Hybrid Approaches to Clinical Trial Supply- Steven Jacobs Interviews Stuart Pullen
Stuart Pullen Global Clinical Supplies Manager Allergan Ltd
Stuart has been the Clinical Supplies Planning Manager for 5 years at Allergan. His background is in new product introduction to commercial pharmaceutical packaging and tablet facilities. Previous companies include GSK, Roche, Eli Lilly. In this interview Steven Jacobs, President at Global Biopharmaceutical Resources Inc. interviews Stuart Pullen about the difficulties in forecasting changing priorities and requirements in clinical trials. Stuart describes what are the characteristics of a good supply team and the two discuss the hybrid approach of in-house and outsourced capabilities at Allergan along with tips for dealing with vendors.
Steven Jacobs: So what are the biggest challenges that you face of Allergan on a day-to-day basis?
Stuart Pullen: Biggest challenges we face I guess in terms of forecasting for IMP are studies that pop up out of the blue, studies that will be low down on the priority list and then because other projects drop out will get escalated up in the priorities. Some of the other challenges that we face is going into new countries and how we can forecast for the supply chain to go in there and whether we would set our IVRS configurations differently in different countries, considering how many shipments you want to put in and how that has an effect on the forecast as well.
Jacobs: If you could ask your stakeholders for anything, what would you ask for and why?
Pullen: Long-term planning with regards to protocols. I know it's very, very difficult to achieve it, but firm dates as to when protocols are going to be approved, good intelligence about different countries and when those dates are going to be approved so that we can then relate that back to the manufacturing plant, get appropriate manufacturing dates, which gives us appropriate expiry dates, which means that the supplies are good for the life of the study.
Jacobs: What characteristics make your supply team good and what can make them even better?
Pullen: Another big question there. One of the things that I think is absolutely great about the setup that we have at Allergan at the moment is the fact that we have in-house dedicated clinical supplies packaging teams, so that means that we can adjust our priorities very, very quickly. We've got the ability to be able to react to those requests in the US and in the UK, and I think that that's a really big advantage over some companies that only have the outsourcing option because no matter how good your relationship is with that organisation you're always going to be not necessarily competing, but there's always going to be another company who's vying for the line time at that contract manufacturing organisation. So having the in-house team, from a quality perspective, from a manufacturing perspective and from a planning perspective, the three really knit well together.
Jacobs: So you have in-house and outsourcing capability, which is wonderful because you actually have a nice hybrid approach. What is it that makes you successful with your vendors and how do you actually go ahead and really make it a good partnership?
Pullen: Working with vendors is always going to be a challenge, especially when you've got systems and processes that you're used to that may not necessarily marry up to the systems and processes that that vendor uses. So I think vendor selection is a very important part of it, clear and open communication and regular communication as well, making sure that expectations... everything is set up well in advance of any manufacturing dates and really just to try and minimise the surprises really.
Jacobs: So based on that good relationship that you have with your vendor, how often do you talk and how often do you meet and, most importantly, how often do you go out for drinks with each other?
Pullen: Well, going out for drinks together, the main vendor I'm working with at the moment is at the other end of the country, so I'm afraid to say that that's not really possible. But speaking, we speak weekly. With regards to your other question, I think the frequency of the meeting is based on the stage of the trial. So are you at the very early stages? Are you still in setup? Are you making three shipments a week at the back end of a trial? In which case you probably only need to meet monthly, if at all. But at the moment the trial that I've got in mind in particular is in its phase of setup and we're just about to take delivery of the stock, so we're in daily contact.
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