It’s not just making sure that you’ve got the right pill of the right color and the right bottle, it’s safety and efficacy and reliability of supply.Dr. Oxana K. Pickeral, Sparta Systems President and CEO
Welcome to Forging Connections, a podcast from Honeywell about the convergence of IT and operational technology for industrial companies. We’ll talk about the future of productivity, sustainability, safety, and cyber security. Let’s get connected.
Steve McCarthy, Sparta Systems VP of Digital Innovation (00:18)
Okay, good morning, good afternoon, and good evening listeners. Welcome to the first episode in our Shaping the Future of Quality Podcast, part of the Honeywell Forging Connections series. Thank you for joining us today. It’s my pleasure to introduce to you Dr. Oxana Pickeral, CEO of Sparta Systems and GM of Honeywell Connected Life Sciences. Welcome, Oxana.
Dr. Oxana K. Pickeral, Sparta Systems President and CEO (00:43)
Thank you, Steve. I’m delighted to be here and excited about the Shaping the Future of Quality Series and of course our conversation.
Awesome. I would like to start by asking you to share a little bit about yourself, your background and your career before taking the helm at Sparta Systems.
Sure. Happy to. I would say from the start I’ve always loved numbers. So initially, I was focused on math and physics and then I got really excited about the mathematical part of biology, which at the time was known as genetics. Times have changed since then and biological science has become more computational. I am excited to have been part of the human genome project at the National Institutes of Health (NIH). My Ph.D. thesis was on bioinformatics of human retrotransposons, what a mouthful. We were able to answer some interesting questions about biology through analysis of DNA sequences. Now, we are focusing on the biomedical research of the biopharmaceutical industry, figuring out how to apply modern technologies to improve the development of medical products, be that traditional small molecule, biologics, medical devices, and increasingly going digital with the digital therapeutics. I also spent some time in pharma at Human Genome Sciences. Before coming to Sparta, I spent five years leading the global healthcare life sciences partner ecosystem business, at Amazon Web Services (AWS). This was a fantastic opportunity to learn about innovation and collaborate with technology companies that are using the cloud. Sparta was one of the partners that I worked with and when the opportunity presented itself, it immediately piqued my interest.
That is fantastic, especially since my background is in healthcare and biology. It’s clear that you have a lifelong passion for healthcare, the patient and life sciences, but you also have an equal passion for technology and innovation. You mentioned a little bit about what brought you to Sparta but what were you most excited about when the opportunity arose?
The combination of Sparta with Honeywell’s capabilities is extremely intriguing. There are not too many companies that can do what we can do especially now with Honeywell connected life sciences. We have a solid software with a modern software offering, and the option to work on-prem. With our modern SaaS software business, we can combine world-leading industrial automation and industrial controls.
Plus, the additional innovation that’s happening under a Honeywell umbrella. I honestly didn’t know much about when Honeywell was acquiring Sparta, because there’s a lot more that’s going on in advanced materials, like the Aclar bottles that became a very important component of the pandemic response. We are in the midst of the software, hardware and industrial world connection and it is an exciting idea of optionality to be a partner with Honeywell. I’m a builder at heart. So, I am very excited to be building more and delivering solutions that are truly unique in the industry.
I agree. I would like to come back to the topic of leveraging Honeywell’s innovation, but let’s shift gears maybe a little bit, and talk about quality in life sciences. I think one of the most challenging aspects of that subject is the topic of value and what is the true value of quality and how do you articulate the importance of quality in life sciences? How can a business put a value proposition on quality? That’s a tough thing to do.
I think first and foremost, if you don’t wake up every morning caring about the patient, then you’re in the wrong business. For me, ultimately the lens on quality is what it means to a patient. Many industries care about product quality, but I think very few feel it can have immediate implications on a clinical outcome or on somebody getting or not getting a lifesaving drug. It’s an intrinsic component for the patient to trust the medical product. When we talk about putting the dollar value on quality it is a multiple dimension in my mind. First, anybody who has ever failed an FDA audit will have an immediate perspective on the cost of poor quality. You don’t want to learn that way by digging out of a hole. But also, we’re living in a world that increasingly has more complex, specialized, expensive products hitting the market. A lost batch of an expensive biologic has an immediate financial impact on the ability to deliver in a timely manner, which has an impact on the patient, the physician and the pharma company, especially in a competitive therapeutic category. That means a loss of share.
I think we pride ourselves on having the patient at the center of things we do and I don’t think it’s a stretch for Sparta because as you said if you think patient centrically, you think about product quality, safety and efficacy of those medicinal products. The quality system has such a critical role in making sure that the patient has the right product on the right shelf at the right time and that is really what it’s all about.
