00:02 Brigid: Good evening and good morning everyone! I’m Brigid-

00:06 Shelby: And I’m Shelby, and we are your hosts for this installment of Coffee and Conversations!

Brigid: Coffee and Conversations is a monthly interactive sit-down event hosted by CSOFT. Every month we’ll feature honorary guests and experts from a diverse range of industries and fields to lightly discuss topical themes important to the life sciences and language services industry. So, sit down and relax, pour yourself a coffee, tea, or a hot drink and enjoy! 

00:35 Shelby: Thanks Brigid! This month, we are joined by our special guest, Professor Victoria Elegant Vice-President, JAPAC Regional Medical Head, and Site Head of Amgen to discuss the evolution of global medical affairs, as well as new innovation, and the importance of patient voices within the space.

00:52 Brigid: The pace of change within global medical affairs is remarkable. Technologies, like telehealth and virtual clinical trials to name a few, are revolutionizing how people connect across borders within the medical field. As a specialty, global medical affairs has had to adapt from where it first began centered around drug development and R&D, to now driving the future of medicine and international collaboration.

01:18 Shelby: You know, that’s so true, Brigid. Global medical affairs really helps to disseminate information and drive the adoption of new technologies between the pharmaceutical companies and healthcare providers all around the globe, really encouraging communication across borders and improving overall global health – something that we have all very much relied upon over this past year. Ok, now we can move forward with introducing our guests: Professor Elegant and Ms. Shunee Yee.

01:40 Brigid: Professor Victoria Elegant is a physician who joined the pharmaceutical industry after postgraduate training in obstetrics and gynecology in the United Kingdom. She has held positions in global drug development, medical affairs, regulatory affairs and drug safety in Japan, Australia, Europe, and Asia Pacific. Prior to Amgen, Professor Elegant was the Vice-President, Regulatory and Medical Affairs, APAC, based in Shanghai for 10 years for Baxter, and Vice President, Medical Affairs, Asia, based in Singapore for Shire. Professor Elegant is involved in the evolving role of medical affairs in being the bridge between R&D and commercial, and in partnerships with healthcare professionals and patient groups to improve patient outcomes and standards of care in the Asia Pacific region. Professor Elegant is President of the Asia Pacific chapter of the Medical Affairs Professional Society (MAPS). She has also published extensively on regulatory affairs, medical affairs, and clinical development in the Asia Pacific region. Born in Hong Kong, Professor Elegant’s passion is improving standards of care and outcomes for patients in Asia Pacific.

Welcome, Professor Elegant! We’re glad you can join us this evening! 

02:56 Shelby: Thanks, Brigid. So, Ms. Shunee Yee is the President and CEO of CSOFT International and CSOFT Health Sciences, which provides end-to-end medical translation services for all phases of the product lifecycle, market access consulting, medical writing, and CTD/eCTD submissions with the FDA, EMA, and NMPA. Shunee is passionate about education and has contributed to Michelle Obama’s Let Girl’s Learn Initiative, the Hopkins-Nanjing Center for Chinese and American Studies, and the Dexter Southfield School. 

Welcome Shunee, thank you for joining us as well!

 So, without further ado - Shunee and Professor Elegant, the floor is all yours!

03:35 Shunee: Thank you so much, Brigid and Shelby! Good evening Victoria! Thank you so much for joining us from Hong Kong today! The last time you and I were together, we were with Dr. King, Dr. Yong, CJ and Pat, at the GBA virtual panel discussing our cross-border challenges and opportunities during pandemic, that was almost 7-8 months ago, last November. Time flies, we carry on. And the world is still battling one of the worst pandemics in the human history. So, my first question, how have you seen COVID-19, reshape our healthcare eco system and changed the landscape of global medical affairs, particularly regarding engagements with healthcare professionals? Can you first briefly introduce and describe the evolution and development of global medical affairs and how it has responded to the challenges and opportunities during this challenging time?

