Table of Contents
Ready to Publish
Ready to Publish
Apr 15, 2022
Speaker & Panelists
- Junaid Kalia, MD Edupreneur at AINeuroCare Academy Vice President, Clinical Strategy at VeeOne Health
- Umar Hayat Ph.D. VP, CMC and Supply Chain at Union Therapeutics A/S
- Dr. Musaddiq Khan Vice President, DCT Solutions at Medable, Inc
Umar Hayat: I can start probably. Why don't you go ahead and do a brief intro, and then I will take back and introduce myself and our speaker.
Musaddiq Khan: Yeah, I'm happy to thank you for the invitation. My name is Mussadiq Khan. I've been involved in the pharmaceutical industry for about 16, 17 years now, focused primarily on drug development projects in the early phase of phase one and some phase three projects.
I've had stints at AstraZeneca Roche and Eli Lilly and Company. Still, in May last year, I joined an organization called Medable, Inc. focused on decentralized clinical trials and providing a technology platform for that to happen.
So I'm a vice president there in their DCT Solutions group, so my role is to understand how to translate clinical, operational protocols into a decentralized solution and identify the efficiencies. So I'm currently based in Abu Dhabi and the UAE, and yeah, I'm very excited to hear about the discussion today. Thank you very much.
Umar Hayat: So about myself, I think most of you guys already know I'm purely a pharmaceutical development guy from discovery to commercialization. I have done a couple of ventures and have food products in the market. I am not going to take much time. I'm based in California, San Francisco, and I'm moving over to Dr. Junaid Kalia, a neurologist by profession and an entrepreneur.
I mean, I always think of entrepreneurs by heart. The one thing which came to my mind whenever I looked at or heard Dr. Kalia is that our future generation has taken their future into their own hands. They do not depend upon the governments; they want to design their own goals and then work hard to accomplish those.
[End of Dr. Junaid Kalia's presentation]
Watch Dr. Junaid’s presentation on Digital Clinical Trials ⌚️🧪 Healthcare Innovation & Entrepreneurship via this link: https://youtu.be/Vna2Deda7cY
Panelists Q&A Discussion
Umar Hayat: Thank you very much. It was an excellent presentation. Do you have time, or do you want to go back and emphasize any of your slides?
Junaid Kalia: Yeah, that's what I do; people get bored now, that's another thing. But one of the things that I wanted was, to be honest with you, was looking forward to Dr. Musaddiq Khan's input on this presentation, and his input rather than me taking up all the time, I thought it would be best we have a little bit of discussion as well.
Umar Hayat: Thank you. Thank you very much. Dr. Khan, back to you if you want to elaborate on some of the slides he mentioned and hope they can be applied. That would be awesome. I have not seen any questions so far, but please, if you have a question, put it in the chatbox, and we will address it as it comes. Thank you.
Mussadiq Khan: Thanks. Yeah, thank you for that comprehensive review. And I'm hoping you're able to share the link, right? You said we could all have a look at that Neurology Pocketbook because there were some gems in there. And I think, you know, you've covered most of the salient things.
I think to highlight one of the things too, and my lens is from a drug development perspective and R&D, is this is still novel tech, right?
And people generally are very resistant to change. As we all know, one of the things that have happened over the past 18-24 months is ironic with lockdown and Covid is that it's catalyzed people's, I suppose, perceptions and risk appetite.
So from a drug development perspective, I was at Eli Lilly as the lockdown started. And you know, the pharma has been notoriously conservative risk-averse, you know, understandably so. And you know, trying to merge it with a kind of "demo-or-die-tech" iterative culture has been a challenge, right?
And it's been happening for a while. Now, what happened with Covid was suddenly all these approaches that previously would have been "nice to have" and were "new things to try" suddenly became the only option, right?
So, having remote visits, having remote monitoring, televisits for consultations, using remote sensors or wearables to try and keep trials ticking along, making the amendments. So suddenly people had to start trying these things and some of those things stuck, right? So, they're kind of the pendulum for innovation, swung one way. And now, I think we're seeing a lot of other things as well. You know, whether it's working from home or whether it's flexibility in working hours, you know, it's how far that pendulum is going to swing back to where it was pre-Covid.
