James Whitehead

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Welcome to Vigilance Unplugged, an eloquent life sciences podcast where we explore
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the stories, experiences and ideas that shape careers across life sciences.
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Before we begin, a quick disclaimer. The views and opinions expressed in this
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podcast are those of the participants and do not necessarily reflect the official
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policy or position of Eloquent Life Sciences, or indeed their own company.
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This podcast is for informational purposes only and should not be considered
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professional or legal advice.
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Today, we're joined by a special guest who will share their own journey,
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the experiences that shaped their career, the lessons they've learned,
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and the reflections on the future of life sciences.
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So today's guest on Vigilance Unplugged is James Whitehead, who is currently
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the Head of Patient Safety and Medical Information at EGITIS,
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but more interestingly, also,
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a visiting pharmacovigilance lecturer at the University of Hertfordshire.
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James, thank you for joining us today.
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Thank you for hosting me.
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So we have to go to the question. and the question is is how did you get into life sciences?
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A summer job in fact so I finished university came home
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needed to earn some money and it turns out my neighbor literally across the road was an EUQPV
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and I never knew this so they offered me a summer job I was supporting literature
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monitor so i was reviewing the literature for generics and
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it all went you know pear-shaped from there i carried carried on
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started a degree because i realized that though psychology was a fantastic opportunity
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it really only prepared me for final commission from the head up i really need
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to or neck up even so took the degree and then yeah as you said the rest is history
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So you you you had this summer job internship job whatever you want to call it,
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And then you went off to university.
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So I did a part-time degree in pharmacovision. So I came back from the University
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of Leicester with psychology.
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And then I took a summer job where I worked out. My idea was to go back to university to do a master's.
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When I was younger, I wanted to be cracker. If you remember that chap,
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he used to solve crimes, forensic psychologist.
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I wanted to do that, but couldn't afford to go back to university.
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And what i really enjoyed when i was doing psychology was the whole was the
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the medicine people part and it's something that drew me to farm collisions
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was you know you are supporting patients but there is a key
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operational component to it things can go wrong and how do you solve that and
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if you look at psychology there's a piece around human factors and how and how
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human error can can lead to mistakes and
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and we see that with medicines you know if you miss a signal if you misinterpret a signal
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so it ended up pharmacovigents offered me an opportunity to to merge the the
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science with the business and as i as i mentioned i i felt a bit inferior when
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i was in my psychology degree so that's why i ended up studying at the university of harborshire
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did my msc there and then wanted to teach because i've always enjoyed teaching
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That's that's that's a fascinating railroad into um into into pv and so so you
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came out of university and you had your first job which was lambda therapeutic research right.
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Yeah the company was called pv solutions they were purchased by lambda so pv
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solutions amanda sibley
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ran it and she was my neighbor she was the eqbd for this company also where
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i first met our shared acquaintance pap he was there at the time
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and and yeah they after their acquisition by lambda i i moved over to to gsk
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i was fortunate to get a contract and i i
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guess lots of people say they've got a highlight but from a people perspective
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i think working at gsk was one of my highlights.
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I met some fantastic people and really enjoyed case processing.
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I don't know if people will often say that, but I think my nine months at GSK
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set a really, really strong foundation for my career now, because if you can
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process a case, I think you can understand the down-and-dream activities.
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I think if you haven't processed a case, then perhaps you,
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when you are doing your signal protection work, you might not really fully grasp
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what you're looking at, maybe theoretically, but practically how did that data
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transfer into the case? Why does it look like that?
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So yeah, I had a great time and met some fantastic people at GSK.
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We're sad to leave, but case processing does have an expiry date.
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I guess the variety of cases that you might have had at GSK at the time was
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quite vast as well. It wasn't just post-market safety cases,
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or was it, again, was it quite a surprise?
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So it was a mix. Yeah, it was a good mix. You got trained across the board.
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My focus was on literature, so I only had to process six a day,
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which in the world of AI would be traumatic.
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Okay but i had to read the full literary literary article and i think that that
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in itself is is an important skill set to be able to pull and pass out what isn't relevant
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you know i'm curious in future where whether with use of ai and technology now
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will is that a skill set that will continue to have the ability to pull out
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the right information because we rely on technology to do it anyway that's a
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bit further down the line
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so yeah i focused on literature i never cracked the the v cases so if anyone
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has worked for gsk there were the i think they were the purple cases and that's
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a v and you had to be a very very good processor
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to do that and i never never never hit those heights i i was envious of the
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people that got to do those those vaccine cases
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Do you know it brings back so many memories you're talking about uh like purple
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cases like for for us when we were at azai we had different colors based off the product,
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and the one thing that just reminded me of is the amount of paper cuts i used
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to get just putting the paper into the into the folder,
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so yeah you had a you had a fairly short stint at gsk but like a lot of people
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in the in the uk industry it was it seems to be one of the basis of a lot of,
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our PV leaders right now, including yourself, and then you went off to Astellas.
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Yeah, so
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I started with CROs for quite a while, actually, my career. Even when I was
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at GSK, I was a contractor.
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So I worked at Aselis. I was outsourced to Aselis from a community called Kynapse.
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So I was, Ameri Qureshi saw me at a university, actually University of Hampshire.
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So one thing I'll say is that I'm very lucky in that I seem to be at the right place, right time.
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There is a nice phrase I've heard is luck is the residue of design.
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So it wasn't that I was there out of luck. I chose to be at the course.
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But as a result, I met Homera and got a job with Kynapt. And I think very shortly
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after, I was brought in to support Estellus with the GVP module. So this is 2010.
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Again, luckily for me, I joined Final Curricence at that transition when GVP
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Was going live and we had the modules being released.
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So I was a backfill and had the chance to work with what I think well I have
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very fond memories of this Imperica I still think it was
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a game changer in the industry there are very few systems I think could claim
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that I think Imperica definitely changed changed the game for Signal so I worked on Imperica wrote
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one of the first RMPs for one of their products worked on PSUR so again very
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lucky to have worked in the Netherlands with Stellis on some of their products
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and because they were shifting I got to learn quite a lot around change management
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and how it used to be done and how it needs to be done based on the new modules
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from volume nine to to to gvp so yeah did
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did enjoy it I think I've been very lucky as I said enjoyed my career decisions
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but it was great in that they did have
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a myriad of products and I worked particularly on a paint product there
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And you stayed at estellas for a while right.
