Darshan: Hey everyone. Welcome to another episode of DarshanTalks. We actually are live on Periscope and on Facebook live and we have Nirpal Virdee with us from sir, Tara and Nirpal are famous for those of you who don't know he was on the NASDAQ building yesterday. He had two different pictures on there cause uh, the company went live, uh, when had an IPO yesterday. And, um, we're really, really excited to have him. Uh, but Nirpal is going to be talking to us about Brexit. And um, for those of you who, who have gone, wait what's Brexit, it's been a while since we've heard about that. Um, we will talk a little bit about what Brexit is, but more importantly, how did that impact, how, how the UK approved the COVID vaccine first and what are the implications of that on future?
Intro: This is the DarshanTalks podcast, regulatory guy, irregular podcast with host Darshan Kulkarni. You can find the show on Twitter at @DarshanTalks or the show's website at darshantalks.com.
Nirpal: Yeah. Hey Darshan, nice to be on again and live. Every time is a, is a slightly different experience. So this is fantastic. We're on camera as well. So, uh, you know, I've had to sort of beat myself up a little bit though. I didn't have time, so this is great. Um, so I'm there Paul being on your show before I head up transparency and disclosure, um, here at Sitara. Um, so you know, all the things that, you know, we generally like to talk about in terms of, you know, sort of, uh, getting data back out to patients and healthcare practitioners, all the regulations and laws, uh, normally falls under my purview, uh, within Sitara. So, um, uh, it's going to be a fascinating conversation cause I know we ended our last talk on Brexit and surprise, surprise we're back on Brexit again. So let's see how we go.
Darshan: Let's ask the basic question. Cause there's some people, uh, especially in the U S where we kind of go, if it's not happening to us, that doesn't happen at all. So, so what is Brexit again?
Nirpal: Yeah, million dollar question. Um, so, so the, the UK is, uh, has decided in a referendum a few years ago now, uh, to leave the E U and there's been a, uh, sort of, uh, you know, a process that's been going on a transition process, but we've actually got a period now, which, you know, we're, we're getting towards. Um, D-Day so, um, you know, the, the end of this year is when the UK officially leaves Europe and we become out of this transition period. So you've probably been hearing on your side some news about final negotiations to try and get some level of, of agreement, uh, you know, for a future relationship. That's a, on a sticky wicket, I would say at this point. So let's see how that goes. Whether we get a deal or come out with no deals, that's Brexit. And obviously it has a lot of implications in many areas, but it has implications too to the space that we work in. So, um, I think that's where we can sort of dive into to see where it affects healthcare.
Darshan: Great lead in. So, so what are the implications that we've already seen? Because again, we haven't even had an official, um, leaving yet, if you will, for lack of a better term. So what do we already know is going to be different as soon as, uh, the UK leaves or even before the UK leaves?
Nirpal: Yeah. I mean, we'll talk about some other, um, you know, sort of topics that are intertwined with this. Um, when we get into some of the, the vaccines and COVID and all of the sort of, you know, potential repercussions it could have on our transport network to even get the vaccine in from Belgium. Um, but yeah, I mean, in terms of, in terms of our space, you've seen that, um, you know, we had a conversation in our, in our last broadcast, uh, just on the fact that, um, you know, MHR re the UK regulatory authority, uh, in, uh, for, for medicines and vaccines, um, you know, has really come out of it. It's, um, you know, connection with you, you and EMA, uh, you know, it was one of the lead countries. So the, one of the things that you are seeing is MHRH has taken a very active, uh, role now with, um, approvals within the UK. So though we're still in a transition period within this funny sort of, you know, sort of, um, you know, balance there where, yeah, where it's like, you know, we're still got one foot in the door with EMA and, and, uh, you know, have to follow some of the things that they have, but MHR, you know, has been gearing up to be its own independent body. And as you saw, you know, you can come out of the blocks really quickly. And, you know, let's go into that a little bit because it's been, yeah, go ahead.
Darshan: We do that. Nirpal. Talk to us a little bit about why would you trust the MHRS? I mean, MHR is just another country. I mean, it's just another agency with another country. Like I, I'm not sure I would trust a random country who, um, who approved, uh, the, the, uh, a new vaccine. Why does M uh, MHR have crept street credit if you will, for lack of a better term.