And I think, it's a similar approach here with having this novel approach to conducting clinical trials. So, it's certainly one of the big things from, from my perspective, the big challenge is around change management because we need to approach this new paradigm very much like a change management process, right?
So, you need to get a few kinds of influences who are, say, within the pharma company, get them on the bus, and, you know, use them to build the momentum and all of those other things. So, I think there's you know, that things are moving in the right direction, but there's still a lot of education that needs to happen. And a big part of that is I think it's Dr. Junaid mentioned is about the language that we're using and how we're making sure that we're all talking about the same thing. When, you know, when we talk about virtual clinical trials, when we talk about decentralized trials, and what that means.
And also that it's not a binary choice, right? So when we talk about a decentralized approach to a clinical trial, you know, an oncology study, you're not going to be able to do the CT scan in someone's living room, right? But what you can do is allow a nurse to come to their house or allow them to go to a local CVS or something to get some of their blood taken rather than have to go to the hospital, you know, to the MSK site or you know, a large site that may take them hours to get to. So, you know, you have this hybrid approach and certainly, that's what we're finding at minimum that most of these trials are following a hybrid approach rather than a fully decentralized one.
And then the last piece, I think that that's it's interesting, and I'd like to hear more about from a from the perspective of Pakistan because I, you know, I only have a superficial understanding of how things are. But I'm very keen to understand how we can kind of leverage some of this technology is that it was saying it's the perfect place to be rolling these sorts of things out, right? If you get the momentum going, we've got a patient population, we've got digital literacy, we've got the mobile connectivity, and then we've got the desire from the physicians who want to do this research and be a part of that.
One of the things that I'm curious about and has been a challenge in Europe, less so in the US, it's still happening. But you know, as Dr. Junaid said, the FDA released specific guidance in the past three months about embracing novel technology and how to use DCT Approaches and digital technologies in drug development.
I think if you can start guiding the regulatory approach to be more pragmatic and to be accepting of novel approaches, suddenly that becomes an environment where other people want to come to. Alright, so we're seeing that in Europe, for example, the Danish Medical, the regulatory agency has also just specifically provided guidance on how to use DCTs. Suddenly, Denmark becomes a more attractive option than France or Germany for a pharma company to go to, right? Because they know that they can start using these more efficient methods. So I think that's one approach to understand.
And then the other piece is also just around the kind of the profile of the people that are going to be involved. So, you know, a big piece, you know, we talked about the diversity earlier, but the big piece is around how you educate people that this is okay to do, right? And that you still keep that patient centricity, so you keep them at the center of how you design the study and how they participate.
You know, the big advantage of being able to use sensors or wearables is that it's passive data collection. So the impact to an individual is relatively low, yet they still provide this data, right? So understanding even in the US and the UK, you know, some people, they like going to the doctor because they feel that they're going to be looked after, right? And so if you say to them, I'll just do a video call once every two weeks. Suddenly that doesn't feel the same for that, right?
Some people don't like having nurses coming to their house or medical equipment coming to the house because the neighbors say something, right? So it's about understanding how people are going to embrace this. And part of that I think is just continuing. So many people already have a wearable or an activity tracker to monitor or improve their lifestyle. I think if you try and make that as seamless as possible, that they just continue doing a similar thing that then suddenly becomes much easier and unless of a hurdle for them to participate.
So I think there are lots of aspects to consider. I think you know, as just to kind of reiterate what Dr. Juniad said, there's a significant opportunity here and I think the timing of it is right. So you know it's absolutely appropriate to be leading the pack on that.
Junaid Kalia: That was an amazing summary. I just want to clarify or maybe challenge a few things because that's what I love to do. So I never thought in my life that I will be doing digital banking. I mean, the one thing that is as close to help is money, right? I mean people will die for money or health, right? What I'm saying is that I never thought in my life that I'm gonna be doing digital banking.
As a matter of fact, up to five years ago there was no such thing as a digital-only bank. If you look at it, I mean the history of it, we always had, you know, brick and mortar banks.