04:47 Professor Elegant: Thanks, Shunee. And thanks Brigid and Shelby for the very kind introduction - it's always a pleasure to be here with you. We could spend about four hours talking all about that to be perfectly honest! So, I think maybe just setting the scene about COVID. There is an awful lot of say but we all know how much COVID has actually changed the landscape, particularly healthcare in the last 18 months, unbelievable. We started in Asia at the end of January, middle of January in China, or end of December 2020, so that is 18 months ago - it is extraordinary how long it has gone on for. But you know, we adapt. I think one of the - several of the major impacts that COVID has had is one we've seen on the development of the vaccines. Normally, vaccines take 10 years to develop and we have seen that really, the companies have adapted really quickly, the regulatory authorities have adapted very quickly, and we have actually compressed that timing to from 10 years to one year, basically. Nobody really thought it would be possible, but you know, anything is possible. There are some things that were done around the clinical trials that have helped that, I think how that is going to impact in the future is that for drugs that are really necessary, people won’t accept these long development timelines anymore. So, as an industry, we will have to work really really closely for drugs that are really meeting huge unmet medical needs to figure out a way to really make the development time faster - so that is one area. I just mentioned the clinical trials, so clinical trials are actually were quite, still are to a certain extent, quite cumbersome. But what we did, we found ways with the clinical trials to do, much, more remote monitoring. It used to be, it was done by the CRAs going out to the sites, we were moving that way anyways. But now, most of the monitoring is done remotely and the regulatory agencies have approved that. We found ways to deliver the drugs to the patients at home. It has never been particularly convenient, to be honest. I think that patients are absolutely wonderful for taking part in clinical trials and being so selfless. It requires a lot of sacrifice to be able to participate in clinical trials - give up your time, accept the risks that there are, that kind of thing. So, we tried during COVID to really try and do things like, do more around telehealth for example, not just in trials, but also in delivery of healthcare - and I will come back to that. And actually tele-trials, where the patients could stay where they were and we figured out how to do the blood tests, send people to do the blood tests, send them their medication, that kind of thing. So, to make it more convenient for the patients and we'll come back to the effect that COVID has had on patients as well. So those are some of things that have impacted by COVID. 

07:54 Victoria: There is the whole, you know the remote engagements, so we'll come back to that. I think the question that you asked me originally was has how has medical affairs evolved. It's a really good question! So initially, the medical affairs function was really a support function that provided some scientific guidance to the commercial organizations. Actually, to be honest, they did a lot of copy clearance. So, they basically reviewed materials, they did medical information, so they answered questions from external healthcare providers, that kind of thing. So, it was really support function. Now, medical affairs is really evolved to what is called the third pillar. So, the pillar, between commercial and R&D and the reason for that is the medical affairs, and the staff and teams within medical affairs, are really, the ones who engage externally, with all our external healthcare provider stakeholders. And so medical affairs is now included right at the beginning of development to make sure that we actually get the insights from our healthcare providers to make sure the compounds we develop are meeting unmet medical needs, that we get continuous feedback from our external stakeholders, to make sure we do that right. Also, that the strategies we employ and as the commercial teams, are the right ones to make sure we get the right drugs to the right patients at the right time once they have been developed. Another big area is education. So, sales teams have sales targets, right... targeted on their sales, which is right, that is their job. The medical teams their job is to engage externally to provide the scientific information and to make sure we provide increasingly education to our stakeholders. So, for example, as compounds get more and more complex, if you think about oncology, my mother died of 

colorectal cancer, and she died about 20 years ago. At that time, the treatment options were very limited. If she had lived another 20 years and got it now, there are all these target therapies, based on mutations, so actually the treatment options are huge. It makes it really really complicated. I was talking to someone yesterday who said to me, 'have you seen the genomic report that comes back when you order tests on breast cancer biopsy?' It is like, eight pages long because of all the different tests that you can do to make sure that the patient actually gets the right targeted therapy. So as those things become more complicated, it is medical’s job, to make sure that physicians and other healthcare providers have the education in order to get the latest updates in the therapeutic area. Also, so they know how to use these increasingly complex drugs. Then the other piece that is coming to more and more on the forefront is, really the patient voice, engaging with patient organizations to make sure that patients have a voice, to educate the patients, those sorts of things. So that has really been the evolution of medical affairs. I believe very firmly that medical will continue to evolve in that same direction and will become increasingly important and making sure as I said, we have the right drugs, to meet the right needs and that they get to the right patients, in the right way.

11:32 Shunee: Yea, so Victoria, this is very interesting there are particularly two things you mentioned about. One is, you know, post pandemic sets different expectations with patients. Patients are not going to want to wait 10 years for the drug, right? So that seems like a driving force, right, for innovation coming from the patient. 

