Reverse Supply Chain

Pharma IQ had a quick ring around with some of our trusted experts who are working in clinical trials to get an overview on current and emerging trends in clinical trial supply. This panel of experts included, Robert Bronstein, Director - Clinical Supply Operations, MacroGenics; Robert Smith, Clinical Trials Expert and Steven A. Jacobs, MBA, R.Ph.President, Global BioPharm Solutions, LLC. [inlinead] Cold-Chain Shipments: The industry continues to look for ways to enhance temperature-controlled shipping , distribution and storage. Trying to control the costs involved with shipments can be quite pricey. In the case of the materials that MacroGenics ships, which should be maintained at a temperature of two to eight degrees celsius, Robert Bronstein, Director of Clinical Supply Operations says, “We tend to have a very small payload and a very large shipper.” He explains, “What might represent a pound in total weight of the payload sits in a 50-pound shipper. So, we’re basically paying for 49 pounds of temperature control around that shipment; we’re constantly looking for more efficient ways of doing that shipment.” There is also concern over the amount of time a shipment might have to sit for longer waiting to be processed because of its weight and size. Steve Jacobs, President of Global Pharm Solutions agrees, “The challenge is how to create something that will allow us to maintain the controls for temperature as well as monitor them, especially with regards to each touch point where they move from one truck to another truck to a plane or the warehouse of the sponsor or anybody else?” The industry needs to come up with new technology that will allow pharma companies to have much longer temperature control, not just for cold chain two to eight, but also for controlled room temperature. Just-in-time Packaging : Agile packaging is becoming more and more a topic that you hear about in the industry these days, especially with bio-tech companies. When you’re dealing with a biologic like the types that MacroGenics produces, there are temperature issues and a number of handling conditions, typically, more drug than is absolutely needed for the event comes into the physician’s office or hospital. Robert Bronstein wonders how packaging can be made as agile as possible –“How can we take this material and potentially use it for different studies that are all studying similar attributes of this drug? We’ve started to do more of a just-in-time pack-out versus if we packed 1,000 vials for a particular study and end up only needing 200 of those vials, then we have 800 vials that have to be reprocessed." [inlinead] Product Pooling: Looking at ways to create multiple vials or bottles of material that have a temporary label on them so that they can be used for multiple different trials in multiple different countries? Steve Jacobs explains, "Once again we’re also doing everything we can from a logistics perspective to avoid or decrease waste so that we are not spending huge amounts of money to get these products actually into different countries all over the world and then find ourselves having the material stranded or having to be destroyed in these countries or completely wasted by never even shipping out of the warehouse because the trials goes too long or goes past the actual stability expiry date and we wind up having to destroy that ourselves." Reverse Supply Chain : Everyone talks about their well-defined supply chains, moving drug from point A to point B? If there’s an adverse event that stops the clinical trial or something within the drug that forces the organisation to stop the trial and reverse the supply process, bringing everything back into depots for reconciliation or for destruction. Robert Bronstein explains, “I think every company hopes it doesn’t happen and larger pharmaceutical companies, when you look at the number of drugs that go into phase-two and phase-three clinical trials the number that actually succeed to become commercially viable products is very small. So, there are studies that end that need to have this whole process performed. To get 100% reconciliation of everything that you’ve produced and where it is around the world so that you can demonstrate that there is in fact no lingering activity that utilises your drug is a very complex process - I see that as an area that needs some attention because it’s very costly to do and there are probably methods that can be implemented that will start to help in that reconciliation.” Moving to a strategic outsourcing model: The days of big clinical trials units that a big pharma organisation uses are in decline as companies are strategically outsourcing, through the CROs and contract manufacturing organisations. Robert Smith, Clinical Trials Expert adds. “I think we’re going to see very many more trials moving out to Russia, Brazil, India and China, that is where the big patient supplies are - you get better recruitment and the investigators out in those countries are very motivated to provide good quality data.” But there are continuing concerns over security and temperature control. “We’re getting more and more into the biotech and the large molecule products, we’re actually now starting to see a trend developing that will probably develop strongly over the next five years, so we’re not just worried about security and temperature control. We’re also going to start worrying about pressure, about humidity, and about vibration,” Steve Jacobs adds. Increased use of IRT : More companies are starting to use technologies like IVRS and IRT in the Clinical Trial Supply Chain. “ I very much see that you can integrate IRT into the whole of the supply chain, says Robert Smith. “ You can use IRT for simulation and forecasting, managing patient medication, pooling and expiry dating.” Growth of Comparators: More trials are using comparators now versus maybe five or ten years ago. Now, with the use of comparators and the cost of those comparators – not only to acquire them, but for purchasing and even shipping and distribution – anything that will help the Pharma industry with regards to planning and forecasting would decrease the amount of material that would then never be used.

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