Michael Shashoua: Hello, everyone. Thank you for attending today’s webinar: Delivering Streamlined Processes and Customer Centricity in the HSL Industry, presented by Certinia and Salesforce.
I’m Michael Shashoua from Fierce Pharma.
Just a few technical notes before we begin. The webcast is being streamed to your computer, so there is no dial-in number. For the best audio quality, please make sure your volume is up. This webinar is being recorded and will be available on-demand within 24 hours after the event. Time permitting, we will follow the presentation with a Q&A session. Please submit your questions using the Questions & Answers tab on the left side of your screen.
All right. Let’s begin. Andy, please go ahead.
Andy Campbell: Good afternoon, good morning. Welcome, everybody. My name is Andy Campbell. I’m a Global Solution Evangelist here at Certinia. We are delighted to host the panel today. We’ve got some fantastic panelists with some great experiences that we’re wanting to share. Hopefully, as Michael said, if you want to join in by asking us questions, please do. We can make this a kind of collaborative event.
Something quickly about Certinia. We are a Salesforce partner. We specialize in providing software (ERP software) for organizations that operate in the Services industry, Services businesses. That, obviously, includes areas like healthcare, life science, and clinical research in particular. We’ve got a number of customers in that space, as well as lots of smaller organizations all around the globe.
One of whom is Castor, and I”m delighted to be able to introduce our first panelist this morning – this afternoon. So, could we bring up the panel, please? Great. What a beautiful bunch you look like. I’m really looking forward to this session.
I said the first of our panelists is Kimberly Tableman from Castor. Kimberly, could you tell us something about yourself, please?
Kimberly Tableman: Yes. Hi, good morning and a good afternoon to those attending today. My name is Kimberly Tableman. I’m the Chief Clinical Development Officer at Castor. I have a 23+ year career in Pharma. So, I’ve spent many years at Pfizer and GSK before going into the startup space during 2020, actually. Which is an interesting story for a different day.
Castor is a company that is committed to democratizing clinical research and making clinical research accessible to all.
I’m really excited to be here today.
Andy Campbell: That’s super. Thank you, Kimberly. Kimberly, to warn us, she’s got a young child that’s running around in the background. So, if anything untoward happens, then don’t be surprised, people.
Second guest today is Christof Wascher from Salesforce. Christof, you’re at Salesforce now but you’ve got a strong experience in the whole healthcare life sciences space.
Christof Wascher: Thanks, Andy. So, I had the pleasure to work in and with the pharma industry for the last 20 years. I’ve had the pleasure to work with Novartis, with Boehringer Ingelheim, and then with a big, big web scaler taking care of one of the largest pharma accounts worldwide. This really got me through the entire value chain of pharma. I also had the pleasure to sneak into MedTech development. Of course, last but not least, to go into the details with all the nitty-gritty elements around computerized system validation GXP from A to Z.
Nice to meet you all today.
Andy Campbell: That’s great, Christof. So, we’ve got some experience of operations people on the ground. We’ve got some experience of people working in the technology space as well.
We’re also delighted to have with us Ben Adams who works at Fierce, one of the editors here at Fierce, who’s got a broad industry knowledge that, again, he’s going to be able to share with us today. Ben, do you want to tell us something about yourself, please?
Ben Adams: Yeah. Hi, everyone. Luckily my toddler’s in nursery. So, hopefully, we should all be good on that front.
My name is Bed Adams, as Andy was saying. I’m the editor here at FierceBioTech. I’ve been covering the CRO industry specifically in life science for more than 11 years now. As Andy said, I’m hoping to give some more of an overview of the trends we’ve seen in the industry over time after talking to pretty much all of the CROs over the last few years.
Both in terms of how new tech platforms are helping streamline different processes, and also – which I’m sure we’ll be talking about a lot – how the pandemic has really changed this ecosystem.
Andy Campbell: Yeah. That’s super. Thank you. So, hopefully, you agree we’ve got some great expertise here. Please do ask the questions. We’ll involve you all in the conversation as much as we can.
We have to start off by talking about the pandemic and what that’s meant to us all.
Kimberly, your experience has been absolutely actively involved in all the stuff going on within research and within the Covid situation. Could you tell us what impact Covid has had on you and on the industry more broadly? And how you’ve had to respond to it?
Kimberly Tableman: Yeah. I think the first thing I’d like to share is that I did hear a staggering number in the sense of clinical research prior to 2018, decentralized the idea of decentralized clinical trials and things like virtual visits, were not being highly adopted or quickly adopted. We have seen in the last couple of years that number has doubled.
So, from 2018 to 2020, the number of companies that are actually utilizing… I’ll call it decentralized methods in the context of a clinical trial has doubled. So, that’s a pretty staggering number in terms of acceleration and adoption of these decentralized methods.
The other piece that I’ll say is that one of the areas that you can really capture the greatest, I would say, impact in cost savings as it relates to running a clinical trial and using decentralized methods is this idea of how people find a clinical trial, how they pre-screen, go through a pre-screening process, enroll, and consent. So, kind of what we call at Castor that integrated patient experience.
