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Modern Data Platform, IoT and the Cloud - how this dynamic trio is enabling virtual clinical trials in COVID 19 era

Prakriteswar Santikary
Chief Data Officer at ERT
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Modern Data Platform, IoT and the Cloud - how this dynamic trio is enabling virtual clinical trials in COVID 19 era
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About speaker

Prakriteswar Santikary
Chief Data Officer at ERT

Dr. Santikary is an accomplished technology executive with over 20 years of experience in building distributed systems, platforms and applications using techniques of modern data architecture, distributed computing and cloud computing. He has worked in the clinical research, pharmaceutical, e-commerce, banking, financial and energy sectors, driving global data and platform strategy and overseeing execution. In his current role as Vice President and Chief Data Officer at ERT, a global data and technology company supporting clinical trials for small, medium and large pharmaceutical and bio technology companies, Dr. Santikary is leading the strategy and execution of ERT’s global data architecture, data integration, business intelligence, advanced analytics, data governance, master data management and data science. Before joining ERT, Dr. Santikary held several technology executive roles across a variety of industries, including serving as Head of Data Engineering and Director of Engineering at eBay, VP of Engineering at Zeta Global, Chief Architect and Technologist at Sunovion Pharmaceuticals, Director of Data Science and Engineering at EnerNOC, Chief Data Architect at PNC Financial, Chief Architect at S1 corporation and Research Scientist at The University of Michigan, Ann Arbor. An industry thought leader and a data evangelist, Dr. Santikary is a frequent speaker at software engineering conferences, summits and symposiums.

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Turn data platform coyote and the cloud and how do you say Dynamic? Trio is in a blanket field clinical trials during covid-19. A little bit about myself. I am the vice president and Global Chief data officer at ERT. I have been in the industry for over 20 years and my expertise lies and building distributed systems and platforms and applications using a modern architecture distributed computing and cloud computing in my current role and I oversee the global data architecture integration and and data science.

Little bit about the company at Erie PA EZ search technology. We are a global data and technology company that minimizes the risk and uncertainty in clinical trials, so that the hour Customer can move ahead quickly with confidence. We have Global. I will global market leader in Eco we have in our respiratory and efficacy and Safety Services. We also have product lines including Imaging and wearables about 3,000 employees. Globally. We have been operating in 12 countries and have been active in

128 countries running trials supports about 114 languages. About 74% of the new drug approval in 2019 was supported by ERT. So that's a very very big statistics are so we have been running as you can see 619 drug approvals 30 therapeutic areas running 15 1500 active studies to 30000 side 5 million patients 200 active customers and over the past 50 years or so. We have been executed about 15,000 clinical trials. No, the legend of that. I am thinking of going through with you time permitting is we're going to talk about the industry challenges and opportunities. We are also going to touch upon

our platform in the cloud modern data platform and hiding some example you can say is that my team has been working on including but your trial and then we're going to tidy up a little bit. Let's dive into the industry challenges. As you know, a clinical trials is is never a straight line from start to finish. It's always full operation uncertainties. It goes M7 flubs, as you can see some of the status ticks at the bottom right-hand corner at less than 10% of clinical trials and on time. 48% of

science subjects volunteers 30% average person dropout rate just because they're enrolling does not means, you know, they're staying throughout the duration of the trial about 30% of the patients table South. I need takes about 10 to 12 years and cost about a billion dollar to launch a drug. Elysian 10% compound advance to FDA approval So this this Statistics are dismal. And then on the left hand side at clinical trial has been the complexity of clinical trial has been increasing steadily

58% increase in size for a 71% increase in average number of endpoint data collection systems and usually your pipe to 12 systems bar Global study that help integrate. Do really gather data from? And then we are seeing in the Life Sciences Industries in general and exponential growth along with more endpoints. Obviously velocity has been increasing the digital ization has increased the speed of information loss of sensor Mobile have the devices you need me

and then I'll be asleep and ID update that is all the same thing. They are you have clinical data data coming from a few minutes and you name it. So not only the information is structured. It is also sometimes unstructured sometimes semi-structured and even know many times if he's been buying it as well. So I just videos Imaging that all that part of clinical trial but that data is buying a teenager. And then I'll be asleep to gain inside your bra line all this data together which which has always been a great challenge. Let's talk about

little bit about particular trials that is when adding more complexity to this whole clinical trial ecosystem. Suggest Why I'm Hot your visits now suddenly slow because of covid-19 that offer soap as you can see PP 9% of patients are willing to use by children. So instead of patients coming to the side side Personnel are using remote Technologies and patience abuses remote Technologies as well. And just how many deities who administered a drug for patient engagement, etc, etc.

