Maria Palombini, Director of Communities & Initiatives Development, Emerging Tech for IEEE-SA at Converge2Xcelerate Conference (Boston, MA)
- IEEE-SA is a leading consensus building organization that nurtures, develops, & advances global technology
- Clinical trial pipelines typically take 12 years from the time of compound to time of approval
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INTERVIEW TRANSCRIPTS: Maria Palombini, Director, Communities & Initiatives Development, Emerging Tech for IEEE-SA
Ed Kim – Host, Traders Network Show: 00:00
Hi, this is Ed Kim from the Traders Network Show. Welcome back. We’re very pleased to have with us today, Maria Palombini. Maria. Hello. Thank you for joining us. Maria is director of communities and initiatives development emerging technology at IEEE-SA. IEEE-SA is the leading consensus building organization that nurtures, develops and advances global technologies. They bring together a broad range of individuals and organizations from a wide variety of technical and geographic points of origin to facilitate standards development. Maria, tell us about your current initiatives and what you’re most excited about.
Maria Palombini – Communities & Initiative Development, IEEE-SA: 00:38
So first of all, I’m really delighted to be here at this conference. The work I lead in life sciences is really looking at how ultimately we can empower patients for obviously better healthcare and better outcomes. So specifically we’re working on two major initiatives right now. One is where we are creating digitalization of clinical trials. We looks at how do we go from study design through endpoint validation, digitalized. In some cases it can be for remote trials and some cases talking about regular site-based trials. And the second initiative, which we call WAMII, which I really liked that acronym, but it’s a wearables and medical IOT interoperability intelligence really looks at how the sensors are in us, on us and around us and how can we have a seamless patient personal area network experience. So by that I mean one doctor will order you to wear one sensor and another doctor will order you to where another sensors and they’re all not following a technical protocol.
Maria Palombini – Communities & Initiative Development, IEEE-SA: 01:30
So we can’t validate that they’re working at the right time. So in monitoring data, how do we validate the outcomes, but more importantly sensors that are drug delivery. How do we know the delivering right? And this is not just at home. This also goes further when you go abroad. So what we’re trying to build is a global framework of global technical standard framework where you will no longer have to worry. Cause when you’re wearing that sensor, you know it’s working right when it’s supposed to. And the data, we can be validated. And then once that happens, we talk about connecting the patient truly to the data. Because now where does the data go? So we’re looking at how do we connect that data back to the patient’s profile and to the rest of the medical device ecosystem. And finally, once we have it verified and validated, when do we start applying intelligence to it? The machine learning algorithms. So we can take it beyond just monitoring.
Ed Kim – Host, Traders Network Show: 02:18
Now you have so many constituencies and stakeholders beyond something behind something like this. Are you finding that you’re getting good cooperation from the people who you need?
Maria Palombini – Communities & Initiative Development, IEEE-SA: 02:27
So one of the good things about being in a standards organization is that you find people who are very passionate and committed to change, and this is what motivates them to put their time into doing standards. So they’re going beyond what is considered their job. In this case, we do have many stakeholders around the world and they all follow a common theme. We’re all looking about having a connected device system to have better health care. But more importantly, how do we empower patients? This is really important. This is not about control and ownership. It’s about consent. As a patient, I should have the to consent share my data with you or with anybody else to transact for my benefit. So this is something, it’s a change in in perspective, right? We, if you think back 20 years ago, you always thought about my doctor has my profile or my doctor has my data.
Maria Palombini – Communities & Initiative Development, IEEE-SA: 03:12
Well, what happens when your doctor’s not there anymore? What happens to your whole history? Right? And so today with all these new technologies and these technologists are here today, are giving us, they’re inspiring us to really think about how can we really make this change? And so this is what we’re doing at the organization but we want a balance because we don’t want to fit into the hype, right? It has to be done responsibly and ethically because at the end of the day, if we’re going to empower patients and give them the right, they want to have that trust that I really do have the right to consent to my data. So these are sort of all the challenges and opportunities we’re exploring at the organization.
Ed Kim – Host, Traders Network Show: 03:45
That’s terrific. Now from a regulatory or legislative level, are you finding that you’re getting the cooperation that you need or what can the FDA do better? What can Congress do better?
