00:00:00
Voiceover: "Cent jours pour réussir" is the podcast from G_NIUS, the Guichet national de l'innovation et des usages en e-santé. Around Lionel Reichardt, meet healthcare innovators and key experts to help you succeed in your projects.

00:00:20
Lionel Reichardt: Hello everyone and welcome to One Hundred Days to Success, the podcast for innovators and entrepreneurs in digital healthcare, but also for anyone curious about the field. This podcast is produced by G_NIUS, the Guichet national de l'innovation et des usages en e-santé. In this episode, we talk about setting up experiments within a facility. To do so, we welcome Louis Létinier, co-founder and medical director of Synapse Medicine, a medication intelligence platform that gives everyone easy access to reliable, up-to-date medical information on all drugs. We also welcome Antoine Pariente, professor of pharmacology and pharmacoepidemiology in Bordeaux, head of the Bordeaux Pharmacovigilance Center and director of the pharmacoepidemiology, drugs and population health research team at the Inserm U 1219 Bordeaux Population Health research center.

00:01:22
Lionel Reichardt: Louis Létinier Hello and thank you for sharing your experience with us. First of all, could you tell us about your training and career path?

00:01:29
Louis Létinier: Hello. Thank you very much for this invitation. I'm a pharmacologist specializing in drugs. I'm the co-founder and medical director of a start-up called Synapse Medicine, and before that I was a university hospital assistant at Bordeaux University Hospital.

00:01:46
Lionel Reichardt: You co-founded Synapse Medicine in 2017, can you introduce us to your company?

00:01:52
Louis Létinier: Yes, absolutely. So Synapse Medicine is a start-up resulting from a collaboration with the Bordeaux University Hospital, Inserm and the University of Bordeaux, whose vocation is to develop technological solutions around the proper use of medication. Whether for healthcare professionals or patients. So, in concrete terms, it's a lot of technology based on computer science and applied math. We can talk about artificial intelligence if you like. But the ultimate aim is really to help doctors prescribe, pharmacists dispense medicines and patients take charge of their own health and treatment.

00:02:26
Lionel Reichardt: So, partnering with healthcare institutions is in your DNA. In 2020, you won a call for projects launched by the Ministry of Health and Prevention with the Prosyte project, initiated with several public institutions. Can you tell us about it?

00:02:41
Louis Létinier: Prosyte is part of what we call a PREPSS, a Research Program on the Performance of the Healthcare System. These are calls for projects issued by the French Ministry of Health. These are national calls for projects, which have the advantage of enabling large-scale collaborations and interesting funding. For this project, we set up a partnership with the Bordeaux University Hospital, the Rennes University Hospital and the Georges Pompidou Hospital in Paris, along with the Synapse Medicine start-up. So, it was a public-private collaboration, which is really what we were doing. The aim was to develop a system that would make it possible to secure hospital discharge prescriptions for patients, because in the hospital, we pretty much know what's going on, and in the city we know too, but often this transition zone, this period when the patient leaves the hospital to return to city medicine and city care, it can be an area of vagueness, an area of risk, and so Prosyte specifically targets this transition period.

00:03:38
Lionel Reichardt: You've launched a number of other projects, one of which is currently underway, notably with ANSM, l'Agence Nationale de Sécurité du Médicament. What is it about?

00:03:46
Louis Létinier: With the ANSM, we set up what we call an innovative public market. It's a very interesting mechanism, since it enables us to contract public-private partnerships without going through the cumbersome and complex process of conventional calls for tender. It's important to know that these public procurement contracts are limited to a maximum of one hundred thousand euros excluding tax, so they're still interesting projects, but with a very flexible limit in terms of funding. The idea behind this project is to help the French pharmacovigilance system. In concrete terms, this means that today, when a drug is marketed, after the clinical trials and all the upstream assessments, it is given to the public. But we continue to monitor it. This monitoring is carried out by healthcare professionals, pharmacologists working at regional level in what are known as regional pharmacovigilance centers. These people have a very important and essential job, but it's a very time-consuming one, and can be very burdensome when a new drug like a vaccine, with potentially many adverse reaction reports from patients, all these reports have to be processed manually, one by one. And that's where we come in, offering a technology that will help these healthcare professionals to sort out these numerous cases, and prioritize them. Having a pre-analysis, we don't replace them at all, we help them. And all this with the aim of promoting and reinforcing vaccine surveillance. COVID-19, this system must be ready by next January. It's a big issue for us right now.

