Precision in Motion: Advanced Therapies (ATMP) Logistics

From regulatory compliance to collaborative platforms like Pharma.Aero, explore how industry experts are navigating the complexities of ATMP logistics and paving the way for a more efficient and effective healthcare delivery system. 

Join Frank Van Gelder and his guest, Olivier Mary, Chief Commercial and Supply Project Director of Euromed Pharma, shedding light on the crucial role of precision logistics in delivering cutting-edge therapies to those in need. 

Tune in for insights, expertise, and a glimpse into advanced therapy logistics.

Transcript

Precision in Motion: Advanced Therapies (ATMP) Logistics

Insights, a podcast by Pharma.Aero. 

Frank Van Gelder: Good day everyone and welcome to the Pharma.Aero podcast series again. Today I have with me a very important guest, Mr. Olivier Mary, CCO or Chief Commercial and Supply Project Director of Euromed Pharma. (Olivier, welcome. Thank you, Frank.)

2024 seems to become the year of the breakthrough in personalized medicine and more specific advanced therapy medicinal products. Considering all the investments are done, what are we expecting? 

Olivier Mary: Expectations in the health care are very challenging now due to we are in front of more and more specific diseases and regarding all the treatment we already experience, we are obliged to think different. Think different means find new treatment to fight against this kind of new disease, new cancer. That's why the cell and gene therapy treatments, that's why the microbiome and microbial treatments, that's why also the MedTech treatment could help the patient to fight against this very hard disease and save lives. It's one of the big challenges of this kind of therapy. 

 FVG: So actually what I hear is it's really one of the most important innovations in medical history. 

OM: Innovation is a key factor for the pharmaceutical industry. But don't forget one thing, we need innovation not for the industry, but for the patients. 

FVG: So with the type of brand new therapies comes a brand new set of logistical requirements and challenges. Is it really so difficult as what people seem to say nowadays when you start transporting ATMP products? 

OM: You talk about ATMP products, so we are on advanced therapy. So in kind of advanced therapy, if I just make the mirroring, I need an advanced logistics solution. It's very important to have the good service in front of the product. In EuroMed Pharma and daily with my team we manage through manufacturing but also this distribution regarding the risk. What about the risk regarding the product? What about the destination? And what about the finance? This is very important. This advanced therapy we already talk about the challenge for the treatment for the patient but also for us to have product compliant and the product has to be compliant hand -to -hand from my manufacturing side to the patient. That's why it's a challenge, it's not my own challenge, it's a challenge in my side but also in the side of with my partner. I don't talk about subcontractor, it's my partner. 

FVG: Regulation, this might be a lack still we are missing in ATMP or do I see it wrong? 

OM: Months after months, year after year, we have to respect the regulation and also the regulation explain more and more exigence. I have one case in France nowadays regarding the microbiote product. There is no regulation and the French medical agency request to the biotech, to the CDMO, okay please help me to manage new regulation for the microbial product. This is very important. That's why the agencies, the legal, the state, is very linked with the industry and the pharmaceutical research and development. This is very important. 

Now, there is no precise regulation regarding this kind of therapy in Europe, but we have to start. If we just have a look just behind us, the industry will push our political to make regulation. It is a good way with a provider. We work so closely. I work so closely with the authority. I work so closely with my provider and together we can success. 

FVG: It's an important statement. 

OM: It's very an important statement and to think 20 years ago, what about regulation? So nowadays we have regulation, there are some certification, quite nice, but the regulation are more and more strict. Why? Because we are more and more faced to this kind of product, very sensitive product, very precise product, a lot of toxicity. We have to be very prudent, compliant, and we have to manage the quality aspect. 

FVG: Actually, what I hear, it becomes a complete ATMP ecosystem where the regulator and the provider and the producer, they all need to be in one ecosystem. Okay, let me then go to some practical examples. When you contract logistics providers, what are your expectations and what do you see? Can everyone, in other words, do ATMP? 

