Swissmedic at the Wyss Zurich Translational Center Promising new treatments on their way to clinical use

Swissmedic's Innovation Office promotes the development of advanced therapy medicinal products (ATMPs). We accompanied Division head Julia Djonova on a visit to the Wyss Zurich Translational Center, a place that brings medicine, biology and technology together and which is run by the University of Zurich and ETH Zurich. The Swissmedic representative spoke to Professor Simon P. Hoerstrup, Co-Director of the Center, about cooperation between researchers and the regulatory authority and the potential benefits for people with illnesses.

It takes just a few minutes for Julia Djonova to travel by tram from Zurich’s main station to the university district. There, close to the University, ETH and University Hospital, is the Wyss Zurich Translational Center, or Wyss Zurich for short. Founded eight years ago, it is a research centre operated jointly by the University and ETH. It was founded by philanthropist and former Bernese medtech entrepreneur Hansjörg Wyss, who was once an ETH student himself. The basic idea is to accelerate the development and roll-out of innovative medical treatments and robotics systems.

Simon Hoerstrup is a founding Co-Director at Wyss Zurich and Professor of Medicine at the University of Zurich. He receives Julia Djonova in his office, where an installation representing a heart immediately grabs our attention. “It’s a work by an Indian artist”, Professor Hoerstrup tells us. She uses robotics in her art. The installation uses built-in sensors to respond to its environment. If things get hectic at the meeting table, it makes the sound of a racing heartbeat. It’s a clever piece of interaction between humans and technology that reminds attendees of what’s really important: the impact of emotionally affecting technology on our lives and how we can make cutting-edge knowledge beneficial to patients.

“Our strength is our brainpower and the innovation this creates.”
Simon P. Hoerstrup
Julia Djonova
Julia Djonova
Simon P. Hoerstrup
Simon P. Hoerstrup
Regenerative medicine and its role model

Wyss Zurich, Swissmedic's Innovation Office, which was founded in 2022, and the ATMP Division headed by Julia Djonova share the goal of developing innovations to the highest standard of quality as quickly and safely as possible. ATMP is the abbreviation for advanced therapy medicinal product and the term is applied to products based on genes, tissues or cells. “As a regulatory authority, we’ve been in touch with Wyss Zurich right from the outset”, says Julia Djonova. But today’s visit is for a discussion, not an inspection. “We want to hear about researchers’ needs and find out how and where we can support and assist them.”

One unit within Wyss Zurich focuses on the challenges of regenerative medicine. “Regenerative medicine is the overarching term for a large number of procedures aimed at restoring tissue or organ functions as completely as possible”, Simon Hoerstrup explains. A good real-world example is the axolotl, an amphibious Mexican salamander that spends most of its time in water. If injured, it can regrow limbs, organs such as its heart and even parts of its brain “A virtuoso of regeneration”, says the scientist approvingly. In acknowledgement of this, and as an inspiration to the people who work there, a large picture of an axolotl hangs in the Center’s stairwell.

Replacement heart valves that grow

The heart is also the subject of LifeMatrix, one of the very first research projects launched at Wyss Zurich when it was first founded. An eleven-member team of medics, biologists, bioengineers and materials scientists is using human cells to develop replacement tissue that could benefit children with heart disease. One in every hundred children worldwide is born with a congenital heart defect. These defects frequently involve heart valves or blood vessels, both of which are important in controlling blood flow. Conventional treatment generally involves inserting prostheses made of synthetic materials. It is a procedure that former heart surgeon Simon Hoerstrup knows intimately, having worked on complex heart operations in infants during a research visit to Boston Children’s Hospital in the USA.

“It’s impressive to see how the babies get through the operations”, he says. “They’re such fighters with enormous determination to live.” Nevertheless, the problem remains that current implants do not grow with the children who have received them. That means replacing them several times, and, as Professor Hoerstrup knows, the risk of serious complications grows exponentially with each intervention. The researchers hope to spare the children this risk in the future by using heart valves and blood vessels made of human tissue that will grow with the patients.

Perseverance is essential

Some twenty years ago, a team of Zurich-based researchers led by Simon Hoerstrup were able to demonstrate in sheep that the principle of using laboratory-grown living heart valves is sound. Today the LifeMatrix team is working on an advanced technology that should ensure that the tissue framework grown in the bioreactor (container for cultivating cells and microorganisms) is compatible with any recipient. Once the framework has been inserted, it degrades as it is repopulated by the patient’s own cells. The regenerative valve becomes increasingly similar to the original, assumes its functions and grows with the child. “We’re now not long from the first clinical trial in humans”, Simon Hoerstrup tells us.