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Yeah yeah so i was there for um initially 12 months came back did some ex-evn
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pd work uh supported the ema project the jubilee detection and then they they
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they had me back for another six months
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so i i was yeah that was one of the key outsourcing pieces that um when you
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get outsourced or insourced to a company while i was there though i did i did had the chance to work
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with people like like g healthcare
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it and others on a few pv xd mpd projects so
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i think one of the benefits of my early career was that i got involved with
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lots and lots of things i think if you work in a pharmaceutical company and
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you go straight into to gsk your case process for several years
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and then you might move to single detection but when you are working for an
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outsourcing company or a contractor
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you are forced into lots of different roles so very quickly I got to get involved
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with lots of different things I guess you could have called me a jack in many
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cases a jack of all trades a master of none and that's probably one of the reasons I looked to change
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after several years of kinaps was I wanted to specialize I really enjoyed signal
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risk so that's why I ended up moving to Navitas
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which was here pure consulting I wasn't operating, I wasn't outsourcing I was
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getting to tell people what I think they should do and how they could do it
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better and they should definitely listen to me because I've done it before
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Yeah, obviously, everyone should listen to consultants.
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How did you find that shift? So you went from being essentially sort of CRO,
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sort of thing, insourcing to being a consultant. How was that shift for you?
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And did you enjoy that shift?
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I enjoyed the shift because of the people. So I was very, very lucky,
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again, to work with some fantastic people there.
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Jeff and Neil particularly at Navitas taught me a great deal and I think I went in
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I guess full of heart to to consulting but quickly learned that there is this
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element of silently listening that was important and you don't have to have
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all the answers I think that's something that was a hard lesson for me was
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you don't have to to know it all that there is that time to go right back And
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look, everything's so fast-paced now.
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If someone asks you a question, you can say, I think it's this.
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Or I don't know, but I'll get back to you.
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So the shift did take me some time.
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I've got some less than flattering anecdotes from my very first consulting role with Jeff.
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I think the one I'll call out was the fact that I couldn't work a toll booth.
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And so I'm in my brand new suit, in an Italian blue suit, white shirt.
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Which I've just stored coffee on on the plane and it's 30 degrees in Tuscany
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and I'm running around this booth trying to work out how to press the button
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and I was like this is my first consulting job and I'm sweaty in Italy covered
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in coffee and I can't even work how how to get through at all
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Wow wow wow wow wow i i i,
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yeah i consulting is a is an interesting,
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place to be especially right now where you know the where it's at the crux of
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so many things we have technology that is ever evolving,
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but one of the things that i love about consulting is the sort of high level
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look you can look at industry with.
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You can see what people are doing in their different silos, whether it be the
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company silos or departmental silos.
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And that's the one thing that I think I enjoy about consulting is that whole,
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viewpoint that you don't get when you're in a pharma company.
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And it opens your eyes because you're right.
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It's like when you come out of university, you have that arrogance that you
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think you know everything. And you have the same thing when you leave a company,
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especially your first job.
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You kind of have that arrogance of, yeah, I know what we're doing.
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And then you find out oh wait there's another process there's another way of
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doing things and consulting gives you that vast look at all the different ways
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people know how to turn us through essentially.
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Yeah i mean the freedom that you have in consulting because you don't have to
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often you don't operate the system you can help them understand it i also think
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there's that independence in in consulting so
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I'm a I'm a big fan of benchmarking not because I worked for for purely because
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I worked for Navitas at the time but because I think benchmark is the place where
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you are able to speak to your peers I think that's ultimately it it's you people
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might not like sharing their information but it's actually no different to me
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picking up the phone and saying to you yeah indeed this is what I'm doing what
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are you doing I'm struggling with this
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and consultants get to have that level of separation
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where they can collect all this data and then think about how it could be done differently.
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Because I do think a challenge that we have in our industry is we are stuck
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in 2010 a little with the GVP modules.
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The individuals that built the system originally, following 9A, 2010, are still here.
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And yes, they have led us to this point.
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To an extent they are still working with the processes that they used to to
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operate with they used to know and how do we develop a way to
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build succession build the future talent and talent that will be able to work
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in the current environment i'll put my hands up in 10 years time i'm not going to be
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the man the the person to shape how we should be processing cases because it's
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very unlikely it's very likely that i will not understand all the technology i'll have to
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bring people in but that's where i think consultancy has has a benefit they
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can they can look at the tea leaves a bit more read where it's going and then
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as long as you know if they've developed a sort of trusted relationship with
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with companies then they can start to say look
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plan for this think about being here in two or three years time but again another thing that i've
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don't think we're doing necessarily well there's planning for the future we
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think 6-12 months ahead whereas I'm
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more akin to thinking of 3-5 years but when's the last time you saw a 3-5 year
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safety plan in terms of developing an organisation and who would wait that long?
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I think that is a bang on. And what is also interesting is the fact that the
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organizational change that we're talking about,
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the conversations that we're having right now, are based off these processes
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that we assume is still the way to carry on doing safety.
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I mean, what does it mean by doing safety anymore?
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And should we if we had a blank piece of paper you know you're obviously a company
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that does rare diseases but if you were in a completely brand new biotech,
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blank sheet of paper would you do safety the way that everyone assumes you do
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safety i i don't think you would not with the technology that we have right
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now and you certainly wouldn't think of it,
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in the same workflow ideal that we currently do, you know, and even,
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the silos that we do things in.
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Oh, the scientists do this, the medics do this, the operations team do this.
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I genuinely don't think that's actually it.
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But I think also the issues stem from the GVP as well.
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The GVP guidances have forced us to look a certain way, which was correct at the time.
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We've continued to build off these documents. And I don't know how many we're
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up to now, but I feel like we're up to 36.
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But the point being is that we're making it more complicated.
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And so when technology is being used right now, we're using it on this complicated,
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state, which is this is what we assume safety to be rather than actually let's
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take a step back and decide what is safety.
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Yeah and i think we've slightly put ourselves in a bind also when when we look
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at how we develop our processes because gvp for me get it gave me a guide early
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in my career fantastic tells me what i need to do and i remember
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coming back to my my career at navitas jeff jeff ho said what i think is is
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is paraphrasing but what's your gvp like
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and i was like all crumbs so i sat down and read all the gvp modules just to
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make sure i was ready for for this first the first consulting position which
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was was to look at a whole pv system so it had some benefits but
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my point being is gvp is not overly prescriptive it is prescriptive but it doesn't
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tell people how to write to run their process but because of the way it's written
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we feel that we have to write our process
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that aligns to that and then we
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get stuck in that plus most companies probably started with volume 9x and so
00:18:49.341 --> 00:18:54.991
they then updated it to gvp so they continue to iterate no one has started afresh
00:18:55.252 --> 00:18:56.698
well some companies have
00:18:57.568 --> 00:19:00.448
looked at they'll call it you know a real org
00:19:01.933 --> 00:19:07.452
The people that lead that, the people that make the decisions remain biased.
