How Merck Research Labs Is Evolving its Global Clinical Supply to Meet the Demands of Newer Modalities
Marta Arias-Salgado, Head of Global Clinical Supply at Merck Research Labs, tells us about the innovations in labeling, just-in-time manufacturing, and the complexity of comparator trials that she’s dealing with as immuno-oncology therapeutics continue to advance.
What work do you lead as the Head of Global Clinical Supply at Merck Research Labs?
We support Merck’s clinical portfolio, and collaborations with external partners or independent sponsors working with any of our products.
We are packaging, labelling and transporting the drug to support our clinical trials around the world, and acquiring/preparing external drugs as needed for comparator trials. That brings an entirely new set of challenges, because using a comparator drug in a clinical trial requires totally different packaging and labeling, and has to fit regulations around the world, and GCP/GMP aspects.
What are the macro-challenges you’re dealing with in your role?
The biggest one is that we are dealing with several new modalities. These are drugs that are completely new to manufacturing, and it can be challenging to manage that novelty, while supplying clinical trials at scale and maintaining speed. We are battling this complexity as we compete with others, and go fast for the sake of getting these potentially beneficial therapeutics to patients.
"It can be challenging to manage that novelty, while supplying clinical trials at scale and maintaining speed."
What’s an example of a newer modality that makes the supply chain more complicated?
ADCs are one such example, because you need three locations to manufacture an ADC. One for the antibody. One for the linker. And one final location to pull everything together. It doesn’t happen in one single facility. Whenever you add an additional piece, it adds risk, whether that be in transit, manufacturing, etc. Plus, there is a lot of competition, thus there are difficulties in where to manufacture. And beyond that, these are novel. There will be more errors, naturally, with more batches that fail.
How are you adapting in order to meet the challenges of new modalities?
One thing we’re doing is examining how we can approach labeling differently. There is new software coming out that we are exploring how they can help, including new technologies, digital, artificial intelligence, etc.
We are also working on better predicting how much drug we will actually need. In an attempt to give flexibility, because we don’t know where patients will be recruited, where the highest-performing sites will be, etc, we often plan for overage, knowing that not all of that drug will be used. But we want to be careful about waste, particularly with how expensive our drugs are, and it is our duty to add efficiency where possible in the clinical trial supply chain.
How are you trying to better predict how much drug you’ll need?
One way is using artificial intelligence or other algorithms added to technology to help us better predict where and how much drug is going to be used so that we don’t overproduce as much.
Another is learning from recent experiences in our last few programs as to what worked well, what we can do even better, how much we produced, to get better predictions.
Finally, I think that we are all experimenting with just-in-time manufacturing, or at least just-in-time labeling, to get as close as we can to the geography in which the drug will be used.
"We want to be careful about waste, particularly with how expensive our drugs are, and it is our duty to add efficiency where possible in the clinical trial supply chain."
What challenges are you seeing coming down the road that would impact patients?
I think at some point we need to have a conversation about cost and feasibility when it comes to running trials, particularly when we discuss comparing new drugs to expensive IO medications. You cannot be constantly running super-expensive trials that go forever. If trials become too expensive without ROI, how does that impact our goal to advance health? That could be a real challenge, particularly for smaller companies.
We’ve had situations in which we might need to purchase a drug for X number of years for X number of patients to be able to compare. We may reach a point where the value isn’t there, and that could be preventing a potentially impactful drug from moving forward.
What is one thing you are trying to innovate?
Many of us in the space are trying to evolve a digital display label. It’s still early work, but has a high potential benefit.
For example, when you’re using a drug in a clinical trial, you might get an extension on the expiration date. Why? Because the drug is in development, and as you learn more about the drug, you can extend the shelf life. That creates a lot of rework, relabeling and shipping. If we had a digital label and the ability to change the expiration date remotely, it would save a lot of time and minimize waste.
You’re moderating a panel on Overcoming Drug and Comparator Sourcing Challenges in Oncology Trials. What do you hope to come out of that conversation?
First, I think it’s always interesting to hear what others might be doing that we’re not, because it’s a difficult and challenging space.
I’m really looking forward to opening the eyes of our colleagues in research. For the sponsors or investigators thinking about trials, they are going to be running comparator studies that go on for years. They might think they are going to compare a study drug to Product A or B, but by the time the study is done, an entirely new comparator might be in that space. We’re going to have very interesting challenges and I look forward to discussing how we can be smarter about the ways that we design future trials.
How did your work on the development side prepare you when you got into supply?
I learned how much of the decisions we make on the clinical side have a huge impact on the time, speed and waste on the clinical supply side.
I’m a molecular biologist by training, and I started in clinical trials. Therefore, I was the customer of global clinical supply. I learned more about supply, and its critical role in being able to start trials. If you have, for example, too many arms, you’re creating waste and challenges in the supply chain. The lack of predictability in recruitment at the site, country, global levels have a huge impact on clinical supply. For this to work better, you need both groups working together.
What is your advice for young people entering careers in science?
Stay curious, and understand not only your job, but where it fits into the bigger picture. You need to understand what came before you, what comes after you, and how you can get better. It’s in those interfaces where the biggest opportunities lie. I was always curious, and it helped me move through my career.
I’ve had a rich career at Merck throughout the years in various functions. Don’t stay in your silo or think, “This is my role, and this is what I do.” Try to understand your environment and the overall picture.
What career advice do you wish you would’ve known earlier?
This is for people who are leading other people and teams. It’s no longer about you. It’s about your team, and how you as a leader enable your team and remove obstacles. Think about how you can enable continual improvement of yourself and others. In general, we should all be looking at ways to get better.
Book recommendations
