Joseph Panetta, Pacific Clinical Research Group - Full Service CRO | LSI USA '24

Joseph Panetta  0:03  
My name is Joseph Panetta. And as you can tell, I am not Australian. But I am here today to answer a question that you probably didn't know you had. Why would you want to do clinical research in Australia? So first of all, how many of you in here have done clinical research? Anybody? Alright, so you guys know how critically important compelling data might be right. So let's start by talking about why you might not want to do any kind of work in Australia. Number one, it's a world away literally crosses the International Dateline, they're literally operating in the future they're in tomorrow already. Secondly, it's very big, it's 2700 miles across that's bigger than the contiguous United States, with a population of 26 million people to put that into context, that's roughly half the size of California's population. And finally, the TGA, which is their version of the FDA is very rigorous and quite complex. But actually, that ends up being in your favor. But let's face it, other countries can offer you easier access, lower barriers to trial deployment. And importantly, for many folks, it allows the physician of your physician to go there and perform the procedure in the room. In Australia, non resident physicians are not allowed to perform the procedure. And sometimes that gives people cause for pause. But the truth of the matter is, if you have a device and a procedure that you plan to deploy globally, don't you want to know how easy it is to train people on it. So we come to an if then, if FDA approval or US commercialization is in your sights than tier one, quality data is critical for your success. So let's dial back for a second. Speaking of tier one quality data and what the FDA regards during the TCT last October, we attended a panel held by the FDA on the evolving clinical trial landscape in the US and outside the US. And they plainly said, data from nations whose standard of care meets our own, and whose protocol procedures mirror our rigor, that data will be considered. And that is where Australia can benefit you. So the reasons that they cited were, there's wanting enthusiasm for the AFS program in the United States, it's just really hard to get it done, right? It's been on for a decade, and we keep hearing time and time again, at this conference, you're up some mess. Even VCs are pushing their portfolio companies to do clinical research elsewhere. If you're a startup in this room, then this pertains to you. cost efficiencies are critical for survival, as well as really good animal labs. And finally, this is something the FDA drilled home very hard endpoint definition harmony, they want to make sure that everyone on the pathway understands the endpoints the same way. So why Australia for clinical research, first money, there's a very favorable exchange rate between the Australian dollar in the US dollar and the euro. And secondly, if you leave this room, not remembering anything else, but this, then I've done my job, the Australian Government wants you to do your research in Australia, to the extent that they will give you back 43 and a half cents for every dollar you spend. To put that in context, a $350,000 trial nets you $132,000 in savings, that's a big number. The second reason you might want to consider is that those centers of excellence as deemed by the FDA, they're the ones delivering that tier one quality data, and they're powered by professional KOLs, world renowned cardiologist, orthopedic surgeons, these are at the top of their game. Moreover, if you have a partner like us with medically trained staff on the ground, shepherding your trial, then you can be assured that that data is going to be superior. Moreover, it gets you speed to trial. So in a country, as small as with 26 million people Australia, we can actually speed your trial deployment much faster. And finally, that regulatory environment, remember I said the TGA is really strict? Well, this is where it pays off. Because not only do you not have a language barrier in terms of communication and that whole endpoint definition thing. But the data that you get is data, the FDA regards I can't stress that enough. So we talked about why What about when these are the first three stages where you're probably going to benefit from using Australia as your clinical research proving ground first inhuman early feasibility and pivotal studies. Now, why when and finally, it's not always 100% the same, some things are different. So as an example, ethics in Australia, in most countries, the ethics team or checkbox exercise in Australia, they hold the marionette strings for everything. In 22 years, PCR G has had one ethics submission that did not get passed through on the first tried. There are multiple ethics committees in each state and some for each hospital. Knowing them and knowing how they work is critical to get to speed for your deployment of your trial. How many Do you have ever seen the TV show to catch a smuggler? It's actually filmed at the Sydney Airport where people are trying to bring contraband into the country. Why are they doing that? Because Australia is very particular about what they let into the country, it has to be labeled a specific way we have seen devices held up for labeling and import, you want a partner who's going to know what it needs to say on the box to get into the country. And finally, governance, governance doesn't look so much different in Australia as it does in other countries. But it starts in a different place. It starts with the Ethics Committee. And finally, this is the way it is executed on a state by state basis and on a site by site basis. So why would you want to listen to us? Well, we're Australia's premier prestige CRO for precision trial execution. We've been doing it for 20 years serving many of the people in this conference a few of you in this room. We have deep ties with more than 30 clinical sites across Australia and New Zealand and we were founded by a world renowned cardiologist. So we're not just in cardiology, obviously this gives you a an overview of all the therapeutic areas that we cover just last year. In the end, we would welcome you to do your trial in Australia. Thank you