Dr. Eva Hemmrich, Regulatory Science Lead, The University of Basel

Portrait of Dr. Eva Hemmrich, Regulatory Science Lead at the University of Basel, featured in NanoSphere interview on nanomedicine policy and regulatory innovation.

Biography

Eva has experience across biotech, pharma, and academia, with a focus on gene therapies, rare diseases, and most recently nanomedicines. At the University of Basel she leads regulatory science work, partners with regulators and innovators, and helps shape policy for nanotechnology-based medicines. She also supports her group’s enzyme-in-lipid-nanoparticle project for lysosomal storage disorders and advises selected programs through PrimeRA Pharma Partners. Previously, at bluebird bio, she contributed to EU and US submissions and clinical trial strategies for a PRIME-designated lentiviral gene therapy for a neurological disorder, and earlier at Novartis Oncology she managed lifecycle strategy for rare endocrine therapies after completing Novartis’s regulatory rotational program. Eva earned a PhD in Chemistry from ETH Zürich and an MSc in Medicinal and Biological Chemistry from the University of Edinburgh.

Interview

NanoSphere: Tell us a bit about yourself—your background, journey, and what led you to where you are today.

Eva: I grew up in the Czech Republic and, after high school, moved to Scotland to study Medicinal and Biological Chemistry at the University of Edinburgh. My industrial year at GlaxoSmithKline near London was a highlight: a great lab team, real responsibility, and my first clear view of how medicines are actually made and tested. Switzerland came next: a Swiss Federal Office of Public Health (BAG) sponsored PhD at ETH Zurich, measuring how people in Switzerland are exposed to UV filters from sunscreens. It was the bridge between chemistry and public health that I was looking for. After that I moved into science communication with the Food Packaging Forum, a nonprofit focused on chemicals in food packaging and practical ways to reduce exposure, a mission I still care about deeply. I returned to pharma through a regulatory affairs rotational program at Novartis. It was a good fit while I was still exploring where to focus, and it led to my first permanent role in Novartis Oncology. Later I joined bluebird bio at a very dynamic time for gene therapy. The science moved quickly, while access and reimbursement remained difficult. When bluebird bio closed its European operations because of reimbursement challenges, I chose a new direction and moved to an academic group of Prof. McNeil in Basel that focuses on nanomedicine and regulatory science. It is not common to work on regulatory questions in academia, but I enjoy doing neutral, evidence-based work on topics that matter to both regulators and companies. Today my work sits at the intersection of nanomedicine, regulation, and patient access. I cover a range of regulatory topics and nanomedicine policy. I also work directly with regulators, and I stay hands on with our team that is developing enzyme therapies encapsulated in lipid nanoparticles for lysosomal storage disorders. In parallel, I advise selected projects through a UK-based regulatory partnership to stay close to the cell and gene therapy field.

NanoSphere: You’ve positioned regulation not as a barrier but as a bridge. In nanomedicine, what are the most critical regulatory bridges still missing, and who needs to build them? What are some of the most common compliance risks nanomedicine developers underestimate, particularly in preclinical or early clinical stages?

Eva: I helped prepare the European Union Innovation Network (EU-IN) Horizon Scanning report on nanotechnology-based medicinal products with regulators across Europe. The takeaway is simple: regulation works best as a bridge built from both sides. Academic teams and young spin-offs bring the science, the candidate nanomedicine, and an early view of the evidence that matters. Regulators bring advice and practical routes. It is shared work and shared learning. We have known this for years, yet in practice it still slips. The EU STARS initiative, although not specific to nanomedicine, reached the same conclusion and offers clear training materials. I encourage researchers to visit the STARS site and use those resources from day one. Nanomedicines are very diverse, so there is no single recipe, but the same compliance topics repeat. For instance, teams run Good Laboratory Practice (GLP) toxicology on material that is not the same as what they plan to give patients. Even small changes in particle size, composition, or impurities (without a documented demonstration that the batches truly match) can weaken the safety case and force new studies. Testing is not ready when the project moves. There is no validated way to separate free drug from drug inside the carrier; the release test is not tied to what happens in people; and specifications for particle size, spread of sizes, and surface charge are too loose. For a clear, and above all real-world look at how these issues play out, see Cristianne Rijcken’s 2025 article, “The translational journey of cancer nanomedicines: biological and entrepreneurial lessons learned,” in Drug Delivery and Translational Research, a well-written piece with hard-won lessons.

NanoSphere: What role do initiatives like the European Medicines Agency's Innovation Task Force or Horizon Scanning play in reshaping how regulators support emerging modalities? Looking ahead, where do you see the biggest opportunity for AI or digital tools to enhance regulatory science for nanomedicine? If you could design one new regulatory pathway or pilot program for advanced nanomedicines, what would it focus on — and who should lead it?

Eva: Imagine a small academic team with a promising nanomedicine. The science is solid, but the path to patients is unclear. This is where the EMA Innovation Task Force and national innovation offices help most. They meet you early, listen first, and translate regulatory language into easier language. In that setting, regulators stop being end of line inspectors and become early design partners. The learning runs both ways. I know I repeat myself here but it is the case. Regulators are curious about new technologies and want to learn from emerging science. Many researchers still do not know early support tools exist. Awareness needs a push through conferences, scientific meetings, university innovation offices, funding calls, and technology transfer offices. A train the trainer approach can give each university a few local guides who can point teams to the right route and the right timing. For digital tools today, I would say use artificial intelligence as extra eyesight in the early exchange, not as the decision maker. It can translate academic questions into regulatory terms, point to the right guidance, help draft a one page pre brief, check for gaps, and keep a short decision log. This lets researchers spend more time testing assumptions and less time guessing forms. Artificial intelligence will do more in the future, but for now this practical support already makes early conversations faster and clearer. Building on the Swissmedic Innovation Office model for ATMPs, regulators could hold short, informal office hours at universities, local incubators, or online. Research and start up teams would meet a small panel made up of a regulator, a technology transfer lead, and when useful a payer. The actual regulatory tools already exist. The first barrier is the first contact so we must lower that.

NanoSphere: If there’s one key message or insight you’d like to share with readers about the future of nanomedicine, what would it be?

Eva: Before you fall in love with the plan, call a regulator 🙂. Joking aside: start early with regulators, share just enough, and test the assumptions, so nanomedicines reach patients sooner and safer. Early ≠ oversharing; late changes cost more than early questions.

Eva`s references

Eva`s LinkedIn