The reason that I believe that the healthcare moves a little slow and especially in the United States and the UK is the reimbursement environment because the reimbursement has to come from government entities. It has to come from insurance companies and there is a hierarchy and bureaucracy that is laid on which stifles innovation a lot.
This brings Pakistan and, in a way, UAE into a fantastic place where this another "D" of digital health which is "democratization" comes in because when you have that less reimbursement burden where you can clearly create a product, you know, and that will be better, people will adopt it.
I mean exactly, Amazon is great because of two-day shipping, right? Now, everyone has to do two-day shipping. Otherwise, that's it, you're done. If I did two-day shipping in medicine, it's not like CMS is gonna give me $100 extra. It's not possible. So that's why I feel like amazingly Pakistan is at the core of creating some of these digital health technologies and the biggest factor was "cost" that is done.
I thank you so much for pointing out that Denmark definitely also did that. And you're right as a matter of fact Germany has a term called apps on prescription: DIGME.
For those who don't know by the way, so for APPNA people, there are quotes from CMS which you are doing you know monitoring and you get reimbursed. So if you're a physician, please do make sure that you have a pathway to get reimbursed for that. Now there's a pathway from CMS to get reimbursed for patient-reported outcomes, it's $20 per month. So if you can activate that somehow into your clinical practice, that's another good revenue source in America.
Same thing in Germany. Germany has a very low reimbursement but they have started under DIGME. That's their German term which translates into English as "apps on prescription". Literally, the patients report outcomes if you do that in your clinical practice, right? No clinical trial, no nothing. You as a physician will get reimbursed for it.
I agree with the hybrid approach and I understand that you're saying that most of them do hybrid approaches. And the question is that if you see, especially India has basically done that labs on wheels and rat on wheels. So we are seeing that a lot in terms of labs on wheels, I agree that there is a perception issue. There's also pop up, you know, clinics that can, you know, pop up and then asthma Bodkin there, you know, there's one pop up and anyone can come and get their ideology done, and labs done for one day, and the next time it goes. So we're seeing a sightless approach is still, I mean you may call it hybrid but still it's quite decentralized still.
I mean you need physical touchpoints. I mean you can't take care of patients without physical touchpoints. But that whole care paradigm. When I talk about digital transformation is basically this wholly unique new experience that is still changing. And thank you for pointing out that, yes, Pakistani physicians have been at the forefront and desire for creating these trials as well.
Umar Hayat: Because it's in the direct interest of the doctors as well as in the interests of the patients. I mean there is no insurance involved, I think potentially.
I have a gentleman with a question for both of you and I will start.
I know biomarkers took time for FDA to be convinced that they will give you the approval based on the biomarkers. And then they developed, even validated biomarkers, which means they have been proven to have a direct and validated link to the disease. And now you don't need to have that subjective valuation. You just need those biomarkers and make decisions. But now you are asking Dr. Kalia to take it to the next level which is a stipulation.
So what comes to my mind was, "Okay, we know that isn't approved, right?" And we always do a comparative study. We are testing here new technology. We need to think differently if we try to fit the digitalization and the old conventional fashion. It's not gonna work like the driverless car with the light's green and red lights. It's not gonna work. You need to have these senses that will allow driverless cars to move without having an accident. But the problem is, and this has been always the case, to try to fit the new technology in the old conventional fashion and it doesn't work.
So my thought was just, "Okay, we need to be a little open-minded. I have a comparative study that I know works and I now implement all the digital devices and all that stuff and then I have my drug, okay."
So in one way by doing reverse engineering I have validated the use for the proof of concept because that drug is proven to work, and now I use the same technology for the new drug. And that's how the comparative studies are done, right? Those are the blind studies. I mean, of course, I'm proposing the open-label study. So there are opportunities to prove it works. That's always the argument. You can have a regulatory body to be convinced, "Yes, we have shown it. It works with the old drugs and the indication of data we are collecting there is valid and now we can use it to make the decision for the new drug."
So I think that's one way to validate, I mean that's how it's gonna start. I will say also, that I remember generations before me if you guys remember how they used to determine the endpoint for veteran regulations. They will hold the Granules in their hand and then they will open them. So if the Granules will fall apart, they will say standpoint if they stick you are over vented. And if they are not making Granules, using but no more, nobody puts their hands nowadays in the blenders or anything like that. But we have so many new technologies.
