Podcast: Advancing CGT trial logistics, advancing patient care

Transcript

Emma Banks: Welcome to the World Courier IQVIA podcast. I'm your host Emma Banks, CEO of Ramarketing. Today we have an incredibly insightful episode lined up. We'll unpack the rapidly evolving landscape of clinical trial logistics for cell and gene therapies. Joining me are two esteemed guests, Andrea Zobel, Senior Director of Personalized Supply Chain at World Courier, and Natalie Sacarakis, Head of Cell and Gene Therapy Logistics and Strategy Lead at IQVIA Cell and Gene Therapy Centre of Excellence.

Our conversation today will cover how advancements in cell and gene therapy trial logistics are enhancing patient care, accelerating the development of lifesaving treatments, the critical collaboration between CROs and specialized logistics companies, technical innovations in packaging and transport, and finally, strategies for overcoming logistical and regulatory challenges. But this episode isn't just about operational excellence. It's about making a tangible difference in patients' lives through improved clinical trial processes. So before I ask the first question, I'd love my two brilliant guests to introduce themselves. I'll hand over first to Natalie.

Natalie Sacarakis: Thanks so much, Emma. Hi, everyone. My name's Natalie Sacarakis, Head of Logistics Strategy and Strategy Lead at IQVIA Cell and Gene Therapy Centre of Excellence. I started my career in an academic research institution as a study coordinator, predominantly in the oncology space, before taking the jump into the CRO world about 10 years ago. I worked my way through progressive clinical operations roles, such as clinical trial manager and clinical lead, before finding my way to my current role about three years ago. Here, I focus on combining the patient journey with the product journey and optimizing the logistics and supply chain strategy for customers in clinical development across the cell and gene therapy ecosystem. I'm really excited to have this conversation with both of you today.

Andrea Zobel: Thank you, Emma – it's a great opportunity, this podcast. I'm Andrea Zobel, I have a PhD in Biochemistry and Natural Sciences and worked 12 years in scientific research, also developing cell and gene therapies in the very early days. Then I moved into the clinical supply area in the CRO space, and now I'm in the last mile at World Courier responsible for personalized supply chain, which includes cell and gene therapies. These therapies are really personal for each patient. So I'm located in Berlin, Germany, and am really interested to see how my journey, which started in science, is now going to the last mile to bring these therapies to the patients.

Emma: Thank you both. So first question, this is to both of you and I'll ask Natalie to go first. From a CRO perspective, what is your current involvement in cell and gene therapies and how has it changed over the last few years?

Natalie: Yes, so from my perspective, from the CRO perspective, my role is really focused specifically and exclusively on cell and gene therapies. I have the privilege of focusing on these therapies and their development every single day. I spend all my time looking at these personalized therapies and optimizing the patient and product journey and where they intersect.

I look for opportunities to support the logistical oversight of cell and gene therapies alongside our courier partners. This includes things like site training, chain of custody, chain of identity adherence, and manufacturing slot management. Essentially, my role is to think about supply chain strategy and how to optimize that strategy. Then, I help manage a team of logistics managers who are the operational arm of our logistics program.

One takeaway is that we've seen over the last several years a real evolution of the challenges in the cell and gene therapy supply chain to be more of a continuum of logistical complexity. For example, some therapies now have complex administrations, such as surgical-type administrations. This means more multidisciplinary teams are involved at sites, such as when cell therapy meets CNS or ophthalmology indications.

We really look at a kaleidoscope of different challenges, depending not only on the type of cell and gene therapy asset itself but also on the goals for the trial, the goals for the study, and the geographical regions impacted and planned for the study. We put all of these together to devise a supply chain strategy with our courier partners and then deliver on that strategy.

Emma: Thanks Natalie – and Andrea?

