Swissmedic at Fondation Inartis in Renens From “necessary evil” to partner

Nothing went as planned that morning. First off, Julia Djonova’s visit was moved to another location. But more trying for someone who can’t live without her morning coffee was the fact that the restaurant car on the train between Bern and Lausanne was closed. However, it takes more than that to faze the Head of the ATMP Division at Swissmedic. “The world of start-ups and innovation is full of unforeseen circumstances; you have to learn to live with it, be a bit creative, spot the advantages.” Turning her words into actions, she pulls a bottle of water out of her bag. “Everyone knows caffeine’s bad for you ...”

This is by no means the first time Djonova, a medical doctor, has been up at the crack of dawn. Following the creation of its new Innovation Office, Swissmedic is sparing no effort in reaching out to start-ups and research institutes. The aim is to support their efforts to bring innovative and safe therapies to market rapidly and without stumbling over regulatory obstacles. ATMP is the acronym used to designate medicinal products obtained from genes, tissues or cells. Realising that many start-ups do not make progress with their ATMP projects – some of which are no less than revolutionary – because they lack the necessary skills in regulatory matters, the Swiss Agency for Therapeutic Products (Swissmedic) decided to initially focus the activities of its Innovation Office on this area and to keep as close to grass-roots level as possible.

Julia Djonova regularly reaches out in order to obtain feedback from institutions and companies that have already benefited from her Division’s support. Today’s objective is to talk to Benoît Dubuis, President of Fondation Inartis, President of the Swiss Academy of Engineering Sciences (SATW) and former director of Campus Biotech. Based at StationR – a former industrial site in Renens (canton of Vaud) that has been transformed into a dedicated space for innovation – this organisation manages a number of programmes to promote innovation and entrepreneurship in the life sciences, including the entrepreneurial hubs StationR/UniverCité (Renens), Espace Création (Sion) and the Health Valley community. At the start of 2023 the Innovation Office decided to test its new support offerings for companies, and it was only natural for Swissmedic to contact the dynamic man from Valais to get some pilot projects off the ground.

A space for sharing

Two cars are waiting in front of the station in Renens. One of them is driven by Benoît Dubuis, who has come to meet his guests in person. At the wheel of the other vehicle is Juliette Lemaignen, who is in charge of operations at Fondation Inartis. Less than half an hour later the visitors from the capital are settled in the spacious and colourful “Gaston Lagaffe” meeting room. “We’re not innovation administrators, we’re people in the field, entrepreneurs,” Benoît Dubuis states. The long-legged start-up expert is already on his feet, urging Julia Djonova – who has happily had time to enjoy the coffee she was longing for – to join him on a tour of the labyrinthine corridors of the former printworks.

“StationR is above all a space for sharing,” explains Dubuis, who has a doctorate in engineering sciences from ETH Zurich. It brings together makers, designers, engineers, doctoral candidates, students, start-ups, spin-offs and “quite simply, anyone who wants to develop a business project”. Currently more than 1,200 people are active in the corridors, rooms and offices of the industrial-style building. “Around 70 companies are based here, several of them involved in medtech, biotech or chemistry.” Fondation Inartis both forges bonds and kindles sparks within the ecosystem that it has set up. For example, the MassChallenge Switzerland programme, which was co-founded by the foundation in 2016, aims to select and accelerate innovative projects from anywhere in the world.

Looking beyond the science

Benoît Dubuis has been involved with ultra-innovative start-ups, particularly those working in biotechnology, for years, either as a founder or as a guiding hand. He has set up several companies. “The researchers and entrepreneurs working in start-ups are too often so focused on science and fundraising that they neglect things like quality and regulation,” he says. “The fact that they generally have few skills in this field doesn’t help.

“They don’t tackle these questions until later, often when they’re in the process of developing a product.” The consequences are all the more serious at this stage, if only for financial reasons. “The clearer your idea of what the authorities are going to ask for, the better you will be able to anticipate the regulatory requirements, work out the cost and budget for it.” Equally, he knows of several companies who had neglected the regulatory aspects of their projects and who “had a rude awakening”.

The assistance offered to small companies by the ATMP Division is “extremely valuable,” Benoît Dubuis enthuses. He goes even further, saying, “Swissmedic can be proud of having managed to establish a relationship of trust with start-ups”. For a long time the regulatory authorities had a very negative reputation. Things have certainly improved, “but Swissmedic is still viewed as a ‘necessary evil’ by many research institutes and companies”. Thanks to the work done by Julia Djonova and her colleagues, “the perception is gradually changing from necessary evil to partner”.

