International Data Corporation reports safety caseloads are increasing by 30% to 50% each year, and emerging technology will be the only way to keep up. But how are powerful technologies like generative AI advancing safety and pharmacovigilance? Is touchless case processing a good or bad thing? And how do we balance AI, automation, and the human touch? We will get answers to those questions and more in this episode with Bruce Palsulich, Vice President of Safety Solutions at Oracle Life Sciences. His portfolio includes Argus Safety, the industry-leading adverse event case processing and analytics solution, and Empirica Signal, the standard for signal detection and risk management. He has more than 30 years of experience in the healthcare and life sciences industry, including 25 in pharmacovigilance. 

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Episode Transcript:

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What is pharmacovigilance? How can technology best handle the tracking of adverse drug events? And is touchless case processing a good or a bad idea? We'll get those answers and more on this episode of Research in Action.
 
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The lead, the Building.
 
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Hello, welcome to Research in Action, brought to you by Oracle Life Sciences. I'm Mike Stiles. Today we are talking with Bruce Palsulich, vice president of Safety Solutions at Oracle Life Sciences. Bruce's portfolio includes Argus Safety, the industry leading adverse event, case processing and analytics solution, and empirical signal, the standard for signal detection and risk management. He's got more than 30 years of experience in the healthcare and life sciences industry, including 25 and pharmacovigilance.
 
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Now, why is that important? Well, International Data Corporation reports safety caseloads are increasing 30 to 50% each year. Bruce is intimately involved in tackling that volume. So, Bruce, thanks for thanks for being with us today.
 
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Yeah, thanks, Mike. Happy to be here.
 
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Yeah. Let's get acquainted with you first. How did Life's path bring you into life sciences technology? How did you kind of wind up at Oracle and what are you tasked with getting done there?
 
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You know, back back when I was still in university, I actually started off doing software development and consulting with a medical device company. And so early in my career, it was working on the actual embedded software that controlled medical devices. And early on ended up joining a consulting firm that started off doing engineering, consulting on medical devices, and eventually working towards quality software and regulatory submissions.
 
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And so came to Oracle in 2009. So we had acquired a company that was that small engineering startup that I mentioned. And this is the company that originally developed Argus Safety, so I managed the team that developed Argus safety originally and through my time at Oracle, I jumped out of a safety for a little while.
 
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For about four years I was running our healthcare strategy. That was when we had a much smaller healthcare footprint than we now have with our acquisition of Cerner. But at the time we did a lot of things in sort of what was called health-information exchange, sort of the foundation for national platforms under Australia and Singapore and multiple provinces in Canada.
 
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And after doing that for about four years and then I came back to the safety side of the business about ten years ago or so.
 
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Well, did you always see yourself doing something in medicine and life sciences, like when you were younger, or did this was this a life path that kind of surprised you?
 
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You know, I ommitted the part where for four years I actually worked in aerospace. So I even though when I was still at university, I started off in medical devices. I did take a job in aerospace for four years. But that's sort of left a hollow feeling and not the same sort of mission driven purpose. When you do have a role that's within the broader health care or clinical development.
 
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So, you know, I think many people like myself that, you know, whether you're on the vendor side or whether you're on the the pharma side of drug safety or pharmacovigilance or even broader clinical development, I think you do appreciate that there's there's a calling and you feel more purpose driven life. I suppose working in a field that's helping individuals, helping patients.
 
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Well, for our audience, and I'm deflecting because our audience is smart, this is mostly for me. Let's just level set. What's what's the main goal of safety and pharmacovigilance? And I imagine safety standards would apply across every step in that drug development process.
 
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Yeah. So drug safety and pharmacovigilance is really trying to understand the safety of drugs that are under both clinical development as well as once they complete their clinical development and are approved for broad market use. And so clinical trials really focus on safety and efficacy, but that's done under controlled conditions with a limited number of patients and and sort of restricted patients as well.
 
00;04;46;07 - 00;05;27;27
And once a marketed drug is approved, it's going to be exposed to significantly more patients. And so during a clinical development, a clinical trial, if you had an adverse event that occurs in one out of 10,000 people, that's that's sort of defined as a rare adverse event or adverse reaction. You can imagine if you gave that to a billion people, maybe, for instance, in the example of the COVID vaccines, Now that rare adverse event that's only occurring in one out of 10,000 people is actually occurring 10,000 times in a billion people.
 
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And so so really, you know, pharmacovigilance is looking at and trying to understand that benefit risk and manage that risk when it's being exposed under real world conditions to to actual patients.
 
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So the study of a drug is hardly done after it's approved by the FDA and goes out into the public, the public market, that monitoring is still happening while safety is paramount, It can't be easy. I mean, for whatever reason, the public does seem to expect perfection without risk when it comes to their drugs. So, I mean, what are the biggest challenges that Pharmacovigilance and the industry has to deal with currently?
 
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So, you know, getting back to sort of those controlled conditions that are under clinical trials, for instance, typically you're not looking at pediatric or children exposure. Quite often you're not dealing with elderly patients or immune compromised patients or patients taking multiple medications. You know, do you have the diversity within your clinical trials such that you're getting genetic differences that might exist within different populations and such?
 
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And so so all of those are exposures that are going to occur during broad use of those products once they get approved. And so so pharmacovigilance is really trying to, you know, track that, trying to collect as many adverse reactions that occur. It's trying to evaluate whether or not those events truly are a reaction that's related to the drug that's being studied and the drug of interest.
 
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Or is it just occurring, for instance, within the general background rate that you would expect within within a patient population? And so all of that analysis is to try and understand, is it more than correlation that just, you know, we have an adverse event that occurred with a drug? Is that coincidence or is that related to other drugs you're taking?
 
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Is that a progression of the disease that the patient is taking a medication for, or is it something that is actually induced by by the drug of interest? And how serious is that reaction? And is that something that should be, you know, updated on the prescribing information that's tracked along with a drug and the, you know, communication and education that's done to the health care community.
 
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So they understand the risks associated with the drug.
 
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So I get the challenge, which is that in a clinical trial to get a drug approved and on the market, there's no way to cover every possible circumstance and every type of person and every type of situation where, like you said, there are other actions with other drugs. And I already get the enormity of the challenge of keeping track of all of those people, all of those interactions, all of those adverse effects.
 
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I imagine technology is tackling those challenges, right, Or at least helping to tackle them. For instance, like how can we better efficiently do data management? How does that play a big role in tackling these problems?
 
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Yeah, So the you know, we talked about the increasing volumes somewhat. It's still generally estimated that somewhere on the order of between five and 10% of the actual adverse events that occur are actually reported. And so many people might just say, well, I felt dizzy when I took that and so I stopped taking