 11:58 Shunee: The other side is very interesting; you talk about the education. So, it seems like not just the internally for professional, get educated, but look like externally, you know, health care givers, and the patient themselves, you know, when you're facing a variety of different the options. So, this is a kind of an interesting kind of lead to me my second question, in your recent paper, Reimagining Scientific Engagement During COVID-19 published on the Medical Affairs Professional Society, you talked about, you discussed the developing strategies or solutions, a change management plan drive new business law, clearly, there's a shift, right, like you mentioned about more telehealth or more decentralized clinical trials, because I want you to tell us, our audience, how this impacted your work and business in a in a daily kind of thing.

12:57 Victoria: Okay.

12:57  Shunee: How slowly and surely, you know, as we're emerging out of the pandemic, so what are the innovation post-pandemic do you expect to see that in response to refocus, like you talk so much about patient centricity? And how we are included, you know, patient diversity through other drug development? Can you elaborate on that and discuss? Thank you. 

13:23 Victoria: So, actually pre-COVID, I like to strategize, and I like to think about where we're going in the future, right. And so actually, even before COVID, I could see that digital was going to really be a major force. And so, in probably 2018, I think I appointed a Medical Digital Lead. And we started doing two things, we started looking at the technology that was out there. So different platforms to connect, right. And then things like AI, and machine learning and how we use that all those sorts of things. So, when actually and we started experimenting, now, I tell you change management in this area is really tough. So, we did a lot of work with our affiliates with the people to try and get them to understand what the need for change was. So actually, in a way, COVID did us a little bit of a favor because of course we went overnight from very face-to-face engagement, especially in Asia, of course, you know, we pride ourselves on face-to-face, to actually digital engagements and using platforms. And so, we had a lot of different platforms. One of the things we found was that the doctors in particular, the healthcare professionals would say to us, "Oh, please don't make us use WebEx." Or "Please don't make us use this back home. We use zoom for everything else. Let's just use Zoom." You know, so we had to change to that. And you could imagine in some, in particular, China actually adapted very quickly because they're actually at the forefront of technology.

15:02 Victoria: Japan was slower, particularly though, the more revered professors, the professors who were, you know, really the ones who were the ones who wanted to engage with because they weren't so tech savvy, but of course, Japan has had to evolve. The interesting country was Korea, because they were the most resistant before we started, but they had amazing uptake. And so actually, now they're all very engaged. So, the result of that was two things: we have to train our staff, right? Because when you do meetings, like this, for example, you actually, especially one on one, you have to plan a bit better, you have to have an agenda, you can't just present on a zoom call, the way you present in person, it doesn't really work. There are tips and techniques, and we probably all know them, you know, look at the camera, speak more slowly, that kind of thing. So, we had to train our staff. And then the other thing that we started getting to the HoloLens. So, what we had already started doing before COVID, we had started using hologram technology for our speakers. And we found that instead of somebody having to get on a plane for 14 hours, come to Asia, do a talk and then go back again, we could actually hologram them in, and so it was literally like they were sitting on the stage. And you can either do it live, or you can do it recorded. So that was we'd already been experimenting with that. And it means you it's not just one venue to one venue, you can do multiple venues. So on the education front, one of the things that we do a lot is we connect people in countries in Asia, for example, we do Centers of Excellence training, and again, previously, it was people would come to the Centers of Excellence, you know, they'd spend a lot of time there, which is always good, because it means they build partnerships and things, but during COVID, of course, we couldn't do that. So, we found this HoloLens technology, and what it is, it's virtual reality, I don't know how many of you have, you know, play video games, or play virtual reality games or that kind of thing. So, it's that, but actually, then it uses hologram technology. So, you put it on, it recognizes your fingers. And so, you have the what the video showed was somebody in London, operating on a patient, and then somebody in Mumbai, and somebody in... I think... I can't remember the third place was, but it was basically three different places around the world, using that technology to actually share the case notes to discuss the patients like real time. 

