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Interview of Zane Arp by David Zierler on October 16, 2020,
Niels Bohr Library & Archives, American Institute of Physics,
College Park, MD USA,
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Interview with Zane Arp, director for Biomedical Physics at the FDA. Arp provides an organizational overview of where his office sits within the FDA and its key institutional partners throughout and beyond the federal government. He recounts his childhood in Texas and his undergraduate experience at Angelo State where he majored in chemistry. Arp explains his decision to pursue a PhD in physical chemistry at Texas A&M with a focus on quantum chemistry through spectroscopy, and he describes his postgraduate work at Los Alamos on laser-induced breakdown spectroscopy. He discusses his subsequent work at Wye Laboratories and Johnson Space Controls in support of the International Space Station. Arp describes his next job at GlaxoSmithKline to work on pharmaceutical development and where he grew into management leadership roles. He describes the opportunities that led to him joining the FDA and he describes his game plan for improving the biomedical device research and regulatory process. Arp explains why this is a long-term proposition and he describes how COVID has, and has not changed FDA’s regulatory environment. At the end of the interview, he reflects on what shifts he been able to put in place so far at the FDA and why his office truly benefits from having a mission statement.
This is David Zierler, oral historian for the American Institute of Physics. It is October 16th, 2020. I'm so happy to be here with Dr. Zane Arp. Zane, thanks so much for joining me today.
No problem. Looking forward to it.
So to start, for the historical record, I just want to say that, Zane, we got in contact late last year, 2019. Feels like a decade ago, before COVID. And as you well know, my idea was to do an oral history project that captured the importance of physics heritage at the FDA. And you were on board from the beginning, and almost nine months later, I have captured, I think, almost everybody with a physics background at the FDA, present and former, with people like Roger Schneider going all the way back to the beginning. So, first, I just want to say thank you for your support on this from the beginning. And you are the last person in this project, so that’s sort of the jewel of the crown, so I'm quite excited for this, and I just wanted to express my appreciation, on record, for all your help on this.
Appreciate it, David. I would say, actually, I'm not the jewel of the crown. I'm actually probably the least important of who you're going to interview. The people that you had the opportunity to capture know a slew of history regarding our organization and how it has grown over time. I have people in my organization with 52 years of experience still working. That’s a lot of experience to capture. And I thought it was a great opportunity for us to capture some of that. So thank you for all your work on it. I know you've had to dig a little, and it hasn’t been as fast as we would have liked, but that’s the government entity that we work with.
That’s the government! But the nice thing, with the timing, is that in the pandemic, this is really a time when people are coming alive to the importance of science. And in my organization, the American Institute of Physics, it’s really a moment of awakening for people to recognize how important physics is generally to human health. It’s not just nuclear weapons and proton colliders and cosmology; it’s MRI and it’s pharmaceuticals, and it’s imaging, and it’s diagnostics. And to be able to demonstrate at a time when the FDA is sort of in the headlines every day that physics is front and center—like you said, the timing has gone a little slower than we both anticipated, but long-term, this couldn't have been a better time for us to do this. So let’s jump right in, Zane. First, tell me please your title and institutional affiliation within FDA.
So I'm the division director for Biomedical Physics in the FDA. I'm in the Office of Science and Engineering Laboratories, which is located in the Center for Devices and Radiological Health.
When did Biomedical Physics come to be its own office start at the FDA?
That’s a great question, and I can’t answer it, per se.
It’s before your time, though?
My understanding is somewhere around probably 2001, is where—and it actually has been renamed since then. I think it actually started out as two separate entities. One of them was actually the Division of Physics, and one of them was the Division of Biomedical Engineering, I believe. Some of the people who have given you their history have already probably gone through the full list of acronyms and different entities. But I want to say somewhere around 2001.
And just to get a sense of where you are in the org chart, who are the key people that report to you, and who are the key people that you report to?
So, the key people that report to me would be my division management, so Deputy Division Director Dan X Hammer, and Deputy Division Director Brian Beard. I believe you've also interviewed Brian, who’s a deputy division director. I have now two assistant directors who are Ksenia Blinova and Sunder Rajan. I have a leadership team that also expands on that—Chris Scully, Kim Kontson and—there’s somebody else—Sandy Weinenger. You may have also interviewed Sandy; I'm not 100% certain.
