What is a Liaison Research Organization?

Dr. Antonio Tito is the Founder and CEO of rEthix in Houston, Texas. rEthix is the world’s first Liaison Research Organization (LRO) facilitating clinical trials in Mexico and Latin America.A search of clinicaltrials.gov shows that several large pharma companies are currently running trials in Mexico. rEthix is leveraging the ICH (International Council for Harmonisation) guidelines to run these trials in Mexico and use that data to support IND-enabling studies in the US. The ICH sets the guidelines that the FDA and equivalent agencies in other countries follow. COFEPRIS, the Mexico Ministry of Health, assesses the laboratories. rEthix also prepares those laboratories to pass that assessment.One advantage is cost. According to Dr. Tito, the cost of a trial in Mexico may be 15-25% of the cost for a similar trial in the US.Another advantage is meeting your goals for testing diverse populations.While it’s common to run trials in Mexico, it is not common to start them there. …that is reflected only that only 3. 5 percent of new drugs are generated out of Mexico. And most of that has to do with communication. It's important that we have these type of channels, like the one that you are promoting, Chris, to teach people that it's okay to start your clinical trial in Mexico. You can approach the FDA about it. Be very transparent with the FDA always. But don't let the communication gap, not only the language, but also the culture… the paperwork is very extensive in Mexico.Don't let that stop you from generating data that you can later use for submitting to your investors and, obtaining more funding.Antonio also mentioned the opportunity to expand into Latin America with, for example, devices already approved in the US.For a 510K device that you already have obtained approval for in the U. S., You can easily transfer that into Mexico very simply because you have all the data that you've used, you’ve generated it to demonstrate that it works and is similar to other predicate devices out there in the market.And you've generated that information for your filing for the FDA. All that information can be then translated by our team and we can pass it on to COFEPRIS and the process is similar to the U. S. as well. But it's... You get the advantage of tapping into sometimes virgin markets where there is absolutely no other alternative to that device or to that diagnostic in Mexico or Latin America.So you have a winning hand in leveraging tactics to negotiate with, like commercializing agencies in those countries. Whereas in the U. S., you have more competition. It takes longer to get your market traction. So it's a win-win situation.Not subscribed yet? Let’s fix that right here.Thanks for listening to the podcast and sharing this post.rEthix is developing an app…Let's say you have a new discovery in your research institute, and you've received approval from your tech transfer office to take your technology out into the commercial markets and you have partnered with us to help you get your innovation out. We are, as part of the app, what it's going to be, it looks at all the data that you have, implements AI, And determines what is the best pathway in terms of the study design, the type of protocol that needs to be developed for better for commercialization for your device or your drug or your diagnostics. Until the app is ready, they are building an incubator in Houston at the medical center to connect life science companies to share ideas and facilitate access to data that will generate traction for IRB studies in Houston.Your deepest insights are your best branding. I’d love to help you share them. Chat with me about custom content for your life science brand. This is a public episode. If you would like to discuss this with other subscribers or get access to bonus episodes, visit cclifescience.substack.com