Let’s talk about this topic of digital transformation. The reality is Industry 4.0 is huge and digital transformation is real and having a significant impact on all industries, but certainly on life sciences. It’s also very clear that there’s an increasing number of ways in which industry can meet these complex needs of quality and supply chain. You mentioned something important that this is this idea of optionality. It can be daunting with the complexity of choice that industries have between broad platforms, solution stacks and different technological ways of approaching digital transformation. I think certainly in our experience, we’ve seen that maybe we could talk a little bit about that complexity and the importance of this idea of optionality.
Steve, that’s a good observation. I’m going to expose some of the Amazonian bias that, has rubbed off on me. Customers like a choice. I firmly believe that. In an industry like this, that is both innovative, but also in some ways, very conservative. This is a very controlled environment and to meet all the regulatory standards for an industry continuity in how you build and develop and go to market with a product and an industry like this, by definition, has to be somewhat conservative while it continues to innovate. I think it would be naive of us to think that the digital transformation switch is going to happen overnight. I’m a firm believer that we need to meet customers where they are, and that means we’re going to continue to see a blend of on-premises solutions, cloud solutions, variety of modern mixes. We need to meet that need with the products and services we deliver.
Absolutely. There’s been an enormous investment over many years into Industry 4.0 and if you think about the complexity of these businesses and the idea of forcing change, forcing digital transformation it is not appealing. We must make sure that we help our customers along with that journey towards transformation.
I’ll add that it’s not just the new possibilities that come with digital we also need to understand the risks that happen along the way and help bridge those risks. For example, you know, the more connected equipment that we have on the manufacturing floor the increased opportunities for cyber-OT events. We need to think very differently now about both discoverability of OT assets and about security concerns and how to manage these concerns proactively. This potential risk may not have existed so prominently in the past, but now we need to be able to manage it well.
I often talk about this bimodal challenge, right? We can’t, as an industry, take our eye off the core, fundamental, basic capabilities of quality and compliance, but at the same time, we must balance those with the reality of not only the digital transformation but the transformation that’s happening in the medical product such as biologics and combinations and gene cell therapy. It is a tough balancing act for everybody, right?
Yes, it’s tough, but it’s doable and that is the exciting part, doing it in a smart way, but also in a way that’s measured and can be done safely.
When we think about digital transformation, I think of data process technology. Data first and foremost, and there’s a greater value placed on making data-driven decisions. One could say, this idea of advanced analytics and the power of data and technology is certainly no longer the rate-limiting factor, as you just said, it’s doable. Right? So, the technology of things like artificial intelligence, machine learning, IIoT and other aspects sort of outpaces its application in a regulatory environment. That technology can do far more than we are able to apply it to in life sciences. Let’s talk about how we position disruptive technologies like AI and the importance of those technologies in analyzing huge volumes and complexities of data. Actually, I want to pick up on a word you mentioned earlier which is trust. I think one of the hurdles, maybe that’s too strong a word, but one of the challenges the industry faces is how we trust things like artificial intelligence and other technologies that are certainly disruptive, particularly in such a highly regulated space.
The way I’m thinking about it is it definitely has to be led by the business need. Technology is here to support. I think all of us have had any number of conversations over the recent years of whatever the latest technology is, how do we apply it? That’s really not the approach that we’re taking here because I can recall any number of conversations saying, “hey, I want some blockchain.” And then “what do you want blockchain for”? And there is no answer. The same with AI/ML, I want some, AI/ML, —but what do you want do with it? That’s clearly not the approach that we’re taking here. I would much rather be talking about, real time batch release and batch rescue for high value medicine. Aggregate reporting is one of the areas that we’re also looking at getting a lot more proactive, predictive, developing those capabilities and risk management solutions and tools before the problem actually happens and allowing for technology to give humans the right level of assist in making the right decision.
Do I think over time, the technology can take on a larger role? Absolutely. Because we’re going to learn, we’re going to figure out what technology can and cannot do, but in the early days, it’s that human assist positioning of AI/ML tools and decision support tools that is going to, again, walk us down that path of becoming empowering humans to make the right decisions in the most, meaningful way.
So, we are augmenting human decision making, not replacing it and solving real business problems, improving efficiency of process and effectiveness of process. The technology is just a means to an end. And, as you said, it could be seen as this, you know, sparkly jewelry that everybody wants when in reality, what they want is a better business outcome.
Yeah. And realistically, do we all dream of a time when we have a self-healing system that saves every batch—absolutely. You know, signal on the manufacturing floor gets fed immediately into a quality management system and gets automatically classified or auto-categorized. That signal then goes back to equipment that self heals. I would love to see that. Absolutely. Are we there today? No, but there is definitely a path that we’re working on that will start getting us closer to that.