No, I didn't get to Sandy.
So yeah, that’s my list of people that are reporting to me. And then of course the most important people are my staff, which actually most of those are staff members, also. [laugh] Which has grown over the last couple years, and we're up to about 42 people. As far as the important people I report to, my direct—I have a direct line to Ed Margerrison, who is the office director for the Office of Science and Engineering Laboratories, who has a direct line to Jeff Shuren, who’s the Center director. And Jeff, of course, reports to the commissioner, Dr. Stephen Hahn.
Zane, obviously the FDA is part of so many important federal interagency projects and processes. Can you give me a sense, on a day-to-day, what are the other government agencies or entities that are important for your mission?
We do operate to a degree in a vacuum, but we do provide insight and opportunity to a variety of different organizations. NIH of course is very important to us. I actually sit on the national strategic board for the NIH National Institute of Bio Imaging and Bioengineering. Actually, I sit there for Jeff, who’s the actual official guy [laugh] on the list. I'm typically the guy who sits on the board for them, though. But that interaction is critical to us, of course, in understanding what new medical devices are coming our way.
NSF is very important to us, of course, because they're very early on in the development phase. So when we're looking at future-state forecasting and where our organization needs to be looking as part of the translation of medical devices, from innovation through to the consumer or the patient, we're the critical step in between and can be a linchpin for them if it hasn’t been properly taken care of. So a lot of the things that we're doing need to be thought about very, very early on. So NSF is a critical component.
Of course, we work with the CDC at times. Like in the pandemic, we have actually been working with CDC, with Department of Army, with TSA, a whole variety of different organizations. In those particular contexts, it’s in regard to how do you put tools in place to handle something like the pandemic? And the FDA has been approving these systems, we also have a lot of experience in what the operational parameters are around them, too.
That was a question on the federal side of things. What about on the private industry side of things? What are some of the most important corporations, organizations, trade groups, that are relevant for your mission?
We don’t of course have any corporations that we would list, because we are agnostic to that. Our goal is to develop tools and capabilities that are broadly applicable to industry in general. We do work with the Association for the Advancement of Medical Instrumentation (AAMI)—looking at this, we have a variety of standards organizations like AAMI and ISO that we're working with to help develop the standards so that the industry has capability to go out and find standardized methodologies to address their needs. We work with a variety of different consortiums of companies. They're not right on the tip of my tongue right now. I guess AAMI actually is—that’s actually one of our industry consortiums. [laugh] I get lost in the acronyms still myself, after two and a half years.
There’s another one that—MDIC, Medical Device Industry Consortium—which is something Jeff actually set up years ago. That actually is a consortium of a variety of the large medical industry group or medical device industry group that’s coming together to give us guidance and provide some insight into where we need to be working. Then on top of that, we are working with academia as part of our efforts to advance our regulatory science. They're a key component because they're very early-phase. They're able to help us address some of this. And sometimes we're working in the same space.
And Zane, just a question sort of a ripped-from-the-headlines; of course, we're both talking to each other from our home offices—what ways has remote work sort of opened up new pathways of productivity for you, and in what ways do you kind of wish it would be great to just be back in the office with your team, face-to-face?
Well, I've always worked remotely in the past. This is not my first time with remote work. In my prior job, I used to travel 60% of my time and my office was in my backpack. So, it really hasn’t affected me as far as productivity is concerned. Being face-to-face with your team, of course, is always critical. I can tell you that my division meetings don’t run as well as they used to. You just don’t have the personal interaction. I'm certain that some of them are tuned out, half the time, doing their email or other important activities. It reduces the capability to have the one-to-one interaction, the ability to break bread together and see each other in person.
Productivity-wise, I get through all my email now. But a lot of my job—like I said, I consider myself to be one of the least important people, as far as the ground benchtop work. Because my job is really to help my people get the resources and enable capabilities to do their work. And a lot of that can be done from home. But it is important to be visible to your people and seen as part of the team. And with COVID and being at home, that has been difficult. And I'll be honest; our teams have taken a hit because of the fact that we're a lab-based organization, and we haven’t been lab-based, and we're just getting back up and spun up. We're taking care of it as best we can and trying to protect our people as best we can.
