Episode 3: Interview with Ron Piervincenzi, CEO of The United States Pharmacopeia

Host Jim Fries speaks to Ron Piervincenzi, Ph.D., CEO of the United States Pharmacopeia (USP), in the third episode of The Patient Safety Podcast. The episode covers topics such as Piervincenzi’s time at USP, the company’s 200-year history of developing standards, and the way those standards were put to the test during the COVID-19 pandemic. Listen in on the conversation about fostering innovation in the pharmaceutical supply chain and keeping patients safe. 

Thank you to Rx-360: https://rx-360.org/ 

Thank you to our guest Dr. Ron Piervincenzi: https://www.linkedin.com/in/ronald-piervincenzi-558b7a8/

 

Read the Interview:

Jim: Hi everybody. This is Jim Fries, CEO of Rx-360, welcoming you to episode three of our patient’s safety podcast. I couldn’t be more excited today to welcome a guest who I’ve actually wanted to get on our podcast since we started it. Ron Piervincenzi from USP. Welcome.

I’m really excited about having you here today. I know everything that USP has done over, you know, a hundred years has been a tremendous asset to the pharmaceutical community. And with your background in a lot of the standards that USP does in conjunction with a lot of the things that Rx-360 does on the supply chain, the patient safety side, the material quality side, they’ve always been very synonymous.

So I really wanted to reach out to you today. Have you join us and really kind of talk through some of the things that USP is embarking upon today and how it impacts the pharmaceutical community. So to kind of get us started here and, you know, again, welcome. But why don’t you tell us a little bit about where USP is today and how you’ve evolved.

Ron: Yeah. Thank you, Jim. Pleasure to speak with you again. And the first time in the context of, of the podcast. Yeah, I’m thrilled. It’s a little humbling being a part of an organization. We celebrated our 200th birthday two years ago just before the pandemic. I’ve been eight years, which is, you know, a substantial amount of time to be a CEO of an organization, but it’s really nothing in a 200 year old organization, USP’s founding is, you know, it’s for the same reasons that we exist today.

And that is to set the bar for what quality is in the simplest terms, what a medicine should be. What does it need to have? What shouldn’t it have from a safety and impurities perspective? How should it perform? How would it dissolve? How, you know, how sterile is it? If it’s a sterile injectable, like a vaccine, those are the basics.

Now over time from 1820 to today, the technology has changed. So what’s in the standards that USP creates that are legally enforced for all over the counter and prescription drugs in the U S and actually 50 additional other countries as well, has evolved the content of those standards have evolved.

The analytical technology has gotten more sophisticated. The drugs have become far more complex and diverse. But the same thing is needed. The very basic Jim, which is to say you and your family, all of us, including whether we’re CEOs in the industry or not, we’ll go into the pharmacy and pick up our prescription, 90% of the time, it’s probably a generic drug and you pick it up and you have, you just believe it’ll be what it says it is and that it will work. 

And that’s based on the fact that it has to meet the specifications of the USP standard, no matter how many different companies are producing that, that the FDA uses the USP standard in, in the approval. And then the audits and inspections for that company. And the standard is, is the touchpoint, which defines the commonality. And you’re right. It’s not, I wouldn’t say it’s more relevant to people like to say now more than ever. I don’t like that phrase because are you sure, more? I think it’s just as relevant, but that’s remarkable.

From 1820 to today to say, it’s just as relevant, it’s bigger and more complicated, but it’s just as relevant.

Jim: And I think that’s a great way to look at it’s just as relevant, you know, if anything, I always like to use the adage sometimes, and I kind of saw it during, during COVID a little bit.

And then even now with some of the situations that we’re having over and over in Europe with Ukraine and that type of thing is events like maybe take the relevance and make us a little bit more hyper focused in those areas. Which actually helps us improve and bring better things to the industry.