Nirpal: Yeah. And that's, that's a great point. And, um, you know, uh, one of the big things, uh, within the EMA is, uh, you know, sort of structure previously was that it was based out in London. Um, so the majority of, uh, of the staff were, uh, from, from the UK, of course, with member countries participating. But what you, what you saw within did not model is UK always has, had had a leading role in, you know, sort of the, um, sort of analysis, the scientific, uh, elements of, of EMA and going through those approvals. So it's always been one of the lead countries with the supplemental to actually sort of work on behalf of the European block to make these types of decisions. So I think what you're getting is some great folks that previously would have been part of an EMA decision, actually, you know, sort of, you know, doing this alone with, you know, for the UK regulator. So I think it's, you know, there's behind the scenes behind the sort of the MHRS that's, I suppose, a little bit unknown, uh, you know, sort of worldwide, um, you know, you've got some great capability that was, and that's always been there as part of the European umbrella.
Darshan: Okay. So, so talk to us a little bit about, okay. Where we had the MHRS, we had them come on, we had them look at this, but why were they better prepared if you will? Why, why wasn't the FDA first? That's what I'm coming at from a us centric viewpoint. I mean, we're used to being number one, so, so how, how did you guys get ahead of us?
Nirpal: Well, I, I think it's like how, you know, England's got his test team and when they team right to the top of the rankings. Right.
Darshan: That I agree with that. Okay. Yeah.
Nirpal: Well, the thing is that, um, what we've seen is, um, it has been, uh, uh, uh, a lot of good organization here. Um, of course, you know, as, uh, you know, MHRH was trying to establish its boundaries, um, and work through what it would look like. It's, it has inherited a lot of the good practice that it put together with the AMA. And then as we discussed before, there's been some divergence around, you know, where it wants to go going forward and sort of trying to, you know, sort of, um, you know, take, uh, collaborations with other, um, regulatory agencies outside of Europe. Uh, but what they did with, with, uh, interestingly with, with, uh, with COVID-19 is either really embrace a new way of trying to look through the approval process. So, um, you know, they got, you know, sort of, uh, prepared pretty early on in the summer, worked through how they could actually start analyzing the data, um, you know, as they received it.
Nirpal: So more of a rolling review, um, and trying to run and support the sponsor to run parallel stages and Paolo phases, um, you know, of their trials to try and accelerate it because, you know, obviously we've all wanted to get to this point as quick as we can. Cause, you know, this is the biggest thing that we've ever seen in our lifetime, right. And we're losing people. So I think that that's really the crux of it very well organized, uh, you know, sort of got their ducks in a row early on, were novel in the way they approached it. But once they got through the rolling review, they've used standard processes to underlies the clinical efficacy and the safety efficacy. And, you know, again, I think maybe not just much RA, but across the board, you see that different relationship with the regulators and the sponsors, you know, where they've said, you know, sponsor go, go away and follow these stages and then come to us with data that they've been really collaborative around, you know, the flexibility, you know, let's work with you, that's, uh, you know, sort of see that data early on and what, what, how can we be flexible, uh, in order to, to get to a mutual goal?
Nirpal: Um, so I, you know,
Darshan: Hold on her about what is that mutual goal though, is the mutual goal approval, in which case isn't that deciding, deciding the standard before it's been approved? What was the mutual goals you saw?
Nirpal: You know, I think everyone in our industry, you know, does this, um, you know, because they, you know, want to give something back, right. They feel a connection, uh, whether it's a personal story or whatever it is, but they are passionate people in our industry. Um, and, uh, you know, I think, you know, folks within the sponsor of realization, of course there are organization for profit. That's what they want, they want to make and, and develop medicines vaccines. Um, you know, I I'm, I'm be successful financially, right. Um, but this has been a very different environment in which, you know, they are getting, you know, a lot of support from the governments around the world, they're getting additional funding, uh, where they would have had to try and, you know, work through some of these things on their own. I think that's where the connection connection really is. You know, the governments, you know, really need to find a way in which we can get over this, um, you know, sort of, uh, pandemic the, the crisis it's hard on, on our lives and, and, you know, sort of losing people. And though this is not a completely financial, um, you know, time for the sponsors, you know, there've been well supported and there's, there's a common goal to get these vaccines out as quick as we can.
Darshan: So, so here's my question. Do you think that there were some lessons learned in developing the COVID vaccine that are going to translate into future approvals?