Zane, let’s go all the way back to the beginning. Part of the best way to establish the narrative of your trajectory is to get a sense of your family background. So first, tell me a little bit about your parents. Where are they from?
Both of my parents were from very small towns in Texas. My mom grew up in a place called Garden City and graduated in a class of four. My dad graduated in a class of six from Imperial, Texas. Imperial actually doesn't even exist on a map anymore.
How many generations back did they go in Texas?
Only about two generations. My grandparents came over on a covered wagon. I didn't know my grandparents on my father’s side; they both died before I was old enough to remember them. My grandparents on my mother’s side we lived with for a while. But I know my grandmother came over on a covered wagon, actually.
Where did your parents meet?
They met in high school, I think. [laugh] I actually don’t know where they originally met. I think they met in high school and then rejoined later in life, after my mom had had her first marriage. I actually don’t know what their story was after that.
And did they grow up on farms?
My mother definitely did. My dad was—I don’t know what his dad did, actually. We never discussed it. This is a good question. I ought to go back and look at my own family history!
Like I said, I think my dad’s mother was a schoolteacher, and I don’t know what his dad did. He died when my dad was 11, so we didn't ever know him.
And what level of education did your parents achieve?
Both were high school diplomas.
And what were their professions?
Well, I should say my mom actually went on to get a nursing degree, an LVN. My father was a non-degreed electrical engineer. He got his training in the Navy during Vietnam. He spent time in the cyber warfare division there and was trained in electrical engineering.
Well, between your home in the health sciences and your dad with the engineering, that kind of sounds like a good background for your trajectory, actually.
They had some influence. We can get into the hard knocks of the life growing up since I don’t have a traditional mom-dad relationship. So— [laugh]
Well, let’s talk about that. What was your upbringing like? First of all, did you grow up in Texas, also?
I did. I graduated in a class of 19. But unlike many people, my growing up wasn’t as happy as others. My mom was a drug addict. She had a massive opioid addiction from the point I was about 11. She damn near killed herself a few times. My father was a good man, but they were divorced at about 11, and he was no longer in the picture on a regular basis. So we would see him for two months a year, some holidays, and talk to him on the phone. I have to be careful what I say. I love my dad. I have to be careful what I say. My brothers may one day read this! [laugh]
Sounds like you had to grow up pretty fast.
We did. Absolutely. We had to take care of ourselves pretty quick. Fiercely independent very early on.
Did you know about your mom’s problem? Did she try to hide it from you at all, shield you?
We knew about it. She tried to hide it from everybody, but it was pretty readily evident. I mean, there were days she didn't get out of bed. There were months we kept her alive on milkshakes. We cooked for ourselves. My older brother, who’s eight years older than me, took care of me and my younger brother for several years, until we moved. There were some problems with one of my mom’s boyfriends due to mental instability.
Was that a little more stable for you, on the home-front, your high school years?
Definitely. I’d say if anything shaped my future career path, it was my high school years. In my high school years, I was on the math and science team. I actually have a whole two very big panels worth of state championship medals that I won in math and science. The math and science teachers became kind of my fatherly figures. Had the ability, though—you know, smaller school, but fortunately I was exceptionally good in the math and sciences. I didn't even know there was such thing as a doctor outside of a medical doctor before I went to college. I didn't know I was going to college until I was probably a junior or a senior because I didn't know what college really was. It just wasn’t something we discussed much.
So it sounds like your talents in math and science were almost accidentally discovered because you didn't really have a situation where that would have been fostered externally.
For the most part. I mean, my parents were always interested in my grades. I was always naturally ahead of the game. Whenever I would sit in a class, I didn't have to worry about the math and science. English and language, on the other hand, are exceptionally difficult for me! [laugh] I still speak my native tongue of Texan, so I'm not gifted in that particular category. I'm not very good in the arts, I would say. But the mechanical sides and the math, science, I definitely came to naturally. But I had the very fortunate aspect of being in an area where I was fostered and grew through the math team and other things.
Was there any question about whether you would pursue an undergraduate degree after high school? Was that a foregone conclusion or not necessarily?
