In November, 2013, Joseph Iacobucci was named vice president of Clinical Supplies and Services at Xcelience. Mr. Iacobucci will oversee the company’s first international expansion in Birmingham, UK, which includes a new depot labeling facility that provides a central hub for labeling and distribution throughout Europe, and is the first step in a multi-stage plan to provide global clinical packaging and distribution services. We spoke a few months into Mr. Iacobucci’s tenure to discuss the company’s move into this space, the opportunities and challenges, its plans for expansion, and how the clinical services sector has evolved during his 30 years in the industry.
—Gil Y. Roth
Contract Pharma: Tell me about your new role at Xcelience.
Joseph Iacobucci: I’ve come aboard as vice president of Clinical Supplies and Services at Xcelience. That covers clinical supply packaging, project coordination, distribution, logistics, storage, returns, drug accountability and destruction of investigational products. The group here is fairly new and we’re trying to build it up to the next level.
CP: What’s your experience in this sector?
JI: In my previous life, I started as a formulation scientist, then went into clinical supplies at two pharmaceutical companies. I joined a specialty vendor called Clinical Systems in 1990. It started as a software company that worked with clinical supply groups and developed a clinical labeling and randomization system. I stayed there for 23 years, until taking this role with Xcelience last November.
This move is an opportunity to get back to my roots, and have all the pieces in place to build something special. It’s such a great group of people to work with here in Tampa, FL.
CP: What’s the culture-change been like for you?
JI: I grew up with Clinical Systems, in more ways than one. I was part of a team and helped build the company but also grew with it. Now I’m at a much larger company; Xcelience has 120 people and is growing every day. So it’s going from a micro-focused company to one that has a suite of services, from analytical and formulation to manufacturing and clinical supplies. In comparison, it’s much more like when I worked at pharmaceutical companies.
CP: What’s the biggest opportunity you see for the company in clinical supplies?
JI: Xcelience brought me in because they want to create a center of excellence for clinical supplies. With that suite of services I mentioned, the idea is that a client’s drug can go through the entire pathway. Adding clinical supplies, packaging and logistics really fits in with the existing offerings at the company.
It’s a great opportunity and we’re working with some very important customers to build this. This business is all about relationships; I’m here to help build very deep relationships with key customers.
CP: What are the challenges in trying to scale up a clinical supplies business like this?
JI: There are two major challenges. Number one is getting the word out. Xcelience is respected and well known in the scientific side of things: analytical, formulation and GMP manufacturing. Getting potential customers to see us as experts in clinical supplies will take some time. Scientists and formulators know who you’re talking about when you mention Xcelience, but this is a new area for the company, so getting the word out is important.
The second challenge is managing the work that is already coming in! We have key customers bringing us projects, so the challenge is managing growth. The best thing I’ve encountered since I came to Xcelience is the quality of the people in my Clinical Supplies group. They’re the key to overcoming the growth challenge.
CP: How has the business changed in the decades since you began working in clinical supplies?
JI: I started in the early 1980s, and things were a lot simpler. The clinical supply group was an internal resource for pharma companies. It was almost viewed as a specialty pharmacy, where the clinical protocol was essentially a large prescription. Rather than medication going to one patient, it went to many patients. When I started: validation, SOPs, qualification, and quality assurance were new to R&D. We actually had no QA group in the clinical supplies unit of either of the pharma companies I worked for. Clinical labels, variable data: you hand-wrote or -stamped on them. It was a challenge.
There was no e-mail or Internet, of course, which may have been a good thing. No personal computers; an IBM Selectric Typewriter was a key piece of equipment.
There weren’t any clinical supply vendors at that time. If you outsourced, you’d go to a commercial packaging company, and you’d make sure you had a man-in-the-plant at all times. You were using their equipment and their personnel, but they wouldn’t understand clinical packaging, treatment groups and blinding and so forth. The key was to oversee so that you could sleep well at night.
In the ‘90s, more outsourcing started taking place as pharma looked for quicker timelines and other savings. Specialty companies started to form. That permitted more complexity in trials, with IVR systems, pooled supplies, and the like. It’s getting ever more complex, as expert outsourcing companies have demonstrated that they can handle these tasks for large and small pharma. It’s been a huge change.
CP: How have clients’ approach to outsourcing changed?
JI: Everyone, even in the 80s, knew we had to outsource certain things. What’s changed is the perspective or philosophy. In that era, my groups were expected to do the work in-house. We had the resources and the funding, so we did the work. If I had to outsource something—say, blister carding—it took a major justification process.
Over time, the pressure at pharma increased to do the work faster, at the same time that internal resources were cut. When I made the jump to Clinical Systems in 1990, my coworkers thought I was crazy to leave a major pharma job.
CP: So you were a trailblazer!
JI: Not exactly, but I was one of the first to make the move. Around that time, studies just became immense and companies started running massive global trials. Very few companies could accommodate those internally. That fueled the fire to outsource. I think it’s just going to keep growing. The advantage we have is that customers can work with Xcelience all along the path of services.
What drew me here is that idea that I’d be in a position to work with clients that had already come to us to do the formulation and then, say, make the capsules and bring them to my group for packaging and distribution.
CP: You’re working out of Xcelience’s facility in Tampa, FL, but the company is also adding a clinical supplies site in the UK. How’s that progressing?
JI: We’re working hard to get that site licensed by MHRA and hope to be fully operational in a few months. It’ll be under the guidance of a very experienced Qualified Person (QP). There’s already a waiting list for that facility; that’s a nice thing to worry about!
CP: Like you said, managing growth is the second biggest challenge.
JI: It’s good that people are asking, “When are you going to be open?” This move will let us move supplies in to the EU. We’ll package things in Tampa, send it to the UK facility, and distribute it in Europe. We can also do secondary packaging in the UK.
CP: Are you looking at other regions in which to expand?
JI: My primary focus is Xcelience in Tampa and the UK. I’m increasing staff for new projects and customers, installing new equipment, expanding our warehousing/logistics area. That acceleration has our adrenaline flowing.
I don’t think we’ll stop after the UK facility is online. I want to move where the customers want us to be. I have no problem with opening more facilities in global locations: Asia, South America, other North American sites. We’ll see where it goes, and where the customers take us.
You need a vision to do something like this. I know it sounds simple, but if you form relationships with key customers and do a great job for them, they’ll come back to you. A lot of companies can’t get smaller scale jobs done, or don’t feel like they’re working with a real partner, and that’s what I’m here to help us do.
Joseph Iacobucci is currently Vice President of Clinical Supplies at Xcelience where he is responsible for Clinical Packaging Operations, Clinical Logistics and Distribution, Project Coordination, and Return Drug Accountability and Destruction in the US and the UK.
Joe has been involved with clinical supplies for over thirty years. Before joining Xcelience, he was the Vice President of Sales at Clinical Systems, Inc., and previously managed the clinical supplies operations area at Rorer Central Research.