OUTSOURCING SUPPLY OPERATIONS


“It could democratise who gets access to drugs. COVID-19 is a perfect example”


“I think the issues will not be around FDA


approval, but rather around distributing technologies. Does it have to be in a central location with a traditional drug manufacturing plant, or can you set up smaller centres? Can the laws keep up quick enough? “When I started out in research, the whole


wall was a computer – now, it’s your wristwatch. It’s mind-boggling when you think about how far we’ve come in a short period of time. In the next 10 years, with this technology becoming smaller in size, how do you regulate it in a local setting? You’ve got to make sure it cannot be used for nefarious purposes. There are all kinds of criminal activities within the drug supply chain that you have to be careful about. “To me, those are going to be some of the


challenges, but I think the technology itself will continue to improve and now that the FDA has  the approval process will be quicker for the next drugs coming down the pipeline. “Right now, Aprecia is working with drug manufacturers to look at other drugs that could be manufactured on their behalf. Because it’s an early-stage technology and it’s new in the market, early adopters have to go out and help explain to others what 3D printing can do, how this changes their strategies in the market, and how it makes them more competitive. Aprecia is doing a really great job of that.”


How can 3D-printed drugs improve global health equality? “I do think it could democratise who gets access to drugs. COVID-19 is a perfect example. The solution now is a shot, a vaccine, but people are working on pill forms. Wealthy countries get access to these medicines much quicker than everyone else. If you could distribute this technology, even in a country that has socialised medicine, they can also outsource that to a private drug manufacturer.


10 | Clinical Trial Supply Handbook


“You would hope that, in the long term, these technologies – personalised medicine, small- batch printing, being able to supply drugs when there’s a shortage – could democratise some of the supply chain and distribute it, not just within the US but also globally, to places that don’t have it. It would be less expensive, allow more local control, and more access for patients that really need medications. “ZipDose technology that allows the medication to evaporate with a drop of liquid could be amazing for developing countries where there may be shortages of good water.”


How can 3D-printed drugs reduce waste and be generally more sustainable? “I think the sustainability component of this is really tremendous because you don’t have that big breakdown of equipment that you have at drug manufacturing plants just to do a small batch. That’s lots of work. “Also, think about the carbon footprint of


moving the supply chain around the world. A lot of active ingredients come from China, from there it may go to India to be put in pill form, then it moves somewhere else to get repackaged. It could totally change that supply chain sustainability by cutting out some of those steps and making the manufacturing closer to where the drugs are actually used.”


How could they help in the response to infectious diseases?


“I think this is something that could be really important for infectious diseases. We already have treatments for many infectious diseases and a lot of those are oral solids, like pills to prevent malaria. Again, for anything that’s an oral solid, this is a potential new way to deliver those drugs locally.”


What do you see in the future for 3D-printed drugs? “For us, the promise of this is just going to keep growing as we get more of the traditional drug manufacturers in front of this technology so they can see what they can do and understand  of new technology takes time, but it is absolutely moving at a much more rapid pace  years, I think, will be amazing to watch.”


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