17:43 Victoria: And in fact, the technologies involved were in HoloLens too, so they have avatars. So actually, you can have the avatar, which now looks like you if you want it to, actually sitting in the operating theatre. So as an example, on Saturday - Saturday, I think? Yeah. We're doing a meeting, which is, a hybrid meeting, so we hope, where we're actually going to get some people together in Hong Kong, some physicians in Hong Kong, we have a physician in Japan, and we have a physician in Thailand. And they're going to be using this technology to share case studies around reducing Clark, its imaging, around reducing atherosclerosis in plaque. And the audience is Australia, Korea, Taiwan, Japan, Thailand, Singapore, and Hong Kong. So actually, using this technology, and using the digital outreach, you can actually reach a lot more people than we could before. You know, technically, you could fly in all those people to a meeting and all the rest of it. But this way, it's actually a lot more efficient. And we've done meetings, not using HoloLens. But we've done other virtual meetings where we've had 2,000 people joining a training session. So, this technology has really allowed us to really broaden it. And, like you, I'm passionate about education, and I think it's really, really important. And so that's one of the big pluses, it's allowed us to do that. 

19:14Shunee: That's amazing, Victoria! Now, kind of, you know, seeing the video and you described, you know, how in reality, you - actually it's happening, your daily work, I'm even thinking about this year is our annual GBA. So, if we're not able to fly in person, so we should try that one. So, it looks like you know, the choice of the going more virtual is not just the choice, it become a necessity, right? So, this is you know, we could talk about hours, you know, just all those amazing innovations improve the patient, you know, centricity in the development and drug development, the care, so maybe this is just the last one, I know that we have a quite a lot of the audience has some of the questions. You mentioned about APAC, you know, there. It's not just one

20:00 Shunee: You mentioned about APAC, how there it’s not just one country, but there's a variety of, you know, diverse regions, in a word. So where do you see specific opportunities that are rising in APAC? Knowing the growth in the clinical trial market there, where do you see our opportunities in APAC, particularly for innovation? 

20:27 Victoria: So I think there's a number of things there. I think, as you said, you know, 50% of the world's population – I have a slide with a circle, and it shows 50% of the world's population – is in Asia. And of course, there's a rising middle class, so more and more people are going to be demanding much better healthcare. And we're already seeing that, you know, with the rise of the biotech companies in China that are now going outside China, we recently had a drug registered in the US on only Chinese data, which was a first ever, which was pretty amazing. So, I think there are a lot of opportunities. I mean, I love working in Asia, because there is such an opportunity to partner and improve the healthcare systems. So I believe that's what we should be doing is we should be part of the solution in trying to find solutions, because the population is so big. And a lot of the governments are struggling to figure out how we're going to meet that patient need. On the innovation side, we see a lot of technology, particularly in China. So, for example, my team in China has just done a big project using AI, and using technology, to really connect much better in real time with their healthcare professional stakeholders. They have a platform on WeChat. They use that to connect with the healthcare providers, they get instant feedback about what the health care providers are, and the publications they're looking at. So, they can really tailor the offerings. That's one big area. Another project that we're working on at the moment is using AI to really have a look at the insights. So traditionally, the way to get insights is we go out, we talk to our stakeholders, we have advisory boards, we collect all the insights. Now you can use AI to actually look at thousands of publications, look at all the congresses, and do it real time, in a very short space of time. So, and then I think the third area that we have a lot of opportunity in Asia, you talk about patients, and patient centricity. So traditionally, in Asia, the patient voice is not so loud, and people tend to listen to what their doctors say. I think that particularly after COVID, we have a real opportunity to work with patient associations, and help the patients and their caregivers, as importantly, really find their voice to actually say what they want to actually make decisions around healthcare, educate them, that kind of thing. So, I think those are some of the opportunities. 

23:00 Shunee: Great! So maybe just one last thought, if you may summarize in one sentence, what do you see as today's medical affairs mission?

23:07 Victoria: The mission for me, it's about – always, it's about – partnering with our external stakeholders to improve patient outcomes and improve standards of care. That's really what we should be doing. You know, we cannot if we all work together, and we make the partnership, not just transactional, but we really make it a part a long-term partnership, then we can work together to improve patient outcomes and standards of care. 

23:32 Shunee: Thank you so much, Victoria. I have so many more questions, that I definitely want to reach out for more discussion offline. But let me give it back to Bridget and Shelby, so we have some audience questions.  

