The backbone of breakthroughs: Insights into clinical trial supply management

Behind every successfully approved treatment lies a nexus of clinical research activities comprising myriad drug types, trial phases, and packaging needs across diverse geographical locations. Compared to the prestige of white coats and stethoscopes, the role of clinical trial supply is often overlooked in the history books of pharmaceutical research. However, without it, the journey of a treatment from petri dish to patient would grind to a halt.

Encompassing everything from planning, procurement, packaging, storage, and distribution of investigational therapeutics and materials needed to conduct research around the world, clinical trial supply management is not simply a logistical achievement; it is a necessity.

So, to learn more about navigating this evolving landscape, Deep Dive (virtually) sat down with Rocco Barone, senior vice president & head of clinical supplies management at Clinigen, to discuss challenges and opportunities to be found in the future of clinical trial supply.

Supplying demand: A race against time

Ensuring that the appropriate drug is delivered to the correct location at the right time is a mammoth task, with myriad moving pieces requiring meticulous planning and attention in order to operate seamlessly. For many companies, this is not a task that can be handled in-house, which is where clinical supply managers, such as Clinigen, enter the picture.

Understanding the specific requirements of the clinical trial landscape is crucial. Different trial phases, drug types, and research locations have individual needs to be accommodated, and choosing the ideal packaging, labelling, and distribution strategy is key to ensuring the safe and timely arrival of the product. Delays can be costly, and not just financially, as any deviation from a trial’s tight schedule can postpone the availability of critical therapies.

“We’re working on timelines that are very, very tight,” he explains. “If something goes wrong with that drug product, not only is it difficult to replace, but it’s also difficult to manage the associated delay, because more than likely they’re [the client] waiting on that product to arrive, to start dosing patients for those clinical trials.”

He continues: “It all comes down to having the right people in the right roles, and making sure that you have the right knowledge and expertise to be able to ensure that that product is managed in the way that it needs to be managed and that you’re really tight on those controls because some products are very temperature sensitive. If they go into excursion, they could be lost for forever.”

But timelines are not the only problem that keep clinical supply managers up at night. Unlike the commercial supply environment, clinical supply is a changing beast – often beginning in one point and ending with a new suite of packaging and labelling requirements that need to be managed.

“Some of those changes could be the addition of another country, the addition of more patients, other changes that they want to make and incorporate. Again, there’s not a whole lot of time to do that,” says Barone. “We have to figure out, through our knowledge, expertise, and connections, how to mitigate and manage all of those changes appropriately, so that the FPI [first patient in] is not jeopardised.”

Championing the human element

As Barone previously mentioned, at the heart of every efficient clinical supply chain is a team whose skills, dedication, and collaboration define the success of clinical trials. To effectively keep all the wheels turning, and quickly pivot to accommodate incoming changes or address supply chain challenges, you need to have the right people in place: individuals who not only possess the necessary technical skills needed to get a product from A to B, but who understand the dynamic landscape of clinical trials.

“What defined our success, when I was on the client side, was working with a team of true experts who understood clinical supply – not just supply chain management, but clinical supply chain management, because it is its own beast.

“One of the things I did when I came on this side was to make sure people were in the best roles for them and for us, as well as bringing in some people who could really help us elevate our game.”

Prioritising the expertise and innovative thinking that individuals bring to the table throughout the organisation is a distinguishing factor for Barone, as he notes that the majority of competitors in clinical trial supply management share similar capabilities in technology, such as refrigerated storage, frozen storage, and ultra-frozen storage.

“We really have spent a considerable amount of time pulling in as much expertise as possible, in the different applications, to be sure that we gave our customers everything that they needed to be able to deliver successfully,” he explains. “That includes quality and compliance all the way down to the technician level. Because, at the end of the day, there’s a fine line between right and wrong.

“When they’re printing those labels, if we don’t have good technicians that are physically inspecting those labels and using our automated equipment to inspect them and making sure that they monitor the signals for when something might be incorrect, a label could very easily go out incorrect, and that could destroy the timelines.”

Golden rules for clinical supply management

Overseeing so many variables is a difficult task, but there are ways to mitigate the risk of deviation. To that end, Barrone offers three golden rules for companies to focus on, to help clinical supply management deliver their best work.

Rule 1: Information is power

Barone emphasises upfront communication and information sharing as the cornerstone of successful clinical supply management. “The more information we can get upfront, the more we can put together the right timeline and avoid false expectations,” he states. This philosophy extends beyond basic details, encompassing a wide range of data crucial for accurate planning and efficient execution.

Rule 2: Building bridges

Collaboration forms the second pillar of Barone’s approach. He stresses the importance of fostering open communication throughout the process. This includes building strong relationships with clients, ensuring they understand the provider’s capabilities and limitations, and being transparent about potential constraints.

“We can always create more,” he says. “We can build more facilities, we can add more, we can buy more freezers. We can do all that stuff, but I want to make sure that we’re not over-promising and under-delivering. It’s really about understanding what it is they want, and then on our side, doing that right assessment, to say, ‘We can deliver on this commitment. We have the capabilities, capacity, and storage’. We don’t want to just take, and then fail to deliver.”

Rule 3: The right people, right tools

If you haven’t already noticed, Barone strongly values the contributions of experienced and expert individuals. Investing in people makes a big difference, he explains, because those individuals will ultimately drive your success. “If you don’t have the right people, you’re not going to get far,” he states.

A burden worth bearing

While he may enjoy the challenge, Barone doesn’t shy away from acknowledging the complexity of his field. However, he notes that overcoming every hurdle to keep research progressing gets us one step closer to the most important element of the clinical trial supply journey.

“At the end of the day, we’re talking about some very sick people who have tried everything else and they’re participating in clinical trials because they have no other options,” he explains. “Getting them the drug product that they need, and making sure that they get those doses, and not only get them, but get them on time is very important to me.

“It’s really non-negotiable. We have to throw everything we can at it to ensure that we can get those supplies to those sites.”

As trials grow in both number and complexity, the challenges facing clinical supply management are also evolving. But, for Barone and his team, this is part of what makes the work interesting.

“[Clinical supply management] is a very complicated process, and there’s opportunity for mistakes, so many different ways every day,” he says. “It’s not a routine day in, day out. You really come to work every day, and you’re really pushed hard.”

“It’s probably why I only sleep like four hours a night,” he jokes.

Rocco Barone is the senior vice president & head of clinical supplies management at Clinigen. Barone holds a Bachelor’s in Chemistry and a Master’s in Business from Moravian University, US, and has more than 18 years’ experience in supply chain and GMP related processes. His expertise includes implementation of latest operational strategies & technologies and operational management with successful application of lean methodologies. After obtaining his undergraduate degree, Barone joined Merck (MSD) as a production scheduler and subsequently held roles of increasing responsibility. His last position, before joining Clinigen in 2022, was director and site head of Merck US clinical supply operations.

Eloise McLennan is the editor for pharmaphorum’s Deep Dive magazine. She has been a journalist and editor in the healthcare field for more than five years and has worked at several leading publications in the UK.

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