We had the opportunity to partner with the World Health Organization on a study called Covid Red. It was to run clinical trials as it relates to the Covid vaccine. We essentially were able with our platform to accelerate enrollment recruitment into the study, 17,000 patients in 15 weeks. Typically, that would take two years or longer.
So, again, a huge opportunity really in that awareness. I call it awareness, education for people to understand what clinical research is, that it is an option, that it’s available, and then allowing people from the comfort of their home to pre-screen, understand whether they meet the inclusion/exclusion criteria. Then, enroll in the trial. That has become very seamless from a technology perspective and now we’re starting to see widespread adoption.
Andy Campbell: Excellent. Thank you. We ran a similar webinar to this, it must have been six months or so ago. The representative said, “One thing that happens – one thing we’re committing to as a pledge – is that when this is all over, we’re not going to go back to the way in which we’ve done things before.” I think that’s pretty much what you’re saying.
Ben, from what Kimberly’s talked about, are you seeing that more broadly happening? Is that common, from what you’ve seen around the industry, or are there other things that you’ve seen?
Ben Adams: Yeah. I would reiterate that, and that’s something else. There’s no two ways about it. Covid decimated the industry in the spring of last year. The large majority of Charles Cross CROs and across sponsors were put on hold or they were delayed. But, I have to say, it’s remarkable how quickly they bounced back. By Q4 I think many of those pauses were back up and running, tapping that hybrid form as we were talking about of sightless, virtual, decentralized trials. Whatever word you want to use for it.
If you look at some examples, we’ve got Labcorp bought out Covance CRO about five or six years ago. They announced recently that they were going to transform into this sighless trial CRO. Which, in practice, means they’ll double-down on all aspects of the virtual model, including things like telehealth, and those connected devices to improve data collection, and kind of help realize this model. For such a massive medical testing company to buy Covanta and then to make that kind of transformation shows you how much the pandemic changed.
I mean, other CROs have massively doubled-down in this, as you were saying. Accuvia, PPD, MetaData. Companies like Novartis, which is already on a bit of a digital binge. Most interestingly, for me – and I wish I had more information about this – is Johnson & Johnson’s biotech unit, in which ran its single-shot Covid vaccine last year through its CRO. Then, it almost completely virtually, through a mix of these telehealth technologies, virtual oversight, and digital patient engagement strategies. You know, one of the most visual vaccines we’ve ever seen was done almost solely through a virtual trial. Which is remarkable.
So, the legacy of Covid to CROs, as you were saying, is a sightless future. But, I think, as well it’s likely to be about speed. We saw lightning-fast trials with new vaccines, going from pre-clinical to approved and in people’s arms within a year – sometimes less than that. Many of the companies I speak to, though, who aren’t working in infectious disease or vaccines are saying, “Well, if we can do that for Covid, we aren’t we doing that for heart disease or cancer or COPD?”
These still kill tens of millions of people every year, and they constitute, for those people, a medical emergency as much as Covid did.
We want trials to be accurate. The time doesn’t need to be taken in the clinical and during regulatory review. But, many have told me the way that they’ve gotten through this so quickly with Covid is time spent on paperwork, waiting for clearance. A lot of those hurdles were removed. I think if we can do more to streamline this, we’re probably going to start seeing drugs get from bench to bedside much more swiftly than what we have done.
Andy Campbell: Yeah. I think that’s great.
Christof, from a Salesforce perspective, I’m sure that you’ll sort of reiterate that point about speed and the kind of change that people can bring about quite rapidly. Is that fair?
Christof Wascher: Oh, yes. Absolutely. So, you also need to understand that we to work deeply with the entire healthcare ecosystem. So, with the payer, provider, the pharma, the MedTech companies as we started to emerge 22 years ago. Right?
What we really see now is, the pandemic pushed, of course, the embracement of digital technologies and digital ways to interact and engage. In this context, also, recent research shows that by 2025, those companies will be able to differentiate themselves in the market, which really has embraced this personalized, integrated care approach. Outcome-centricity is key. Putting the patient in the center. This will become key. But, of course, there is more than the patient. There is the HDP as well.
At the end, what we see coming, which impacts the companies – the life sciences companies. So, this really means pharma and MedTech. There is this huge push for data and digital technologies. So, data will become the new currency, to exchange data within this ecosystem.
Here, of course, we also need to understand there are legal boundaries. But, you know, if I would have a magic stick, actually, I would like to piggyback on this push towards data becoming the new currency to really reassess the current regulations, so that these technological advancements could be embraced, so that the patient could really be put in the center of this ecosystem with the payer, provider, pharma, MedTech. So that at the end, per the data exchange and the leveraging of digital ways to interact and engage – so, hybrid engagement on all levels – so that the ecosystem becomes more effective, more cost-effective, to be precise. But the patient experience gets elevated. I think this is really something which we will see going forward. There is no turning back. So, companies need to embrace.
