Podcast Transcript There s clearly no question that without the use of technology, such as IRT, the clinical supply chain to some of the more complex global studies would be virtually impossible to manage, certainly without significant resource implications. Thought Leader: Tony Street, Director, Clinical Trial Supplies and Logistics, Parexel Recording Date: 03/20/2015 Welcome to the PharmaVOICE Webcast Network. In this episode, I meet with Tony Street, director, clinical trial supplies and logistics at Parexel. Tony addresses questions about the role of technology in a fully integrated supply chain, from forecasting and proactive planning, to distribution to sales and patients, to final reconciliation. Tony will talk about the current state of the art and future considerations and prospects for technology to bring predictability, visibility and control to the clinical supply chain. At the end of the podcast, I ll tell you how you can download a related whitepaper on this topic. I m Dan Limbach, your host and producer of the PharmaVOICE Webcast Network. Dan: Welcome to the podcast program, Tony. Tony: Thanks Dan. It s good to be here. Dan: Tony, what are some of the biggest challenges you see today in clinical trial supplies management? Tony: To be honest, I haven t seen much change in this area for some time, but really what we re seeing is a continual drive to do more with less. This obviously puts pressure on resources, time, and budget; and this ongoing drive to do more with less can also drive an increasing complexity of projects with an increase in adaptive designs and inclusion of regions that perhaps may otherwise have been overlooked if there wasn t so much pressure on delivering. 1
It s important to stay away from what I describe as the set and forget mentality. The increase in diversity in countries included the need for our up to date information and management of local regulations and trade compliance to ensure that we can have the best systems in the world managing supply chains, but if something gets held up with customs because we didn t have knowledge of the local regulations, that can be catastrophic. So having that information is clearly key. Lastly, that pressure that I mentioned to deliver more with less can also result in us making decisions perhaps sooner than we would in an ideal world with perhaps less information, and this can result in post go-live changes. How we respond to those changes actually is, again, central to the success of the study. Dan: Very good. What role does technology play today in helping to address the challenges you mentioned? Tony: So I think the first point here is that, from my perspective, I think the technology can be both a barrier and a facilitator in these challenges. There s clearly no question that without the use of technology, such as IRT, the clinical supply chain to some of the more complex global studies would be virtually impossible to manage, certainly without significant resource implications. However, when this technology is applied inappropriately, it really can make changes difficult and particularly in the live study environment. It s important to stay away from what I describe as the set and forget mentality. This can really lead to firefighting and reactive supply chain management. It s very important that we stay focused on the ongoing management of the tools that are available. Over recent years I would say that forecasting has been a real specific area of focus for the industry. I d also say that perhaps it s an overrated word whenever I see concept and slightly controversially, perhaps. But really, I believe that when we implement the word or use the word forecasting, we need to recognize that yes, it s important; however, we 2
Generally we re seeing an increased interest in integration with other technologies and quality systems, such as GMP systems and GMP ERP systems and one key area of focus in that respect is the management of temperature excursions and temperature data associated with products during transit and arrival at site. should also acknowledge the fact that most studies that I m aware of has ever run exactly true to forecast. Therefore, in my opinion, we should dedicate significant more resources to optimizing the supply chain, to respond to what things, like in my eyes to be almost inevitable changes. Really, we can achieve this by building in flexibility in both physical supply chain and the technology to support this. In the past, I would say the set up times have been perhaps more of a concern when implementing systems such as IRT. But really in today s world, I think people are familiar with how long it takes to get system studies up and running. And evolution in technology has left us now where actually the bigger issue of focus is the ability in flexibility to respond to the changes or the post go-live changes that I referred to earlier; being able to manage those changes and being able to integrate those changes or measure the impact of those changes with other technologies, such as PMP systems and ERP systems. That s also a key part of being in development. Dan: How is RTSM and IRT evolving? What enhanced benefits does it bring to clinical supplies management? Tony: Generally we re seeing an increased interest in integration with other technologies and quality systems, such as GMP systems and GMP ERP systems and one key area of focus in that respect is the management of temperature excursions and temperature data associated with products during transit and arrival at site. We ve mentioned on a couple of occasions in this session that agility and flexibility is very, very important and having enhanced system platforms that facilitate changes both pre go-live and post go-live, that s going to be something that s increasingly more and more important to ask clients and to the industry. I think it s also worth noting that it s not just the technology actually that s evolving, but also the way that it s used. Really, with the unified project management approach, both IRT services then integrated into 3
