Interview with Catalent’s President and Chief Executive Officer, Alessandro Maselli

Alessandro Maselli became Catalent’s President and Chief Executive Officer on July 1, 2022, and now heads a leading development and manufacturing company with a history going back over 90 years. Catalent enables its partners in pharmaceutical, biotech, and consumer health to optimise product development, launch, and commercial supply of around 8,000 products to patients around the world. Each year, the company produces more than 80 billion doses of medicines and consumer health products for more than 1,200 customers.

• What are the biggest changes in terms of the industry as whole that you have witnessed as a company over the last 10 years?

There are three changes I consider most significant. The biggest we’ve seen is the nature of our customers and their expectations of Catalent as a partner, so we’ve continuously evolved and adapted to meet their needs – while anticipating the future demands of the market. Whereas 10 years ago, late-stage drug development was mostly the preserve of big, multinational pharmaceutical companies that would acquire clinical programmes from smaller biotech companies once proof of concept had been established, it is now far more common for smaller and virtual innovators to use development and manufacturing partners to retain project ownership through, and beyond commercialisation.

The nature of drug projects has changed too. The pipeline is large and healthy, but it is rare for any treatment to have the potential of a ‘blockbuster’ in the way we have historically understood, and the molecules in development are more frequently challenging, diverse, and targeted. Oral dose remains the gold standard, but small molecule development is now focused on complex drugs, often with poor solubility and bioavailability, so delivering them orally is by no means straightforward. Biologic drugs are now well-established, but there are efficiencies yet to be realised in their development and production, and the emergence of new modalities – such as mRNA drugs and cell and gene therapies – require more specialised analytical and development expertise and capabilities, and often bespoke and less efficient manufacturing solutions.

Finally, given that smaller companies have limited internal resources, and often little or no manufacturing assets, the role of a CDMO has changed from a purely transactional partner into being a strategic development partner – offering expertise and guidance throughout the development stages towards commercialisation. As a result, we work closely with our partners to understand their goals and provide frequent input and guidance on the precise development path and the manufacturing technology needed to deliver the drug to the patient. This requires mutual trust, so deep relationships with trusted partners and an understanding of their individual needs has become more important than ever.

• How has Catalent evolved to meet these changing requirements?

Looking at how the company has evolved over the last decade, we’ve grown significantly – in terms of the number of people we employ and the areas in which we work. We have invested billions of dollars in both organic and inorganic growth, and are continually enhancing our physical sites, and the expertise that we can offer to customers, to ensure we provide broad and deep support for a vast array of drug development projects.

Our global workforce now exceeds 19,000, including 3,000 scientists and technicians on four continents, and we launch some 150 new products every year with our customers. It is vitally important for us to share the knowledge and experience that we gain as we work on these programmes, so we’ve invested in creating tools and complex networks, so that our experts can learn and collaborate – regardless of where they are located. This collaboration takes many forms, from in-house learning to sharing solutions for specific circumstances, and we’ve been able to adopt proven techniques and practices to bring rigour to the development and manufacture of new modalities.

Another area where we’re focused is investing in the novel technologies, capabilities, and capacity necessary to maintain Catalent’s leadership position. To meet the growing demand for advanced therapeutic modalities, we’ve broadened our scientific expertise to include biologics, antibody-drug conjugates, cell and gene therapies, and mRNA-based therapies. We continually evaluate emerging technologies, with a view to not only how they will assist in early development, but also how the dose form could be scaled to commercial volumes. This means that when the demand presents itself, we are able to immediately take the next steps and transform a concept into a viable prospect, which reduces the risk of unnecessary cost or waste when persisting with difficult to scale dose forms.

• What is the potential of cell and gene therapy, as we seem to have accelerated very fast in this area?

Cell and gene therapy treatments offer patients the hope of a cure for diseases that can otherwise potentially cause a lifetime of debilitation or early mortality. We’ve witnessed the huge growth of research in this area, fuelled by recent regulatory approvals and Fast Track designations.

Catalent’s strategy as a development partner in cell and gene therapy was a very deliberate two-step approach. First, for gene therapy, we waited until the technology had matured and there was more validation on the use and development on the therapeutic modality before entering the market at scale. We did that with the acquisition of Paragon Bioservices and its proven adeno-associated virus (AAV) technology in 2019. This not only allowed us to forego any delay in building infrastructure, but also gave us access to established partner programmes at various stages of the developmental and clinical pipelines. I’m also proud to note that our Baltimore facility was the first CDMO location to be approved by the FDA for production of a commercial gene therapy.

For cell-based therapies, our approach was to enter slightly earlier in the maturation cycle, as the pipeline was already well established and the infrastructure needs were not as demanding. We acquired MaSTherCell in Gosselies, Belgium, in 2020, and have subsequently built a cell therapy campus through the acquisition of other facilities nearby and the development of complementary services. In April 2022, we acquired a commercial-ready facility in Princeton, New Jersey, which gives us increased capacity with multiple CGMP manufacturing suites, as well as laboratories for analytical, quality control and microbiology testing.

Additionally, we saw a significant opportunity to enter and rapidly scale our capabilities in plasmid DNA manufacturing, both at clinical and commercial scale, through a number of additional acquisitions at our Gosselies campus, and through organic investment in Baltimore.

• Where do you see as the biggest disconnect / challenge in the industry at the moment, and how can a company such as Catalent look to bridge it?

As mentioned earlier, the role of CDMOs has changed, from being contractors that customers used to “plug the gaps” in development for specific technical needs, or provide surge capacity, to partners that are a critical and strategic component in customers’ plans.

New therapeutic modalities bring the great promise of treating and curing patients but, at same time, create new challenges for the industry in supplying them efficiently. Patient populations tend to be small, as do drug product volumes. They rely on very capital intense technologies and assets and comparatively inefficient manufacturing processes. These dynamics pose significant challenges for innovators in terms of efficient deployment of capital on manufacturing assets and this is why the role of CDMOs has become so critical, as we provide the economies of scale necessary to make these treatments accessible and available to more patients.

Our ambition in the biologics and small molecules space is to be a crucial partner to maximise the chances of success, and support innovators throughout the clinical development journey. We achieve this through the development and application of enabling technologies, such as our GPEx® Lightning cell line technology, which significantly accelerates the development of stable cell lines and generates the highest titres of biologics such as monoclonal antibodies. In addition, we are building world-class assets across our global manufacturing network that offer our partners the capacity and capabilities to support products throughout their life cycles.

Our challenge is to be in a position to support partners of all sizes on drug development platforms throughout the industry. At one end, this could be large pharma looking to build deep partnership structures to support multiple programmes at various stages throughout the development and commercial route. Or, conversely, with a virtual company, with no physical assets and one drug candidate, looking for a partner that can add expertise and assist in development decisions and be flexible in a fast-moving process.

Although these paths can be different, the end goal of all of Catalent’s partners is to provide patients with the very best drug treatment possible, and together, this is a goal we strive towards each day.

This interview was originally published in the June 2022 edition of Drug Development & Delivery