So one thing I totally agree with and it's very unfortunate such a sensitive industry but have been lacking technologies big time. I used to say even the bulletin bag and just like make the politician bags, you guys all go and do the shopping. There is no hole in it, you can put the water and in Pakistani people buy the milk in it. And 10 years later, I mean it's such a thing I mean, can you imagine what kind of technology they are using? Unfortunately, pharmaceutical has been way behind in terms of adopting the technology. I understand one is the regulatory and then of course the education of the people.
So I do have a question here. Somebody was asking, "How we can get in touch with your organization?" Please send the email or share the email. We will get back to you on that front.
The other comment, I mean, I'm not cynical or I'm not criticizing, these comments are coming from the old people. New people are not thinking the same way. "I need to get out of my house, go and see the doctor. I feel comfortable." Yeah, 87 guys, surely feel that. The new guy? No, he wants everything on his lap. So things are gonna change for sure.
So, that was one of the comments. Like it gives the opportunity to change the environment. And that's very true. But that should not stop the new technology because the benefit of the new technologies outweighs those comforts and good feelings. All right. So, as Dr. Junaid has mentioned, conducting a trial. My goodness. It's a very company sweat and suffers if the recruitment is very low. It's costing so much. And all you need to do is hit the like a finishing move to the next point.
So there are very valid points. Dr. Junaid, you brought. And I'm very happy to say that this is the kind of presentation we need. We are not going to grasp the idea today. I mean, that's for sure, probably not us, but the new generation will certainly ask for that idea. So, those are my comments.
Junaid Kalia: So a couple of things I want to add too. So my daughter does tele-karate on a computer, on a tv screen. FYI. Now, I had to build a camera on the tv screen because, in all the classes, she can see it better. So I would never have thought that you know, and she enjoys it. I mean, there's once a week she does her dance classes online now. Of course, Quran classes are online and also in person.
The second I want to do is that that is one of the beautiful things that you brought up. "Is there any drug on the market that is FDA approved on a subjective endpoint?" That is if I'm going to give a medication or a patient and the endpoint is not left medical ejection improvement, you know it's not that improvement of asthma, shortness of breath lives to be better, getting better, vital capacity. These are all objective markers.
Is there any drug on the FDA that has been using a subjective endpoint? That is the feeling of the patient doing better on heart failure. First time in history, in the last 100 years, FDA approved a drug for heart failure for exactly that. A second-round...
Umar Hayat: So most of the CNS drug goes to that part.
Junaid Kalia: Very correct. And which was, CNS we're okay with it like you know, but "heart" wise? Like why would you do that? This is amazing that we are seeing these secondary endpoints so important now. And then another thing, right? As far as the validation you were talking about. Another big issue is that we have moved the signs forward. Right? I mean Alzheimer's is a big issue. It's been $50 billion dollars have been spent in the last year. The one medication that came out has been properly, you know, has an issue. Why are we how are we going to move this forward? The only way to move this forward is to get baseline data from the patient. Early detection, early detection, early detection, so you can do early intervention. So for neurology, it is an absolute must as far as that is concerned.
And the last one that you also mentioned is the risk factor. And that's how Germany has been doing beautiful work. Germany has basically done category one, which is observation. Now going to category two and they have a whole pathway that has been designed for the next five years in which they're gonna implement these different technologies in a step by step fashion. So it doesn't look like, Junaid is coming in saying, let's do this and it's not a youtube channel that you're creating. It's medicine. So they have a way, a proper design way of managing risk and digital clinical trials and digital health technologies. So if anyone is interested, definitely look at Germany's model as far as this is concerned.
Mussadiq Khan: So you may have heard about the FDA recently approving a video game as a prescription for ADHD, right? And so there is there's you know there's a whole new stratum of "digiceuticals" (digital pharmaceuticals) that are opening up, right? Non-pharmacological interventions that may be beneficial. I think that the big question now and you know this was something that Lydia is very focused on. I know other big pharma companies are is defining what those validated digital biomarkers will look like moving forward.