Maria Palombini – Communities & Initiative Development, IEEE-SA: 03:57
So, from the point of view, we have a great relationship theatrical essay with the FDA. We work with the CDRH and Cedar. They actually participate in our standards development around obviously the life science working groups. And that’s really critical having them part of the development process because one, they’re exposed to a consensus driven approach to standards. They get to have a say and they also hear what the counterparts are saying from technologist to the pharmaceutical professionals. Once the standard is developed, they’re fully in the know. So when it goes back to policy development, they’re like, w we have this standard that we were a part of in developing and let’s see how we can integrate it into policy. And this is traditionally how we work even with, you know, NIST or the ONC or the NIH. This is the relationship that we have and when they come to us and they might ask us for some sort of supporting documentation or what new standards are out there. We always are very responsive and provided to them. So we have a very strong collaborative relationship with them.
Ed Kim – Host, Traders Network Show: 04:53
That’s great. Are you finding interest from the European medicines association or Health Canada organizations like that?
Maria Palombini – Communities & Initiative Development, IEEE-SA: 05:03
So in Europe, we know there is a big push for this open data format. We’ve been working with the European parliament and different industry industrial areas, specifically, they have a vested interest in AI, responsible AI and ethics and AI, but as well as in blockchain and from the agriculture side, from the pharmaceutical side of the pharma supply chain, especially with the new initiative with the EMA, the serialization of data. So we’re seeing a more conducive approach to blockchain there because the nature of the healthcare system is very different than the US so and we’re seeing more like the NHS get involved in blockchain. So the idea of empowering patients with their data to manage their health pro profile. Seems a little bit more progressive in Europe. It’s just because the nature of the system is conducive to that.
Ed Kim – Host, Traders Network Show: 05:51
I understand. Now, earlier you mentioned one of your focuses is in clinical trials. Could you elaborate on that a bit?
Maria Palombini – Communities & Initiative Development, IEEE-SA: 05:58
So we all know that clinical trials pipeline takes about 12 years from the time of compound to actually approval. And in that time, that’s 12 years in development. That’s 12 years of expenses. And meanwhile there’s patients sitting on the sidelines who are waiting for that for the opportunity. One of the biggest problems in clinical trials is patient recruitment. So what we’re working with a global consortium of you know predominantly pharmaceutical professionals, but blockchain technologist, patient advocates, the regulatory side to understand how we can actually use blockchain for patient recruitment and consumption. What we’re talking about is if a patient was empowered with all their data and the right to consent to be query for a trial, how could we change trial study design and how can we change patient recruitment? Right. Because right now what we’re doing is we’re, we’re doing a study and trying to fit patients into the study.
Maria Palombini – Communities & Initiative Development, IEEE-SA: 06:49
So the inclusionary and exclusionary criteria is like the problem. Cause we’re saying, well we built it without them. But the question iis if we had a validated, verified pool of patients who are already consenting to be found for a trial and we designed a study around that, how could we really control that time? So, but inpatients would be incentivized, you know, through a compensatory model, what that compensation looks like. We, you know, could be anything, could be money, it could be access to Medicare, get data back from a trial. But the idea is that there’s many patients, especially in rare diseases who are desperate for a trial and sometimes they’re not found and clinical trials are their last resort. And there is a very large community globally who believed that this might be a solution.
Ed Kim – Host, Traders Network Show: 07:31
Well, it’s a, it’s a huge problem. The time, not only the time to market as you say, but the cost involved Alzheimer’s, something that’s personal to me. And, and there hasn’t been, the FDA hasn’t approved the new drug and Alzheimer’s in 15 years. What do you think something like your approach could do to expedite, accelerate research in those types of diseases?
