Biotech Buzz: Don't Call It A Drug
Worcester firm's technology straddles drug/medical device line
Don't make the mistake of calling Worcester-based Crescent Innovations Inc.'s injectable pain-reducing polymer a drug.
Doing so may cost the company's president, Al Prescott, a boat load more money in developmental and regulatory costs.
Prescott's innovation is not a drug, even though it treats pain like a traditional drug like Advil might, and even though it is broken down by the body and eventually disposed of like most drugs.
Instead, Prescott's proprietary biologically-derived goo (for lack of a better term) is classified as a medical device, due to the way it interacts with the body and the size of its active molecules, Prescott said.
This kind of "clear Jell-O" medical device, as Prescott calls it, is a far cry from the heart stents and artificial joints that most people consider to be traditional medical devices, but its classification as a non-drug offers a marginally less expensive and less tortuous regulatory route to FDA approval.
Drugs, by classification, cause cells to do something different through some kind of physical, chemical process, explained Jordan Fishman, president and chief scientific officer of Marlborough-based 21st Century Biochemicals Inc., manufacturers of custom antibodies and peptides.
Medical devices, by contrast, act in a mechanical way, he said.
Gooey Technology
Prescott's polymer technology then, while not a traditional mechanism like a heart stent or hearing aid, still acts in a mechanical way, by staying outside of a pain or inflammatory-causing cell and bumping into it or bonding onto it and eventually causing it to clear away from a given target area, Prescott explained.
The polymer developed by Crescent Innovations is also not a drug because it does not circulate throughout the body before acting on its target area. The goo is instead injected directly at the target area, another trademark of a medical device, which acts only on one area of the body, Prescott said.
There are three levels of medical classification of products, Fishman explained.
The first, or "lowest," classification includes the types of research and development reagents that Fishman's company produces, suitable for use on animals and only in a laboratory setting.
The next level includes medical devices, which may be used on humans and are closely regulated, but still do not require some of the extensive, and expensive, regulatory approvals that traditional drugs do.
The final level includes traditional pharmaceuticals. They require hugely expensive clinical trials before commercial approval is granted, upwards of several hundred million dollars in most cases, Fishman said.
"In non-therapeutic or non-pharmaceutical medical fields, like medical devices, there is a much lower threshold for approval, which makes them much less expensive," said Fishman.
Which isn't to say they are any less effective than traditional drugs at treating certain disorders.
Prescott's goo was developed in part when his sister-in-law, who suffers from pain in her jaw joint, asked him if he could leverage his chemical engineering expertise to help find a solution that didn't involve jaw replacement surgery or copious amounts of traditional pain-killing medication, which both have potentially severe side effects.
He created his polymer with help from an NIH SBIR Phase 1 study grant, and it was found to be effective in animal testing. He is now in the process of applying for a Phase 2 grant, which will hopefully carry him through clinical trials and eventually to market.
Depending on the kind of biological agent Prescott embeds in his polymer, it can be adapted to treat a variety of disorders. A bone-regeneration molecule he is developing could help physicians avoid having to place pins in severely broken bones by encouraging those bones to bond naturally with one another, he said.
The treatment holds great promise.
Just don't call it a drug.
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