First, file a patent. Then get your study published by a medical journal.
How far has your research gone? Do you have results from infected patients or just from culture lines? Have you made comparative trials vs. all of the current methods?
Pharma companies will ask questions like these before they get interested in your idea, but at this early stage their support may consist simply in funding more studies. And you will absolutely need to get studies published, even before you call a pharma company, to make your idea visible.
But ultimately, adopting your method as the standard is not so much the pharma company’s decision. Doctors won’t routinely use it until it’s endorsed by a guideline document from whatever association of infectologists publishes those guidelines, and those guidelines are only published every few years or so, at their big meetings. And they’ll want to see LOTS of confirming studies before they say everyone should use it.
Whatever pharma company buys your method may also need to show the studies to the FDA before they can legally promote it.
So, congratulations for making history, and brace yourself for years of paperwork.
(Don’t get too stressed. You’ll laugh at it all after the Nobel committee hears of you.)
But ultimately, adopting your method as the standard is not so much the pharma company’s decision. Doctors won’t routinely use it until it’s endorsed by a guideline document from whatever association of infectologists publishes those guidelines, and those guidelines are only published every few years or so, at their big meetings.
Pharma representatives who pitch products to doctors do have some influence on what products those doctors use.
True, but in order to promote the product, the sales rep has to cite the supporting literature and be ready with evidence to address doctors’ objections. It’s another side of publish or perish.
Hey, thanks a lot for your comments and for your encouragement! :)
Have you or anyone you know gone through this process before?
I ask because I’m a programmer (my friend is the cell biologist) and so what I’m familiar with is making a quick MVP to show to a party responsible for doing the purchasing.
To answer your questions: the research is all done and we can make a demo of the diagnostic in a long weekend; our results so far are not on patients, just culture lines; and there’s no need to do comparative trials since antibiotic tests in use in hospitals all require culturing which takes far longer than our method.
I haven’t gone through the process, but I work at a publishing house specialized in medical literature, and I’ve learned some things about drug development.
After you file your patent, I recommend you partner with a university hospital to run trials on patients. (As a routine step, the hospital’s ethics committee will ask to review your study protocol to check that it complies with the Helsinki Declaration on human experimentation.)
It’s very important to test your method on samples taken from patients, though you may start with lab animals divided in groups whose infection status you’re blind to. With culture lines you already know what’s in the Petri dish; now you need to see whether it detects the right organism when you don’t know what the patient has, or whether it’s actually an infection in the first place. Parameters other than speed (namely, diagnostic sensitivity and specificity) will be essential in positioning your method against the existing ones.
Edited to add: you also need those trials to find out whether there’s any class of germs that your method cannot detect. I don’t think you have tried with all possible pathogens.
First, file a patent. Then get your study published by a medical journal.
How far has your research gone? Do you have results from infected patients or just from culture lines? Have you made comparative trials vs. all of the current methods?
Pharma companies will ask questions like these before they get interested in your idea, but at this early stage their support may consist simply in funding more studies. And you will absolutely need to get studies published, even before you call a pharma company, to make your idea visible.
But ultimately, adopting your method as the standard is not so much the pharma company’s decision. Doctors won’t routinely use it until it’s endorsed by a guideline document from whatever association of infectologists publishes those guidelines, and those guidelines are only published every few years or so, at their big meetings. And they’ll want to see LOTS of confirming studies before they say everyone should use it.
Whatever pharma company buys your method may also need to show the studies to the FDA before they can legally promote it.
So, congratulations for making history, and brace yourself for years of paperwork.
(Don’t get too stressed. You’ll laugh at it all after the Nobel committee hears of you.)
Pharma representatives who pitch products to doctors do have some influence on what products those doctors use.
True, but in order to promote the product, the sales rep has to cite the supporting literature and be ready with evidence to address doctors’ objections. It’s another side of publish or perish.
Hey, thanks a lot for your comments and for your encouragement! :)
Have you or anyone you know gone through this process before?
I ask because I’m a programmer (my friend is the cell biologist) and so what I’m familiar with is making a quick MVP to show to a party responsible for doing the purchasing.
To answer your questions: the research is all done and we can make a demo of the diagnostic in a long weekend; our results so far are not on patients, just culture lines; and there’s no need to do comparative trials since antibiotic tests in use in hospitals all require culturing which takes far longer than our method.
I haven’t gone through the process, but I work at a publishing house specialized in medical literature, and I’ve learned some things about drug development.
After you file your patent, I recommend you partner with a university hospital to run trials on patients. (As a routine step, the hospital’s ethics committee will ask to review your study protocol to check that it complies with the Helsinki Declaration on human experimentation.)
It’s very important to test your method on samples taken from patients, though you may start with lab animals divided in groups whose infection status you’re blind to. With culture lines you already know what’s in the Petri dish; now you need to see whether it detects the right organism when you don’t know what the patient has, or whether it’s actually an infection in the first place. Parameters other than speed (namely, diagnostic sensitivity and specificity) will be essential in positioning your method against the existing ones.
Edited to add: you also need those trials to find out whether there’s any class of germs that your method cannot detect. I don’t think you have tried with all possible pathogens.