23:50 Brigid: Okay, yeah! So we have a lot of questions coming through. And thank you so much for such an insightful discussion, Professor Elegant and Shunee. The first one I think is important because this person wanted to learn or clarify a few points on medical affairs. They say, the world of medical affairs is expanding past drug development and commercialization. And their question is, end to end, how is medical affairs different than Clin Ops?

23:07 Victoria: Oh, completely, completely different. So it's always confusing, and different companies, to be honest, use different language, but clinical operations generally means the people who are responsible for the operational aspects of the clinical trial. So it tends to be the people who go out to the sites, the clinical research associates, the project managers, that kind of thing. They will work with the clinical development people with their development protocols, for example – they they're the ones who will develop the protocols and develop the science. For medical affairs, as I said, the focus is really about the external engagements and bringing the insights in. So medical affairs, generally, are the people who will provide the insights to make sure that those protocols when we do drug development and then further through the life cycle, as you talked about commercialization, we get the insights to make sure we have the right strategy, essentially. 

 25:13 Victoria: So, operations, I'm just trying to think of an analogy, the operations people are like the people who actually conduct the trials, medical affairs sort of sits alongside a lot of the other functions. So we all work very closely together. For example, in managing the sites for the clinical trials, medical will work, because they have often really good relationships with the investigators, for example. So the operations people will be the ones who get the trials done, and medical, we'll work with them to make sure we choose the right sides to engage with the investigators, that kind of thing. 

25:46 Shelby: That's great, thank you. So we've actually had another question come in just now from our audience. So thank you for sending in your questions. So, this one is assuming that access to healthcare is key, how would the initiatives developed during the pandemic be of help in the future? So how would the role of intercultural communication and providing this access be affected? 

26:05 Victoria: Absolutely critical, actually, the whole issue of access is so important. As we all know, there's no point developing a wonderful medicine, if no one will pay for it, frankly. So you have to actually think about the access aspects, right at the beginning of when you're doing your drug development to make sure that the clinical difference that you're going to make really is breakthrough. And then you actually need to be doing those partnerships, as we talked about before, with not just our healthcare professionals, but our payers and the government and those people to actually make sure that that drug will actually get to the patients that need it most. I think what COVID has done again, is it's probably raised the importance of actually having the right medicines even further. But it's also enabled us to think more about accelerating the drug development and shortening the timelines. So I think we'll see a lot more around things like adaptive trial design, or having regulatory approvals that are then approved, but then dependent on trials that will confirm you know, you'll do a confirmatory trial, that kind of thing, so as to make sure that we get access to the medicines more quickly. But medical plays a very, very important part in terms of access and putting the evidence together. So access is not just about price, but it's about, you know, the clinical effect. And so the medical teams are the ones who are best placed to actually put those arguments in place, if you like, about the clinical effect, and why it's so important, the fact that it's breakthrough, that kind of thing. So most of the industry is discussing this a lot, and thinking about how to really best leverage medical and their expertise to make sure that we get the access that the patients need. 

27:54 Brigid: Thank you so much. The next question is on the importance of patient centricity and patient diversity. How are these two themes reflected in drug or clinical trial development? 

28:08 Victoria: That's a great question, and it has two different answers. So, I'll talking about the diversity first. Actually, last year, with everything that happened in the US and Black Lives Matter, and all the things that have been happening in the US, it's really called attention to the fact that in our clinical trials, actually, the diversity has not been particularly in the US I'm talking about has not been perhaps as it should be. And so there's huge initiatives underway, there's a cross industry forum that is looking at this to make sure that we have targets to actually put in diverse ethnicities in particular. And so that's ongoing. The other area, at least for me, which is sort of close to my heart, is to make sure that we have enough Asian patients in our trials. So that's another area and in particular, and actually one of our thought leaders in Singapore published a paper about three years ago about the lack of Asian women in clinical trials, actually. So we're all looking at what we can do to make sure that we actually increase that diversity in clinical trials because, you know, different people react differently to drugs, we know that women sometimes react differently as well. If they're not in the clinical trials, then we just have to wait till after the drugs approved. So it's really important to make sure that we have those in. So that's one piece about the diversity. The patient centricity is really interesting, actually. So and I think, as like we were talking about earlier, patients, the voice of the patient, we need to really help to find a way to amplify that. Healthcare systems are not built for patients. I don't you know, you've all probably been a patient at some time. It sucks. Honestly, being a patient is just horrible. You have no control. You're just at the mercy of the system. You have to wait for hours people come and tell you what to do, if you're in hospital, you know, all that sort of stuff.