Maria Palombini – Communities & Initiative Development, IEEE-SA: 08:01
So right now we are a very siloed system. So sometimes you hear there’s a disconnect between medical and clinical, right? And this is exactly what it is. You have medical diagnostics practice here, clinical research here, all the data sitting in silos. So every time we start an idea, we go back to scratch and start the research again, which costs money. So the question is, is how do we create a system where even if things failed, but there’s probably nuggets of gold in that failure that we could extract towards another trial or towards another development of a compound. And now there’s been this proliferation, obviously we know in genome sequencing and biomarkers and labs, you know, we’re, we were just talking to another consortium of 19 clinical academic laboratories who are trying to set a standard just for genetic testing, right? Because there’s so many variants about all, we got 400 biomarkers or 300 or 200 it’s like all over the place.
Maria Palombini – Communities & Initiative Development, IEEE-SA: 08:49
So there’s just so much being done. But again, it’s like this. So often many tell me, I did a case study in Estonia like wow, Estonia has this, you know, blockchain health system. And one of the key things they told me is that it’s not just the health system, it’s all our public service benefits are on the blockchain, right? So it’s an interrelated work. It works functionally for public service benefits. If we take the approach here, like healthcare, your hospital system is here and that’s one blockchain and this is another blockchain and in the FDA sits here and then pharma sits here. We’re back to just building more silos, right? How are these things going to interconnect and from a standards organization, this is critical to us. We are already almost towards the, I don’t want to call it the exit strategy, but the connection strategy, right?
Maria Palombini – Communities & Initiative Development, IEEE-SA: 09:33
How are we going to connect all these chains together so that we’re not back to just a whole bunch of siloed blockchains. We want this system to work the way it has to work and this actually would benefit all the stakeholders in the process. It’s not about, you know, many people saying blockchain is this too disinterment is this intermediate entities? What we’re trying to disintermediate is bad behavior. Doesn’t mean it’s a person. It’s just a behavior that’s there. Maybe it’s a legacy behaviors. I know the solution and this is what we’re trying to try to see blockchain can fix.
Ed Kim – Host, Traders Network Show: 10:04
You mentioned Estonia earlier and how and the success of the model in a country that size, how do you possibly translate that into a market like the United States that is 300 times larger, infinitely more complex? How do you translate that model so that you can integrate those types of silos here in this country?
Maria Palombini – Communities & Initiative Development, IEEE-SA: 10:24
So there was a really great learning experiences from the study in Estonia when I was there at one was they only have 1 million citizens, which is 1 million patients, which is by far a lot smaller than what we have in the United States or any other really larger country. The second part of it iis that 100% of its citizens have access to broadband cable. So when we think about blockchain on public service benefits on a blockchain, there’s the assumption that everyone has access to the internet. And even in a developed country like the United States, I would argue that maybe 15% or more still don’t have access to the internet, whether it’s infrastructure or cost or whatever the prohibition is. But third of all, the first thing they said is don’t try to take the case study we did here and replicate it in a country like the United States or India or that kind of thing.
Maria Palombini – Communities & Initiative Development, IEEE-SA: 11:07
What they have said is that there are some case studies on how we’ve figured how to collaborate and actually build a system that works for us. And I think the takeaway was, is how do we better collaborate between all these different entities? If you want to have a government driven blockchain, which is pretty much what’s going on in Estonia was built by the government, then how do we get all the governments, you know, all the different agencies to work together, which we know would be a massive challenge here. Just because of the nature of our study. So I think it’s trying to figure out where in that case study we can replicate at a smaller scale, but in a way it’s designed that can scale up. And I wish I had the answer because if I had the answer, I’d be the richest person here right now, but I think it’s just going to take a lot of open collaboration and those who really want to see a system, a healthcare, a blockchain, a healthcare system, then we’re going to have to bring all the parties to the table and figure out how we’re all going to work together. You know, it’s not just about the technology, we’ve all heard it. It’s really changing, you know, business operations, you know, some portion may be policy, you know, redefining policy, the financial incentives, you know, there’s a lot, there’s a lot of intricacies built in in that blockchain is disrupting. And the question is, is how can we make it all work without people feeling like they’re being you know, shut out of the system or are they going to wreck their revenue cycles or that kind of thing.
Ed Kim – Host, Traders Network Show: 12:00
That was tremendous. There’s a clearly doing very important work. Maria Palombini, director communities initiatives development, emerging tech IEEE-SA. Thank you for joining us Maria.
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