The process of manufacturing living tissues in a laboratory is known as tissue engineering. LifeMatrix illustrates just how challenging a project of this type is and how much perseverance is needed until it can be transferred to patients. The project has flourished thanks to Wyss Zurich. The Center deliberately supports promising treatments during the transition from basic research to clinical use, a phase during which they are particularly vulnerable. This phase is known as the “valley of death” because “a lot of good ideas fail because often highly complex medical research technologies are exposed to commercial logic too early as part of the company start-up process and also go to market too soon”, Simon Hoerstrup tells us.

Bridging the “valley of death”

Wyss Zurich therefore chooses research teams from the University and ETH, which it then helps across the valley of death by giving them access to its infrastructure and resources. Among other things, it funds initial clinical trials. This enables the researchers to continue developing their project in an academic environment for a few years longer, Professor Hoerstrup explains, “and get it to a level of readiness where it’s truly viable.” This is all the more important in medicine, he says, because proof is ultimately delivered in the patient. As the project teams continue to work towards real-world application, they also polish up their business acumen. They get help in founding a start-up company so that they can successfully launch their project when the time is right.

Swissmedic has been and continues to be actively involved in Wyss Zurich in a regulatory and scientific capacity that ranges from acceptance of the clean room structure to the clinical development of ATMPs. Division head Julia Djonova is keen to emphasise that the Agency is working hard to help nurture Swiss innovations. “We want to give products of the type created at Wyss Zurich a chance to develop and get used.” The anticipated benefits are very large: “Patients should not have to wait unnecessarily."

“Learning to understand together”

With many new technologies progressing at such enormous speed that there are as yet no clear established technical norms for them, Swissmedic actively tracks the latest scientific developments in addition to focusing on the legal aspects. “We provide knowledge and advise researchers and start-ups on the manufacturing conditions under which a product can be authorised or what conditions need to be met for a clinical trial or authorisation application to be approved”, the Division head explains. “The decisions have to take account of complex factors because every product is specific and different.” It is an approach that the Co-Director of Wyss Zurich welcomes: “That way we learn to understand together where the challenges lie.” The LifeMatrix project is an example of this, he says. The design, creation and legally compliant operation of the manufacturing facilities for the replacement tissue took place “in cooperation with, and with plenty of feedback from, Swissmedic.”

Wyss Zurich is keen to involve the regulatory authority at an early stage: “That way we make the fewest possible avoidable mistakes.” It also provides security for investors, Professor Hoerstrup maintains. From his perspective, Swissmedic's new Innovation Office institutionalises pre-existing cooperation. “It’s essential for Switzerland as a location that we work together particularly effectively on special applications and the more complex authorisation projects”, he says. As a small country, Switzerland cannot gain an advantage with large-scale trials and big patient cohorts: “Our strength is our brainpower and the innovation this creates.”

Innovation: Switzerland is a leading location

When it comes to innovation, Switzerland is one of the top locations in Europe, the respected scientist says. And the combined knowledge of its University and ETH gives Zurich a particular advantage. What’s more, there are patients right on the doorstep thanks to the University Hospital. In response to the question of what Swissmedic could do better from Wyss Zurich’s perspective, the subject of digitalisation arises. Anything that speeds up processes would be welcome and there is plenty of room for improvement when it comes to digitalising regulatory processes. Julia Djonova offers assurance that Swissmedic is aware of the issue and has made digital transformation a top priority.

Then the Wyss Zurich team give Visible a glimpse of their “nerve centre” on the clean room floor. This is where the promising treatments are created. Looking through glazed panels, we can see researchers in full protective clothing between the cooling tanks and computer-controlled laboratory equipment. The conditions under which they go about their work are strictly controlled. In addition to the LifeMatrix scientists working on heart valves, seven other research teams are currently using the clean rooms for their projects. One of them is Liver4Life.

This is a project that aims to provide a new treatment option for people with liver disease. The researchers have developed a machine that can preserve and regenerate a liver outside the body. Last year saw the first successful transplantation using this method. A damaged donor liver that would otherwise have been unusable spent three days in optimal environmental conditions in the project’s perfusion machine, after which the recovered organ was transplanted into a patient. The researchers are now working on a clinical trial involving several transplantation centres.

Swissmedic: “Open for discussions”

After lunch we leave Wyss Zurich again. What has Julia Djonova taken away from her visit? Above all, the head of the ATMP Division says, she was glad to get reaffirmation of the rewarding partnership. “It was good to hear again that Professor Hoerstrup and his team find us helpful.” Swissmedic is open for discussions, she says, and researchers and start-ups can contact the Agency at any time if they have questions. Doing so would ensure that forward-looking treatments could advance in compliance with regulatory requirements. Going forwards, lines of contact will become shorter and dialogue will be stepped up. In addition to the firmly established scientific advice meetings, Swissmedic intends to develop additional resources, such as on-site presences. Following on from Geneva and Lausanne, the Swissmedic Innovation Office will now have a presence in Zurich, where it will provide regulatory and scientific advice to support researchers and start-ups.