Andrea: Yes, as I said, I'm at World Courier in the strategy department overseeing cell and gene therapy logistics and contributing to the overall strategy. As a courier, we are focused on delivery to the patient and hospitals. We've seen that it makes sense to treat cell and gene therapies separately because of their very special requirements. One is time criticality, especially when we have a patient-derived therapy like an autologous cell therapy. There's also the involvement of many different parties and a new temperature range, as we are now starting the era of cryogenic logistics.

This wasn't necessary before; we now need cryogenic storage and distribution. This change is linked to the development we've seen in recent years. It started small with a few clinical trials, but with the first commercial therapy — a CAR-T therapy, an autologous therapy — we saw a huge increase in shipments and logistics requirements. Now, new therapies are being added, so we have gene therapies and patient dosages that are extremely expensive, like in vivo gene therapies. We now have more allogeneic cell therapies and are dealing with large volumes of cryogenic products.

We see a lot of cooperation necessary between different stakeholders and technical improvements, especially in shipper technologies.

Emma: You touched on patients and hospital interaction, which is probably a bit unusual in terms of its level of complexity. So my next question is about just that. Treatment centers are responsible for patient recruitment and cell and gene therapy administration. I remember from my experience at a previous company being part of the Advanced Therapy Centres network here in the UK and how complex the pressure was on the hospitals. So I'm interested in how your relationship with the treatment centers is and has to be, and are there possibilities to improve their situation? I'll go to Andrea first.

Andrea: Yes, of course. As a courier company, our drivers go directly to the hospitals to pick up patient products, for example, apheresis or tumor biopsy, and they also deliver the final therapy. There are a lot of detailed challenges, such as finding the right door, the right person, and how the handover process works. We also see that there are not many treatment centers because of the many requirements, which restricts patient access. More hospitals and treatment centers would improve patient access to therapies.

We try to build relationships with treatment centers to establish standardized processes. This is critical for treatment centers dealing with multiple sponsors and therapies. Even with the same type of therapy, like CAR T therapy, the processes can differ. Is this necessary? The ATTC initiative in the UK, which World Courier participated in, aimed to bring treatment centers together. This initiative will continue, and it's a good example of the importance of engaging treatment centers to articulate their needs and help sponsors develop therapies that increase the number of treatment centers and improve patient access.

Emma: And Natalie, your view from a CRO perspective?

Natalie: Our relationship with treatment centers is multifaceted. As a CRO, we support sites from various perspectives. From a supply chain perspective, we aim to simplify things for study coordinators and nurses who may or may not have experience with cell and gene therapies. We assist sites with training on product handling, apheresis scheduling, and manufacturing slot management. Sites want people to make their lives simpler so they can make patients' lives better.

High-volume treatment centers are constantly reminded that every study they're running is the most important. Our logistics manager role is to be the site-facing coordinator around complex handoffs and tight logistical timelines post-manufacturing. We look at the complexities around the specific therapy and patient journey, and how that impacts areas like patient recruitment and retention. The idea is to distill these areas and make them as simple as possible for sites.

Emma: Thank you. It's great that we're doing this podcast, an initiative between World Courier and IQVIA. It begs the question, what is the benefit when a CRO and a logistics company work closely together? Natalie?

Natalie: When a CRO and a logistics company work closely together, they can leverage a lot of efficiencies. So much of today's world is about data, and clinical drug development is no exception. When CROs and logistics companies pair and compare their data, they can help inform things like country selection, site selection, drug depot utilization, and increase efficiency in the supply chain process, leading to improved timelines. We work together to leverage each other's tools and work synergistically for sites and the study overall.

Emma: Thanks, Natalie. And Andrea?

Andrea: Yes. We have so many variations in processes even for the same type of cell and gene therapies. When at least two parties, the CRO and the courier, have agreed processes, know each other, and work consistently together, it helps a lot. This partnership benefits treatment centers and sponsors. Sharing experiences is also valuable. It's like a pyramid: at the top is the sponsor, who knows their product but only their product. When a CRO and courier share best practices and experiences with the sponsor, they can decide on a process that works well.