Win-win

A partnership can only be seen as a win-win situation. Swissmedic’s primary interest is of course in offering patients access to modern, innovative therapies as rapidly as possible, without making any concessions in terms of quality or safety. “But for the start-ups, too, there are many advantages to working closely with the regulatory authorities,” Dubuis observes. “Establishing robust quality management not only ensures safe, compliant production but also guides research and development.” Moreover, “if these companies are faced with due diligence when they are bought out, everything has already been documented in detail”.

Another benefit of early and proactive collaboration with the regulatory authorities, the innovation specialist adds, is the potential time gained by start-ups. He mentions the example of the biopharma company GeNeuro, which he co-founded. “When it kicked off, the aim of the project was to provide safe and effective solutions to halt the progression of disability due to multiple sclerosis by neutralising the possible causal factors encoded by HERV (human endogenous retroviruses).” The company recently started a new chapter in its story when it turned its attention to the post-acute complications of long COVID. “The fact that we had thoroughly considered the regulatory aspects when the company was set up saved us precious time” during this second phase of activities.

“It’s really important to keep getting the message across to small companies,” Benoît Dubuis concludes. “And what about big companies?” Julia Djonova asks. “Do you think we ought to be reaching out to them more actively?“ The President of Inartis thinks for a moment. “I think there is less need to raise awareness – and to provide specific assistance,” because their processes are more structured and usually include regulatory aspects. However, he does mention major room for improvement with respect to clinical trials. When a company develops a treatment for a rare disease, it often needs to carry out decentralised trials with patients at centres in a number of cantons, and this entails additional logistical and administrative effort. “The associated costs represent a major challenge for a small start-up.” Julia Djonova concurs. “Swissmedic has been looking at this topic for some time, and we are working on solutions.”

Benefiting from the skills of others

As the President of Fondation Inartis and the Head of Swissmedic’s ATMP Division reach the end of their “grand tour”, Julia Djonova expresses her amazement at the diversity of the companies operating at StationR. “This diversity is precisely what makes us so strong,” says Benoît Dubuis. “We operate as a network, everyone benefits from the specific skills of others. This means that everyone can concentrate on their added value without having to be an expert in everything.” He reminds us that “a large part of medical innovation today is derived from other areas of expertise”. He mentions the example of cerebral implants, a development in which specialists in energy systems, materials, etc. are involved. And something that is becoming more common, collaboration between life sciences and informatics in order to develop connected medical devices.

“Here, if a start-up needs to develop software it can call on a student at Ecole 42 (ed. a coding college that is part of a network operating in over 50 countries),” Benoît Dubuis says. “Can you give a specific example of a something implemented in healthcare that was the product of internal collaboration?” Julia Djonova asks. “I can give you several! One very illustrative example is a digital cane for people with impaired vision. It uses sensors to detect the nature of the ground, for example, wet conditions on a pavement.” StationR is home to electronics workshops, a digital design space and a maker space, allowing this intelligent object “to be designed and developed from start to finish in Renens”.

Innovation is the future

Benoît Dubuis’s eyes shine when he talks about StationR and the hive of activities and projects that it represents. He is visibly in his element in this great sea of innovation that brings together science and entrepreneurship. “We want to help, because innovation provides solutions for healthcare.” But he advises caution: “It’s more important to add life to the years than years to life!” Which is why the President of Fondation Inartis believes it is so important to “redesign healthcare to promote healthy living and healthy ageing”.

Even if his belief in the power of innovation is crafted from steel, the man from Valais has not fallen into the trap of dreaming of immortality. “Time flies, and we too often forget how little of it we have left.” The indefatigable creator imagines a wake-up call in the form of a watch which shows the remaining life of the person wearing it on the basis of an ultra-perfected algorithm. “It’s not meant to frighten people, it’s a call to action, a way of encouraging us to make the best possible use of the time left to us to pursue our ambitions and, why not, to make the world a better place.”

Julia Djonova won’t be taking Fondation Inartis’s sophisticated time-keeper with her when she leaves Renens. But she will be taking plenty of ideas back to Bern, and a renewed belief in “the value of the work done by the Innovation Office for start-ups”. Her host was so enthusiastic and talkative that she almost lost track of the time, and she makes it to the station just in time to catch the train back. In the past she would have stopped for a coffee. Today, the jolt of inspiration was more powerful than caffeine.