LogiPharma Europe 2025: Complex Novel Modality Preparation

It’s no secret that personalized therapies offer effectiveness for patients, but the financial strain it places on supply chain stakeholders can prove costly.

Keeping that in mind, LogiPharma Europe wanted to find ways to remedy that challenge, and welcomed a panel discussion on “Future-Proofing for Complex Novel Modalities: How Can You Deliver Personalized Therapy Operations on Time and in Budget.”

Moderated by Susana Pereira, vice president of MNX operations and advanced therapies at Marken, she was joined by Massimo Rigodanza, vice president of advanced therapies technology with Johnson & Johnson; Sebastian Schneider, global head of E2E cell and gene value chain with Roche; and Balazs Hargitai, consulting director and life sciences supply chain lead with Deloitte, to explain various aspects of personalized therapy, including how to implement the most practical strategy around people, processes, and technology to support future pipeline demands; implications of the therapy manufacturing networks; best practices that can be taken from specialized supply chains that are also applicable toward other life science supply chains; and more.

Pereira kicked the session off with a poll: does your organization work actively with the personalized therapy space? Sixty-two percent of the audience voted “no,” indicating that there is plenty to learn about the sector.

When it comes to the state of the industry and how one envisions the next three to five years, it’s important to first provide a general overview.

“We are talking about personalized therapies, which are basically therapies that are tailored to the individual needs and characteristics of patients. So that actually is a collection of different therapies itself, it includes cell therapies, gene therapies, radioligands, antibody drugs, COVID-19, mRNA therapies, and cancer vaccines,” Hargitai explained. “What is very important to understand is that these therapies are all very different from each other, from the supply chain perspective. Some of the therapies require our supply strategy, which is made to stock, some other therapies are made to order, and some other gene therapies are actually designed to order.

“ … When I did a survey of the personalized leaders of the companies that are producing them, results were quite positive. When we asked how optimistic there were about the portfolio and performance in the last 12-18 months, 80% of responded ‘positive’ or ‘very positive.’ We also asked them, how optimistic they were about the next 18 months, and 90% of them noted ‘very positive.’ Based on that, you can conclude that there is a good momentum on markets. In terms of the opportunities and challenges, I think the complexity of this therapies come with a lot of questions, a lot of problems that supply chain and market access has to solve. I also think this is something that technology will need to support.”

Schneider, who referred to himself as an optimist, continues to be excited by the potential opportunities that lie ahead.

“I think maybe one perspective is, if you would ask the question, is your company engaged more toward your research organizations or your technical development organizations, you would get a different picture. If you would ask me if I see a drop in clinical trials or if I see a drop in research, the answer is no, and I think it is important perspective, because at the end of the day, what we're doing here is evolving science.”

Rigodanza, who represents the digital technology function at J&J, offered his perspective about the reality of how much it truly takes to build a cell and gene ecosystem.

“First and foremost, to hear that everything about technology leaders [from this sector] is somehow the same as a lot of technology leaders for every other business—meaning that technology has to be driving the business impact and has to drive its outcomes—I think the first question in this big advanced therapy business is, what do you need technology to do? Is it to launch, scale, create volumes, drive costs, and affordability? If I take experience of a personalized made-to-order cell therapy—which is essentially a PhD supply chain to put it in different words—there are some key elements that are key in order to succeed.

“One is, this is a space where you do not have a standard technology template, where you can just copy, paste, and implement. When you define your technology target, architecture, or roadmap, some of the building blocks are commercially available. Some of the building blocks have to be developed. In my professional experience, you have to develop some of these components … The other key dimension is this is an area where you need to think in an interconnected way. This is a business that starts from a patient, it ends with a patient. Process, technology, and skills need to be built across R&D, supply chain, commercial, external, and internal. We need to think of technology as this interconnected ecosystem.”

He also expressed this need for having a “digital first” mindset much earlier in the stages of the lifecycle when comparing it to other industries. However, in the spirt of debate, Schneider added that this process often involves a learning curve that comes after working through manual processes—what truly matters in his opinion is how you react to implementing change. About five or six years ago, Roche had to pivot between different cell and gene modalities, beginning with autologous cell therapy. The company then focused more on a gene therapy, and at that point—a year prior to launch—was when the reactive moment started to occur.

“Whatever you do, you can be as strategic and smart as one is, but there’s got to be a reactive moment. What I mean by that is you cannot anticipate everything that's going to hit you, because there is no template,” Schneider explained. “These supply chains—whatever you do in cell and gene—will be different in nature. They will be more personalized. There will always be this direct connect to treatment centers and made-for-order pieces, stronghold of logistics like this. You cannot participate in everything, and at a certain moment, it becomes reactive, and that's what helps you, if you actually started with a digital-first mindset, you don't even get a choice. You actually move in that direction, because it's going to get directed, and I think that's happened to us.”

Reference

Pereira S, Rigodanza M, Schneider S, Hargitai B. Future-Proofing for Complex Novel Modalities: How Can You Deliver Personalized Therapy Operations on Time and in Budget. April 9, 2025. LogiPharma Europe 2025. Lyon.