Oh, not necessarily. A lot of the guys in my area—small towns in Texas are little black holes. They don’t let go of their people easily. I’d say actually I don’t know how many people out of my graduating class—I only graduated with 19, but I would say probably less than a quarter of those actually went on to college to get a bachelor’s degree, would be my guess. I can’t remember—I haven't kept up with them. I wasn’t that tight with my classmates. [laugh] So it’s not something that’s a foregone conclusion in small towns like that. As a matter of fact, it’s more likely—you know, the Country Western song—you grow up, you marry your high school sweetheart, you work in the town, and you don’t necessarily need a college degree to go do that—be an oil hand, or be a ranch hand.
What schools did you apply to when you realized that college would be feasible for you?
Well, the one I ended up going to was Angelo State. I actually had recommendations for all of the military schools, so Air Force, Army, and Navy. I actually failed a physical due to an potential colorblind problem. Whole different story, probably not relevant to today’s discussion. Texas A&M, Texas Tech, Mainly Texas schools, and then the military academies. I was really interested in getting into flying. I really wanted to become an Air Force pilot, but failed the physical, met a girlfriend, and decided not to complete the process. [laugh] Typical young and dumb things, but I wouldn't be where I am, if I hadn’t done that.
What was your undergraduate experience like? Did you major in science? Was that the plan from the beginning?
No, I went in as a—well, again, not understanding the education system as far as the bachelor’s degree is concerned, I went to a college thinking I was going to go into chemical engineering, hell-bent that I was going to be a chemical engineer, not realizing that the college didn't offer an engineering program! [laugh]
So I went into what I thought was the next best thing, which was chemistry, and majored in chemistry from the day I walked in, to the day I walked out.
What were you good at in chemistry? What were your special talents?
Oh, I don’t know that I had any special talents. I mean, I just understood it. I understand the concepts behind it. I understand the physical—you know, I earned a PhD in physical chemistry because I understood the physical interactions that occur at the very base level. And that was probably the thing that I’d say is my special talent, the ability to see some of the nuances for what goes on in chemistry from a very basic level, which is a critical component of building up from the microscopic to the macroscopic vision of what occurs in a system. The mechanical aspect of the system is almost the way I would describe it. Your building blocks build up into what happens at your macro scale.
Were there any professors who took you on in a mentor/mentee kind of relationship, as an undergraduate?
Oh, yeah, I had a couple of professors. Dr. Michael Carlo, who was a toxicologist and Dr. George Shankle. He took me on really early on, I think. He saw that I had potential and helped steer me as far as my career in chemistry and where I wanted to go, as far as my future state was concerned. So, yeah, I would say a couple of them. Carlo was kind of a buddy and [laugh] helped with some of the social aspects. He helped us understand some of the other parts of the game.
At what point, Zane, did you realize that you could go on for a graduate degree? You said before, growing up, you didn't even know that there was such a thing as a doctor outside of medicine? So, I'm curious when it dawned on you that you could go for a PhD in this field and pursue a career at a high level.
Probably at about my junior year.
What kind of professions were interesting to you at that point? What industries?
A job. That was [laugh] what was interesting. One that paid real money.
Probably some stability, right? Something different than your own childhood.
That used to be my commonplace theme, that I was looking for job stability. My father got laid off when I was in college, actually in grad school, and that was one of the things that I constantly was watching was him and his cycle of jobs and money, and I knew I wanted to make money. I'm a fairly open guy about my beliefs and what motivates me, et cetera. And I'm a financially motivated individual. I look at things from a financial perspective and I wanted a job that paid me money! And lots of it. That’s [laugh] the ultimate goal, right? In many instances.
I felt like I had the skill set and capability, and I was being encouraged by my—like I said, some of the professors who I mentioned—that I really needed to go on and get an advanced degree if I really wanted to move up the chain. I think they saw the potential of where I could go. So they were pressing me to do it. They turned me on to an NSF research experience for undergraduates in my junior year and really pushed me to apply to some of those, so that I would have an opportunity to go see what research life is in a college, and get that exposure. That’s when I went to A&M. [laugh]
That’s where you went for your graduate degree?
Yeah. I only applied to two schools for my graduate degree, much to the chagrin of my professors. My professors really wanted me to apply to the MITs, Berkeleys, the bigger-ticket grad schools. Their feedback was I could probably have a career there and do well at one of those schools. I wasn’t interested. I had always wanted to be an Aggie. I'm a big Texas A&M football fan. When I applied to colleges, even—I said earlier I'm financially motivated—I went to Angelo State University, which was a smaller college, more of a liberal arts, primarily due to the fact that I had an absolutely full ride. [laugh] So it was a balancing act on the finances. I loved A&M, and they offered me $200, and the Angelo State offered me—a lot more than that! [laugh] Now that I'm a little more mature and older, I see things where maybe my pathways were selected a little bit based off where I went to school. But I was hell-bent on going to A&M, and that’s where I went.