When you look at the whole idea or the whole world of USP and standards, kind of two-part thought process here, Ron, is how do you look at the fit between standards and the medicine supply chain, and then really, how does that dovetail into patient safety?

Ron: Yeah, so the short answer is that over the 200 years, USP standards have evolved to meet the needs, all the things that are needed to ensure a medicine reaches the patient is the quality it’s supposed to be, that it’s going to work basically. And over the time as this, as a supply chain has gotten more complex, it doesn’t take long. In 1820, a physician would see someone and they would say, oh, I think you need this medicine.

We didn’t even have pharmacies in America in 1820. So the physician would turn around and he, almost surely was a he, would have a pile of powders, jammed some things together, grind some stuff up and then hand it to you. So that was the supply chain. It was not great, but it was simple when you really think about it. And so at that time, the USP standard was basically a recipe and even quite literally a recipe grind this up, throw it in some water. So what is the equivalent today? The truth is you can actually track every step along that journey today. Although people were wearing different hats. So USP standards affect ingredients and medicines.

They determine what a finished dose or basically, you know, your pill or your sterile injectable, how it should perform, what it can have the test that determined to make sure that it’s safe. How it’s shipped, the temperatures and durations that can be on the shelves, the label that it’s written to a standard that is then the same across all prescription drugs. So patients don’t have to try to reinterpret in different circumstances, the quality and the quantity of doses, like for children’s medications. They’re all USP standards. That’s why we have over 7,000 of them to cover the drug supply as well as the different stages in the supply chain. And there is no quality until it’s met its purpose.

And in advanced therapies, if I can, you know, maybe just end with this because you think to me, the supply chain doesn’t end until the drug is, is actually at the affected place within the body. So let’s say you have a patch, it’s a transdermal patch for your medicine. To me, the supply chain continues until it’s actually entered the bloodstream.

In the sense that if it doesn’t, if the patch is ineffective at transmitting the medicine, it doesn’t matter that the medicine and the patch is good. It’s not important to you until it’s reached to your bloodstream. So the patch has to operate and that’s the true supply chain in my mind. 

Jim: Yeah.

That’s a really interesting way to look at it. Cause ultimately if the medicine’s not getting through you with that patch, the supply chain is interrupted. So I 100% agree with you. And we think about that a lot at Rx-360, because much like as you described you look at the supply chain from beginning to end. From, you know, that raw material all the way to like the patch analogy, you just used. We do the same thing at Rx-360 and even kind of play a role, not only in the security and integrity, but also that material quality through our audit program and that type of thing, so I appreciate that. And I appreciate the patient safety component. 

One of the things that, you know, we touched on it in the first couple of minutes here, Ron, but the whole idea about, you know, some of the things that we saw during COVID-19 and, you know, that changed a lot of the way that we developed pharmaceuticals, the way that we delivered pharmaceuticals there are so many things that we adapted to that I think were ultimately best practices. So to say, I mean, some of those things that we put into play during that time period, I don’t want us to go back to the way we were, because we actually learned to do things better.

But from your perspective, how in the world with the standards and the dedication that USP has to that, how did you guys keep up with all the innovations?

Ron: Yeah, actually there was a literal answer to that, which is not a figurative answer. A literal answer was how do we keep up? We moved way faster. That’s how we kept up, between 10 to 50 times faster.

And so we recreated our processes, but we did not change any of the expectations. We have a quality system too, of course, right. You have to, if you’re going to set the quality bar for everybody else to better have one too. And a lot of our quality system is what we have quality about our laboratory work and our science, of course, but we also have an entire quality system around how we set our standards. It’s a transparent public standard setting process. And because our standards are enforceable through law, we have to be rigorous. 

So when the pandemic comes in, we have to be able to turn around a standard. For example, we were ensuring there was an ethanol contamination in hand sanitizers.

We had to turn that around over a 48 hour weekend to make sure that there was available testing because people were getting poisoned. People died from ethanol as I’m sure, you know, we all saw in the news. There were needs to turn it around for looking for the substandard and counterfeit Remdesivir.