30:00 Victoria: What we've discovered is that actually, if you include the patient voice, and you work with patient associations, and you make sure that you talk to them, as you're doing your clinical trial, they can actually look at the clinical trial and tell you if it's going to work or not – what you need to put in, what you don't need to put in – so that's one piece, and it's been shown that if you do that, you can get recruitment much faster. Another area that's becoming much, much more important is patient reported outcomes. So we've always done well, not always, but we do quality of life and all sorts of other areas. But patient reported outcomes are really now increasingly becoming more and more important, particularly in chronic diseases. And then the other area that's becoming really important is about patients as authors and making sure that we have opportunities for patients to author publications. And, again, if we have clinical trial results, that we have clinical trials summaries, that are in plain language. We did that for consent forms and things years ago, but now, increasingly, what we're doing is clinical trial summaries in plain language so the patients can understand it. Because, you know, I was having a conversation with a friend of mine the other day about the language around law, for example, or around finance, it's sort of like a secret society. And medicine is the same, but it doesn't need to be. You know, you just have to write it in language so that people understand. So increasingly, what we really want to do is to make sure that the patients have that voice, particularly in Asia, where, you know, traditionally it hasn't been so loud, and it's getting better. We're putting some things in place to do that. 

31:50 Shunee: That's fantastic. That's amazing just hearing about a how to put the patient in the center of the whole drug development. That's amazing. 

31:50 Shelby: Yes, absolutely, it sounds like on both sides, it's beneficial to have, you know, the patient voice incorporated into the clinical trial. So we just have time for one more question. I know we're running a little bit over. So, our final audience question is, what is the driving force behind the increasing number of clinical trials being conducted in Asia? 

32:18 Victoria: Oh, well, so once upon a time – I've been working in Asia for a while – once upon a time, everybody was frightened about coming to Asia, because they were worried about the languages. They were worried that there were no clinical trial centers that had the capabilities to do the clinical trials to the standards that, for example, FDA wanted. There was also the issue, particularly in China, of course of IP, and worries about IP, those kinds of things. But increasingly, now, people have realized that many of the trial centers have investigators who all trained overseas and then come back. So they're really, really experienced. There are a lot of patients in Asia. To that point, you know, sometimes you get patient populations in other places that you need to come to Asia to actually get the numbers in the trial that you need. Those are some of the things. It used to be that it was cheaper to do the clinical trials in Asia, but not so much anymore. That's really not a big factor. And then I think the centers here also have, at least – again, I haven't worked in Europe for a while – but certainly we're looking at things like the data banks here. Some of the hospitals have amazing databases for patients. I went out to one of the hospitals in Hong Kong yesterday, and they were showing me their Health Authority patient data system. They have 20 years’ worth of patient data from all the 7 million patients in Hong Kong that have gone through the Health Authority, all a database, all with the imaging. And that's replicated, say, in Korea, all sorts of places like that. So that also makes it easier to work with academics, to actually access those data to answer research questions, apart from just the prospective clinical trials. So increasingly, you will hear people talk about real world data. And that's really one of the areas that's growing. And in Asia, we have great sources of those data. So those are several reasons. 

34:25 Shelby: Wow, that's super interesting, and it makes sense when you think about it, of course. So unfortunately that is all the time we have for questions today. On behalf of CSOFT Health Sciences, we really want to thank you, Victoria and Shunee, for a fascinating and insightful discussion, as well as all of our audience members who submitted questions ahead of time, about the current state of global medical affairs and advancing global health. If you loved this podcast episode and you want to catch up on previous episodes, you can find any of them on our website as well as any major podcast platform. Just search ‘CSOFT’s Coffee & Conversations’. Additionally, we invite you to come join us, CSOFT Health Sciences, at DIA Global’s Annual Meeting, held from June 27th through July 1st, so that’s Monday through Thursday next week. We would love to see you there and see you visit us at our booth. 

35:20 Victoria: Thank you so much! Really it’s always such a pleasure to talk with you. 

35:28 Shunee: Looking forward to connecting again!