But, Kimberly, to your point, with the decentralized and virtual engagement within clinical trials, I couldn’t agree more. I would put it as hybrid engagement. Yeah? Maybe as per given indication, there is a need for a more closer engagement, face-to-face. Then, there will be better possibilities with digital endpoints in clinical studies as per the clinical protocol to defined, there will be ways to have less face-to-face engagement. But, in the end, it will be a hybrid engagement, and we will see this hybrid engagement not only for interaction with the patients in clinical trials but also to support them with care plans, care anywhere, really supporting the patients. In adherence to their care plans, we will see this also within the companies themselves having hybrid engagement. It doesn’t matter anymore where the people are working. Hybrid engagement will become key. This offers lots of opportunities for precision medicines, personalized therapies, and new commercial strategies really going across sales, marketing, and regulatory.
So, this is really something which will change the market. We see, by the way, also very good real-life examples. If you have a look at Estonia, for example, they have embraced this push for a digital healthcare ecosystem a few years ago already. I think they are, if you have Europe as a whole and putting Estonia against, I think they are advanced 10-12 years or so. So, they are ahead of Europe. But this is really the future and is a great role model of how an ecosystem could evolve putting the patient in the center.
Andy Campbell: Yeah. That’s fascinating. Estonia is such an interesting use case across the whole of government and public sect about the way in which they have been able to dramatically change in sort of post-communist times. Quite interesting.
Love this conversation around the hybrid model. It’s not relevant for every kind of trial. But, Kimberly, does it reinforce your thoughts, you think?
Kimberly Tableman: Oh, yeah. Absolutely. I agree with Christof wholeheartedly. Hybrid is really… The way that I think about it is more flexibility and choice. Right? So, when you talk about patient-centric and putting the patient at the center, patients want to make those kinds of decisions. What I mean by that is they’re going through a clinical trial. Perhaps, this week, I want to do a visit from my home via video. But, perhaps, next week I’m not feeling very well and I would like to see my physician.
So, we, as an industry, need to be able to respond to and support that.
I think the other piece that we, as an industry, need to respond and react to and be able to support is this idea that you can get simple procedures done at your primary care physician. You can get simple procedures done at your local pharmacy. Again, we have to have an ecosystem that supports that because, at the end of the day, we know that we all create a clinical trial record. Right? Which captures data and the currency within the clinical research is data. It is data collection and our ability to prove the safety and efficacy of the therapy that we’re studying.
So, we want to support that level of convenience. If you can go to your local pharmacy – which is a mile away – and have a simple procedure done, even a blood pressure taken or something of that nature, then what we need to do is enable that from a tech perspective for that data to land in your clinical trial record. So that you have a complete record of your procedures and the data collection that you’ve gone through.
So, when I think of hybrid and making it more concrete for patients, that’s what it looks like. You know? It looks like that flexibility and that choice and fitting into a person’s lifestyle and making it more convenient for them.
Andy Campbell: That’s great. So, what I’m hearing is convenience, which requires flexibility and it needs a mindset that is kind of patient-centric.
Coming to you, Ben, next. Christof mentioned something as well that was quite interesting about a renewed focus on outcomes. Not so much on process, but I almost got a sense that there was a sort of mindset shift within companies to actually make sure that all the ducks are lined up – to use a strange metaphor. All lined up to make sure that we actually deliver what we need to. Are you seeing that as well?
Ben Adams: Yeah. Definitely. I mean, outcomes is what you’re going to base your ROI and your business on. So, no. I completely agree. Not that outcomes were unimportant before, but I think, as well – and this is a point I’ll probably make a little later on – about the world is watching as well.
CROs and the life sciences industry generally do things sort of quietly. We don’t really know the name of many of these companies or the trials or the industry itself. Yet, in the last 18 months, we’ve all become quite specialists on this. People are going to be reporting on that. The mainstream media are going to be reporting on it.
So, the visibility of what your outcomes are are becoming much greater. I think the industry itself is becoming more aware of that.
Andy Campbell: Yeah. Interesting point there. Where do we see…? Christof, what do we see are the trends in the next sort of three years or so? We talk about a sort of virtualization. We talk about patient-centricity. Issues around scrutiny and visibility? What other kinds of topics do you see coming over the next three years or so that we need to be cognizant of?
Christof Wascher: I think this elevated experience will be demanded from the market. In this case, from the patients. Right? Because each and every one of us has this very convenient way of one-click buy from Amazon. But, at the end, this integrated experience we have, this will also be demanded for a treatment plan, for a care plan. So, this is what I really see patient experience.
Then, of course, there will be the push for personalized therapies. We all know the CAR-T therapies where you have this very, very targeted individual treatment approach, but this needs to be orchestrated. Right? Here, actually, the patient is in the center of a mini-network, if you wish. With the look of [unknown 0:19:57], for example, and then the shipment, and then you have the manufacturing piece with it, and the product ecosystem could learn from this. So, personalization. But, this means, also, individualized therapies. So, for given treatment, you could say, “Hey. We add care plans to this. We support with diagnostics, sensors and everything. We connect the patient to make this given treatment a kind of individual treatment as per the individual, so that we can make, also, an average treatment and individual. Not a personalized, but at least an individual treatment.”
So, this will definitely happen.
The ecosystem. I shared this example from Estonia. It starts to get together. So, payer-provider, pharma, MedTech, this ecosystem will grow together, leveraging the possibilities we have to exchange data. We have the fast healthcare interoperability resources, leveraging the [unknown 0:20:56] that. It’s all the same, same. But the difference is we have ways to go. Yeah?