So we suddenly needed to take what was a quality standard for a manufacturer and turn that into an analytical tool that could be used for testing of intentional counterfeit. Which of course in a quality system, you’d never have an intentional counterfeit which it’s not the same. So how do we do that over 48 hours and still have a public period and such?

Well, it took a lot of changes, but when you have that emergency, you just said it, you just say, okay, throw all the boundaries out, what could we do? Our volunteers, our expert volunteers, were available all weekend. We were working virtually. And so we’re not going back for sure. So you know, sometimes the answers, how do you move fast?

Well, you have to work smarter. Yeah. But sometimes you just have to work faster too and we did, we worked faster. 

Jim: Yeah I 100% totally agree. And that’s actually something that I’ve talked a lot about, is that idea of not going back, we learned so much there’s best practices. We shouldn’t let them go away because all they do is set us up for success down the road when it comes to how we improve the pharmaceutical community.

Before I go any further, after you just told that story about working over the weekend and working faster and smarter and all that, I personally want to thank everybody at USP for being able to push through those innovations in that speed that the industry was changing. I think you guys did a tremendous job during that time period.

Ron: Thank you, Jim. And one thing that was maybe implied when you asked the question, is that sometimes you have to do things in an entirely different way where you meet new needs. And we were really proud of the work specifically related to the vaccines. And again, because of the long – I think we didn’t say it before, but you and I both know that when people talk about supply chain often, they mean sort of the middle part. They’re thinking of literally the shipping of a finished drug to pharmacy and right now that is in the supply chain, certainly, but we also know the front and the back end of that are usually more important for quality then even in the middle. 

And in the context of vaccines, we all know that was true. We all talked about it. You know, for the first time in the world, we all talked about the supply chain of a particular thing, including the last mile. We called it the last 100 feet because in truth, getting it to the pharmacy or physician office wasn’t that hard. But how do you get it in the patient’s arm in a fast way? We have five different vaccines with four different dosing regimens. And so, you know, we created these, what we call toolkits because it’s not a standard per se. It’s more like a how to. More of a practical guide, that was used by thousands and thousands of administrators for millions of doses of vaccine, distributed by the CDC.

And the learning to us is that you have to create a solution. You have to look for a solution, and sometimes you get used to it because it just becomes obvious every drug we have to make sure we test for impurities. And so you don’t talk about it much, but it’s not always obvious. You have to look for that solution. And the disruptions we’ve seen recently to the supply chain that have brought more awareness to people who have not been closely involved, makes them start to ask questions about those solutions.

That’s why I think this is a unique time for us.

Jim: Yeah, and what’s interesting is that whole idea of how we do contribute to the industry because I think USP and Rx-360 have a lot of similarities like that. I mean, one of the things that we operationalized very quickly at the beginning of COVID was, literally I’ll use your 48 hour analogy that you used before – is, you know, COVID hit and all of a sudden, a lot of our pharmaceutical manufacturers, their auditing almost came to a halt.

You know, and we kind of got together as a consortium and, you know, kudos to the people that did it – got together as a consortium and put together a very robust remote audit program that anybody in the industry could utilize. And I think those are examples.

And I know that USP in today’s world really is doing a lot of contributing to public health also. Could you maybe talk about some of those tools that you guys have put into play that kind of helps in that public health perspective, or some of the things that you guys are doing?

Ron: Yeah, and the way we asked this question was in – so in the context of COVID, we asked a series of questions that started with one, are our staff safe? Are our staff and our volunteers safe? Which was not straightforward, of course. How do you keep working but be safe? Second one we asked was in what ways can we ensure that our operations continue?

Essentially, our standards are part of the global medicine supply chain. And so we had to make sure that we’re not a part of any challenges and shortages, and we were able to achieve that, quite well, not instantly, but quite well. And then third was what can we do to actually fight the pandemic?

