they end points that make it in. But really, when you have to start thinking about the trade-offs across a very large portfolio. It’s a different ballgame.
Alexander: Yeah, and also if you look into the cost of medications, yeah, so if you think back 20 years ago, yeah, there were hardly any biologics on the market. Yeah, and biologics have a very different price tag to the usual pills. Yeah, and also kind of the price decrease for generic for you know, usual pills is really drastic. Yeah, for these blockbusters, yeah, as soon as they go out of pattern, you know the weeks after you have a 95 percent decrease in price sometimes. 95%. And that speaks a little bit to the cost of goods actually for a couple of these things. Yeah. But it also shows you that you know that the cost was a really, really different thing at that time. And the easy cost of these maps that we have now everywhere is significantly higher. If you see a kind of blockbuster 20 years ago, don’t know, three, four, five billion revenues per year, Humira had fall five times of that. And not sure whether it’s still there but you know, some of these treatments are really, really expensive.
Jenny: Well, and Humira was an interesting case, right? Because they had many indications. They found that it was an effective treatment for many indications and that likely had an impact on the negotiations they had with HTA bodies.
Alexander: Yeah. Yes. This is really, really interesting. It’s now very different, the price is actually decreasing with each indication you’re at, yeah, because CPA says. Whoa. No, you have even more patients you are treating with this expensive drug. Yeah, you need to help us control our budget.
Jenny: Right. Because you can’t have a different price for a different indication.
Jenny: That’s something that we have learned. As you can’t charge some patients more for the same drug given in the same dosage. And so that has been an interesting kind of market correction.
Alexander: Yeah. Yeah, and it leads to all kinds of interesting consequences. Yeah, so if you for example launched in a specific indication where you need a higher dose. Yeah, and then your prize is set on this higher dose and later on you go into another indication where you actually have a much lower dose that can actually lead to lots of problems. Because this low dose becomes a new anchor. Yeah, and yeah you may even decide not to launch answers in this indication.
Jenny: I mean, I think it really depends on the size of the population and the impact that you can have on that population in terms of their overall health.
Alexander: Yeah. So HTA is a really really new field. I think there is real world evidence we have talked about it, lots of lots of different changes. I think also there’s a pendulum, you know, spinning backwards and forwards of how companies are organized globally versus locally. Yeah, I think, generally the global headquarters have much more strict rules on managing data because they have been burned in the past. Yeah. I know that several of these big companies sell antidepressants and antipsychotics. Yeah, when it came out that it had metabolic side effects and, you know, led to all kinds of different things. They need to, you know, collect all their studies. And I know from inside of these different companies, they had, you know, study hunting teams. They were teams that kind of traveled around the world to go into the different affiliates to find these studies that were conducted and find the data. Yeah, which ended up on a CDs that was encrypted and they didn’t have the password anymore. Also it was, you know, piles of CRFS that were in cardboard boxes somewhere and all these kinds of stories. Yeah. And of course, nowadays, it’s a very different thing. That is nothing anymore like something local. Yeah, you know, remember 20 years ago, that was before the internet bubble. Yeah, it’s kind of you could do something locally and it wouldn’t have an impact globally, but nowadays there is no such thing as pure local communication. Everything ends up somewhere. Yeah, and so these have much more scrutiny on a global scale that say we need to, you know, manage things much more tighter. Yeah, and we can’t just kind of have lots of people running loose and doing whatever they like.
Jenny: It is really interesting. And that’s something I remember from my public health days is at the time there was this kind of big separation between information technology departments and health care. And information technology would come in and say, all right, we’re going to teach you how to structure your data and then they realized how much of it there was but then the digital revolution in other industries took off and IT actually became much more savvy about how to handle, you know, terabytes and more of data and suddenly there was a lot to learn from these partnerships. And now you have a situation where a lot more information is in the cloud and there really is no excuse not to be able to keep track of this data. But of course it is, it is about management and kind of thinking about how to migrate to new systems that can account for new data. And so you see big Pharma companies using software, you know, making big changes in softwares that they haven’t made in years and decades.
Jenny: And that’s a fascinating and wonderful thing to see because you should be able to see a benefit for affiliates to be able to address the questions that they need to address in their own studies or by having access to global studies.
Alexander: Yeah, one of the things that I still see, however, is these, you know, fights within the companies, you know, local versus global people. I’ve seen it across many, many different companies, across many different areas. It’s typically the story goes like this, the global people say, the local people have no clue. These are kind of, you know, cowboys. They do kind of crazy things and they, you know, not adhering to our strategy and we need to, you know, hold some really, really tired too. So they don’t damage things and we control the information so that you know, we control the organization. And then the story from the local side is very, often has these global guys, they don’t have a clue what’s really going on in the market, you know, they sit somewhere and have, you know, they’re not accountable for the sales that we need to do. And don’t know exactly about our systems as you know, they’re either they are from the US and don’t know about Europe, and they’re from Europe and don’t know about the US. Yeah. And it’s kind of very often these kinds of proximity biases going on. Yeah.
Jenny: Definitely and I am pleased that in my own context I see a real shift where I see global reaching out to lots of affiliates to get their input and have sessions dedicated to understanding the local markets and the local concerns and what is driving, you know, what is driving the patient population and their markets so that we can develop strategies that are better able to address them because again, you know, when the goal goes beyond sales to having an impact on patients and society, one does need to think about, you know, what is the cost of leaving a market behind? You know, what does it mean for these patients that we’re not going to attend to their needs? And so, you know, that is something that I’m very proud to see that lots of affiliates are coming to the table despite the fact that they manage entire portfolios to talk about the needs in one disease area. So, their needs can be accounted for in the development and launch and lifecycle management strategies.
Alexander: I think those companies that balance these global and local needs have a lot of trust in the communication. Yeah, these companies generally do much better. Yeah. Work is much smoother, there’s much less kind of, you know, friction, communication channels are much more open, you know, both sides learn from each other much faster, but if you have these, you know, us against them mentality within the companies puts so many kinds of problems into place.
Jenny: Well, it’s sort of the bigger stage of what we’ve been talking about is statisticians and medical affairs. We are much more successful when we have really good relationships with our late phase, in our early development colleagues and can promote these ideas of, you know, the bigger picture and getting the drug, all the way to patients earlier and these affiliates have much more success when they can work together and learn from each other and learn from global to have their needs met.
Alexander: Yep. And statistics can actually play a quite interesting role because usually it’s a much smaller number of people. And so, communication and building trust is much easier than if you have, you know, 10 times the amount of medics or sales, probably 100 times the amount of sales people and other commercial aspects. Yeah, so it’s really cool to leverage the strengths of the opportunities of smaller teams and build connections, you know, whether you’re sitting locally or globally, working together, building trust, learning about the needs of the other people and working together that can only strengthen the position of stats within the overall environment status to see the actions that best works together across the different silos, stats has a much bigger impact.
Alexander: Thanks so much Jenny for this first episode and will continue to have these discussions in the future. So watch out for much more content to come.
Jenny: Thank you very much.
Alexander: 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 and serve patients. Just be an Effective Statistician.