Around the world, personalized medicine is reshaping our understanding of health, disease and longevity. Advances in genomics, biotechnology and data science are enabling more precise prevention, earlier diagnosis and treatments tailored to biological, lifestyle and environmental factors.
Europe is emerging as a major driver of this shift, from large-scale genomic initiatives to growing investment in precision oncology and gene therapies. Lithuania, specifically, is one of the countries trying to drive the research field forward with innovation and discovery.
In this Q&A with Labcompare, professor Sonata Jarmalaitė from Vilnius University discusses what it takes to move from innovation to a fully integrated, sustainable personalized-medicine system.
Q: What are the current challenges behind implementing personalized medicine on a large scale?
A: The breakthroughs in personalized medicine have brought major changes in the diagnosis and treatment of various diseases, including the need for genetic sequencing for precise identification of disease subtype and the ability to interpret this complex genetic information in the context of clinical data for selection of the most efficient treatment. The path toward implementation of these innovations is not easy. There is a lack of clear regulation for compensation of the expenses for precise diagnostics in clinical practice. Quality control and legal regulation of such diagnostic procedures is also not uniform in Europe.
Despite the world-leading position of the EU in life science and biotechnology publications in parallel with U.S. and China, the country still struggles in translation into practice, regulation and manufacturing of health innovations. Venture capital and investors are not in a hurry to support the development and implementation of tools for personalized medicine. For example, U.S. biopharma start-ups receive 9x times more funding than EU-based start-ups. Innovative clinical trials of personalized therapies, like cell therapy or gene therapy, also face bureaucratic obstacles and shortage of financing. In addition, an important topic is the training of specialists of personalized medicine and their professional development. Such study programs are available only in a few EU universities and their career path is not well defined.
Q: How are researchers and scientists in Europe addressing these challenges?
A: Even though personalized medicine innovations have already proven many times that they save health sector resources and human lives, the path of life tech innovations to the patient remains long and complicated. Early-stage innovations are mainly originating from research projects ongoing in scientific laboratories. The EU is rich in world-class universities and scientific institutes, advanced research infrastructures, highly skilled personnel, and well-developed research granting systems, however, the instruments for further innovation development, scale-up and translation to practice are quite limited. Only now, when the gaps for scientific innovations translation became obvious, we have started to talk about the need for Pan European instruments like EU Biotech Act to accelerate translation of innovations into commercial products and clinical practice.
Based on the EU funds for research and health innovations, like Horizon Europe, EU4Health or EP PerMed, large consortia were created for the advancement of personalized medicine in the EU. PRIME-ROSE is a Horizon Europe project with 28 partners from 19 European countries, aiming to develop infrastructure for innovative clinical trials. ERDERA is the key EU project for the advancement in rare disease research. The EU’s flagship 1+ Million Genomes initiative was developed for secure access to genomics and the corresponding clinical data across Europe to support personalized healthcare progress and improve disease prevention. We can find more great examples of partnerships in the EU, but for the real progress in translational research and personalized medicine these project-based initiatives must turn into legal Pan European infrastructures with sustainable finances.
Q: What types of instrumentation and technologies are critical to the future of personalized medicine?
A: Genomic, proteomic tools, next-generation sequencing technologies have already found their place in clinical laboratories. The time has come to standardize and implement artificial intelligence and digital tools. Along with cell therapy come gene editing tools, which are still awaiting clear legal regulation, quality standards, and meaningful refunding of laboratory spendings.
Q: Are there technology challenges the lab industry needs to overcome to more effectively implement personalized medicine? Or is it more about money and public/government systems?
A: We need to think about fast-track for innovations. Fast-track from the discovery stage till clinical validation, manufacturing, and marketing. Scientists and innovators must stay in their own space—in laboratories. Other personnel should take the burden of intellectual property protection, registration, clinical trials organization, packaging of the final product and marketing. Under governmental responsibility also remains the organization of national priority programs, legal framework, and infrastructure.
Q: What are some positive advancements you have seen in personalized medicine innovation recently?
A: Science is making rapid progress. Gene editing, cancer vaccines, molecular glues, liquid biopsy, digital twins—all these innovations sound like science fiction, but in fact they are already tools on their way to the clinic. And the first results of clinical trials are really promising.
Let’s take cancer vaccines as an example. After sequencing tumour DNA, most important mutations are used to train the immune system to find cancer cells all over the body and can be used to treat even metastatic cancer. Phase three clinical trials are successfully ongoing for melanoma therapy, as well as earlier phase trials in other localizations of cancer.
The newest trend in cancer therapy innovations are protein glues. These small proteins can be trained to find oncoproteins and to direct them to the cellular protein destruction system – the proteasome. Thanks to this innovation, a cancer cell can be cleansed of bad proteins and to heal itself. The FDA is already evaluating the effectiveness of the first such drug—proteolysis-activating chimera or PROTAC—innovative therapy for breast cancer.
Digital twins are virtual 3D replicas of the human body or part of it that mirror physiological and biological processes. They enable real-time monitoring of internal processes, simulation of medical treatments, thus can replace clinical trials or even laboratory experiments in the future.
The potential of science is immense, we just need to use it properly and help scientists smoothly transfer the most promising innovations into practice.
Q: In the short-term, who/what would benefit most from the large-scale implementation of personalized medicine? What about in the long-term?
A: It is true that personalized medicine requires significant investments, but the return is incomparably higher. For society, these investments return in the form of the opportunity to live a longer and healthier life, predict and prevent disease risks, treat most fatal diseases, and improve quality of life. An additional return is valuable resources for future innovations. Personalized medicine accumulates abundant clinical, behavioural, biological, and genetic data. In addition, biobanks can provide biosamples with a detailed biological and clinical description, while AI tools can assimilate clinical records and radiological images of each person. These resources for personalized medicine have huge potential to revolutionize life and health sciences and yield powerful returns for society in the long-term. This includes individual disease risk assessment, personalized prevention programs and control of rare and currently untreatable diseases for a healthier lifestyle and longevity.