Yeah, absolutely and it may be obvious, but I think this is really important as well, right. If we recognize the critical importance of data then this topic of data readiness is really critical and is still often overlooked. In my experience industry must make sure that their data is complete, concise, accurate and accessible. So let, let’s talk about that a little bit.
Across data sets, right. You, you don’t want to compare apples and oranges and different measurement units across different systems.
So, let’s talk a little bit about the challenge of data readiness and where within this broader architecture of enterprise systems is this critical data that we long to get access to?
Yeah, absolutely. And I think that is a challenge that we see many of our customers struggling with even the more sophisticated organizations that already have complex data lakes built in their own environments for R&D, clinical, manufacturing, or post market, there is that next level problem that appears of different systems of record that are not necessarily talking easily to each other. If you look at a quality event, for instance, a lot of the information that will categorize and help catch quality events in a proactive, predictive way can live in LIMS, can live in batch, in historian, in other systems in MES. The ability to pull reliably and well understood data sets across those systems and then deliver tools and analytics and decision support mechanisms that draw from this in an easier way is a very significant and untapped opportunity.
100%. And that architect sector becomes increasingly complex as the way in which we manufacture becomes more complex and how much outsourcing is going on. Often that architecture is not yours. Now it belongs to a third party, a supplier, a contract manufacturer, a CRO. So those levels of external complexity add another whole flavor to the challenge as well.
And that question of who the data belongs to is a whole separate line of debate. Any number of opinions out there will say, ultimately, if we’re talking about the clinical trial, does the data belong to the patient? It belongs to the company, does it belong to the clinical institution that participated in this, clinical phase of research? If there are analytics companies stepping in and owning data sets and figuring out how to monetize those data sets, that becomes the next challenge. And at least in the architecture, in the approach that we’re taking customer owns the data, we don’t try to monetize and sell it back to them. We are looking to provide enabling solutions that will help the customer make decisions. We have transient access to data to do something useful, but we definitely don’t need to own, we don’t need to hold any limiting license terms for the customer to get access to their own data, to put it in their data lake. I much prefer taking this customer-friendly approach and let them own the data and, ultimately own what they do with it.
So, data democratization versus data acquisition. We don’t want to copy it. We don’t want to move it. We don’t want to take it from a data lake and put it somewhere else. We just want to be able to democratize to free up that data so that we can provide the analytical power that’s so important. This is a great segue to the Honeywell connected life sciences vision. Let’s talk about that a little bit, but also let’s talk about some of the key principles and elements of the vision. Let’s start with why—why is our vision, what it is, what are some of the core challenges and value gap that, that the Honeywell connected life sciences vision addresses?
I would say it’s pretty simple. Really one of the core principles is the principle of optionality and meeting customers where they are, and that integrates several levels of optionality. So, it’s an optionality of what systems of record are used to feed the analytics and the decision support tools that we are going to deliver. So we are never going to come in and rip out the system of record because we have a different one at Honeywell. What we are going to provide is an ability to tap into the portfolio and the systems of record that a customer has in place in order to drive and feed the analytics and inform the analytics to help make better human decisions. The other key principle here is the customer owns the data. So, we only tap in for the minimal level of access that is required to provide the analytic, feed it back, and then the customer owns and controls it. Ultimately, do we think that we all need to be here and be a true partner to help customers get ready for that digital journey? Absolutely. But until we get there that optionality between on-prem and modern cloud solutions is another key component of how and what we are delivering.
And digital is more than cloud, right? Digital absolutely is mobility. And as we’ve said, enabling IoT smart sensors, the connected factory, the connected laboratory, things like AI, even things like how we connect the worker. The worker is, is, is no less important, right. We have to still connect the human to the digital increasingly digital factory. So, augmented reality and human machine interface, all of those things can sound like science fiction, but in reality, we know that they’re happening already in industry and certainly in life sciences.
They’re certainly happening. And one of the things that we did at Sparta earlier this year that I was super excited about was we ran a customer obsession challenge. And one of the things that our own employees are so excited about is, what does augmented reality on a manufacturing floor look like? And I think that that next wave of innovation is here and we are going to figure out smart ways to feed it and support it and deliver value.
100%. And I think it is exciting. And, you know, to be part of it now is a privilege. We talked about cloud, we talked about SaaS. Let’s talk a little bit about service. How do we serve the customer while focusing on how we help them along this journey of digital transformation? I see it often as a complex journey from this current state that is variable to a future state. It’s like a convergence strategy to this north star of digital transformation. How do we focus on the customer and be customer obsessed as they take that journey towards the rapidly approaching future of digital transformation?