But, I think a good step in the right direction is currently conducted. There is another one. You know, I think I mentioned it, also. Sweden. They also started to embrace e-health. They have an initiative where they say, “Hey, we are halfway there to embrace this completely by 2025.”
Even the conservative German market, they will start the e-recipe for prescription medicines in January.
Then, again, data. Data is the new currency. The patients will become data empowered. The HEPs will become data empowered. There are huge data assets also available within the pharma company, within the CRO. But, you know, imagine all the data assets which we could collect from the patients being treated. So, no clinical study can have this amount of data pulled.
Actually, I was thinking, if we would enable this electronic health ecosystem where we could share data within the legal boundaries but maybe we need to reassess given the latest advancements, then the States, they would be able to combine the data and really learn what works best for patients, what works less. This could then be shared back with the pharma companies, perhaps. Then, you could think of a subscription model.
So, at the end, it would mean that the pharma companies would pay for this data, but at the end, the pharma companies would not need to conduct this amount of real-world evidence studies, phase four studies. Yeah, they may continue to do so, but with less big of a footprint.
So, this is what I see as a vision, as a magic wand, if you can put this in going forward. But I think here, we’re in the baby stage, I would say.
Kimberly Tableman: I can build on that.
Andy Campbell: Some interesting ideas there. I was hoping you would, Kimberly.
Kimberly Tableman: Yeah, I’ll build on that from a data perspective.
So, I agree wholeheartedly that data is the currency of the future. Christof, I also agree with your last comment. I love your vision. Then, I want to talk about this crawl, walk, run.
So, I love talking about data. At Castor, it’s a big focus for us as well. One of the things we’re focused on is this idea of collecting data in a standardized format. Which, by the way, is not the fun, sexy stuff, but it is the foundation that allows you to do and enable (if I can say) Christof’s broader vision.
I’ve actually seen in action where that has not been the cast. Both, at Pfizer, we did a huge project to integrate a large swath of clinical trial data. The struggles started, actually, when we tried to get the data out. Which is interesting.
So, integrating it and bringing all the data together actually was not the hard part. The hard part was getting the data out in a meaningful way that really allows you to derive insights. So, if you think about all of this data, you have data that’s specific to the clinical trial record or what all of us know historically is the case report form. Then, we’re now trying to layer in real-world pieces of data, whether that’s from an ActiGraphperspective or your sleep data, or I want to bring in my genetic information from 23 and Me. That is still a quandary right now today in terms of how do I bring that data in, how do I land it in a standardized format, and how do I then bring that data out and glean insights from it? Because the other piece, as we all know with real-world data, there’s a lot of noise in the data.
So, it’s critically important to understand what is important in that data, and you’re pulling out the signals that are meaningful. These are all real things that we have to solve today before we even get to… I love talking about machine learning and artificial intelligence. But here’s a little secret. You can’t train the machine until you understand the data and you can pull insights out of that data.
So, once we’re able to do that – which I think a lot of us are on that mission – in a healthy way, once we’re able to glean those insights and start seeing those driven back into study design earlier on in the process, then we’ll really start to be able to get into, “Now I can train a machine. Now I can start moving into artificial intelligence. Now I can start talking about smart trials,” which is Nirvana. Right? We want to get there.
I also love what Christof said about getting to a place where we can leverage digital twin data. So, that reduces the number of people (or patients) that you have to put through a clinical trial. Sometimes, that can be challenging for a patient, and there are a lot of procedures that are required, etcetera. So, getting to that ability to leverage that data that’s available from a digital twin would be really useful. Again, I think that’s part of the future and the vision.
The only other thing I wanted to step back on in terms of the future and tie together, Andy, something that you and Ben were talking about previously is this idea around accessibility and diversity. I would argue that decentralized methods, again, really promote our ability to make clinical trials more accessible to more people and increase diversity. I also just use this as an opportunity to make a plea to the industry that there’s a lot that we can do to build relationships with communities as well. That increases trust.
So, I’ll use the example of the fact that people now know the names. Like, “What vaccine did you get?”
Right? Everybody. The global population knows who they got their vaccine from, and actually, they care. A lot.
So, I know a lot of people that feel very strongly. I won’t go into who, what, where, and how, but they feel very strongly about who they got the vaccine from because they say, “I trust this particular organization.”
We, as an industry, really need to think about that and hear that because creating that relationship and having people say, “I trust this particular company,” is actually a big deal. There’s a lot that all of us can do to continue to build those relationships and create trust so that when we need support and help as it related to medical research, the relationship is already there.
So, that was just another area that I wanted to sure we circled back around on because I think it’s a very important point.
Andy Campbell: This is fascinating, some of these things that we’re bringing out here. Thank you so much for all this.
One thing that we, of the past month or so, have been working with Fierce to put together some research. We’ll be asking people watching the webinar if they want to contribute to that research as well.
I’m really interested in what’s going on. Ben, an off-the-wall question for you. We’ve heard lots of things about the more personalized, being more flexible, being more agile, being more patient-centric, etcetera. Which means change and all sorts of things. When we did our research and we said to people, “What are the biggest challenges that you face?” Number one, rightly, was around the efficiency and effectiveness of trials. The second was around cost control. I wonder how you balance the need always to manage costs with the aspiration that we have all shared around doing things differently? I’ll be interested to get your thoughts on that dynamic.