Subarticular trial the concept has been around for a long time, but it has really expedited. It is contraction of the say because of this. So what does that mean? Like as you know it from from sponsors point of view from pharmaceutical companies going to feel they need separate trials officiants? I'd caught in the timeline. You stayed up 10 to 12 Beers candesartan the timeline so that they can bring life-saving drugs and therapies to the market quicker engage patients.

And then in the new world UE UE you continue to need engaging written those patients who are being a part of the clinical trials. You need to relive his realize that data and the results on the race in one place. And I'll be asleep. Most of the trials are Global in nature that even poses additional challenges. The pink about the typical patient participation that Westside Building in clinical trial, right? So drive-thru clinical clinic for an appointment and I've said to

go to the reception Words Their pillow some paperwork receives treatment consultation and clean a shield and our statistics so that over 70% of patients sleep. Osla promise. I do all that ministration that you need to do. So if you go to the new way new ways patient completes all deities and information at home on hand head and that data stream into a centralized data store. And then obviously consultations on site assessment everything happens. But really so flexible dryer says to suit patients needs so it fixed with the modern Lifestyles and

expectations so you can minimize this site visit. And it's the last time the dead to spend their site and obviously more convenience. And we recently DJ service and here are some of the things that we we found out talk to you soon as keeping you up at night that is particularly talking to our customers like pharmaceutical companies biotechnology companies Seattle contract research organization 79% and let you know this is screening new patients is a big deal side engagement 61% or 56%

and biggest issue impacting trash in the next 6 to 12 months style management, patient Recruitment and enrollment patient compliance. And then we also ask, how are how will you collect data in Virtual trial 75% patients using devices to enter on the photo using Telehealth to meet with side Personnel instead of visiting to the side and 48 persons capturing data from sensors like Fitbit Union Apple watch you name it. And most important Collision from covid-19 25% say Implement Padre

Technologies, 18% stay open-minded flexible and and you know, they say no hitting technology. You know that process you need me. And then 88% of patients willing to use a smartphone during clinical research as you can see 99% use a smartphone 78% use their smartphone at least every other so that's that you see the train here. Similarly 96% of patient survey would be willing to use a fitness watch or share data for research purposes. So that that thing is also involving dramatically 31% use a fitness watch

12% Check their Fitness. What at least every hour. 96% would be happy to use a fitness watch during clinical research. And then 59% would be happy to have a partial visit, you know instead of going to a doctor for the clinical visit. Do all because of convenient if we were to summarize more immediate than convenient specially in the causes something minor such as a cold then why go all the way to the doctor's visit save money on gas. Most of my issues can be discussed over video and would send me the

time no waiting in the waiting rooms with a bunch of sick patients. Sometimes it's not physically possible for me to get myself to the clinic. Think about Uncle IG patient terminally ill patients. They don't have the energy to drive 2 hours to clinical side clinical trial ideas are really getting traction. And we have but we we just talked about little bit about the capabilities that we have. Obviously, you know, he has been collecting data outside upside visit 454 bunch. Of course, it's nothing

new to us. And if it's actual trial in the operation and planning between all trials take orders stakeholders decide your patient you have sponsorship euros, and then I'll be asking you know that as a third-party folks like yeah companies like also to all and then all different kinds of Bender are all a part of the ecosystem clinical trial ecosystem and stakeholder. So so busy engaging the weekend patience is a big deal visualize data and results as I as I stated and supple studies globally. So

particular Technologies enabling all these things beautiful. Virtual travel capabilities as you can see alarm mode and join the study if you can just think about and what Chloe here on this device is not talking to each other and getting things done much really so you just sign up and then you just collect data you watch are integrated wearable device, or you can have your own bring your own device Arlington probation our power device to you as a patient and all the video call with the medical staff

real-time study insides receive notifications on motivational messages to all these things can be integrated together to really present a child's capabilities and and a New York have the perfect spot to drive this and give him the expertise. We have not only in the data collections page, but also in enabling Triad dashboard send talk about a few of those use cases. Obviously no provision devices you can use web you can use combination of any devices that that that that the patient weighs. And I'll be asleep but we

have sight fishing products with a patient fishing products and enabling at home video consultations between patients and investigative side with simplifying participation in the trials and post-approval studies improving patient engagement and study continuation. And obviously, you know our link to secure compliance and clinical trial data technology. It'll pop up from patient perspective the same thing used to access the app and invite your consultation. So this is a patient perspective of departure trial

