Eurofins

Stefano Baila

In your experience as a managing director at Eurofins, what would you say are some of the recent changes you witnessed regarding the implementation and use of technology?

The core of my work is linked to the world of cell and gene therapies. It is that part of life sciences where innovation is important and is something that the industry is proactively looking for. Cell and gene therapies are innovative medicine, as they can provide life-changing solutions and ultimately be a physician's weapon. However, there is currently no clear model for those.

We have autologous and allogeneic cells, fresh and frozen cells. These are pieces of the puzzle that can make these products simpler from a manufacturing perspective or, more importantly, more sustainable from an industry perspective. Sustainability is the key element for manufacturing cell and gene therapies.

How important is collaboration when it comes to developing and researching new medications?

Historically, collaboration is how the front runners in cell and gene therapy were developed. Identifying the right strategy or the right target for cell and gene therapy and medicine was a major priority. It is vital that young startups, biotech organizations, and other companies with fresh portfolios can leverage collaboration.

In the early days, we witnessed something that reflected true collaboration. In today's world, it is about recognizing the value that each team member brings. That is also why it is so common to see big consortiums at the European level trying to develop new medicine.

How has technology helped you accelerate your projects and make your cell and gene therapies safer, scalable, affordable, and more efficient?

For many years, the big question was about how we could manufacture cell and gene therapies. Our new focus is on making them sustainable. The important aspect of being sustainable is analyzing the impact of innovation, new tools, and collaboration on cutting costs for manufacturing, goods, and logistics. Engaging with regulatory bodies from a pricing and reimbursement perspective also plays a key role in sustainability. We are at a point where making products more sustainable begins with the manufacturing process.

Additionally, we should not solely look at prices from a material-purchasing perspective but the cost to achieve good quality as well. How risky would it be to produce products using tools that, for instance, are not completely valid? If a batch is lost, that is an enormous financial loss. Instead, using advanced and verified technology can reduce the risk created when achieving quality.

How important is patient data for achieving and maintaining sustainability?

We have often seen a return to a "one product, one patient" mindset, especially for cell and gene therapies, but not all patients respond in the same way. 

During the clinical phases, segmenting the population and finding a way to identify the proper parameters is very crucial.

In one instance, we saw a clinical trial reach the end of phase three and fail because they did not properly segment the population. After reviewing the data, it was found that 30 percent of the population was well-impacted by the drug, and 70 percent was not. For this reason, collecting the right data every time you encounter a patient is crucial for success.

On that note, the way to measure a drug's successful impact is not only by measuring its action but also its effect on the quality of life. It is imperative to monitor the real benefits of the drugs we give. At the end of the day, if you measure an improvement that is just a number and the patient experiences no real impact, it is pointless. If you can prove that you are impacting a patient's quality of life, there is a tremendous value.

Eurofins has caught onto the advancement and is developing CAR T-cells. Can you share your thoughts on these developments?

Cell and gene therapies have proven to be extremely successful in segments like rare diseases, which are mainly impacting pediatric patients and cancer patients. The CAR T-cell segments are tremendously effective in treating liquid tumors like leukemia, especially impacting the pediatric population. We have all celebrated the life-changing impact of CAR T-cell therapy, as we can treat rare diseases that affect a very small population.

Recently, the news of a young girl's treatment in the UK using the drug Libmeldy was spotlighted. There was a big debate about how it was able to save her but not her older sister, despite their age difference being less than two years. There was also discourse on the drug's cost of around £3 million. One injection of Libmeldy is all that is required, but the cost is a heavy factor to keep in mind.

That said, we finally have a new set of weapons that can change the way rare diseases are treated, especially when they are of genetic origin. The next step is to find a way to attack solid types of cancer, like tumors. The CAR T-cell has not been successful there yet, but we are working on a more potent cell type that will work similarly to CAR T-cells and trigger the immune response against tumors. Immunotherapy is already big, but it will grow further over the next few years.

What is some advice you would like to give other senior leaders in the sector?

Our industry needs more opportunities and collaborations to reach a state where more players are involved. Each one should understand the different needs of their peers while collectively aiming to serve patients. I hope that we, as an industry, can engage with regulatory bodies and service providers more and make sure the challenges we are facing, from a drug supplier perspective, are addressed. We see a lot of innovation, especially from the device side and the molecular tool side, but sometimes we struggle to implement them.

This industry is in crucial need of knowledgeable people. Not only people that have the right knowledge but also those that are passionate about this work. In this industry, there is a lot of failure before reaching moments of celebration. Having perseverance will give you the satisfaction needed to keep going. Hopefully, that's something that will be addressed with time.