00:19:07.917 --> 00:19:11.858
And that's inherently human. That's not a negative. That's just, we all have bias.
00:19:13.133 --> 00:19:21.133
I would love to take the ICSRs, take it to university or take it to even GCSE
00:19:21.133 --> 00:19:24.479
level. You know, 14-year-old, how would you do this?
00:19:24.619 --> 00:19:26.597
Or 18-year-old, how would you do this?
00:19:26.958 --> 00:19:31.480
Because actually, it might be very interesting to say, for them to say, why are you doing...
00:19:32.117 --> 00:19:37.313
These multiple checks here why just just process the case at the very end check
00:19:37.313 --> 00:19:39.727
it there or why are you even processing it just
00:19:40.589 --> 00:19:44.143
use artificial intelligence change you know just run it through and then get
00:19:44.143 --> 00:19:48.683
someone to check it so do we that qc check that we talked about so your medical
00:19:48.683 --> 00:19:50.206
review your qc check well
00:19:51.288 --> 00:19:56.606
how would those work in reality in in in a new place so yeah your your blank sheet of paper,
00:19:57.307 --> 00:19:59.821
I think is a great idea.
00:20:00.129 --> 00:20:04.384
I would love to say that I bought a blank sheet of paper to my current company. In my head, I did.
00:20:05.208 --> 00:20:09.313
But I often will find that I have my inherent biases. Well, this is how we did
00:20:09.313 --> 00:20:12.073
it at my previous company. I'll even catch myself saying it.
00:20:12.073 --> 00:20:15.587
Oh, but we did it this way. And I have to stop and say, no.
00:20:16.772 --> 00:20:19.320
Don't want to do it that way because i obviously didn't like it doing it that
00:20:19.320 --> 00:20:24.180
way when i was there so why am i trying to do it here yeah i mean how but indeed
00:20:24.180 --> 00:20:26.182
how would you how would you start again though
00:20:26.829 --> 00:20:30.701
if you had to you know do we have the opportunity if you're an established company
00:20:31.032 --> 00:20:36.303
to start afresh you know what are the risks i guess because if it's not broken in your mind
00:20:38.580 --> 00:20:44.320
So i think i think what we're what we're essentially doing right now with technology
00:20:44.320 --> 00:20:49.310
is just replacing one thing for another we're not we're not innovating and and
00:20:49.310 --> 00:20:51.880
that's my kind of gripe and.
00:20:53.102 --> 00:20:56.109
This is meant to be me interviewing you no one's ever interviewed me before,
00:20:56.860 --> 00:20:59.220
this is a this is a turn of events but,
00:21:00.435 --> 00:21:06.880
but for for me i'm looking at what is the fundamental core question the problem
00:21:06.880 --> 00:21:10.495
statement that we're trying to answer as a as a safety professionals,
00:21:11.272 --> 00:21:16.790
and you know i always look at it and say well for me it's about making sure that,
00:21:17.440 --> 00:21:24.820
our products that we are giving to people are safe for the person that is needing
00:21:24.820 --> 00:21:26.809
that medication and that's kind of,
00:21:27.486 --> 00:21:32.502
the basis of everything that I think about and so when I'm sat here thinking,
00:21:33.328 --> 00:21:37.188
hearing these conversations of you know ai is changing everything,
00:21:37.974 --> 00:21:41.237
and and then the next thing that they say will be,
00:21:41.899 --> 00:21:49.155
oh you can use ai to do literature searching and i'm like is that changing anything that we currently do no,
00:21:49.695 --> 00:21:55.970
then the next question is we can use ai to do narratives it's like great is
00:21:55.970 --> 00:22:00.490
that changing anything that we're doing in safety no we're just we're just changing
00:22:00.490 --> 00:22:03.505
the vocabulary of what we're doing the actual,
00:22:04.039 --> 00:22:07.806
fundamentals that that is there is not changing,
00:22:08.838 --> 00:22:12.205
and we're in a world of so much data so much data.
00:22:13.440 --> 00:22:18.988
That you wonder if there is something that could be done more from a local level
00:22:18.988 --> 00:22:21.920
point of view rather than a global level point of view.
00:22:22.518 --> 00:22:25.148
And what I mean by that is that, you know, at the local level,
00:22:25.148 --> 00:22:35.800
you have specifics with the ethnicities and so forth and cultures of those local countries.
00:22:36.387 --> 00:22:43.858
And the way that they process the drug, or maybe there's like a cohort of people
00:22:43.858 --> 00:22:46.779
that can't particularly do things, that you feel that,
00:22:47.450 --> 00:22:52.258
we still look at things from this global perspective, that safety is literally
00:22:52.258 --> 00:22:55.328
just information in and information out.
00:22:55.954 --> 00:23:00.498
We're not truly looking at the question and answering the problem statement.
00:23:00.956 --> 00:23:04.229
And and and that's why i know that,
00:23:05.010 --> 00:23:08.749
give it five ten years time we will probably do safety in a completely different way,
00:23:09.415 --> 00:23:13.878
i have my opinions and i don't want to carry on because i will i will go on
00:23:13.878 --> 00:23:18.268
forever those of you who have ever met me in a pub will know i can go on forever
00:23:18.268 --> 00:23:24.327
on a lot of these matters so let's move on from where you were at avitas to,
00:23:25.031 --> 00:23:29.199
let's be fair the thing that made you your name. You went to AstraZeneca. Is that correct?
00:23:29.726 --> 00:23:33.567
Yeah. Yeah, I think it did. So I
00:23:35.595 --> 00:23:40.584
you can only talk about how to do something for so long and not have done it
00:23:40.584 --> 00:23:46.029
before people start to question you. And I didn't think I was outwardly questioned. Well, not to my face.
00:23:46.588 --> 00:23:50.611
But certainly felt that I needed to get back into doing.
00:23:50.721 --> 00:23:57.561
So I was very fortunate that a chap called Chemtwey took a chance and brought me up to Cambridge.
00:23:57.935 --> 00:24:04.686
And I joined the oncology group, AstraZeneca, and wouldn't have changed a thing.
00:24:05.296 --> 00:24:08.704
I really enjoyed being based outside of Cambridge and learning a lot.
00:24:10.604 --> 00:24:14.063
It was enlightening to see how such a large company would operate.
00:24:15.086 --> 00:24:19.918
And while I was there, it also allowed me to see where I felt I could offer most value.
00:24:20.151 --> 00:24:24.487
So lots of people talk about the value they bring to organisations.
00:24:25.685 --> 00:24:30.788
And I think that it's a combination of what you're good at, but also what you're passionate about.