Yeah, the that’s something that I know both myself personally and also other people on the team think of quite a lot. Every time we have a chance to work with the customer, both in the early process of understanding what digital transformation means to them, but also hands on in implementation and daily operations. It’s very informative. So, one of the things that, I’m picking up in recent conversations is how do we focus on the most value added features, how do we deliver packageable insights, if you will. So, for example, when regulatory climate changes and country A, B or C, how do we capture those new requirements in our product? Do we deploy it? So we don’t have to have the customer double guess or, you know, have to have to rely on additional expertise. Some of the work that we’re doing around QPA, our quality process accelerators in my mind is one of the ways to combine that simpler implementation with infusing industry expertise and regulatory know how with doing things faster, cheaper, and on a greater scale.
In my mind, that’s one of the paths on which we’re going to be successful. And another one is learning about what, what those value adding capabilities next stage capabilities are, and co- innovating co-deliver with customers. That’s where our recent conversations about real-time batch release come in. That’s where we are talking from, in aggregate reporting, going from a once a year occurrence that takes months to, delivering those types of support in a much more predictive, proactive, real time way. And I think that’s how we’re going to get better and deliver better over time.
So, to be customer obsessed and to think of the reality of the challenges that they face. And that idea of data, process, and then technology, it’s not only about technology, we put data and process first and, and think about value. Okay. So let’s wrap up a little bit. We’re going to talk about digital transformation in summary, because it’s not about if in industry will transform it’s about how and when, and as we’ve just said, the value of transformational quality management and its impact on industry and the patient is very clear and it’s significant, and we have to think differently about what quality management means in this rapidly approaching future for the life sciences industry. So that’s why Sparta and Honeywell think so much more broadly across the entire supply chain, right?
Not just in that traditional mode, one quality sense. So, let’s talk about that a little bit. Let’s talk about the ultimate customer of the industry, primarily the patient. And let’s go back to that word that we mentioned earlier on, which is trust. I want to just kind of wrap up with your thoughts on how a partner to the industry such as us can really play a role in making sure that the patient has the right product of the right quality, right. Efficacy, it’s safe, it’s on the shelf when they need it to be. What are your closing thoughts on this?
I think the components that you’ve listed Steve are exactly what the quality management system brings to the table. It’s not just making sure that you’ve got the right pill of the right color and the right bottle, it’s safety and efficacy and reliability of supply. And that’s where certainly in customer conversations, I’m hearing a lot of interest in other advanced analytics work. Qualitywise.ai, for example, support that we deliver around predictive and proactive around supply or quality management that allows you to better understand your broader ecosystem of suppliers and be able to both analyze and to a certain extent control and adjust in near real time. And then on the right side of the value chain the work that we’re already doing in analytics around complaints, that’s a very natural bridge for us to go deeper in proximity to the patient in what experience patients and physicians have with pharma and med-tech products.
And then again, feed that back into the next set of products and applications that we build, you know, on the supplier side. What I think is it, it’s important to understand how complex our world has become. And, and I think we all had a demonstration of that during COVID when a single event can disrupt—be that, a pandemic, but the same thing can happen with a major cyber event. You can cause a systemic disruption to a significant percent of your supply chain. And as you’re scrambling to find alternatives, having visibility, and in options that you have in your supply chain can actually be a factor of competitive advantage because every single one of your competitors is, is scrambling in the same way you do. So if you have a better set of capabilities in understanding and managing the quality of your supply network, that can quickly translate into dollars and cents, and also in your ability to deliver to the patient.
Okay, Oxana, quick fire round. First thing that comes to your mind—what was your pandemic lockdown discovery?
All right. Sailing! An activity that you can do outdoors and beyond the water in, in the weather and in beautiful places. So, yeah that was mine.
Awesome. Is the outdoors part of your passion?
Yes. For sure.
Okay. Next one. Superpower. So, if you could be a superhero, what’s the one superpower you’re going to want?
Teleportation. I love that
Still so many places to see and not enjoying air travel as much as I want to get around. So yeah.
Having spent so many countless hours in the airport and on that airplane, I can certainly share that one with you. Okay. Last one. Hogwarts house.
I’m going to say Ravenclaw.
So that’s what the hat would choose for you?
I think I’d end up in Ravenclaw, pretty sure. But one of my favorite characters ever is in Ravenclaw, which is the delightful loony Luna Lovegood. So yes Ravenclaw is it for me I think.
I’d end up in Slytherin. Unfortunately, I have an evil side to me.
Well, Oxana, thank you so much for your time and for your insight and for your leadership. And thank you, our audience, for your attention. I hope you enjoyed our conversation today. I hope you look forward to the rest of our podcast series and I’m sure I’ll see you there along the way. So again, thank you all very, very much.
Thank you, Steve, and everybody who listened. We welcome any questions that you have afterwards and look forward to engaging in a dialogue.
This has been Forging Connections, a podcast from Honeywell. You can follow Honeywell on LinkedIn and download new episodes from our website, Honeywellforge.ai. Thanks for listening.