Ben Adams: Yeah. I mean, I would say, with costs, I mean, what is it. 12 years, $1 billion, $2 billion depending on who you ask to create a new drug? I mean, it’s an absolutely massive amount. I think we can cut that down dramatically using things like machine learning and artificial intelligence. Making patients more central to what we’re doing with clinical trials and doing better matchmaking services. That’s the kind of thing that a lot of new startups in this kind of CRO, this hybridized kind of CRO drug development space are trying to do.
So, there are lots of complex issues around using things like AI and electronic health records to try and find the patients for the best trials. But, I think having that as one of the main elements of what we’re trying to do, I think …going to help the most. I mean, I think, quite often you’ve got patients having to scroll through clinicaltrials.gov in the US and similar systems here in Europe and the UK to try and find trials that might match them themselves. That is a laborious process, and one that doesn’t help us, it doesn’t help the development, it doesn’t help the industry.
I have a family member in stage four breast cancer and had to come to me to try and find a way of being on a trial that might help them. That is not how we want things to be.
We talk a lot about AI and machine learning, as Kimberly was touching on, but I think we need to get the basics right, too. If you ask yourself how many trials you know about, it’s not going to be that many. If you ask how AI systems and algorithms can really get into the EHRs, the EHRs are not a consistent, centralized process, and nor are a lot of these new technologies and new platforms that we’re using. You’ve still got what’s called the “swivel chair interface,” where you’re having to manually put in things still, like we did 30 years ago, to try and replicate what you have been doing.
I think trying to find a centralized approach that uses all these things together, not getting too carried away with all of the fancy new tech. Also, remember that the patient is really at the heart of all of these trials, and their experience is incredibly important. It can also help the next trials so that you can, again, cut down on costs, get more drugs out there more quickly.
Kimberly Tableman: Yeah. I was going to add, Ben, I have an actually very funny recent story related to that from yesterday. Which is, I was at BioFuture (the conference), and I sat in this session and they are literally talking about brain implants.
I had to laugh. I talked to my fellow panelists and I said, “I just want to get pharma off paper.” Like, I just want to start there. Starting with the basics. For example, 63% of studies still use paper consent. So, I just want to echo what you’re saying. I get super excited about the future and the opportunities that are in front of us. But we’ve got to the basics sorted out.
Ben Adams: Yeah. Going back to your point about diversity, I’d like to echo that, too. It’s something that we talk about a lot at Fierce. It’s that we don’t have enough diversity in gender and race in trials. I think it’s something we’re talking to talk about slightly more, but some of the trials that we’ve seen – even for these big vaccine trials. I mean, I won’t name names, but some of them are like 93% white subjects. That’s not acceptable.
I mean, I remember a report out. I think it was last year. Let me look at my notes.
I mean, African Americans, or races identified as Black, account for 13.4% of the earth’s population. But the trials used to approve new medications for Covid vaccines only use 3% in the past six years. We’re underrepresented 79% of the time for five years between 2015 and 2020. It’s a very similar story for Asian and Hispanic descent. We really are failing there. I feel sometimes we pay lip service to it, or bigger companies are. We really need to do something about that. We know especially, with Covid, that it can affect people – the Black, Hispanic, and Asian descent – disproportionately as well. So, not only are we under-representing them in trials, but we’re probably even further representing them because they’re the ones that might be more likely to be hospitalized or even die from Covid.
I really think it’s something that when we’re talking about, as we were saying, brain implants and AI and how my Apple Watch can detect if I have fibrillation and can tell my doctor that. Well, if we’re not seeing enough outcomes and data from the people that we need to see it from, how I react to a drug as kind of an Anglo-Irish, 35-year-old man is very different to how a 71-year-old Thai-Chinese woman is going to react to it. We need to know how both of those people will.
I think more and more, I’m hoping we’re going to be throwing money and time and pay more than lip services towards that.
Sorry, I got on my high horse for a little bit there, but it is really something I think we need to engage with.
Christof Wascher – Yeah. If I can just compliment what you just said, there is more individualized treatments, also, of a non-CAR-T therapy or for a given drug, actually, having exactly this understanding of the 35-year-old Irish man versus the 57-year-old Chinese woman. This is really key going forward. It will help to reduce the overall cost, but elevate the patient experience at the outcome. But, to be able to do so, again, we need to double down on data, leveraging AI and machine learning.
But the devil is in the details here. You know, there is a lot of talk around machine learning and AI and what it can do. But, at the end, it has to start with a data model. The algorithm has to start with the data model. To your point, Kimberly, if you have to pull this data model together, you first need to understand the data you’re dealing with. Otherwise, you will not be successful to pull this data model together and then to put the algorithm in place.
Andy Campbell: That’s interesting. You mentioned some of the research. While it plays to that point, one of the questions we asked was around how organizations rated the consistency and timeliness of their data for using across the enterprise. Something like 30% of the organizations were rating it sort of good or very good, which is good to hear. It’s skewed towards the positive.