As a medical courier, we work with many different sponsors and CROs. Knowledge sharing is a great opportunity. We provide visibility into the process, from shipment arrival times to conditions. This helps CRAs, investigators, and teams plan effectively. Smart shippers and technology provide full visibility, making life easier for everyone involved.

Emma: Hearing you both speak highlights the complexity and the critical role of interactions at treatment centers and hospital sites for the success of the trial and patient treatment. What recommendations would you give to a cell and gene therapy manufacturer or clinical trial sponsor? What are non-negotiable actions they should take? Natalie?

Natalie: In short, start thinking about your supply chain and how it will translate for sites as early as possible. Consult with CROs and logistics providers early to build in time for country selection, manufacturing considerations, cost efficiency, and geopolitical considerations. For example, navigating parts of the Middle East and Eastern Europe adds complexity. Start early and adjust as needed, but early conversations and considerations help mitigate risks.

Emma: Great, thank you. And Andrea, your perspective?

Andrea: Yes, I have practical recommendations for sponsors and manufacturers. We often encounter shipment conditions and logistics requirements that are difficult or impossible to implement. For example, cell therapies requiring fresh shipment of apheresis and finished therapy have very limited shelf life. Shipping across the Atlantic with only one manufacturing site isn't feasible for scalable strategies or commercial products.

Sponsors should challenge their R&D departments to find conditions where the minimum number of viable cells still have therapeutic effects, making logistics feasible. Additionally, some regulations are unnecessarily strict. For example, dangerous goods classification for some genetically modified organisms is more tradition than scientifically based, and "Do Not X-ray" requirements can cause issues in political crises or security-sensitive areas. Calculating and reassessing these requirements can simplify logistics.

Emma: Thank you. This is hugely complicated for many reasons. I have a penultimate question and then I'll ask you both to summarize. According to your experience, which technical innovation is most helpful for cell and gene therapy trial sponsors moving forward? Andrea?

Andrea: I have a simple answer: visibility. Real-time tracking of location and temperature is most important for our customers. It provides control for planning, confidence in product condition, and oversight. For couriers, it allows for contingency planning if issues arise, ensuring full visibility for sponsors and accurate data recording. Smart shippers and GPS devices already provide this visibility, making life easier for everyone.

Emma: Thank you. And Natalie?

Natalie: I echo what Andrea said. Supply chain orchestration software has been a game changer. We've seen advancements like blockchain technology being woven into this software. But ultimately, it's about people. Technology combined with experienced operational teams closes gaps in complexities and variables. Technology can only go so far; the right people at the right time, supported by technology, make the difference. Combining tools and platforms with experienced leads improves clinical development.

Emma: It's a lovely way to nearly conclude. I have one final question for you both. What do you see as the greatest opportunity in this area? Natalie?

Natalie: The greatest opportunity is to increase overall efficiency of tools, capabilities, and vendors. Sites are overburdened with multiple platforms and studies. Efficiency across systems, aligning SOPs, and best practices can streamline the site and patient experience. Simplifying processes reduces risk and improves data quality. Streamlining and simplifying as much as possible is key as therapies and protocols become more complex.

Emma: Thank you, that's a great summary. And finally, Andrea?

Andrea: The greatest opportunity is to reduce complexity and make cell and gene therapies more accessible and affordable. Some regulations apply pharmaceutical standards to cell and gene therapy, which isn't fitting. Simplifying import procedures and labeling requirements for cryogenic products are low-hanging fruits. Increasing manufacturing capabilities, such as allogeneic therapies or point-of-care manufacturing, can also reduce costs and improve availability. Standardizing processes can make these therapies more economically viable for sponsors and vendors.

Emma: Great, thank you. You both see the same opportunity from slightly different perspectives. A huge thank you to both Natalie and Andrea for incredible insights into this complex, exciting therapeutic area within life sciences, which has the potential to transform patients' lives. Thank you for listening to the latest episode of the World Courier Insights podcast series.