Q&A: Catalent CEO sees a bright future for the company under Novo Holdings’ ownership
It’s been more than six months since Novo Holdings completed its landmark $16.5 billion acquisition of Catalent, one of the world’s largest contract development and manufacturing organizations. Alessandro Maselli, who became Catalent’s CEO in July 2022 after a long career with the company, navigated the CDMO through very challenging times — including the COVID-19 pandemic — and is now charting a future course under Novo Holdings’ ownership as a private company with the benefit of expanded resources.
Catalent’s size and scope remain formidable. Each year, the company supplies nearly 70 billion doses of more than 7,000 products and assembles over 320,000 clinical supply patient kits across 1,200 different protocols, according to Novo Holdings. Catalent has 1,500 active development programs supported by more than 2,500 scientists and technicians and has had a role in nearly 50% of FDA new drug approvals in the last decade.
In an interview with Pharma Manufacturing, Maselli — who began his career as an automation systems engineer in the food industry — discusses Catalent’s global CDMO capabilities and the areas in which it continues to invest and expand its offerings to best serve pharmaceutical and biotechnology customers, while positioning the company for future growth.
This conversation has been edited for length and clarity.
Greg Slabodkin: You became CEO of Catalent in 2022 after a long career there and during a very challenging time for the company. What can you share about that time?
Alessandro Maselli: I’m incredibly proud of what the Catalent team was able to accomplish during the period from 2020 to 2023. We played a pivotal role in the pandemic response and helping the world navigate out of the lockdowns.
We did have a challenging period after the pandemic, with the correction in the biotech funding environment and other headwinds. During that period, we were fortunate to have a highly engaged workforce and key leaders who played a critical role during these difficult times — for which I am very grateful.
Tell us about your background, how you advanced at the company, and what you see as important today for leadership?
Maselli: With regard to my background, I am an engineer by training and a native Italian. I’ve worked in many different countries. It’s been a long and exciting journey where I’ve had the opportunity to work across different industries. Those experiences were instrumental in providing me with the skills needed to navigate challenging times. You use those learnings as you go forward to make your organization much stronger.
When it comes to Catalent, we deliver unparalleled customer service through our incredibly talented teams. There is no way we can be a world-class organization without world-class talent. At the same time, we are laser-focused on our customers, partnerships, and ultimately patients.
We are a Patient First organization, which is important particularly during turbulent times. And, of course, we have an incredible focus on the balance sheet of the company and cost management throughout good and bad times. Yes, we’ve had challenging times, but Catalent is in a great place today and much stronger for it.
GS: What are your top priorities now that you are a private company?
Maselli: Moving the company to private ownership has given us important investment opportunities and time to focus on our long-term growth.
Our two top priorities are about customers: better aligning with the top priorities of our customers and ensuring customer service excellence. We are focused on strengthening our relationship with customers and continuing to deliver on our promise to provide unparalleled service. We strive to be the best of the best when it comes to service to customers. We will continue to focus on that as a priority.
GS: What is your assessment of the current external environment as it pertains to healthcare and CDMOs in particular? With tariffs, FDA job cuts, and other recent actions, how are you planning for the future?
Maselli: There is no doubt that we’re currently in a period of probably the highest uncertainty in decades across different dimensions. For CDMOs, the implications of monetary policies and interest rates are critical. The biotech industry relies on external funding, which is very sensitive to interest rates, so what happens there is going to be incredibly relevant to our industry. I’m also mindful of other dynamics such as pricing and FDA regulations, which are very important for the approval of drugs.
When I look at all these dynamics, as much as they bring uncertainty, they also bring clear opportunities for CDMOs to help their customers mitigate risk with flexible options. Catalent provides its customers with the flexibility of not having to invest and deploy capital, while providing them with solutions that mitigate the risk with our capacity and capabilities to deliver services they need.
More than ever, it’s going to be important to have a flawless CMC (Chemistry, Manufacturing, and Controls) journey for the candidates. Catalent sees hundreds of those candidates every year, so we’ve accumulated a lot of knowledge and have the experience as to what works and doesn’t work in CMC. The room for error in terms of CMC as part of submissions is much smaller than in the past. Being right the first time is going to be incredibly important.
GS: With all the noise on these topics, what are you hearing from your customers right now and how are you addressing it?
Maselli: With this level of uncertainty, no one really knows where the trade balance is going to end up. So, the need for a resilient, reliable, and adaptable supply chain is going to be very important. I hear a lot more discussions around accessibility and affordability. These are true challenges, and we contribute here as well through good solutions when it comes to supply chains as a global CDMO.
Geographically, we are present in Europe and the United States primarily, but we also have a presence in South America and Asia. So, we can provide a footprint as a manufacturer in many different geographies to ensure our customers have options in all the major markets they are targeting. It’s an environment where we are best positioned to address some of these main challenges that are top of mind for our customers.
GS: What trends are you seeing in the CDMO market? What do you believe is the biggest shift for CDMOs?
Maselli: The biotech industry has become a bigger focus for CDMOs, especially over the last few years given the funding environment and IPO market. In the period between 2018 and 2021 many VC backed biotechs were able to reach liquidity events, either IPO or acquisition, in relative early stages, sometimes already in Phase 1. Today, later stage data need to be produced to get to that stage, which means that biotech companies need to bring their assets to Phase 3 or sometimes to commercialization. This is an advantage for fully integrated CDMOs that can provide these companies with end-to-end services, from development all the way through to commercialization.
Challenging times separate the best from the rest. We are seeing a widening gap between the top-tier CDMOs and second-tier companies. The top-tier CDMOs are holding the fort so to speak from a top-line standpoint, while the second-tier ones are facing challenges in keeping volumes, revenue, and market share.
GS: How does Catalent leverage artificial intelligence today? How does AI fit into your growth strategy?
Maselli: Artificial intelligence will have a profound impact on the CDMO space. We are at the forefront of the transition to AI. Catalent started early compared to others. Early adopters will have a competitive advantage and it’s very important for the company to stay on the leading edge of AI.
Catalent is implementing AI in our workforce to increase productivity and accomplish more with their time, while providing a better work-life balance. On the shop floor, AI is helping us to leverage the tremendous amount of data we generate each day in order to identify improvements that we can bring to optimize our processes. I believe it’s going to be transformational for us.
GS: What are Catalent’s biggest opportunities?
Maselli: We definitely have an opportunity to gain market share in most of the markets we serve. Through our investment and capital expenditures over the last five years, we have the capabilities and capacity to take advantage of the opportunities in biologics and other new modalities. We have everything we need to really meet the needs of our customers.
GS: Where do you see Catalent going over the next three years?
Maselli: Because our approach is to establish long-term relationships with customers and be less transactional, we will increase the number of strategic partnerships. Our care for our employees will continue to make Catalent a great place to work and an employer of choice for high caliber talent. Over the next three years, we’ll start to see the benefits of AI in our balance sheet and in our service to customers, as we make people’s lives better. I believe we have incredible opportunities ahead to grow as a business and drive positive impact for our employees, our customers and patients.
