Empowered Patient Podcast How International Clinical Trials Accelerate Medical Innovation with Julio Martinez-Clark Bioaccess
Julio Martinez-Clark, Co-Founder and CEO of Bioaccess, a Latin American MedTech CRO that works with US-based medtech and biopharma startups to conduct their first-in-human trials outside the US to accelerate development and recruitment. Data from overseas clinical trials conducted to international standards is considered valid and can support conversations with investors, strategic partners, and the FDA. Drawing on resources in the Balkans, Latin America, and Australia, clinical trials can get faster approvals, more easily recruit patients, and benefit those living in the communities where clinical trials are conducted.
Julio explains, "The mission is to accelerate global clinical trials, and the type of clients is mostly us. Occasionally, we have European clients, but they're mostly San Francisco-based, Boston-based, San Diego-based, Minnesota-based, or Boston-based companies that are looking to execute a first-in-human clinical study outside of the United States. And for many reasons, Latin America is an obvious choice, at least for the exploratory phase. When they're looking for different countries, they usually explore Eastern Europe, Australia, and Latin America. And we help these companies, which have been predominantly US-based MedTech startups. More recently, we have expanded to biopharma as well. But let's talk with the conversation on MedTech startups, and their struggle to conduct these first inhuman trials in the United States. They seek help when they want to go overseas, and they call for us to help them find investigators and to recruit patients and to get past approvals, etc."
"There is one single thing, which is that these companies are startups. Getting this type of trial approved is really, really difficult and expensive. And the timeline to get them approved is really uncertain. So when you have a startup that has investors backing the company and they have a business plan, they have some milestones, it is difficult to predict when you're going to hit these milestones, and you need to keep the investors happy. So if you don't have a solid business plan, then you are not going to be able to raise more funds to continue your operation and development."
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