by Dr Claire Skentelbery, Director General, EuropaBio, and
José Peres, NAC & SME Coordinator, EuropaBio


Humans are, by nature, curious beings. Scientists and children more so. Both share this remarkable quality of asking too many questions in too little time. Most often, inconveniently.

This curiosity to break things apart and see what is inside is one of the main drivers for innovation. Innovations, very rarely, are radical, disruptive breakthroughs. They usually are a series of minor and simple improvements in an existing product, method or process. They are incremental changes to fix or understand an issue. They are the result of curious minds.

Small and medium-sized enterprises and entrepreneurs are the primary deliverers of innovation. They are often mentioned for their role in job creation, economic growth and social cohesion. Still, one outstanding feature that often goes unmentioned is the significance of their role in creating new and better health solutions and save lives.

Advanced therapy medicinal products (ATMPs) are medicines for human use that are based on genes, tissues or cells. They can be used to cure, diagnose or prevent diseases, and focus on diverse conditions, including genetic disorders, cancers or long-term disease, increasingly in a single treatment, eliminating the need for unpleasant and long term interventions that reduce QoL and an active economic and societal role for the patient. ATMPs offer unique long-term benefits for patients and society. One of the main drivers for their discovery and manufacturing are SMEs.

Among the most common challenges for SMEs working in the ATMP field is the lack of investment, and how competitiveness can be unlocked. When we analyse the issue in further detail, we can easily conclude that it is not merely about financing itself but the investment environment as a whole. Public and private resources can be much more efficiently managed if Europe addresses entrepreneurship's main challenges to growth. SMEs face giant regulatory hurdles, a fragmented market and countless other challenges, including access to skills for each scientific and business stage. When discussing long decision-times, we often regard them as an inconvenience, however for most SMEs, it means they will not be able to reach the market at all, not just later.

Despite these challenges, small enterprises and entrepreneurs continue to push forward, as is their unstoppable nature.

In 2017, the story of Hassan, a Syrian "butterfly child" treated in Germany with the gene therapy developed by Prof. Michele De Luca, co-founder of the university spin-off Holostem was widely and deservedly reported. The approval for compassionate use from the German regulatory authorities, saved the little patient allowing him a quality of life he never had before.

As for SME ingenuity, to address the lack of qualified personnel, notably on ATMP GMPs, Theracell, a Greek SME, sponsored a Master's degree in partnership with the University of Patras & University of West Attika that offers hands-on experience and prepares the next generation of European ATMP professionals.

Theracell and Holostem are just a few examples of how European SMEs are realising a true knowledge-based economy while delivering life-saving long-term solutions to patients.

EuropaBio is the home of European Biotechnology SMEs, and EuropaBio's SME Platform is commonplace for them to share experiences, challenges, practices and ambitions. On May 31st, we will hear them and discuss their main challenges in regulatory pathways, market fragmentation and other bottlenecks for growth and how we raise their voices and together, move forward.