When you ask them another question, which is how tightly integrated are your processes that actually act as a source for a lot of that data? Then, that number goes down to about 20% or so. So, whilst people have got an understanding of the importance of the data, the processes themselves are kind of somewhat disjointed.
Kimberly, are you surprised by that or not?
Kimberly Tableman: Yes. However, Andy, I just want to let you know that my daughter is no longer here. She left for nursery, and yet I’m getting a little background noise on the line. So, I’m just trying to figure out… I don’t know if you guys are hearing that as well, but I’m trying to get that sorted out with our technical support.
So, Andy, if you don’t mind just repeating the question, I’m happy to answer that for you.
Andy Campbell: Sorry. Yeah. When we had the research that I was talking about. When we asked people about the quality of their data, about 40% of them said it was reasonably good. When we asked them about how integrated their processes were, that number went down quite dramatically to about 20% or so. It was kind of interesting that the sources of their data seemed to be a bit disjointed.
Kimberly Tableman: Yeah. I mean, that’s interesting.
Andy Campbell: Does that make any sense?
Kimberly Tableman: Yeah, it makes perfect sense. It is an interesting number, though, Andy, I will say, because my experience – and I’ll just speak at a high level internally at pharma – is the biggest challenge we had at times in terms of aggregating data was actually holes in the data, for lack of a better term. So, just the fact that you’re trying to standardize a record and you would have pieces of data missing. Not relevant, obviously, from the perspective of collecting the data for the study itself and being able to go through the process – interim analysis, final analysis, and submitting from a regulatory perspective. But it was more this idea that even how data was collected. Sometimes blood pressures collected differently. Male and female collected directly. Which sounds… It sounds trivial, really, but it’s not when you talk about data standardization and the quality of the data and being able to reuse the data.
So, actually, the fact that 40% of people said that they felt that data quality was high, that’s encouraging from my perspective.
As far as integrated processes, again, I would argue that is an area that is problematic on multiple levels. Again, some of it has to do with the legacy and the history of how we have historically managed clinical research. I know, again, coming from the inside, that each study is treated as a study. Right? It’s its own independent entity. The data is collected. The protocol is written by a specific team. The scientific hypothesis is generated by that team. They talk about the data that needs to be captured from an end-point perspective.
I know some of the struggles that we had internally – again, going back to the kind of internal view – is the number of endpoints that we were capturing. There is a push in the industry right now to say, “What is the data that is actually needed to support generating the hypothesis?”
Yes, there may be some other interesting data, but how far down the line do we want to go with secondary and tertiary endpoints? Because, if you talk to, let’s say, Richard Young over at Viva and data management, he talks about the fact that 50% of data is not used from clinical research. So, there’s this idea that we need to balance. I call it “simplifying the protocol,” while, at the same time, gathering data that’s of high value. You know, high quality, high value. That really is going to drive or lead to some deeper insights that are going to move our industry forward.
So, it’s moving away from this idea of collecting data for the sake of data and getting to a much more… I almost want to call it a critical thinking exercise about what do we really need here to demonstrate, again, our safety and efficacy and also potentially drive some deeper insights so that we can improve the overall clinical research model?
So, definitely an opportunity to do that in a far more integrated fashion.
Andy Campbell: Yeah. So, what I’m hearing is we measure what we can measure rather than what we should be measuring, and we, perhaps, need to take more of a data architecture view – to use a hackneyed term. More of an architectural view about what we’re measuring and why and what outcomes we’re trying to achieve, rather than just capturing what we can and making do with it.
Christof, I can see you nodding away there. Do you share that view?
Christof Wascher: Yeah, absolutely. I think the push for data-driven decisions is across the different departments within a pharma company, for example. Yeah. This means, of course, if you double-down on drug development, we have to use the right data, fast, accessible, to be able to do the right decision. Okay?
For this context, I think they don’t have a strategic approach or departments, if you wish, to track development operations. They don’t have a strategic approach to really aggregate the data physically. Then, on top, try to lump data together so data orchestration integration, leveraging these fire capabilities. Then, the layer of engagement on top of this.
We, at Salesforce, really have made an assessment. So, what can we do to help here? We have doubled down on our partnership with AWS to really embrace the physical data aggregation. So, now we are able to virtualize data out of a given data lake, for example, in AWS. Also, recognizing the need for data residence and data compliance. You can virtualize it and then leverage it in the data of engagement.
With our system of engagement capabilities – and this is an anti-solution stick. There is also a select part of the game to make this the layer of engagement for the applications needed within a given function. So, you could think of this clinical study team being responsible for one clinical trial.
Kimberly, I completely agree. I remember my days in drug development. This is really like a company in a company. At the end, the people struggle very much. “Okay, which is relevant for my daily work? Which of the systems I’m using? Which is relevant to really making good progress within the study? Which is more extensive collaboration within the company?”
So, think of systems which really give you this view and this access to this application you really need to do your job. But, then you could also process data flows and improve processes within such an entity to enable these data-driven decisions more and more, and better and more effectively. This is something which I think is really missed. People don’t think holistically about data. There is the data architecture perspective, yes. A great data architecture is put together, but maybe they missed talking to the clinical operations leaders. Maybe, then, these guys missed talking to what’s coming out of early research. So forth.
