Auditing, Artificial Intelligence and Augmenting Pharmacist Options: An Interview With Former FDA Auditor Patrick Stone

Narrator: This is the DarshanTalks Podcast. Before this week's podcast auditing artificial intelligence and augmenting pharmacist options in interview with former FDA auditor, Patrick Stone, Darshan will introduce this episode with the recap for the week of Thursday, July 23rd, 2020. Darshan: This week was really interesting because there seemed to have been two separate issues that have grabbed a lot of the headlines. The first seems to relate to the FDA's announcements. The second relates to clinical trials. Let's talk a little bit about FDA announcements, the most important one, from the perspective of what a lot of people were waiting for is that the FDA just came out with a draft guidance on how to do cannabis related clinical research. The cannabis community has consistently pointed out that the FDA seems to withhold research and discard research. So the idea of putting out guidances on how to achieve that furthers the FDA's position that it wants to encourage the research as appropriate. Second announcement that I saw is the idea that the FDA is extending enforcement discretion for certain regenerative products or regenerative medicine products. Darshan: That should be interesting as well because, regenerative medicine has gotten a lot of FDA issues and while certain types of 361 CTP S have not received attention, some have, so the FDA is continuing to extend its enforcement discretion. The other things to look at is the fact that the European Union is still putting out some more information. And big question is, are companies ready for the clinical trial regulations that are coming out? In the context of transparency, the big one is the fact that there will be a central website that will allow for companies to talk a little bit about the type of clinical research they're doing. That goes to the spirit of transparency. This EU clinical trial portal and database will be a single central portal or platform for sponsors to submit applications and notifications. And it's built to allow one time submission across multiple European countries. That should be interesting for a lot of companies. At the same time, there have been other interesting announcements in the context of clinical research. People are starting to question whether in this era of diversity, why are patients diverse, but clinical research primarily being done on white individuals. Darshan: There is also some question about... well, the FDA also announced for example, that they will resume domestic inspections and foreign inspections probably will be soon thereafter. But outside that piece of clinical research, the other bit of information that did come out is that the US is accusing hackers of trying to steal coronavirus secrets for China. Recently there was another allegation that Russia was doing something similar. So coronavirus is causing companies and countries to try to save lives and why I think that that is inherently a good thing. I'm not sure that stealing researchers is how you get to it, but maybe there needs to be a discussion about how do countries share data in the context of a pandemic. And if all these countries are trying to steal US data, the question then becomes is US really paying for research in the beginning itself? Are other countries carrying their weight in other times. The other questions that keep coming up are just ways companies should consider doing research, health tech companies are beginning to complain that, while there are concerns around privacy or government surveillance, the fact that there wasn't a coordinated nationwide pandemic response shows the innovation is problematic in the healthcare industry. Darshan: Now inherently, that's not news because I think that everyone knows that that progress ...