OM: The first thing we are looking for is the compliance. It's impossible for us to have a distortion between the manufacturing and the distribution. I need my supply provider for distribution. We have to have a mirroring between us and them. If we have very precise manufacturing and the distribution is not at the same level, the compliance will be not at the good level. Don't forget the patient at the end. So we expect this. 

After, we expect every aspect of what we can find on GDP, training, quality system, managing of subcontracting. It's very, very important. Each provider we are looking for, they have to be involved in our mission and our product. If I would like to send my clinical trial in the US, my provider has to know which kind of clinical trial. Either IND is still open or not. It's very important. We are partners. I need the help of my provider. We work together. We are not in the big volume. We need tailor -made solutions, but also we have to think. Sometimes we are in the face of one issue due to a freight offload, due to a custom issue. Yes, solutions. Finding of the solution is experience. I have a lot of examples regarding IND, regarding different universes we can find on the FDA for drugs, for biologics. And if you are on cell engine therapy, it's a drug. No, it's biologics. We have to be very precise and for cell & gene therapy, for MedTech, for microbiome, I explain, the treatment are very precise. For the patient, I need the same level of precision with my provider. 

FVG: So no empty promises? 

OM: No, no empty indulgence. Yes, we can see a lot of things on the marketing of the leaflet. That's quite nice. We have to be very pragmatic. Don't forget one thing, more specifically for this kind of product, we have to manage the risk. You have the quality. Yes, it's the basis. But it's mandatory. After, prove what you say. This aspect is only the aspect we have between the pharmaceutical company and the provider, but also between the agency and us. We cannot qualify a transportation plan. We have to manage. We could validate, but everybody knows, more in pharmaceutical industry, the transportation aspects are not stable. It is a fact. How can we manage this instability? FVG: … and stick to your plan when you have a plan, right? 

OM: Every time is the plan. One of the big challenges we have with our supply chain provider is we build together a plan. Please, Mr. Provider, respect the plan. If I asked hand -to -hand at plus five, please manage at plus five and tell me the proof. If you cannot propose plus five degrees in the airport, in Australia for example, okay, say me, I will manage my supply due to this lack of service. Okay, no issue. But tell me the truth. It is very important for this temperature and more and more for this advanced therapy, because for this advanced therapy, we are under frozen environment. Yes, deep frozen. So with under minus 150, minus 80, minus 20, and more we are advanced, more it's frozen. But don't forget one thing. We have to be compliant. So if I ask Mr. the transportation company, Mr. Trucker, please deliver the product at 9 a.m. It's not the day before at 11 p.m. Because of shelf life. Yeah, we talk about the precision, precision of the product. So please, Mr. Providers, precision of the service you offer. 

FVG: Precision therapy needs precision logistics, right? And then, last question to you, Olivier, and thank you very much for the insights you give us. What can we do with our platform like Pharma.Aero, together with people like you, with companies like you, to help and to assist to prepare the industry better for what is going to come? 

OM: The main aspect I see with Pharma.Aero is the discussion exchange we have between each part of the supply chain. As a manufacturer, I could discuss with an airline just to explain my risk, to the airport to explain my risk, to be transparent. We have to know each environment of each other. It's very important. We have to understand how does it work in a ground handling. We are not in a manufacturing site. And on the other way, this community has to know how does it work in a manufacturer. It's very important. And together, with this kind of understanding, we can upgrade the level. It's very, very important. And every discussion I had pleasure to have in Pharma. Aero, since We are on the good way and also together. The industry, airline, air freight, freight forwarder said, OK, what can we do now to be better, to offer better service. It's very important because we are on this kind of advanced survey. We need this kind of service. Think innovation. This is very important. And in Pharma.Aero we discuss together. We share the experience. And thanks, Frank, for this. 

FVG: Thank you, Olivier, for giving these insights and these tips. What I take back of what you say is sharing insights through collaboration to continuously improving the industry services. Yes, surely. 

Thank you. With this I would like to thank you Olivier for giving these insights for this podcast and I also want to thank our listeners that listen to our podcasts every time. My name is Frank Van Gelder, I'm the Secretary General and I hear you next time.