And that’s not to say that A&M is a slouch of a school. It’s got some world-class programs!
Oh, no, absolutely. And it’s a world-class program in chemistry. There’s absolutely no doubt about it. But the professors that I was talking to in my undergrad would have indicated that I probably could have had my pick of the litter of where I wanted to go. I had a 4.0 chemistry average. Well, I think it came out to a 3.9. My last semester, I did jack around a little bit.
I let one grade go to a B. But their perspective was I probably could have gone just anywhere I wanted to, so why not pick the best? Or the absolute top tier. And MIT and Berkeley at the time were kind of the top tier. I just chose not to even try. I didn't even apply. It wasn’t interesting to me. I wanted to really go to A&M.
Now, did you go straight there, or did you take some time off and work in industry first?
Oh, no. Straight through. My parents were both still around at the time. My father, in particular, was really encouraging me not to stop and go to industry. Because there was just no real need there. And I said bachelor’s degree—I didn't know about doctorates, for sure, until chemistry. I know my dad pushed me at times that I really needed to go get an advanced education earlier in life because his career was definitely muted by the fact that he didn't have a bachelor’s degree. He was definitely capped because he was a high school diploma working in a field where everybody has a bachelor’s degree.
What year did you start at A&M?
’96, okay. And you started in physical chemistry, or you took on that specialty later on?
Oh, no, I started straight into physical chemistry. I specified what I wanted to do on the day I went in and that’s what I went out with. In the case of A&M, part of that selection was I was told that physical chemistry was the hardest area to get a degree in. I had already done research the summer before, so I had a three-month head start and was almost finished with my first paper. So [laugh] I'm like, “I'm going into physical chemistry. I'm going to [laugh] go into the hard stuff!” [laugh]
Zane, I'm curious—what role did theory play in your curriculum? What’s the theoretical aspect in physical chemistry?
Explain the question a little more. Because I'm trying to—
In physics, we have the classic divide between experimentalists and theorists. And of course, there’s a theoretical dimension in chemistry as well, although that divide is not nearly as pronounced as it would be in physics. So, I'm curious if your curriculum was strictly lab work and instrumentation and all of that, or you did have theoretical aspects of your work.
No, we had plenty of theory. I would argue most of advanced quantum chemistry is nothing more than theoretical potential applications. I mean, I said it earlier—I'm more of a mechanical person. I can take things apart, and put them back together again, whether that be my car, my truck, my house. So, I'm much more hands-on and much more applied base. We had theoretical aspects. I always laughed at the theoretical aspects. Because many a time, you couldn't prove the theoretical aspects. And I like things that I can prove, that can be conclusively proven wherever possible. But I'm much more the applied side, myself. That’s due to my hands-on nature as opposed to the thought aspects and thought experiments.
I always loved the theoretical papers of some molecule that can’t possibly exist and looking at spectral properties of it. Well, you can’t measure it, you can’t see it, but you know, maybe it exists in space someplace [laugh] as a massively unique one-off! [laugh] You know? So that just never really was aligned with where I wanted to go or my interests. I was applied from the day I went in. I enjoy the theoretical aspects. You know, throwing tennis balls at walls, and one magically going through is an interesting concept. There’s a theoretical backing to that. And that’s interesting to me, but not what I want to be exploring as far as a scientist was concerned.
And what kind of lab work did you do during your first years as a graduate student?
I was in an applied spectroscopy laboratory. It was lasers and spectrometers and understanding quantum chemistry through spectroscopy. My dissertation was two-dimensional potential energy surfaces of a variety of different molecules plus Van der Waals forces and some other stuff. I've always been a little bit broader—I've always gone for breadth over depth on many things. But a lot of the work was around—well, first off, using spectroscopy to determine what the energy states, the quantum aspects, of a molecule look like. And then utilizing that to understand how it bends and folds like a piece of paper. You know, how much energy is required to bend it. How much is required to twist it? How much energy does it need to take it apart?