Then of course, that feels like a long time ago in the sense that we’ve then kept doing that, asking that same question more broadly. How can we bring about advanced manufacturing more quickly to realize the benefits of speed and efficiency and, and high quality? In what ways can USP standards speed up the innovation of innovative new medicines?

And I think it can be under-appreciated the amount of time, and not by you, Jim, but I mean, just broadly – that can be spent on some of what people consider the basics. Let’s say an innovative new therapy in cell or gene therapy, about getting the package right? Making sure quality is sustainable and consistent over time.

And if each of those therapies has to start from scratch, it takes much, much longer to develop that. If they can develop their new products or new innovations, even the new advanced manufacturing technologies on a platform of standards, they get to start on step three or four. It’s really that simple.

It’s logical. It’s kind of obvious. If every time you built a house, we had to reinvent electrical codes, it would be very hard to build a house. But the problem, when you have an innovative space, is that the public health need is clear, but when it’s new, well, how do you set a standard when you haven’t done something before? And so that’s where the collaboration comes in. 

And what we’ve learned over time, and I think especially more recently, is that we have to be on the frontline for some of these, so that we’re creating the knowledge and the work that can then soon, not immediately, but soon become the standard that everything is based on.

And that’s both technological as well as medicine.

Jim: Yeah, I think that’s one of the things that always amazes me about kind of – I’ll refer to it as the volunteer model that USP has, or the consortium model that Rx-360 has, is the power of that group think in the pharmaceutical industry is something that I have not seen a whole lot of other places where people come together to develop standards or develop guidelines, or really think through a best practice.

You know, it’s one of the things that amazes me every day with Rx-360 in our consortium model – is how people come together to do those things. That’s why I really resonated when you used your 48 hour analogy. 

Ron: Yeah. You know that to stay on that – I think the reason that you don’t see it more often, isn’t because it’s not effective, it’s because it’s not free. 

What I mean is that it, it won’t, it’s not self-sustaining. It requires a lot of care. A lot of diligence. It requires real work to maintain those in order to get, I think, which is an amazing amount of value. And so we have about 800 scientific expert volunteers and 500 convention members that power USP, but we have dozens – well more than dozens – hundreds of staff. We have 1200 staff total, but we have hundreds of staff whose job it is to work with those – with that network of expertise to bring about the standards. And without that support, it would, it would dwindle, right? 

I think the power there and I, you know, why I applaud the consortium, you and the consortium, but I applaud the consortium for recognizing that it’s worth investing in, in order to get that output over time.

The volunteer model, the convention model USP has, is desperately old-fashioned in the sense that it’s a mindset. Like, why do people have to do it? None of them have to do it. Nobody has to do anything really. I mean, this is a collaboration people choose to do people and companies and governments and practitioners.

And it’s been sustained and it’s more than sustained. It’s been growing ever since. And I think it’s there, but the underpinning of all that, that can bring a little bit of worry and not so much for USP, but in general is it’s all based on trust. I just said they don’t have to do it. So why did they do it? Because they trust that they’re going to do the right thing and they trust you and that people are going to pick up.

But trust is dwindling. I mean you feel it.

Jim: I don’t disagree. And that’s why I really appreciate when I interact – it still amazes me every day when I interact with our membership in the consortium and see, cause sometimes it’s counterintuitive, right? I mean, you know, by nature, a lot of us are competitive and that idea of collaboration for the betterment of everything is just counterintuitive sometimes.

And when you think about that trust to work collaboratively, to solve an issue in our industry, that’s why I always say, when I look at the industry that the both of us play in Ron is – to be able to volunteer, to be able to bring something better to the industry truly is a calling. You know, because in many cases, most people have day jobs too, and then they’re also doing this and I just think it is amazing to watch on a daily basis.

