The cell and gene therapy industry is experiencing rapid growth and evolution, presenting both exciting opportunities and unique challenges for researchers and logistics providers alike.
At the forefront of this revolution is Emilio Frattaruolo, Vice President of Cell and Gene Therapies at CSafe. In a recent interview, Frattaruolo shared insights into the changing landscape of cell and gene therapies and the critical role of cold chain logistics in their successful delivery.
As these groundbreaking treatments move beyond centers of excellence to reach patients globally, researchers face new hurdles in maintaining product integrity during transport. Frattaruolo emphasizes the need for robust, reliable cold chain solutions that can handle the complexities of cell and gene therapy distribution.
The interview explores the increasing demand for real-time visibility technologies and high-performance shipping solutions. Frattaruolo highlights the importance of thinking holistically about supply chains, from early-stage research through to commercialization and scaling up for larger patient populations.
As the industry eyes potential breakthroughs in areas like type 1 diabetes and solid tumors, the logistics infrastructure must evolve to support sustainable, cost-effective distribution models. Frattaruolo's insights offer valuable perspective for researchers and industry professionals navigating this rapidly changing field.
Want to hear more from Emilio? Watch the full interview today!
Zohaib Sheik:
Hi, I'm Zohaib Sheik, Head of Content at Fierce Life Sciences. And today I'm excited to be speaking with Emilio Frattaruolo, Vice President Cell and Gene Therapies at CSafe. Welcome, Emilio.
Emilio Frattaruolo:
Hi, how are you?
Zohaib Sheik:
So set the scene, what's happening in the cell and gene industry that's making it more common practice?
Emilio Frattaruolo:
Yeah, so there's a lot happening in the cell and gene space right now. We're seeing more approvals. We're seeing the regulatory bodies becoming, I think, a little bit more comfortable with the data packages that are coming through. And I think overall from an infrastructure perspective, I think there's a lot more that's happening in terms of helping these therapies get out into the market. So we're seeing a lot more on the supply chain side and we're also seeing a lot more on the point of care side.
Zohaib Sheik:
What does this mean for cell and gene researchers? What challenges are they now faced with?
Emilio Frattaruolo:
So I think from a cell and gene researcher perspective, there are a lot of new technologies that are coming in that are going to help them bring their therapies to the patients. We're seeing a lot of new technologies that are allowing these therapies to move from what were previously just centers of excellence, so locations where therapies could be created and administered onsite. And now there are a lot of new technologies that are allowing those therapies to move throughout the globe and be where the patients need them. So it's really about increasing the ability for patients to have access to these therapies, which is a really great thing. And also, I think that poses some new challenges because these therapies are now going to be going into places that maybe previously have not been set up for them. It's an interesting time and we're seeing a lot of new innovation.
Zohaib Sheik:
How are cold chain partners stepping in to support this industrialization?
Emilio Frattaruolo:
So it's very interesting. I think over the last couple of years, a lot of organizations have really jumped into the cell and gene space. It's been a very hot topic. And I think there was maybe from a sense of hope to be able to help these organizations that are looking to distribute the therapies out into the world, that they could just come into the space and do what they were doing and provide services to new customers. But I think there has been a bit of a realization that what is, let's say, commonplace or more of an acceptable practice within the broader pharmaceutical world is oftentimes not really enough for the cell and gene space. These therapies are very valuable, obviously on the monetary sense, but also on an intrinsic sense. When you're talking about an autologous therapy that's for a patient who is severely immunocompromised, these therapies are just not replaceable.
So as of late, we've seen a lot of need for critical solutions that have a lot of buffer in terms of performance and duration. We're seeing a really good demand for and introduction into the market of real time visibility technologies because everyone wants to know where these therapies are, what the condition of them is. And it's a very interesting time for some of these researchers because they're not just thinking about the next step. I think a lot of what we've seen previously has been putting out fires. Everyone's trying to get to the next phase, the next step in their process of commercializing, going from translational to clinical and then into commercialization.
But what's really becoming a focus now is how do you get these therapies beyond just these one or two locations in a country? How do you get them into points of care that are in maybe more rural areas? So really investing in new technologies and looking at cold chain solutions and supply chain solutions that will give you the ability to really move through the current network instead of having to create a new supply chain every single time you bring a therapy to market.
Zohaib Sheik:
What do researchers need to be aware of when selecting a shipping solution for their therapies? Example, data performance, et cetera?
Emilio Frattaruolo:
Yeah. I think there's a lot to consider. There are tons of options and what I think is really critical is that researchers are thinking about their supply chain holistically and their product lifecycle beyond just getting it to market. So what are you doing early stage when you're doing translational medicine, when you're trying to get into the clinics? And how does that translate into commercialization? While it's great that there are so many options that can get you from a laboratory into a hospital and then into the eventual patient, a lot of the solutions that are being used now are extremely high cost. So we hear stories all the time of people chartering aircraft. We hear stories of people hand carrying products across countries through airports and doing these herculean tasks. And that's all fantastic. And it's really encouraging to see the effort that is being put into place to bring these therapies to market.
But ultimately, when we start looking at therapies that are going to serve a much broader patient subset, it's going to be important to think about how these solutions translate in a way that's actually sustainable, both financially and just from an overall organizational perspective. How do you go from 10 patients to 10,000 patients when you're no longer just serving ultra rare disease? There's talks of type one diabetes therapies on the horizon. Solid tumor is obviously the brass ring for the industry. So what happens when these therapies come and you're able to now serve a patient's subset that's tens, maybe millions of people.
So really looking at not only what type of solutions you can use today, but what does that look like as you go through and you have to scale up, what are the costs associated with that? What kind of durations do you actually need? Are you picking partners that can grow with you from your early stage where you're having to generate data? Can they support that type of work in terms of preparing for a filing, understanding the type of data that you might have to generate, doing design of experiment? And then also having the network both internally within that organization, but also a partner network so that you can get these therapies all over the globe in a way that is going to be manageable.
Zohaib Sheik:
And what excites you most about the future of the cell and gene industry?
Emilio Frattaruolo:
I think it's all exciting. The industry itself has grown extremely quickly in the last couple of years. We saw a lot of investment just prior to the pandemic and through the pandemic. There has been some pullback. But I think it's back in full force. And that's really exciting for everyone in the field and really for patients. I mean, we're talking about potentially curative therapies for some pretty significant ailments that affect a lot of people throughout the globe. There's a lot of very encouraging research that's being done. And I think it's the next level, it's the next big thing and we're just really happy to be part of it. And I'm super excited to see where it goes.
Zohaib Sheik:
Well, thanks for speaking with me today and I appreciate you sharing your insights.
Emilio Frattaruolo:
Yeah, absolutely. My pleasure.