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OUTSOURCING SUPPLY OPERATIONS


What do you see as some of the main  “If you think about the way we manufacture drugs in the US, a pharma company will go to the plant that is going to manufacture their drug and schedule the amount they want to make throughout the year. If there is a shortage of the drug, because you have to break down that equipment in between every drug that’s manufactured, clean it and ensure there’s no contamination, the manufacturer can’t comply because they are at capacity for the year. “Equipment for a 3D-printed drug is much smaller than that of a factory or manufacturing plant and you can print in small batches. Plus, you don’t have any waste of the active or chemical ingredient. It could really revolutionise the way we deliver and manufacture drugs around the world. “I believe 3D printing could be a distributed technology. Just like with MRI or CAT scans, you could put a 3D-printing centre located close to major medical centres and different places around the world to allow manufacture there. If there are shortages of an adjunct therapy for oncology, for example, let an academic centre like Harvard print it. “We are not there yet, but just as other


computerised technologies have shrunk, 3D printers will get smaller and smaller over time and be amazing in eliminating waste and being able to locally control the supply chain without security issues like contamination and fakes. “Right now, it doesn’t replace everything. 3D printing is for oral solid medications that have an active chemical ingredient – but that’s around 96% of everything that we take in the US. For the vast majority of things that you put in your mouth and swallow – a pill, capsule or tablet – this is a technology that could replace what we do today.”


  “Personalised medicine came about after we mapped the genome. The promise of personalised medicine is that it’s genetically  able to realise that promise in therapeutics but have a little bit in diagnostics. “Part of the reason is, you need very small batch printing. Your genetics are your genetics.


There may be cohorts that have similar genetics where you can also have a small batch of printing, but it’s impossible to take a large drug manufacturing plant and suddenly specify that to small groups of people in similar situations. The cost would be astronomical. “3D printing could deliver patients something very novel and revolutionary that we haven’t seen before. I don’t know any other way, therapeutically, that we’re going to be able to do this that makes sense economically. So, we think long term, this is the technology that is going to make a difference.”


   “Aprecia is in touch with children’s hospitals that have expressed interest. They often have patients with very rare diseases which have small patient populations, so being able to print small batches would be great for them. “Then, because Aprecia’s ZipDose technology, where the drug just evaporates in the mouth with a sip, is just game-changing for kids being able to take medicine. “Also, it’s not uncommon for folks over 60 or those that have certain diseases to have trouble swallowing. It’s actually a pretty common phenomenon. Having a 3D-printed drug embedded in ZipDose technology is very helpful for people that can’t swallow and are fearful of taking lots of pills, or worried about choking, so they can stay on their medications. “Then if you think about pet meds, giving a cat or dog something that evaporates on their tongue would also be tremendous.”


   “Spritam is what I would call a proof of concept. When you have a new technology, you need to get real-world evidence that your technology works. That just takes time. “The normal regulatory environment at the


 Now they’re doing rapid approval, so things are getting in the market much more quickly. For anybody who wants to do 3D printing, now that the technology has a proof of concept, getting new molecules approved will be much quicker.


Clinical Trial Supply Handbook | 9


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