00:05:14
Lionel Reichardt: As you can see, there are a lot of projects for Synapse Medicine, experiments with public institutions. What do you expect from these experiments and partnerships?

00:05:24
Voiceover: These experiments and public-private partnerships have two main types of advantage in my eyes. The first is technical and scientific. It enables us to pool the know-how that is specific to both worlds. On the one hand, when you work with a university hospital, you have the obvious advantage of expertise in the field, where you have seasoned doctors, a whole team of biostatisticians and epidemiologists. But on the other hand, the start-up can bring its own specific technological skills. They'll have data scientists, genius geeks and so on. A strong osmosis can be created. And then there's the second advantage, which I think you have to fully accept and even promote. It's in terms of image and notoriety, because this kind of collaboration allows the company to benefit from the legitimacy and aura of the public partner. It's interesting to say that we're working with this university hospital, we're working with this body, and that immediately lends credibility and gravitas. But on the other hand, the public can also benefit from a certain image, particularly innovative and modern. So it's really a win-win partnership that's quite obvious to me.

00:06:37
Lionel Reichardt: What are the strengths and weaknesses of the players in this type of experimentation and partnership?

00:06:42
Louis Létinier: I'm really looking at the small start-up scale. The strong point is often going to be agility. Because we have few constraints, in any case, in terms of organization, and we can attract a variety of profiles, often dynamic, attracted by challenges, etc. On the other hand, we have less maturity in terms of the way we work. On the other hand, we have less maturity, we're not always well structured in all areas, we don't have all the expertise in-house and, in fact, the funny thing is that we really do have a mirror, because on the public side, it's exactly the opposite. What's going to be the difficulty? It's going to be the administrative and organizational red tape, all the layers, the time between making a decision and taking action, there can be a succession of meetings and decisions and intermediaries. It can take a very long time. On the other hand, we're dealing with something that's experienced and well-established, with multiple structures, field experience and practical experience. So it's quite amusing to see that we're really on two almost opposite models, but which are in fact very complementary.

00:07:52
Lionel Reichardt: When the experiment is set up, what framework should be given to it in contractual and legal terms, in terms of funding for access to medical data?

00:08:00
Louis Létinier: It's a real subject because public-private partnerships are developing in France and this is nothing new, but we can really feel that there's a dynamic, it's being set up more and more. One system that I use, that we use and that I recommend is the framework agreement system, i.e. we draw up an initial general contract between the private structure and the public structure. This contract, which may have a certain formality, is above all there to say that the two entities are committed to working together, to respecting rules, major principles and so on. And once we've signed this framework agreement, afterwards and for each dedicated project, we'll make an amendment and draw up our own contract. The advantage of this is that it gives us flexibility and responsiveness, and means that every time we experiment with a structure, we don't have to go through a year-long process of signing contracts. So, it's really a model, we didn't invent it, we're not the first to do it, but we like doing it and we've already signed several framework agreements today and it's really a model that I find interesting.

00:08:58
Louis Létinier: On the financing part, as I was saying, there's a device that can be interesting in certain cases, it's the innovative public market. So I'm going to repeat myself, but it's an interesting piece of data, limited to one hundred thousand euros before tax. The advantage is that it's very fast and very flexible. Otherwise, of course, we always have the option of going through a call for tenders and a public contract. After that, what can be interesting are the invitations to tender, of which there are many, there are an enormous number. I don't think anyone knows them all. What's important is to keep up to date, to find out what's going on in your field. For example, in healthcare, there are a huge number of calls for tender from the Ministry of Health, and there are also European calls for tender, which can be very interesting because they involve much larger sums, so don't hesitate to keep an eye on them. And above all, don't hesitate to try your luck. Invitations to tender are a bit like a competition: you try ten and one or two get through. And that's how it works, but it's very good.

