BIO-Europe Spring 2025 Panel: ‘On-trend strategies: Navigating the biopharma services landscape’

On the first day of the BIO-Europe Spring event in Milan, BioXconomy’s Editor Millie Nelson hosted a lively panel on “Navigating the biopharma services landscape”. In a changing, and challenging, life sciences ecosystem, where therapeutics have evolved in complexity from mostly being small molecule chemical entities, to Advanced Therapy Medicinal Products (ATMPs), what’s the art to staying ahead? Simple: By working with those who provide expertise and enabling technology. Depending on where you’re from they may go by different names: vendors, services providers, CDMOs, CMOs, CROs, tech-bio companies, innovation facilitators, and more. But whatever you might call them where you are, they all have essentially the same end in mind: to support your success by efficiently accelerating your molecule to market and deliver patient benefit.

But why outsource at all, was a key question asked by Millie. Ergomed’s SVP of Business Development, Nikola Strumberger, succinctly set the scene: with 60-70% of the global pipeline in the hands of biotech companies, who are struggling due to difficulties in raising finance, it becomes ever more important to work with vendors who bring knowledge and expertise to the table, to reach the next milestone. And once you reach clinic, and costs ramp up through the roof, you don’t want to find you’ve chosen the wrong regulatory strategy, as that can be a very expensive mistake.

Suppliers can help you on the path to value and avoid the pricey pitfalls. As is often heard from investors, they are waiting on the data. As Frontier Science Scotland’s (FSS) Executive Director Darren Gibson, put it, ‘data is the new currency’. And, in these times of uncertainty, data from clinical trials is the best currency to have, so why wouldn’t you want to work with people who really know how to design, manage, and analyse complex clinical trial data sets? FSS has done that for multiple big pharma, for medicines including major breast cancer therapies, which have significantly improved patient outcomes.

The biology of disease is not simple, and pharmaceutical products have correspondingly become much more complex, including gene therapies, and immunotherapies. As NewBiologix’s CEO Igor Fisch said, there’s no way for one pharma to deal with all the issues, including manufacturing, across a breadth of therapeutic areas. Specific service providers, by their nature, are spurred by curiosity to dig deep into the science and find solutions to long-standing problems such as how to manufacture viral vectors at scale, economically. If this can be done well, it can expand patient access to medicines, from beyond the few, in rare diseases, to the many, in more common disorders such as cancer.

Millie asked the panel for tips on how companies choose a supplier. As Igor set out, the art is in convincing scientists at the company, that what you’re doing as a vendor is valuable: this means showing them you really understand the problem and have possible solutions. Plus that you are using the right language, as all technology areas have their own vocabulary set. These conversations can help create ‘ambassadors’ for the vendor at the potential client company, who can champion the work internally.

Heiko Richtzenhain Limardo, Head of Sales and Business Development at Menarini Biotech, highlighted there may be the potential of risk-sharing with your partner to offset some of the development costs and share in the future success of a project. Igor added that risk-sharing is a function of the progress of the trial. It’s easier earlier in research, but much tougher after an IND has been approved as clinical trial costs become much more expensive. It is better to secure advice and support earlier, as it can save a huge amount of time and money later. Well-crafted contract documents are, possibly unexpectedly, an asset here: the more precisely you can tie down what’ll be delivered when, the more aligned all parties are around the deliverables, even before the project starts.

What’s the vendor of the future look like?

As Nikola highlighted, the last two years have been challenging for biotech. Many are trying to cut corners, save on planning strategies, and internalise projects. But this can be a false economy, as shown by the highest numbers of companies hitting a regulatory rejection. If they’d invested just a little into professional consultancy, they may not have made the mission-critical mistakes along the way that ended up with the company hitting wall after wall. Service providers bring added value to the table and help streamline processes and workflows.

Darren commented that an increasingly important area in clinical trials is participant diversity, with the intent that when a medicine is approved, it can be beneficial to as wide a population as possible, with that specific unmet medical need. Engaging with patient groups, and understanding issues around data protection, and the responsible use of data, is essential here, to take a drug asset through concept, to analysis, and on to commercialisation. Darren added that in securing high-quality data, patient centred trials will be critical, including in gene therapy, where choosing the right design of a trial will be critical. Plus, as Heiko said, suppliers are very accommodating these days in providing solutions so it’s well worth finding out what is possible.

Lastly, the panel touched on AI. As Igor put it, the service landscape will become more consultative, as pharma will have access to the data, but the vendor may have visionary ways of using AI to extract insights from it. Nikola added that the expertise of vendors will speed up, as they incorporate novel technologies, including AI, to enhance their service offering. This is the moment for nimble specialist companies that can help others bring their medicines to patients faster, and more cost effectively. A canny biotech achieves more by building up a network of partnerships, as Darren observed, and provided the final comment: don’t ignore the small players, as they have a wealth of talent.