Ron: Yeah, and my pessimism isn’t that it’s hopeless. It’s that it’s a reality. And therefore I think it takes, requires, and it’s worth, and requires more care. More stewardship to maintain that. It’s worth it is what I’m saying. And I think actually the value of effective consortia or in USP’s you know place, a network  of scientific experts coming together, that the value goes up relative because when trust diminishes elsewhere, you become, you know, This is still standing.

So it’s worth it. And in something like medicine, supply and quality medicines, there is no substitute for trust. It can’t work without it. There can’t, there’s no way you can test every pill that somebody is going to take. You have to create a system where there’s mutual trust and accountability.

There is no shortcut.

Jim: Well, if people like you continue to have your type of enthusiasm, I think we’ll be able to, to overcome any of those barriers.

Ron: I agree. And maybe even, you know, maybe turn the tide a little, it’s a little glass full.

Jim: That’s right. That’s right. Hey, just to kind of wrap up here, Ron, it’s been a great conversation.

I could not be more happier about having you here today and you know, maybe we can even do it again in the future and maybe even a different topic or something like that. You know, to kind of wrap up today – when we take a look at, you know, where we are from a standards perspective and maybe where USP wants to go, what’s your message as we, as we kind of leave the podcast today, what’s your thought processes about, you know, “Hey, what do we want to continue to do? What are we happy about today? What are we not happy about today?” What’s the message you want to leave everybody with?

Ron: Yeah, let me answer it this way. Innovation. And I’m going to go across three buckets and I’ll kind of leave it there.

So innovation of medicines and medical products and how do we make sure we don’t fall behind in the support and not just for standards, including standards, but standards and the systems that support them so that those innovations don’t either get slowed down or trip up once they recede. 

Some of the most exciting innovations, for example, in cell and gene therapy, are challenging to develop, of course, but they’re also distributed models of administration. Think of it like drug compounding, which means the supply chain is more complex and wider and it requires standards even more.

I think we should think about innovation in terms of the supply chain itself. And I mean, in the traditional definition, meaning we’re concerned about breakdowns and shortages and all this. It’s real. But what does innovation look like there? Well innovation looks like – we always say well it’s complex. We don’t know where it is. Well, I think the days are over. That’s not an excuse anymore.

We’re doing our part at USP and we hope others step up to solve it. We put together a medicine supply map, which is not completely finished, but it’s meant to represent where our medicines are coming from, where the ingredients are, and we can start to use that data to make better decisions about resiliency. So it’s like innovation in this case, it’s the digital innovation on what I would say is pretty traditional suppliers.

And the last kind of innovation is technological.

And in this case, I’ve got the manufacturing and the distribution of medicines, which is quite old-fashioned compared to any other industry. And I’m sure Jim you talked about this all the time. It’s true. In medicine, the batch manufacturing of medicines, both biological as well as solid oral dosage forms, is one of the few things left doing that of any kind of product in the world. I mean, certainly advanced technologies, automobiles, food products, they’ve all moved on to much more advanced continuous manufacturing type systems.

So what’s the excuse here? Well, the innovation is going to require better standardization. So the hurdle, the barrier to entry to these technologies is much lower, and the barrier today prevents generic manufacturers from participating. That’s 90% of our medicines, so it’s not good enough. So our vision of what we’re looking towards is looking to those innovations and asking what solutions are necessary to bring them about better, you know, faster, reduce barriers to entry, and allow the innovations to occur more freely.

That’s what I would leave it with, which I think is a very positive note. 

Jim: Oh, it is. And I’ll just dovetail real quickly before we say goodbye to each other. Your word was innovation. My word is collaboration. I think as long as our industries, even this conversation that you and I are having, I mean, Rx-360 and USP.

As long as we continue to collaborate, the industry trusts each other, we’re going to end up better on the outside. And those innovations will all come to fruition. So I appreciate that, Ron, I appreciate your time today. And we will definitely be back in touch and I continue to look forward to working with USP.

Ron: Thank you, Jim. And good luck to you and in your leadership of Rx-360. 

Jim: Thanks Ron.