00:09:54
Lionel Reichardt: Data access, is it the framework contract that defines the ethical aspects?

00:09:58
Louis Létinier: So it's true that when it comes to healthcare, data is a sensitive and particularly topical subject. It's a two-stage process. Let's say the framework agreement already sets out a framework, as its name suggests. So we already have a good idea of what we can do and, above all, what we mustn't do. But after that, it's project by project, because depending on your subject and the data you're using, you're going to be dealing with sensitive data, you're going to be dealing with personal data, and every time you go up a notch, you're going to have to tighten up your requirements. The important thing is to be uncompromising about this, of course. Often, what happens - not always the case, but often what happens is that data must remain where it is produced. So, in principle, in practice, when we work with a hospital, for example, what often happens is that it's the data scientists or engineers from the start-up who go to the hospital. We're more likely to move people than data. When you can do that, it's a lot easier from a regulatory point of view.

00:10:57
Lionel Reichardt: Is it important to have a project leader? Does it have to be part of the start-up or the healthcare establishment? How does it work?

00:11:03
Louis Létinier: Effectively, it's essential to have a project leader, quite simply because this public-private coordination has its advantages and disadvantages, but above all, it's not always natural. We're talking about two worlds which are quite different, and which above all have a different time-space. The old, important public structure doesn't live at all in the same time frame as the dynamic start-up. And to coordinate and articulate these two worlds, you need a conductor, someone dedicated to the task. So we need a project manager who's really dedicated to focusing on this collaboration, quite simply to enable teams from both entities to understand each other, work together and keep to reasonable deadlines. When you have someone who wants to work in a week and the other in six months, it's not possible. What I'd say is that, in my opinion, the most natural thing is for the project leader to be on the start-up side and on the private side, as this is more in line with the type of profile found in these entities. But it's also possible to imagine the opposite. It doesn't seem impossible to me.

00:12:05
Lionel Reichardt: How do we mobilize doctors who are often overworked? How do you include them in this type of project?

00:12:10
Louis Létinier: I'll answer with my own vision, but it may be biased because I'm a doctor myself. What I think is most important is that the entrepreneur, the private company, has to attack from the field, it has to attack through the health firms or through the people in the profession. I think that what can be a mistake, what can be dangerous, is to go over the top, to say "I have contacts, there are investors, through my reputation I can go and see the hospital management, I can go and see the people in charge". That seems complicated in terms of access and acceptability. Doctors will say, "What's all this about? I've got my job, I've got my patients." On the other hand, if you go to the doctor, you go to the pharmacist and say "Look, I've got a product that I think might interest you, might help you in practice, can we evaluate it together? Do you want to do clinical research together?" There's much more chance of it working.

00:12:59
Lionel Reichardt: To conclude, what advice would you give to a project leader who would like to launch an experiment with a healthcare facility?

00:13:06
Louis Létinier: So yes, there are several pieces of advice that I recommend, after that everyone is free to follow them or not. I think the most important thing is to ask yourself the question and be honest with yourself: do I have in-house field experience? Do I know my subject? Or shouldn't my first step be to talk to professionals in the field? Put the project together, make sure it's coherent, and then tackle the partnership. You really have to do things in the right order. Having an idea in a field you know little or nothing about is very risky, and it's rarely the real good idea.

00:13:43
Louis Létinier: So then, what I think is really important is to think about financing methods as we discussed earlier, there are financing possibilities, but it remains complicated. In France, the public-private partnership is still something of an innovation, a little, shall we say, unusual, at least atypical. Which means that financing is not easy. You can't say to yourself, "The university hospitals have plenty of money, the institutions are the state and they have plenty of money, so it's going to be easy". No, it won't. You have to think about these financing methods beforehand. You have to study the calls for projects, you have to study the possibilities, and above all, you have to talk about it from the start. You have to talk about it from the outset, and be transparent. Are we asking for money? Are we asking for human resources? Are we just asking for legitimacy or an image? In any case, we have to ask ourselves these questions right from the start.