and then we have the sight perspective of much are trap. But if I were to just summarize all these challenges and you know, I have a big four buckets one is obviously disparate data multiple data sources multiple devices multiple data types mobile and then I'll be multiple vendors multiple stakeholder complexity of the protocol because Protocols are increasingly getting complex and then I'll be asleep but your child so that's like all you know, they got election-related complexity and then I'll be asleep

you'll be integrated that they'd a scale as well. So and then then that that data integration and inside has to be really tight. So weird seeing like lack of real-time access to integrated information Lac update. I mean to be a time lack of visibility into actions being taken to address issues because there are so many vendors and so many systems and they don't talk to each other. So once and he resolved within one system ain't no that's not get translated back into the other system. So lost it mean if he

she announces and then I'll be a slave that breathes did equality shoes using data collection by patient compliance issue side compliance issues. Where is Elysian a text longer visit compliance and then obviously and this is pretty and regulated industry oversight in monitoring is a fair amount is a Paramount importance what side of the study oversight of the vendor oversight of the Sierra Rose and monitor things before they become raised preemptively. That's when

we'll talk about Predictive algorithm and collectively have obviously tons of challenges to running a trial but the companies like ourselves as you will see if we have a fillable platform that can ingest data off any tide coming to eat at any velocity and then we have real-time dashboard that our customers used to dealing with you is almost like for clinical trials and then they use to Jill Monica before they become rare. Show with that do you know our customer service and seeing all these they're like

drowning in data, but the information is key. So high quality data generates good information. So that's where the scale of the block phone comes into a picture. What are you going to bring all the data together from various systems, including variables and streaming data you name is structured and unstructured binary together and then you really believe here Dad. When you said to Barton Creek tractor, we enter data into multiple system difficult motive for this pain confirming that you raise your Betta than

interpreting it for decision making Obviously that generator cost overrun And Delay to time-to-market, but that's where your customers are crying out for help and then they're just saying getting can you simplify the complex? So let's talk a little bit about our modern architecture. How are we simplify? So it's all about impressing operational efficiencies speed quality and inside it boils down to this food 5 Business drivers obviously savings is a big part of it. When you are running a trial

efficiently by Design cost. You are reducing the clinical trial timeline as we talked about is helping not only the sponsors and the pharmaceutical companies. It is also helping the patients because the drugs are coming to the market quicker and it is not taking 10 to Claudia. So let's talk a little bit about architecture as I have been abducted data. It has hook for unstructured data eat has hook for swimming data. They all go into a central data leg that we have built in the cloud. And then obviously

we have an allergic sandbox. We are persistent data store week. You read the data We Energies the date. We also load not only the clinical data such as customer care data. Are you name it? And you pull all that information together and then really cute ready and then create value-added de Tomar sometimes data warehouse. Sometimes you do data science, depending on you to use guess that could be automation related that could be up in my using the letter that could be

predicted in nature and then obviously Seltzer is bi where customers can use our two and then create their own custom report. They can match and merge data set with the data said that we provide them at their own day-to-day can collect them together and create custom visualization and then I'll be at the end is governed by their we did that binds all the stakeholders together and they agree on their standard the beyonder the quality metric they have neon data

integration rules and all kinds of things that are all a part of the government. So we have that cross-functional team. We have big that has team members from R&D that is team members from Operations it commercial study you made me the best of collective cross-functional team providing the outside of the quality up that tea that within the data light that's like critical ingredient to making a digital Exeter. And then I'll be asleep. Our architecture is alarmed architecture that is a

speed ladder and the bachelor air time from sensors and devices and then obviously a bachelor. Just collect that data together cute ready and then probably down to the right right customers and Android stakeholders and then we have different kinds of material that we do sometimes real-time sometimes bad. Sometimes that scale and then remove that we enable data science group so that we keep them out of latex Sandbox app, and that way they can really you know

that they prepare the day before they can start applying out the top of it and then I'll be at the analytics and visualization to as you can see speed limit is a low latency data back to their data processing to support complex analysis and I'll bring Gladys. What is responding to queries in an object that obviously support large volume of 5 L and near real-time analyst. And then obviously provide scale is cloud-based lbs in a modern stacked governed as I said and it enables

microservices best architecture with Cerberus Computing modern data management with data governance page into it will provide a scale we have adapters and connected to all third-party EDC vendors open source libraries in August. I need a lot of benefits to that decision making skills abuse reporting and analytics enable monetization. I'll be asleep and reduces complexity and improved quality enable vibration making and speed to Market that up life-saving drug test. Most important and critical speed to Market and