So, there is disconnect everywhere. I think what we can do – and Salesforce is, of course, the market leader for customer relationship management globally. But, because we are this relationship management, this is why we also have a big, big capability to improve system of engagement, the layer of engagement. We can also embrace, let’s say, XRM. It’s all about relationship management from various different angles.
I think the potential of the solution capabilities of our stack is not understood very well here. Of course, we really need to work towards a broader perception. It’s not only about CRM. It’s because of CRM, but that’s why we are so strong in these other areas as well.
Andy Campbell: That’s great. This is sprinkling pixie dust, isn’t it? This is where we want to get to – some of our future places to be.
You said you wanted a magic wand, Christof. A magic wand. So, Kimberly, if you had a magic wand, what would you want to put in place?
Kimberly Tableman: I mean, I think Nirvana is that all people and all patients – which include all of us, frankly – that we have an awareness of clinical research as an option as we move forward. So, if you think about the healthcare journey that you… Even if you go into the doctor, I like to say, for eczema and you may be using a current, first-line treatment, that you have the option or optionality to even know if there is a clinical trial accessible to you.
Also, the fact that I would love to see a space where clinical research is kind of hailed as, “Wow! I get really specialized care and I feel really well taken care of in the context of my participation in a clinical trial.” Because you have to go back to what is going to motivate people to want to participate. The reality is if there’s isn’t a motivator for them on an individual or personalized level, then they’re not necessarily going to participate. That’s really across the board.
So, we all know, we all get to pick where we spend our 24 hours in a day, how we spend our time, and what we’re doing with our time. I think if we feel like we’re able to give back to humanity through participating in clinical research but we’re also having a really unique, specialized experience as we go through that, that’s impactful.
I can speak just for myself, different conditions and journeys I’ve been fortunate… I’m quite healthy, but I do suffer from migraines. So, again, having someone that is with you on that journey and understands what that is like, and then also goes through a process of trying new therapies that are on the market. In my case, there are new therapies. I’ve had migraines for 20-something years. So, I can stay on the treatment I’ve been on for 20 years, but I can tell you that if my primary care physician said to me, “Hey, you know, there are some new treatments available. May be more effective. May work faster. May allow you to not even go into that space,” then that may be something that I want to participate in.
So, I just want to bring it back to kind of the realness of life and what it’s like being a person or a patient, and what that experience is like for them.
So, I think there is a lot. I believe there’s a lot that we can do as an industry to really improve that overall experience. I always like to say it wasn’t that long ago that we used to call patients in clinical trials “subjects.” Now we call them “patients” and “people,” which seems appropriate. So, we’re moving along the continuum here. Now, we really need to get to what’s that experience for that person, and that should be our primary focus.
Andy Campbell: Yeah, I love it.
Ben, when we did this research that I’ve alluded to, one of the questions we asked was around coming out of the pandemic. Are you going to be investing more into digital transformation? More than 60% of people said that they were going to be significantly investing in digital transformation initiatives in their organization. Which I don’t think is much of a surprise. But if you had a shitload of money to spend, where would you invest it? You could always buy loads of Salesforce and Certinia if you want to.
If you had some money, where would you look to invest it?
Ben Adams: I’m going to be a little left of center, being a journalist. That shouldn’t be surprising.
But if I had the money – and I’m going to keep harkening back to this – I would always go back to the basics, which I think we forget too much.
It’s important to remember that behind every number and every piece of data is a patient, quite often one who is very ill and hopeful that they’re going to be getting a new drug and that it works. I mean, signing up to a trial is quite a big, brave act. Sometimes you’re going to be taking that new drug or technology where nobody else has. Sometimes, patients may even die within a clinical trial either because of their disease or even because of the intervention. I think that’s something that should always be recognized.
I think, moving on to my main point, what happens quite often is that sponsors with a lot of these data – and this is something I’ve been banging on about for 11 years – aren’t being transparent with the clinical data itself. That’s something where I think they need to spend more time and more money: having these results coming up as swiftly as possible for the scientific community to be able to read and to be able to see.
It’s something that trial participants and patients deserve to be honored for what they’ve done for their trial. I also think it absolutely, whether it’s negative or whether it didn’t happen to hit the commercial height that the sponsor had hoped, I think burying them (which is still a massive problem)… It’s been easing in years with a lot of pressure from various groups. But the FDA, the VEMA, and others are trying to put more pressure on these companies, slowly but surely, to release this data.
It’s something that, again, they pay lip service to. I think it’s something that they need to spend more money on. I would say, as well, becoming more visible. It seems like a weirdly kind of hidden, stealthy industry. I think it could be an open community. My toddler broke my TV this week, and I looked at forums about what’s a good TV to replace that toddlers can’t break so easily. Why can’t you do that with trials or with medicines or with companies? Why don’t I know how well PPD runs a trial? How do I not know where I might be able to fit in? Why can’t I talk to other people that have been in these kinds of similar trials? You can with almost anything else, remarkably. But, you can’t in this clinical trial space.