00:24:31.628 --> 00:24:38.792
Though i was okay at safety science i think i was i was i was decent enough
00:24:39.511 --> 00:24:43.581
it wasn't necessarily where i thought i could i could help the company the most
00:24:43.807 --> 00:24:51.538
so i again was lucky to have a secondment into the process group and i over over oversaw
00:24:52.078 --> 00:24:57.274
rewriting and redoing the the peer safety area supporting the safety safety
00:24:57.274 --> 00:25:00.491
signal system so they had a new safety system being put in.
00:25:01.568 --> 00:25:05.322
And while I was there, the FDA combination rule came up.
00:25:05.862 --> 00:25:09.844
It was being implemented through our combination products and the EU MDR was happening.
00:25:10.506 --> 00:25:13.112
And there was this gap, I think,
00:25:14.351 --> 00:25:20.347
Success in terms of, I guess, making a name for yourself, but success in safety
00:25:20.347 --> 00:25:25.117
is identifying the gap, identifying what's missing, and whether that's a gap
00:25:25.117 --> 00:25:27.777
in knowledge of a product or gap in process.
00:25:27.777 --> 00:25:34.287
So I was, again, lucky, fortunate to then pick up the FDA combination rule and
00:25:34.287 --> 00:25:35.892
medical devices from a process.
00:25:36.246 --> 00:25:39.236
And when you look at the process, you identify what's missing,
00:25:39.784 --> 00:25:44.444
where you have to adapt the systems. But one of the areas of change was people.
00:25:46.618 --> 00:25:49.433
You mentioned earlier, indeed, that if we had a blank piece of paper,
00:25:49.433 --> 00:25:50.954
would we have some of the silos we had?
00:25:51.740 --> 00:25:56.403
Well, what became quite apparent is the silos between the administration of
00:25:56.403 --> 00:25:58.404
the product and the active ingredient.
00:25:58.758 --> 00:26:03.501
The way that we were operating, there was no safety, merely focus on the device.
00:26:04.099 --> 00:26:08.430
Safety got involved, but it wasn't centralized. There was inconsistencies in risk scoring.
00:26:08.685 --> 00:26:14.213
So after several business cases, and probably often what you don't see is you
00:26:14.213 --> 00:26:18.542
see the creation of a group, but you don't see the 12, 18 months that led up
00:26:18.920 --> 00:26:21.102
and the rejections of business cases.
00:26:21.352 --> 00:26:26.534
After a while, the CMO at the time and the head of safety at the time agreed
00:26:27.283 --> 00:26:32.793
to creating a group. So I formed the device and digital safety group. And by the way, I left.
00:26:33.133 --> 00:26:36.453
I think we're about 13 people, safety scientists, safety physicians.
00:26:36.453 --> 00:26:40.541
And I think we have created a more holistic safety group.
00:26:41.973 --> 00:26:45.006
It wasn't a new idea. I've seen companies like Nova Nordisk do it.
00:26:45.122 --> 00:26:49.423
But then they were pure combination products in my mind at that time.
00:26:49.423 --> 00:26:52.998
They azed 30% of the portfolio was.
00:26:53.619 --> 00:26:57.183
So that was a great opportunity to not only look at process,
00:26:57.183 --> 00:27:01.130
people, governance. It exposed me to so many parts of the business.
00:27:01.653 --> 00:27:03.783
Parts of the business that I would normally get involved with,
00:27:03.783 --> 00:27:05.873
with operations, complaints, EQCs.
00:27:06.621 --> 00:27:11.763
The device engineers. And then also, it brought me into touch with people who
00:27:11.763 --> 00:27:16.391
didn't want to know me, but perhaps needed to know me
00:27:17.391 --> 00:27:19.999
Or I had to ask them, are you sure you don't want to do this?
00:27:19.999 --> 00:27:22.685
Because there is a component of when you take on something new,
00:27:22.992 --> 00:27:28.004
so it doesn't matter whether it's AI technology or you're bringing a new product,
00:27:28.160 --> 00:27:30.601
you can't assume that someone else doesn't want to do it.
00:27:30.891 --> 00:27:34.589
So in my case, it was checking that the clinical group, the medical affairs
00:27:34.589 --> 00:27:37.961
team, they didn't want to do the device work that I was saying that I could do.
00:27:38.338 --> 00:27:41.577
Because why would they not do it? If you look at a drug product,
00:27:42.181 --> 00:27:46.759
you've got your stages, your phases, and you hand off between the groups the
00:27:46.759 --> 00:27:50.669
clinical group to the medical affairs team in terms of you know that that shifts
00:27:50.669 --> 00:27:53.326
your product from clinical development onto onto market
00:27:54.010 --> 00:27:58.279
but with the devices my argument was well that doesn't really make sense i think
00:27:58.279 --> 00:28:00.749
you should have a group that goes all the way through because this device would
00:28:00.749 --> 00:28:03.316
be used in multiple medicines and
00:28:04.670 --> 00:28:10.009
It it would cause confusion from a risk perspective if you started to have a
00:28:10.009 --> 00:28:13.429
difference of opinion on the risk scoring and that would change once you go
00:28:13.849 --> 00:28:16.372
from a clinical setting to a post-market setting
00:28:16.976 --> 00:28:21.057
so again it did require the business to think about safety in a slightly different lens
00:28:21.904 --> 00:28:26.909
now I haven't been successful in doing that in the medicine world but I think
00:28:26.909 --> 00:28:32.399
the the experience taught me that it is worth re-evaluating how you would perform safety
00:28:33.114 --> 00:28:37.049
but that doesn't happen overnight it does take a long time to change people's
00:28:37.049 --> 00:28:41.429
minds on how you can address safety how you can perform safety because we are
00:28:41.429 --> 00:28:43.153
entrenched in what we know and
00:28:43.862 --> 00:28:48.487
we value what we know you know we're comfortable with that and there's a there's
00:28:48.795 --> 00:28:51.465
people like comfort you know change can be difficult
00:28:52.258 --> 00:28:55.430
but there's a lot of change i i mentioned earlier i i
00:28:56.567 --> 00:29:00.817
One of my favorite roles was the GSK processing. What I'm most proud of is probably
00:29:00.817 --> 00:29:04.015
the people that I brought into AstraZeneca for the device and district safety group.
00:29:04.326 --> 00:29:09.241
Really proud of that team. I was really sad when I left them, particularly.
00:29:09.734 --> 00:29:15.827
But you don't get many chances to sort of bring a product to market and head up safety.
00:29:15.947 --> 00:29:20.122
So I took the chance, even though I do miss them terribly.
