Automating processes to scale CGT manufacturing with PA Consulting’s Paolo Siciliano

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Erin Harris: How is PA Consulting different from other organizations?

Paolo Siciliano: “What makes PA very unique is the fact that we really focus on technology innovation. PA has about five technology centers today where we have electronic engineers, mechanical engineers, scientists, molecular biologists, like myself, where we develop technologies for our clients. We do product development for them and with them, and we bring new products to market from our hardware and software perspective. When it comes to cell and gene therapy, that is the reason why you and I are having our conversation today. We're a new player in the in this space. We've been actively working on cell and gene for the last four and a half years. We work across the value chain. So, we work with technology developers, we work with therapy developers, we work with hospitals and suppliers of different solutions. We provide a number of services that span from technological development.”

Erin: You are the first person from a consultancy that I've had on the podcast, so this is really exciting for me. You mentioned manufacturing. How can these companies scale manufacturing with limited resources and limited funds? What would your best advice be to that specific type of company?

Paolo: “We know that manufacturing is still the main challenge that we have in the cell and gene therapy industry. Processes are not streamlined, or not efficient in a number of ways, and it's something that you potentially would expect from a new industry. The challenge with cell and gene manufacturing today is the cost, which at the moment is dropping. So, if we think about how we fix this from a manufacturing perspective, how do we enable scale up the manufacturing technology space? We're seeing a large number of organizations that are trying one way or another to bring automation and different solutions to the market, from new bioreactors, new cell processing machines, filling finish, introduction of new digital platforms and all that. And one very interesting thing that we're seeing is this internal battle between the one machine approach, the fully automated and the modular approach.”

Erin: Maybe drill down even a little bit more on talking to the biotech about how to address tomorrow's scalability challenges. What are some of the best practices that companies can be doing now to get ahead of it?

Paolo: “First of all, make sure that you identify what are the right technologies that you need to bring in. So, try to understand which type of equipment you need, which type of digital technologies you can implement, which type of facility you will need. The second stage is to identify who are the right partners that will help you bring this to life. Are you doing everything in-house? If you were working with external parties, which are the relevant ones and the best ones for you? The third point is to start working early with the regulators.”

Erin: I want to talk just for a brief minute about the state of investment in cell and gene therapy broadly and just kind of your personal take on it. We know 2020-2021 was very successful, for 2022 in cell and gene therapy the investment was down, I think it's like 85% down, for the rest of the world in terms of the number of deals being made. With that bigger slowdown, what do you think we can expect in 2023 and even in the short term few years beyond now?

Paolo: “Some of the investment in the cell and gene therapy space didn't really deliver on the return we were expecting or the results that they were expecting, and these were both from the therapeutic side but also on the technology side. We can't forget about the COVID vaccine relying on the cell and gene therapy industry, because obviously the success of the vaccine for the covid wave provided a lot of publicity and the confidence in the market. What we will see in 2023 and beyond is that we are definitely expecting some consolidation. From a therapeutic perspective, if you look at certain indications, there are different ways we can tackle user conditions. And from a technology perspective, I think what we'll start seeing now is larger technology developers actually acquiring IP and technologies from smaller players. Now some of the smaller players that work really hard to bring new technology innovation to the market are getting closer to market and launch. On the other side, we will also still see some fragmentation. Because the market is still quite fragmented at the moment, especially when it comes to different modalities in cell therapies, they we still see the race of which cell type is better for XY and Z is still very open, so I think there will still be some fragmentation in that space and from a platform perspective. So overall, I would stay optimistic. 2022 has been a bit of a slowdown, but hopefully it will pick up in 2023.”