It gets back to my point about not knowing the names of these companies, the names of these drugs. The vaccines have certainly become more visible, but I think that will all die down. It will be interesting to see if more people will get into trials.
I mean, recruitment and retention is something that we have not talked directly about, are the two main issues for clinical trials. Boosting that, I think, having an open community, knowing who these people are and their philosophies, and how their ways are, and knowing these drugs, knowing where you fit within that, and belong able to know that if you’re part fo something but it will be given to a broader community and scientific critique, I think all of those things are very basic but they definitely need to be worked upon.
Andy Campbell: Yeah we talk a lot about data visibility and the democratization of data. Now, I like what you’re talking about sort of institutional boundaries and individual silos being broken down, looking at processes in totality, looking at design, looking at architecture – rather than just doing piecemeal approaches. I think that there’s a lot that we can learn there.
Christof, we’re coming towards the end. If anybody’s got any questions, please drop them in the chat. Christof, any final thoughts from you around this whole area? Perhaps one piece of advice you might give to CROs looking to move forward?
Christof Wascher: Well, the CROs, especially, I would advise them to see what’s possible within the given frameworks. The legal frameworks, for example. Yeah? With regard to creating these patient communities. There are possibilities to do this with the current constraints, of course, but they should really double down on what’s possible. Really try to leverage the latest capabilities from a technology perspective to really create these communities and practice sharing groups.
This is what I would advise on end.
Secondly, really put a lot of thought into a strategic data integration motion, and how that can bring the data assets they have. It’s a challenge. We’ve discussed this today. But I see a lot of point-to-point solutions because of the lack of a broader strategy being put in place. This should be stopped.
Having a more strategic approach, reusing APIs. Of course, it’s more expensive at the beginning. But, at the end, it will pay off. This will also help them with the communities, by the way.
Andy Campbell: We’ve had a question just come in. If I can just read it out. It’s for you, Christof. “How can data insights help to personalize how you engage with patients and improve the experience?” Could you give us, perhaps, an example or an anecdote about how that might happen?
Christof Wascher: Yeah. I think if you think, for example, of drug-device combination products, you could also have a device like a FitBit or so and a given drug. As for the specific living circumstances of the patient, this service could be created to help the patient to get the most out of the treatment.
So, if the recommendation is this treatment is taken in the morning before breakfast, and for whatever reason, this is not possible, of course, the service can try to help to adhere to this. But, then, what’s the next best alternative?
So, I think these patient support capabilities, this is what I was adhering to.
Andy Campbell: That’s cool. Thank you.
Kimberly, could I come to you for the last question? You’ve been in this space for a considerable amount of time. You’re right at the sharp end, doing it all. What one piece of advice or perhaps what is one key learning that you’ve had?
Kimberly Tableman: Yeah. A couple of things. I would argue mightily for partnerships. What I mean by partnerships is that there is just a lot of amazing stuff happening. I had the benefit of also attending DTX East last weekend in Boston. The work that the digital therapeutics companies are doing is fascinating as well. So, and I see marriage opportunities and partnership opportunities with CROs and pharms with some of these smaller digital therapeutic companies.
Then, also, just the ecosystem at large. So, there are companies – obviously, Castor is one – that are doing innovative things from a tech perspective and pushing the envelope, and thinking about these things every single day. So, when we talk about enabling… Earlier in the conversation, we spoke about enabling flexibility and choice in clinical research. We are actively looking at how to build technology and software to support that.
So, again, I think there is just an opportunity for partnership in the ecosystem. I think, at the end of the day, the winners are the patients who have a better experience and enhanced experience and are more engaged overall with clinical research.
Andy Campbell: That’s super.
I think, with that, we’ll possibly have to wrap up. Thank you so much, indeed for all of my panelists today.
What have we learned? Well, the whole drive towards virtual, democratized, distributed trials, is here and it’s going to continue where it can do. The importance of data, the importance not just of capturing data but making sure you’re capturing the right data. I’m thinking about including issues like diversity and inclusion to make sure that we’re doing the right things. Focusing on outcomes, not necessarily on processes. Recognizing there is going to be more oversight over us as an industry. Perhaps, a desire for us to change significantly as a result to some of the lessons that we’ve learned from Covid, where we have been able to achieve great things as an industry. There are a lot of lessons that we can learn from that.
If I can finish off with one last comment from the research. One of the questions was, “If we were to think about the improvement in utilization of some of your human resources (CRAs and people like that), what percentage increase do you think you might be able to realize?”
Almost 50% of people said they could get a 10% increase of utilization of some of those key resources. I mean, the potential benefits we can realize from doing some of the things better is vast. So, grasp the nettle!
Thank you very much, indeed, everybody. I’ll hand it over now I think back to Michael to give us our final wrap-up. Thank you very much.
Kimberly Tableman: Thank you.
Michael Shashoua: Thanks, Andy. Okay, thank you all for attending this FiercePharma webinar and sending so many great questions.
I’d like to thank our speakers for participating, and Certinia and Salesforce for presenting today’s webinar. They are also working on more research. They have a research survey happening on operations in the field. We’re asking for your help to take that survey by clicking on the handouts button. You can access the survey there. We appreciate your help on that.
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