00:29:20.916 --> 00:29:26.807
And while you were at astrazeneca it it allowed you or enabled you to be,
00:29:27.488 --> 00:29:33.277
more in industry and you know it's it's very evident of how about how you are
00:29:33.277 --> 00:29:38.787
with people are you are you are probably you're more passionate about people
00:29:38.787 --> 00:29:41.317
than maybe pv or if if not pretty much,
00:29:41.947 --> 00:29:45.067
equal equal footing and you,
00:29:46.207 --> 00:29:50.467
it i mean going through your history it seems that astrazeneca enabled you to
00:29:50.467 --> 00:29:53.909
be able to do things like be a guest lecturer,
00:29:54.438 --> 00:29:58.487
EU, 2P, University of Hertfordshire, Transcelerate.
00:29:58.947 --> 00:30:04.877
There seems to be this connection that you then had of being able to go out
00:30:04.877 --> 00:30:08.330
and help people in some sort of way.
00:30:09.247 --> 00:30:12.427
Yeah, so the guest lecturing at University of Hertfordshire and EU,
00:30:12.427 --> 00:30:16.067
2P I had and they allowed me to carry on.
00:30:16.617 --> 00:30:21.038
What I thought certainly changed was my work with the DIA.
00:30:22.699 --> 00:30:28.021
Magnus Yassander, probably, he would be one of the people I would say has changed PV.
00:30:29.247 --> 00:30:33.445
There are a few people I think that have changed industry. I think Magnus Yassander is one of them.
00:30:33.921 --> 00:30:40.162
He asked me, would I be happy to speak on devices in digital? A DIA event.
00:30:40.586 --> 00:30:45.317
I started off with a 30-minute webinar presentation. I think I followed Vicky Edwards.
00:30:46.287 --> 00:30:49.487
And so, yeah, a very hard act to follow.
00:30:51.738 --> 00:30:56.034
That then led to being invited to one hour.
00:30:56.428 --> 00:30:59.894
And then it was, would you like to be part of this committee for risk management?
00:31:00.364 --> 00:31:04.114
And then after, then it was, could you support the EUQPV boardroom for a session?
00:31:04.625 --> 00:31:10.827
Then it was, could you support EI Europe? So I was co-chair for two years on that.
00:31:10.827 --> 00:31:14.077
So Magsysand opened doors. And I think that's it.
00:31:14.077 --> 00:31:20.467
You know companies may give you to allow you to but the connections I made actually
00:31:20.467 --> 00:31:25.497
particularly Magnus and then at the time Ked in allowing me to do this and then
00:31:25.497 --> 00:31:28.968
Ken comes up again with Transcelerate Ken was supportive of me picking up
00:31:29.560 --> 00:31:33.084
the digital health and and the co-lead that one was a
00:31:33.801 --> 00:31:38.827
bit of a funny story because I was one of the the members um sort of the part
00:31:38.827 --> 00:31:42.303
of the team and the co-lead at the time was someone called Anna,
00:31:42.426 --> 00:31:45.319
Anna, Anna Amish, who was at Novartis.
00:31:45.725 --> 00:31:50.947
I ended up hiring her into my team at AZ so she could no longer be the co-lead for the Chancellor.
00:31:52.000 --> 00:31:55.387
And then I became the co-lead. So there is definitely a complaint of,
00:31:55.387 --> 00:31:57.967
did you hire someone so you could usurp her?
00:31:58.658 --> 00:32:02.567
So I always feel a bit bad about that. But yeah, I was lucky enough to bring
00:32:02.567 --> 00:32:06.600
Anna into the company, but then lead the Chancellor team with a chap called Rajesh.
00:32:07.269 --> 00:32:12.428
And I think we were a bit early in our assessment, is PV ready to talk about digital health?
00:32:12.692 --> 00:32:17.057
Similar to what you mentioned around, are we ready to talk about how to do things
00:32:17.057 --> 00:32:18.627
differently from a process perspective?
00:32:19.608 --> 00:32:27.496
I think we're not necessarily ready for the use of digital health technologies to deliver safety.
00:32:28.561 --> 00:32:33.124
That's not us as industry, so pharmaceutical companies, also to regulators,
00:32:34.089 --> 00:32:40.392
because are the regulators ready to embrace remote monitoring and post-marketing and clinical trials?
00:32:41.108 --> 00:32:45.013
Because of my role at AstraZeneca, and again, I'll use, I mean,
00:32:45.164 --> 00:32:51.855
after this podcast, which I was AI, how many times did James say the word luck, fortune or lucky?
00:32:52.244 --> 00:32:55.339
But I was fortunate, lucky and luck
00:32:57.358 --> 00:33:03.761
To be involved in regular discussions on remote monitoring and i think it's clear that
00:33:05.030 --> 00:33:08.891
technology moves so quickly how do they write legislation that allows them to
00:33:08.891 --> 00:33:13.122
do that and if you think of a mission for them and us it's patient safety
00:33:13.714 --> 00:33:18.062
so if you think about it that at its core there are some things that they could
00:33:18.363 --> 00:33:23.965
quite rightly say you can try but we are expecting that you keep the standard of care
00:33:24.592 --> 00:33:26.246
the same as if they were in a in a in
00:33:27.221 --> 00:33:31.990
in the study so if you went to remote monitoring at home cardiac monitoring
00:33:32.810 --> 00:33:37.411
and your lungs be at home they're expecting you to to act immediately if a patient
00:33:37.411 --> 00:33:39.740
goes into cardiac arrest it doesn't matter if they're at home
00:33:40.379 --> 00:33:43.561
because usually they would be in a study site with you but you've sent them
00:33:43.561 --> 00:33:49.150
home with the remote monitoring so you can't wait 24 hours 48 hours to look at that
00:33:49.951 --> 00:33:53.713
so then that becomes a blocker to to remote monitoring
00:33:54.383 --> 00:33:59.051
because we can't agree how to utilize it and that's where I think safety has
00:33:59.051 --> 00:34:03.466
to to to think about well talking of business value so what's value to a business
00:34:03.978 --> 00:34:08.401
but really we get caught up in that what what's the safety value and I would
00:34:08.981 --> 00:34:13.851
I would love to work on something where we're able to start to to add numbers
00:34:13.851 --> 00:34:16.580
to or define what is safety value
00:34:17.124 --> 00:34:20.851
because yeah I think sometimes we get a bit caught up with business value so
00:34:20.851 --> 00:34:24.201
you're doing more for less I hate that phrase yeah
00:34:26.014 --> 00:34:30.554
Yeah, I think that's fascinating. I mean, you're talking about remote monitoring,
00:34:30.554 --> 00:34:37.794
and I've had ideas on this for a couple of years, which is not for today because
00:34:37.794 --> 00:34:38.792
I'm more interested in you.