But actually we believe that with the use of technology, we may be able to overcome some of those barriers in the not so distant future. the complete supply chain management process, providing full oversights and insights to the intelligence that s within the data so we can actually use that data and optimize the entire supply chain. Dan: Excellent. Tony, what do you see as some of the future considerations in developments for further improving and simplifying clinical supplies management? Tony: I can think of three key areas direct to patient supply is a very, very interesting area for development, specifically the role of mobile technologies in that area and in managing what is actually from a regulator perspective via complex process, the number of hurdles that may prevent or seemingly prevent direct to patient shipment from occurring. But actually we believe that with the use of technology, we may be able to overcome some of those barriers in the not so distant future. Secondly, I m pretty confident we re going to see greater integration of GTP and GMP systems really moving towards one quality system. We re already beginning to see the competent authorities are expecting the activities with both GTP and GMP as an integrated inspection. I personally have been part of inspections such as that where the GTP inspector from competent authority A has quite simply come in week 1 to do the GMP inspection and on week 2 come in to do the GTP for the same organization. So that blurring of lines is very, very real. I think increasingly we ll see it managed as one process. Lastly, where we re considering the regulations, there s a new clinical trial regulations that is soon to be implemented next year and Annex 6 of those specifically states that expired dates must appear on both the primary and secondary labels. This is in contrary to the current wording in Annex 30, which permits the exclusion of expiratory dates on labels when is absent can be justified through the use of systems, such as IBRS or IRT. This really does present us with something of a challenge in the industry and oddly, it s up to us to redefine the role of 4
I would say planning for the unknown and building flexibility across the entire supply chain, and that includes right through to returns and destruction of accountability piece is something we don t focus on as an industry because we re so focused on first patient in. technology and how we handle what will be inevitable expiratory dates update requirements at study sites and at depo locations around the world. Dan: Finally, Tony, what are the top three areas you d recommend that clinical supplies leaders should focus their improvements or efforts on in 2015? Tony: First, I would say planning for the unknown and building flexibility across the entire supply chain, and that includes right through to returns and destruction of accountability piece is something we don t focus on as an industry because we re so focused on first patient in. But that will always leave us with a nasty supply at the end of a project if we don t focus on that right at the start, and really move away from that set and forget mentality that I referred to earlier. The second area that I believe should be focused on truly understanding all of the cost drivers in supply chain and traditionally the supply chain managers the focus has been on minimizing shipment costs and minimizing wastage. But there is also a cost associated if we run too lean. For example, the cost of stock out of sites can actually have a much more significant impact on the cost of the study, including potential protocol violation and at worst case, patient s data being excluded from analysis, which clearly has a significant cost associated with it. And then finally, the amendment in the regulations that is coming with the expiratory dates requiring to print everything on both primary and secondary packs. That is something that s going to present a challenge to some organizations and it s going to come whether we like it or not, and it certainly is an area where we need to put our attention in planning for managing that process. Dan: That s some great advice. Tony, I want to thank you for sharing your thought leadership and expertise with us today. 5
Tony: Thanks Dan. It s been a pleasure. And that does it for this episode. To download a related whitepaper on good manufacturing practices, entitled Optimizing the clinical trial supply chain, go to PharmaVOICE.com/whitepapers and locate the listing by title. And don t forget to check out our other podcasts at PharmaVOICE.com/podcasts. Until next time, I m Dan Limbach. 6
Over the past 30 years, PAREXEL has developed significant expertise to assist clients in the worldwide pharmaceutical, biotechnology and medical device industries with the development and launch of their products in order to bring safe and effective treatments to the global marketplace for the patients who need them. Headquartered near Boston, Massachusetts, PAREXEL operates over 70 locations throughout more than 50 countries around the world, and has over 11,000 employees. To learn more, please go to www.parexel.com. 7