reduce the timeline of the clinical trial and then and centralized and performance metrics in one player because now that you're all the DJs in one place that way you can correlate different data points and the really a preemptive Leigh mazur that is before they become an officiant sex money and operational efficiency and always and by enabling this data and then integrating it in one place automatically. You have a pretty good star Part D i n m l but as you know, I did I mention and

data curation and data preprocessing sometimes text 62:8 80% before it. Data, science group can start thinking about applying a i n m l on top of so so so very very critical. So let's talk about some useless as quickly. So obviously as I said, he's not a high in our case and they personally speaking I have been doing a iPhone for a bunch of BS before this role. I was at eBay as the head of data engineering there would be lots of the name of those days and it in my

academic Life by Irish Fest on that simulation domain. We have been applying as you can see a clinical trial for customer care by spot for Customer Care customer sentiment analysis automatic study design. SC State guard except a / D Imaging operate similarly. We are also lots of Automation and optimization on on Smart data management Lake smart cleaning app Smart this year and all this is making the process more efficient to run smoothly to reduce the time of the clinical trial and then I'll obviously smart data packet Lakeside physical recruitment is is a big challenge

no patient. No clinical trial. So you do make sure you enroll the patient's quickly and then not only that once you enroll them your you can make sure they stay engaged throughout the course of the clinical trial. So that's where I think a patient patient site and sponsor the other three big stick. Listen to clinical trial. Another drug use cases recently. We beat covid-19 dashboard as you can see we run clinical trials globally about 1,500 conquering clinical studies are running on all platforms and they're dispersed globally clinical sites are there globally

so as you can see, we already know the site location because we have integration with the way up with Google API and always and then we also interject an integer that data was John Hopkins data, and we can we can really bad guy. Patience and sites and sponsors that you got going on is the hotspot or not that kind of analysis competitive performance of key metrics by country inside currently Active covid-19 cases by volume in relation to side part taper Providence Drive other people form in smithwick's related to device tablet

this year. We can all in particular trials because we have all these things going on. But really and how wide does metric changing if the tile is not much of a right. So we have we have bad day. For pool so we can come up with the comparative study as well and each has gotten tremendous traction from our customers because they can see just by visualizing it up. Obviously this dream down capabilities and all this way. They can really go down to the zip code to see which side is getting affected by the pain. I'll be asleep by Sandy

Berg bought for internal and external customers. Currently. We are employing this chat button twice. But how do I customer care service that way? I think they don't have to login into multiple systems to be Ali s Harbor customer care take it they can use the data. We've been to chatbot and Parks Board around a tree has the intelligence AI to delete query that I have a dentist or and then get the answer that quickly first call resolution time alone and I'll be asking you that data quality is also good because it is

quitting and the integrated and curated invalidated data set from the dead. Another one is as I say. That's where we use Predictive Analytics. Like you have all these centralized are almost like a command center. Where do you have that you are seeing the helicopter study in the clinical trial in a globally with all kinds of metals compliance Matrix that you made me. Do you have like, you know 50-metre your Benadryl make Matrix and you can be little doubt. You can color them green red yellow whatever answer you can

really do be down in the deal is C on the other is the all-time base is the health of your clinical trial globally huge large customer. Kitties and under the great use case off of integrating iot devices like it is a migraine study. We are integrating with Philips device and then obviously endpoint data like Eco asleep and activity analytics data Dexcom continuous glucose monitor right inside. You are integrating with a Tigre. So these are all like a pig be type of piano activity monitoring and the streaming data and you are platform. We're taking the data relating with our

operational clinical study data together and then solving a big problem here. And then I'll be asleep too glad to hear he's asleep activity and some kind of dance Port Hardy can't really see correlation of activity sleep whether medication use respiratory event interactive data visualization. If you can just go to this complex journey and I from one central location to add a sport. Other than one is continuous glucose monitoring. Why why are you know, what data is

getting stream? Do you know and that video? It's it's coming to our platform and we can guests Puritan Kool-Aid them with the other day that you know side did a patient that you name it and then the dearly dearly and correlate some of the things together. So the takeaway is that you know, as I said, it's a pretty complex problem. And so basically modern data platform is basically enabling us integration of scale analytics fat scale + Cloud. He's obviously giving us the demand

and productivity speed efficient and AI is giving you a confirmation enough to make with that. I am going to conclude and then I'm going to be happy to be answering any questions that you may have.

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