00:34:39.835 --> 00:34:46.736
And so you leave AstraZeneca in a sort of,
00:34:47.439 --> 00:34:53.354
I'm going to say something very British now, in a sort of top gear going to
00:34:53.354 --> 00:34:58.274
the Grand Tour sort of situation where you're there driving a mustang across
00:34:58.274 --> 00:35:02.217
the desert and you go to agitas and,
00:35:02.908 --> 00:35:05.520
what was your reasoning for that for that change.
00:35:07.475 --> 00:35:16.568
So it felt like the time was right to to look at a a chance to to formulate a pv system
00:35:18.292 --> 00:35:25.054
so when you work for a huge company like astrazeneca that the cogs are huge
00:35:25.054 --> 00:35:29.064
you know there are so many cogs you can't really influence the system too much
00:35:29.064 --> 00:35:30.868
I had implemented with device and digital
00:35:32.703 --> 00:35:36.716
If I wanted to shape or have a go at shaping a PV system, I would have to move.
00:35:37.571 --> 00:35:41.977
And someone got in touch with me to say, this company is looking for a head of safety.
00:35:42.963 --> 00:35:46.381
And I thought, why not? Take a look.
00:35:46.963 --> 00:35:54.443
It gets me back into medicines, pure medicines. Allows me to formulate a system,
00:35:54.443 --> 00:35:57.461
your designer system. Not from scratch, but close enough.
00:35:58.070 --> 00:36:02.203
On my first day, it was the first day a patient actually received the first commercial product.
00:36:02.203 --> 00:36:09.136
So it was very very you know it's new to market it would give me a chance to work on the US
00:36:10.407 --> 00:36:16.503
hopefully we we get approval but yeah it was just a chance to to set up a system
00:36:16.503 --> 00:36:22.538
and operate system and have responsibility for that system which is the scary part the scary part is
00:36:23.384 --> 00:36:28.673
though that I think I'm doing an okay job I have to remind myself that I'm responsible
00:36:28.673 --> 00:36:32.453
for the patient safety system and it and it's everything from psuas to case
00:36:32.453 --> 00:36:35.290
processing to pvas to the qms
00:36:35.708 --> 00:36:39.737
so whilst there was some someone for every single job at astrazeneca
00:36:40.370 --> 00:36:43.157
if there isn't someone in this company it's probably your job
00:36:45.160 --> 00:36:50.123
Yeah that that is interesting going from such a such an established company
00:36:50.123 --> 00:36:54.587
like astrazeneca to essentially a completely new new world,
00:36:55.669 --> 00:37:03.233
one of the one of the the things that i have listened to you in the last in
00:37:03.233 --> 00:37:04.726
this whole conversation is,
00:37:05.191 --> 00:37:10.589
you're very gracious to the people that helped you throughout your career,
00:37:11.318 --> 00:37:15.713
you mentioned ken magnus jeff neil and even the qp in the first.
00:37:15.713 --> 00:37:16.399
Place who
00:37:17.370 --> 00:37:23.888
Who who let you uh have a summer job and maybe again linking this to technology and,
00:37:25.438 --> 00:37:29.806
The realities are is that, and even going back to the blank piece of paper,
00:37:30.260 --> 00:37:36.378
the realities are the way that you learn PV has fundamentally changed.
00:37:36.942 --> 00:37:42.084
And I wouldn't say actually it's due to technology. I think the last several years,
00:37:42.918 --> 00:37:51.306
the shift from internal resources to vendor outsourcing has also increased this,
00:37:52.003 --> 00:37:53.512
what I'm going to call knowledge gap.
00:37:54.983 --> 00:38:03.209
And we've we as a pv group have moved away from again in my understanding,
00:38:03.900 --> 00:38:10.868
trying to solve the the the problem statement to just following and again we
00:38:10.868 --> 00:38:14.274
kind of mentioned that again with the gvp guidances,
00:38:15.355 --> 00:38:23.035
are you concerned about the future of pharmacovigilance talent and how we do safety.
00:38:23.974 --> 00:38:31.038
Yes yeah yeah i really enjoyed switching i enjoyed why reason i think i enjoyed
00:38:31.038 --> 00:38:37.001
consulting process work is that you in effect teach i think one of the
00:38:38.226 --> 00:38:43.548
the pitfalls that that is present in both of those roles is you're teaching
00:38:43.548 --> 00:38:48.068
what you think is is is right because you're in a company however only when
00:38:48.068 --> 00:38:53.203
you get into sort of academic settings are you not teaching a process you're teaching the theory
00:38:53.829 --> 00:39:01.050
and I think I'm not talking of theory of here's how you process the case data entry but the theory of
00:39:02.058 --> 00:39:06.278
what you have to deliver is submitting a case so you need to you receive a case
00:39:06.278 --> 00:39:09.798
and you need to get that to an authority your safe database in effect is a postal
00:39:09.798 --> 00:39:14.917
system but why do we want to to process the case why do we collect
00:39:15.538 --> 00:39:18.168
medical history why do we differentiate between
00:39:19.158 --> 00:39:20.798
concomitant medication and suspect.
00:39:20.798 --> 00:39:26.005
Why do we share and why do we put lab data? Why would you put imaging data in?
00:39:27.293 --> 00:39:32.337
What I'm concerned about is that without the teaching part,
00:39:34.453 --> 00:39:38.253
We will have people who only understand their company's process.
00:39:38.532 --> 00:39:42.203
They don't understand why they're doing it. And they will think they understand
00:39:42.203 --> 00:39:44.013
why. I'm not being rude about them.
00:39:44.433 --> 00:39:48.081
They will think they understand why, but they'll probably understand their company values.
00:39:48.714 --> 00:39:52.243
And their value will be, oh, patience first.
00:39:52.243 --> 00:39:57.333
That is a value. But I'm talking about why do you do case processing?
00:39:57.333 --> 00:40:03.276
Why do you do signal protection and it's a more fundamental than just your company value it's
00:40:03.984 --> 00:40:08.563
a to b it's more than compliance as well so without without courses without
00:40:08.563 --> 00:40:10.248
practical understanding
00:40:10.735 --> 00:40:15.573
of moving it through can we also even use technology so if you don't know how
00:40:15.573 --> 00:40:21.670
to process a case can you really design a process that would that would use technology
00:40:23.062 --> 00:40:28.462
I don't think so and i think i can teach though i can teach pv
00:40:29.174 --> 00:40:32.590
i can't teach some of the skill sets of you know design thinking
00:40:33.200 --> 00:40:37.573
so you mentioned earlier this problem you know problem statements you know there
00:40:37.573 --> 00:40:43.066
was there's some really nice analogy out there on jobs to be done um you starting with the idea i will
00:40:43.670 --> 00:40:47.629
i i think that's what we need to get back to so i think the softer the skills
00:40:47.791 --> 00:40:52.923
will also be lost, those analytical thinking, because we rely on AI to do it.