00:14:37
Louis Létinier: Then, we talked about it, but it's really essential to have a dedicated project manager. I'd like to come back to this point because in my experience and with the first partnerships we formed, we didn't necessarily have someone available 100% for this task. That can create difficulties. So really, it's not a luxury to have someone in charge of this coordination. And finally, I think that the most important thing for things to go well - because obviously, most of the time, things will go well, but we're not immune - is to be transparent. You have to be transparent about your objectives. I think any public structure can understand that you come to them for their data, that you come to them for their experience, for their expertise, for their healthcare professionals, for their image. It doesn't matter what your reason is. But the important thing is to play the game, and also to agree on the communication strategy. That, too, is fundamental. You don't communicate in the same way when you're a private company as when you're a public partner. And so, from the outset, we need to agree: do we issue joint press releases? How do we do it? What do we say? What can we say and what can't we say? Anticipating these questions can also avoid major disagreements.

00:15:52
Lionel Reichardt: Louis Létinier, thank you for your feedback. Do you have any questions about setting up experiments in public establishments? Antoine Pariente, Professor of Pharmacology and Pharmacoepidemiology at Bordeaux University, head of the Bordeaux Pharmacovigilance Center and director of the Pharmacoepidemiology, Medicines and Population Health research team at the Inserm U 1219 research center at Bordeaux Poplation Health, provides some answers. Antoine Pariente, hello, could you tell us a little about your background?

00:16:26
Antoine Pariente: Hello. My background is pretty standard. I trained as a doctor. I did a specialization in public health, so epidemiology, the study of population health, and in this specialization I very quickly became interested in drugs, first via pharmacovigilance, then later via pharmacoepidemiology, with a research career in these two disciplines as a result.

00:16:49
Lionel Reichardt: You work for several public bodies. What role does experimentation play in your projects? Is it research?

00:16:56
Antoine Pariente: So, it depends on what you mean by experimentation. But experimentation is logically always research. You don't experiment on patients in the context of normal care. Experimentation in the context of research, for the one I'm conducting, consists of finding innovative methods or, on the contrary, using proven methods to evaluate the interest, efficacy and safety of drugs in real healthcare situations.

00:17:22
Lionel Reichardt: When it comes to technological innovation within experimentation, do the same prerequisites and issues arise as in research?

00:17:30
Antoine Pariente: This is a broadening of the issues we already had in the field of drug evaluation in real care situations in the general population, globally. There have been several stages or generations of studies and research methods or techniques. The one that has been the most important over the last twenty years has consisted in using very large health databases, but which were highly structured databases such as health insurance or hospital databases, and using them on the basis of hypotheses generated a priori on the knowledge we have. The digitization of our environment means that we now have other sources of data that can also contribute to this assessment. The data is much more heterogeneous, much more extensive, and can come from the patients of each and every one of us when we're not a patient or a doctor, but just giving our opinion. And it's also data that we may want to integrate into our assessments. And for the time being, the traditional techniques we've been using are no longer appropriate. We need to find others, and we need to find other media.

00:18:36
Lionel Reichardt: Why is it important to encourage experimentation within a public establishment?

00:18:41
Antoine Pariente: Why is this important? I'd say that for a university hospital, i.e., a healthcare establishment that is backed by a teaching and research structure such as a university, it's part of the mission. It's compulsory to constantly seek to innovate and find new methods to improve patient care and the efficiency of caregivers on the other hand, so it's absolutely compulsory and in this context, the research that is carried out in research laboratories and then when, how shall I put it? When the expertise that exists in these laboratories can find interesting complements in terms of skills in the innovative sector that there are outside public institutions, you have to know how to go looking for it, and that's what we're trying to do.

00:19:31
Lionel Reichardt: In these experiments, what does the private sector bring? What does the public sector bring? What are their respective strengths and weaknesses?

00:19:37
Antoine Pariente: Each person's strengths and weaknesses, that's perhaps a long story to tell, but in any case, what each person brings to the table, that's simpler. As for what the public brings to the table, particularly for a healthcare establishment on the one hand, and an academic research and teaching establishment on the other, it's inevitably professional expertise, both in patient care and also a certain knowledge of data and the context of diseases, the context of treatment use, in short, everything that makes up knowledge of the object of research, somewhere. This is where private players, who are also innovation players with whom we can collaborate, have a role to play. They have another way of developing approaches, which does not necessarily take up the same amount of time as research, with another capacity for attracting talent, which is not always, unfortunately, that of the hospital or university. Together, we can make the most of each other's strengths, so that there are no weaknesses.