Nirpal: I think, you know, the landscape has changed for good, you know, I think, uh, the, the nature of collaboration that we've talked about, I think now is going to continue on all the way through. I think, you know, we've learned a lot of new things, right. Even working from home in many industries, it's like you, this, this would work for us, but we've proved it does. Right. Um, so I think, you know, a lot of the things that we've seen, you know, these rolling reviews, getting access to the data early, having that, um, collaboration with the sponsor rather than, uh, you know, we're the agency, you're the sponsor relationship. I think those changes are here for good and, and, and, you know, for the better, um, but
Darshan: Wouldn't, wouldn't a group I can, I can see someone coming out and saying what you did was you, you bypassed the idea of, uh, the agency acting as a filtering system. And what you really got was an agency that's partnering with you to bring something to the table, bring something that's approved. And the result of that could be safety issues in the future. Uh, what do you say to something like that?
Nirpal: Well, the thing is, you know, partnership doesn't mean that you, you, you lose your, the accountability that you, you know, the rest with you in that relationship. So, you know, though there might be some, you know, sort of real collaboration to try and facilitate, you know, smooth, the process is just to smooth the process. It's not to shortcut any of the analysis that needs to be done, uh, to prove, uh, you know, something works and it's safe. Um, you know, and th this collaboration is, is all about, you know, sort of streamlining a process rather than trying to change that dynamic in any way.
Darshan: I think it's interesting. You talk about streamlining. One of my more interesting news is news. I came out was this idea that, um, the data that was submitted to the EMA for approval got hacked in and therefore, and the analysis initially suggests whether that's my dog Murphy, there's a, there's an analysis which suggests that, well, one way to speed up the processes or steal it, steal the data from someone else early on. Therefore your approval process will be a lot faster. Uh, what is your take on, um, sorry.
Nirpal: That's okay. Well, I wish he was this quiet or, you know, when I see him in person being on the other side of the campus,
Darshan: Uh, what, what is your take on if we're going to see more situations where data is being submitted to governments and, uh, what the implication of that is actually, you know what, I have an idea. Why don't we hold that question for another podcast? So, uh, any last words before we close this one?
Nirpal: No. I mean, the, the thing is, you know, from a transparency perspective, you know, this is going to be a great journey and I'm really excited of course, for the UK to have been first. And I think, you know, they've, they've shown that there's no shortcuts in the rigor that they go through. Um, that's for sure and everything that they publish, but I am super excited that health Canada, as a, as approved this vaccine, because it now means that we can start to see some of those, uh, reporting, uh, elements that were published in the public domain. I know you're, we'll get there as well, but you know, this point, you know, the they're still further along and haven't got to the approval stage yet. So that, that is going to be interesting. So here's a question before I, before we sort of call it a day on this podcast, um, who approved the vaccine in the UK.
Nirpal: I thought that was kind of interesting as well. Yeah. I mean, the thing is very interesting. So as I said at the onset, you know, we're still on the, the, you know, sort of, um, the transition period within, within the EU. So, um, at this point, um, the image, uh, MHR rate has given the, um, sort of recommendation, if you like, and though it's been publicized that it's a recommended, it's an approval, not technically true. It's still a hot to be secretary of state intervention to give this approval. Um, and when, you know, most of the EMA approval is done before the end of the year, then the UK, um, you know, it will fall under the approval mechanism at least until the beginning of next year. So, um, that's a little bit of the nitty-gritty, uh, going into the same nitty gritty. Uh, we, we recently had approval in the U S except, um, it wasn't an approval either.
Nirpal: It was an EUA and, uh, an emergency use authorization, which is similar to what you're talking about, which is it's sort of a bypassing the system because it's an emergency. So, um, let's see how this all plays out because, uh, at least in the U S one of the things we're looking at now is, um, is this idea of, well, we we've got systems out there, but, uh, OIG, the office of inspector general is looking at issues of fraud. Uh, and, and is there any concern going forward that we shortchanged processes, and this might be also another good sort of conversation to discuss, um, what happened with the Oxford AstraZeneca vaccine and what the implications of that is. So stay tuned. We'll have another conversation with Nirpal very soon. That should be really exciting, pretty quickly. So stay tuned, everyone. Thanks again, Nirpal. Yep.
Outro: This is the DarshanTalks podcast, regulatory guy, irregular podcast with host Darshan Kulkarni. You can find the show on Twitter at @DarshanTalks or the show's website at darshantalks.com.