00:40:52.923 --> 00:41:00.081
So ideally, I would love to see more apprenticeships, more graduate programs,
00:41:00.637 --> 00:41:06.423
but ones that teach how and why to do the job in a way that allows them,
00:41:06.690 --> 00:41:11.153
if they are to leave their company, they don't leave with thinking that their
00:41:11.153 --> 00:41:15.196
company did it the right way. They just did it their way.
00:41:16.850 --> 00:41:20.030
There's a few courses out there that I've seen that do it, like the five-day
00:41:20.030 --> 00:41:24.647
DIA course that they do with the MEB. That's fantastic. That's five days of intensive learning.
00:41:25.100 --> 00:41:30.460
But it's expensive, and I think there's an element of arrogance in our industry
00:41:30.460 --> 00:41:33.591
that, oh, no, we can teach you ourselves.
00:41:34.143 --> 00:41:37.640
I'm a big proponent of sending people out to courses so they learn from others.
00:41:38.517 --> 00:41:43.690
But we've also got, I'm not going to say, it's not jealousy,
00:41:44.050 --> 00:41:45.016
but we don't want to share.
00:41:45.219 --> 00:41:47.431
Maybe that's it. We don't always want to share what we're doing.
00:41:47.692 --> 00:41:52.777
We're happy to beat our chest to say, oh, we used AI to do this.
00:41:53.450 --> 00:41:57.067
But I'm not interested in you telling me what you did. Show me the results.
00:41:57.983 --> 00:41:59.620
Tell me what you actually did.
00:42:00.660 --> 00:42:05.180
I don't know if there's a way that we could come together and actually say,
00:42:05.180 --> 00:42:09.044
right, what does case processing look like? What does signal texture look like?
00:42:09.154 --> 00:42:16.550
What's a PSUR look like effectively and do that in a space where we're not worried
00:42:16.550 --> 00:42:23.391
about sharing what we think is IP but your process isn't IP it really isn't it's not confidential
00:42:24.620 --> 00:42:29.350
But then that starts to move us towards this idea of having one process to rule
00:42:29.350 --> 00:42:32.719
them all, like the one ring. I'm not talking about that, but you then have that
00:42:32.852 --> 00:42:38.574
pitfall of if we all did it the same way, are we moving to a overly centralized model?
00:42:39.218 --> 00:42:41.980
And then we will be supporting what you described about the locality,
00:42:42.300 --> 00:42:47.875
you know, countries, cultural norms, ethnicities, specific healthcare systems.
00:42:48.177 --> 00:42:52.136
I think that is going to be our future complexity for patient safety.
00:42:52.780 --> 00:42:56.440
It won't just be the medicine. It will be the medicine's complementary pieces
00:42:56.440 --> 00:42:58.730
of diagnostics, digital health,
00:42:59.644 --> 00:43:02.814
the device itself, and how that factors into the healthcare system.
00:43:03.429 --> 00:43:09.024
Because you and I are both in the UK, so we both know the NHS does not connect to itself.
00:43:09.575 --> 00:43:13.279
But NHS Digital does not allow you to move your records around.
00:43:13.616 --> 00:43:15.502
But we are lucky enough to have EHR.
00:43:16.164 --> 00:43:19.740
So you design a fantastic system that uses technology.
00:43:20.415 --> 00:43:23.602
Does that work in sub-Saharan Africa? No.
00:43:24.402 --> 00:43:27.910
So what are you going to do if you keep designing it with the with these ground
00:43:27.910 --> 00:43:33.710
plans of technology and using so like you said i i do think the the idea of
00:43:33.710 --> 00:43:39.312
how a global ruling i think technology might even get rid of global groups it will actually be more
00:43:40.260 --> 00:43:44.760
oversight but more emphasis on the local local countries allowing patient safety
00:43:44.760 --> 00:43:50.551
to be a bit more holistic so i know i've gone off away from from people into a more
00:43:51.631 --> 00:43:56.110
Visionary thought on on safety but The way it tracks back to your original question
00:43:56.110 --> 00:44:03.094
is I think the future of pharmacovigents in patient safety are people that know a bit more than just
00:44:03.950 --> 00:44:07.867
the pharmaceutical science, that they understand the healthcare systems,
00:44:08.302 --> 00:44:13.660
that they understand human factors, so human psychology, that they appreciate
00:44:13.660 --> 00:44:17.573
the use of technology and they know how to use it as a tool,
00:44:18.183 --> 00:44:22.619
but they don't depend upon it because what if it breaks?
00:44:23.610 --> 00:44:28.030
How are you going to process a case if you don't know how to do it because you've
00:44:28.030 --> 00:44:32.160
relied on AI and you have no idea how it works i know indy you've got some strong
00:44:32.160 --> 00:44:37.988
views on if you don't know how the technology works then perhaps you shouldn't be using it
00:44:38.630 --> 00:44:45.648
Yeah i i mean it's not even about knowing how the technology works like in reality i,
00:44:46.194 --> 00:44:51.006
i'm lucky enough to come from a company that designed an ai software so i i
00:44:51.238 --> 00:44:59.220
i roughly know how it works but but i can explain which is probably more useful for me.
00:44:59.220 --> 00:45:04.080
I can't have knowledge in a thousand different things, but I need to be able
00:45:04.080 --> 00:45:08.074
to explain it. And I always find this with QPs as well. I'm always fascinated
00:45:08.510 --> 00:45:12.150
with QPs that as long as they can explain stuff, they don't need to know the
00:45:12.150 --> 00:45:13.816
details as long as they can explain it.
00:45:14.466 --> 00:45:20.510
And I feel that that's the same for technology. I am not, I always profess I
00:45:20.510 --> 00:45:23.034
am not an AI expert. And that is true.
00:45:23.970 --> 00:45:28.044
I do not understand algorithms. I'm not a mathematics expert.
00:45:29.130 --> 00:45:35.330
I do not understand how architecture of servers and APIs and stuff like this
00:45:35.330 --> 00:45:39.658
all should fundamentally go together to make a very efficient system. Not me.
00:45:40.388 --> 00:45:47.770
But can I explain why data from the start has changed due to something in the
00:45:47.770 --> 00:45:52.500
middle and then this is the output I should be able to explain that because
00:45:52.500 --> 00:45:54.465
it's my data I own that data,
00:45:55.092 --> 00:46:00.553
I am not passing responsibility off to a software vendor a CRO I can explain it,
00:46:01.340 --> 00:46:03.163
but going back to what you were talking about.