To both of your points, the Holy Grail will be to have the primary objective using a surrogate, right? Or a digital biomarker. Now, we're not there yet. Even with just biomarkers in general. Right? So digital is the next step. The closest maybe is with companion apps or you know in the same way you have a companion diagnostic in oncology. You know companion apps for respiratory and making sure that you know your inhalers are being used properly and smart trainers and all of those things. But you know we want to get to the next stage and I think if we're thinking about Pakistan specifically and the opportunities that are there, I think you know certainly from my perspective one is to create an environment that attracts others to come to Pakistan because it's an environment where pragmatism and innovation are encouraged.
From a regulatory perspective, the whole environment is such that you're you encourage that, and those companies then that I want to develop drugs in that way come to those regions they specifically look for them. So you have an opportunity with that, I think there's an opportunity as Dr. Junaid said, with defining that the studies, is from an academic perspective, the barrier is low to entry now. Right? To use some of these digital technologies. So with the intellectual capacity that exists in Pakistan in the medical community, to start running some of these academic studies and gaining some of these answers quickly, creating an environment where it feels attractive to the global companies to come to.
And then the final thing was more a question for those that are involved in there. You know, digital technology and telehealth for example have been, have existed for a few years now, but penetration in Pakistan has been low. What's the reason for that? What are the, what are the barriers? Is it individuals or is there something else that's causing a low uptake? That's just a general question. I don't know what the answer is.
Junaid Kalia: I don't know the numbers to be honest with you, as far as adoption is concerned in Pakistan specifically for telehealth. But the question is that anecdotally of course there was a lot of buzz in the last two years which everywhere, once you're talking about pendulum swinging and everything. But I still believe that in this model, there are 18 different companies now in Pakistan, there's been massive investment going on. There are constantly growing numbers of people being seen, but there is, as I told you, in Pakistan, the level of trust is already slightly low. And the more important thing is that digital literacy is still a big factor in terms of. So the minute this generation of 10 years goes on, it's gonna be the same thing. Nobody's gonna have a bank account and a physical bank. I mean you go to a physical bank when you have some big, big stuff to do but otherwise everything is going to be digital.
Umar Hayat: Yeah, we're getting very close to the finish line. I do have a Dr. Samia Muslim, who has a group of researchers, all in clinical microbiology. I would love to be in touch with you.
Anybody who has the last question, please raise your hand. I mean you can click at the bottom of the screen and raise your hand, and we will give you the mic and you can comment or share.
Dr. Babar Rao: I just have a comment for Junaid. I'm obviously very much into this field but the way he summarized it, I am kind of proud of APPNA MERIT and Junaid, you made it very simple.
Umar Hayat: Thank you. Thank you. Thank you very much. Yeah, if there are no questions, we have 9:58, I will ask Danish to do some close-up remarks Danish. Not on the seminars, not on the educational workshops, more on the entrepreneurs, let's request. So pleased to you, Danish. Is he online? I know he was there, I think he was there earlier, but I don't see him now. Okay, Dr. Rao, why don't you close the session?
Dr. Babar Rao: I think when we started this many years ago we were more into doing online lectures in Pakistan, hiring faculty from here, not hiring, but asking and do deliver so we did hundreds of lectures. And then Danish came in and he basically turned it into more objective teaching modules. And then, most recently over like a year and a half, so we have been looking into anybody who's in healthcare technology in Pakistan or outside Pakistan but wants to work in Pakistan. We are focusing on that and related to that, we have a group of people with who most of these panelists are involved. If anybody is interested to get in touch so obviously throw an email to APPNA MERIT or Danish. But mostly we're looking into anybody who's trying to do anything in healthcare and technology in Pakistan or is living outside Pakistan but interested in Pakistan, please contact us.
Umar Hayat: Thank you very much. We are right in time. It's at 10 AM in pacific daytime. Wonderful, thank you very much, everybody. Thanks, Junaid. Thanks, Dr. Mussadiq. Thank you very much for all and thank you to everyone who dialed in. Thank you very much for your precious time and see you next time. Thank you, all the best.
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