00:20:44
Lionel Reichardt: What's in it for start-ups to experiment with a public institution?

00:20:48
Antoine Pariente: In the particular context of the collaboration we have, the start-up is able to check that the tools it develops are valid. It's really something very important. There's a question that's always the same in terms of research or innovation. You can imagine a lot of things. And then afterwards, sometimes it works, sometimes it doesn't. Here, having access to hospital and university expertise on the one hand, and a set of data sets on the other, to finally validate the fact that the tool is indeed supposed to provide the service for which it was imagined, is necessarily fundamental and an added value that is extremely important, I think, for the start-up.

00:21:26
Lionel Reichardt: What is the entry point for a start-up? Who should it talk to? School directors? Are there any forms to fill in that are accessible on a website?

00:21:35
Antoine Pariente: Of course, there are mostly sites, hospitals or on all sites, care structures, there is a special start-up tab. Unfortunately, no, that's not the case, and I don't even think it would be the efficient way to proceed. The efficient way to proceed, as in all situations, is to seek out collaborations, and I think it's exactly the same whether a start-up wishes to approach a public institution or another, is to identify the teams working in its field, and to approach the head of these teams, or the researchers who have already worked on the question. This is exactly the approach I'd recommend to any start-up wishing to enter the healthcare sector. Healthcare research has been around for a long time. There are expert players who are very well identified. They're the ones to contact first.

00:22:19
Lionel Reichardt: What role do hackathons play? Is this a good way to forge partnerships?

00:22:23
Antoine Pariente: Hackathons, challenges or competitions in which innovators, start-ups or teams that form on purpose are asked to make proposals to be able to respond to a healthcare challenge and a challenge of using healthcare data, particularly in the sector that concerns me. It's a very good way for these teams of innovators to get together, because the hackathon is often an opportunity to meet other players and set up a project with them. And then, afterwards, to use what may have been developed during the hackathon, and possibly be rewarded, as a calling card to say "This is what we're aiming for, this is how we work. This is what interests us. Here's the collaboration we've already been able to set up, and how it's won awards or been shown off. "Then show interest and build on that to develop other partnerships.

00:23:11
Lionel Reichardt: In this type of public-private experimentation, is project management the key?

00:23:16
Antoine Pariente: The imperatives of advancing research for the hospital and the university meet the imperatives of advancing development for the start-up. Start-ups need things to move fast. Hospitals and universities are delighted when things move fast. So, in effect, you need highly efficient project management. The start-up may be slow to get going, because the institution isn't always at ease with setting up collaboration contracts, and the start-up isn't always the preferred contact for universities or hospitals. So there can be a phase of getting to know each other, of getting to know each other, of getting to know each other, which can sometimes be a little long, but after that, you have to make sure that, on both sides, once the project has been launched, there are no more obstacles and that things can continue as quickly as possible. Quite simply because projects too have their lifespan, obtaining tranches of funding is conditional on progress and the start-up has, as I said, its imperatives has too.

00:24:10
Lionel Reichardt: In summary, Professor Pariente, what advice would you give to an entrepreneur who would like to conduct an experiment with a public establishment?

00:24:19
Antoine Pariente: I don't know if I should give him advice or have asked him already, knowing that he has an entrepreneurial spirit that I don't have. I'd advise him to keep things very simple at first. And then, once he's identified a hospital or university contact with whom he can set up a project based on this project, which will then be backed up and developed, and which will enable him to put into perspective the intentions of the start-up and the desire to develop in order to improve patient care, to go and see the institutions to see what collaboration framework needs to be found around this project.

00:24:56
Lionel Reichardt: Our episode comes to an end. Thank you for listening. We thank our two guests for their availability. Don't hesitate to subscribe to the podcast on your listening platforms. We look forward to seeing you soon for a new episode of One Hundred Days to Success.

00:25:15
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