00:46:04.455 --> 00:46:12.473
Absolutely fantastic point of view and as we come to a close of this podcast,
00:46:13.669 --> 00:46:19.245
i'm going to ask you to go a bit wider and i'm going to ask what do you think
00:46:19.245 --> 00:46:23.716
the future of life sciences is going to be in the next few years.
00:46:28.100 --> 00:46:32.322
So it's probably a combination of things that we discussed today um
00:46:33.043 --> 00:46:37.508
and like you i don't profess to be an ai expert even when i was building the
00:46:37.508 --> 00:46:40.398
team at az i wasn't an expert in every part
00:46:40.851 --> 00:46:44.958
what is critical is that you hire the people smarter than you and i hired a
00:46:44.958 --> 00:46:47.132
lot of people that were smarter than me
00:46:47.585 --> 00:46:53.338
and i depended upon them so i could explain what they were doing uh but if people
00:46:53.338 --> 00:46:57.918
wanted to see it to go into detail you have to put those forward so i think
00:46:57.918 --> 00:47:00.301
the the future of life science is
00:47:00.958 --> 00:47:08.574
is where you've got teams that have been created around expertise that we are utilizing
00:47:09.295 --> 00:47:10.983
i guess masters
00:47:11.775 --> 00:47:17.438
But they are jacks in terms of understanding so they understand they understand
00:47:17.438 --> 00:47:21.642
the system okay so broadly life science you understand it yeah
00:47:22.258 --> 00:47:26.768
end to end you understand it but you have your domain you have your pillar of
00:47:26.768 --> 00:47:29.200
expertise and you own that expertise
00:47:29.834 --> 00:47:35.028
and even if I'm your boss I don't tell you what to do for your pillar I can
00:47:35.028 --> 00:47:40.063
guide you I can help you shape it and I and I can and I will advocate for you but
00:47:40.713 --> 00:47:44.137
it's your responsibility because we are coming to a point where
00:47:44.771 --> 00:47:50.628
it would be arrogant and unsafe for me to ever say that I know everything in
00:47:50.628 --> 00:47:54.228
this pv system so i think life sciences is going to have to create more
00:47:54.858 --> 00:48:00.818
more expertise more capabilities so have individuals that's that can
00:48:01.530 --> 00:48:06.938
deliver ai that don't know patient safety themselves but they know ai and they
00:48:06.938 --> 00:48:12.314
partner with someone who does know it so technology ends up being that that that that's horizontal
00:48:14.574 --> 00:48:17.844
End up not having a straight horizontal because i often see that in diagrams
00:48:17.844 --> 00:48:22.814
a horizontal with technology but it's not that it's multiple horizontals because
00:48:23.737 --> 00:48:28.744
i i think someone even in it can talk about every single part of the technology
00:48:28.744 --> 00:48:33.674
infrastructure you end up having a few of those horizontals and they partner
00:48:33.674 --> 00:48:37.464
so i think there'll be more partnerships more capability building i think more
00:48:37.464 --> 00:48:38.679
refreshing of knowledge
00:48:39.623 --> 00:48:48.214
and i would say more opportunities or more of a need to have sandboxes, to have spaces
00:48:49.172 --> 00:48:50.182
to test things out.
00:48:50.362 --> 00:48:56.534
So whilst I don't necessarily always advocate to bring things in elsewhere,
00:48:56.534 --> 00:49:00.740
so we shouldn't have to try and be like another group.
00:49:00.903 --> 00:49:04.444
So patient safety shouldn't try and be medical affairs. We should be a patient safety.
00:49:04.978 --> 00:49:09.134
But we could learn from other industries what they do.
00:49:09.714 --> 00:49:16.754
And we've seen how companies have ideated and they've allowed testing
00:49:17.654 --> 00:49:22.434
they have an innovation ecosystem of sorts and that's a separate topic that
00:49:22.434 --> 00:49:25.964
maybe you and i can talk about another day but that was my mba and one of the
00:49:25.964 --> 00:49:30.918
things that became very clear for patient safety to innovate is that we just don't have the space
00:49:31.615 --> 00:49:33.884
to to fail there are
00:49:34.911 --> 00:49:39.523
so again life sciences is going to have to come to terms with having spaces to fail.
00:49:40.995 --> 00:49:45.025
Adapting, learning. And I think the last piece is going to be transparency.
00:49:45.025 --> 00:49:49.245
I know everyone talks about transparency as in value. I'm not talking about transparency of data.
00:49:49.245 --> 00:49:53.805
I'm talking about transparency of being comfortable to talk about a problem
00:49:53.805 --> 00:49:58.835
with a regulator or regulators having confidence they can talk to us about a
00:49:58.835 --> 00:50:00.765
problem and we're not going to use it.
00:50:00.765 --> 00:50:04.705
So it's an element of trusted transparency. It's to use up, you know,
00:50:04.705 --> 00:50:05.975
to make up that little phrase.
00:50:05.975 --> 00:50:11.065
But the idea that there's more interaction between regulators and industry that
00:50:11.065 --> 00:50:12.705
they can come up with shared solutions.
00:50:12.705 --> 00:50:17.715
Because the last thing I'll say, and someone at the EMA said it first to me,
00:50:18.092 --> 00:50:23.227
is pharmacovigilance and patient safety is one of the only areas where we both have to do it.
00:50:23.505 --> 00:50:27.453
So why wouldn't we work together to develop an improved patient safety system?
00:50:28.178 --> 00:50:32.706
They have to monitor signals. We have to monitor signals. Why aren't we doing it closer together?
00:50:33.304 --> 00:50:38.255
So I think that's where life sciences will have to go is improve collaboration.
00:50:38.406 --> 00:50:41.855
That collaboration has to be coming back to this creation and people has to
00:50:41.855 --> 00:50:43.833
be at that created level.
00:50:44.338 --> 00:50:48.959
So it's not with the VPs and heads of safety who don't do the job.
00:50:49.452 --> 00:50:53.225
The people that should be in those conversations are the individuals who do
00:50:53.225 --> 00:50:56.035
work with the technology, do work with signal management. And therefore,
00:50:56.035 --> 00:51:00.552
it's empowering them to have those conversations and possibly becoming comfortable
00:51:01.086 --> 00:51:02.694
that I won't be in the room for everything.
00:51:03.158 --> 00:51:05.805
And I think that in itself is always going to be a challenge because I like
00:51:05.805 --> 00:51:10.165
being in the room to talk about things, but I need to give other people the chance to do it.
00:51:11.682 --> 00:51:16.155
James, thank you for the conversation today. It has been absolutely fascinating,
00:51:16.155 --> 00:51:18.705
and I hope we get to talk again soon.
00:51:19.233 --> 00:51:20.876
Very charming. Thank you.