GAFAMS, STARTUPS & INNOVATION IN HEALTHCARE by PHARMAGEEK

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[From The Readout by STAT] With 3-D printing, the drug industry is “going to be only bounded by imagination” in how to design pharmaceutical products, Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said on December 5, 2017, at the FDA/CMS Summit in D.C.

“You can imagine printing a drug on a film and so then you can sort of cut pieces of film [to decide] how much dosing you want, or tear it off like candy that comes in little squares,” Woodcock said.

Woodcock also said that drugs could be printed on top of devices — perhaps an implantable device coated with a therapeutic film.

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Once considered a futuristic technology on the distant horizon, 3D printing of medical devices, medications and human tissue is quickly becoming a promising reality. Patients have already benefitted from 3D printed medical products through access to personalized devices and innovative drugs that have led to significant health improvements. But the FDA is now preparing for a significant wave of new technologies that are nearly certain to transform medical practice. We’re working to provide a more comprehensive regulatory pathway that keeps pace with those advances, and helps facilitate efficient access to safe and effective innovations that are based on these technologies.

The FDA has reviewed more than 100 devices currently on the market that were manufactured on 3D printers. These include patient-matched devices tailored to fit a patient’s anatomy. Examples include knee replacements and implants designed to fit like a missing puzzle piece into a patient’s skull for facial reconstruction. We also approved the first drug produced on a 3D printer (SPRITAM), which is used to treat seizures and has a more porous matrix than the drug manufactured in the traditional way, enabling the drug to dissolve more rapidly in the mouth to work faster. This is likely just the tip of the iceberg given the exponential growth of innovative research in this field. We envision that burn patients in the near future will be treated with their own new skin cells that are 3D printed directly onto their burn wounds. Further down the road, there is the potential for this same technology to eventually be used to develop replacement organs.

Today we are issuing new guidance to help advise device manufacturers on technical aspects of 3D printing, referred to as additive manufacturing, that clarifies what the FDA recommends manufacturers include on submissions for 3D-printed medical devices. It includes our thinking on various approaches to 3D printing, including device design, testing of products for function and durability, and quality system requirements. Overall, it will help manufacturers bring their innovations to market more efficiently by providing a transparent process for future submissions and making sure our regulatory approach is properly tailored to the unique opportunities and challenges posed by this promising new technology.

But this technical guidance -- categorized as a “leap-frog” guidance because it helps bridge where we are today with innovations of tomorrow -- is only intended to provide the FDA’s initial thoughts on an emerging technology with the understanding that our recommendations are likely to evolve as the technology develops in unexpected ways. We are already seeing the beginning of this evolution as hospitals and academic centers use their own 3D printers to create innovative dental implants, replacement knee joints, and experimental heart valves and bone implants for use in clinical studies. An increasing number of surgeons across the country have been saving infants born with a life-threatening breathing condition by creating patient-matched 3D-printed splints to install in their patients’ tiny airways, which expand and degrade as the babies grow.