So, a lot of it was energetic physics of small molecules. So the components of that included taking spectral aspects, which tells you all the quantum information of the various levels of it, and you can do that under different conditions, and that will tell you different aspects of that molecule, that could then be utilized in quantum theory to predict the energetic levels and how much energy it takes to go between different cycles and states, or combining two different things in van der Waals theories. That’s actually the easier part of the studies, because most of the time, you were using bum equipment that had to be repaired all the time.
So, my hands-on aspect was almost always building or rebuilding or figuring out why the system was broken. I spent probably I would argue two thirds of my graduate career doing nothing but repairing equipment or figuring out why the hell something wasn’t working the way it was supposed to work.
I bet that served you well in the long run, though—having that ability to work as a mechanic, essentially.
Absolutely. I mean, understanding the insides and outsides of a piece of kit are just as important as understanding what it can give you. Too often, people go, “Oh, I can go toss it into this, and it’s gonna give me something.” But they don’t understand the something, because they don’t understand everything else going on behind it. Or they get something out, and they say, “Oh, look—look at this really neat thing.” And you look at it, and you go, “That’s crap! And that’s crap because you don’t understand the system just screwed up, and what you're seeing here is an anomaly out of the system.” Understanding the full components of it was a critical piece of it. I got to do everything from break down a full Michelson interferometer and have to rebuild the thing, to putting together high end laser systems that you could use to weld. That comes with all kinds of fun safety concerns. [laugh]
[laugh] Zane, who was your graduate advisor, and how did you develop that relationship?
Dr. Jaan Laane was my graduate advisor. As with other leaders, most of my career has been luck. I would argue that my development of my relationship with Dr. Laane was quite lucky in many ways. He’s exceptionally good at what he’s doing. I think he’s a professor emeritus now, kind of in retirement, or pseudo-retirement, but still working at A&M. I was steered by my undergraduate people to look at a National Science Foundation Research Experience for Undergraduate (NSF-REU) opportunities. I had applied to A&M, and I think the University of Arizona. And I had always wanted to be an Aggie, so I went to A&M for my research experience for undergrads. I was paired with Dr. Laane, enjoyed the work I was doing in the lab, enjoyed my time inside and outside the lab at A&M, and just ended up going there. And I'm a little lazy; I already had a head start, [laugh] so why not continue with my head start on the rest of my graduate friends, and continue the work I was already doing?
And what was Dr. Laane’s research? What was he known for?
Two-dimensional potential energy surfaces of non-rigid molecules. He came up with a variety of different programs, especially early on. I mean, we used to have the cardstock in drawers at the lab, of the original codes he wrote in Fortran, that could go in, and utilizing the spectral information that we would gather from our systems, our jet-cooled fluorescent systems, our Raman systems, our infrared systems, our far infrared systems, you could actually take that information, you could stick it into essentially this code that he had developed that would then be able to predict what the energy states look like and what the transitional components look like.
So, in something like trans-stilbene, where light can change the configuration of trans-stilbene along the double bond, his lab was the first one to actually go in and calculate the energetics behind that and conclusively show how much energy is required to do that, which is an important component now, I think, in some photo switches. Because that transition acts as an optical switch. And I forget where it’s being used now, but those were the types of things that you could do with that type of research, was figure out what the energetics were behind the optical switch, and now dial into it, so you could switch on and switch off, at a molecular level. He was doing that very early on, back in the ‘70s, ‘60s.
Now, I don’t think it’s quite as exciting as it was. I think a lot of that has been determined, although you could continue doing it for a variety of different molecules. It’s not as slow as it used to be, because equipment has sped up unbelievably over the time period of my career. Things that used to take me 24 hours, 20 years ago, are now done in minutes, on much smaller systems. But that was what he is really known for, I would say.
Zane, of course developing a top-notch dissertation is a perfect microcosm for understanding the larger field—advances in the instrumentation, the big research questions. So in developing your dissertation, what were the larger questions in the field, and how do you see your dissertation being responsive to them?
[laugh] Well, in academia, you're often operating in a microcosm, right? [laugh]
Yeah, right, exactly.
A little bitty spot! [laugh]
I will argue that many of the things in my dissertation did not address big-ticket items. My dissertation was focused on the two-dimensional potential energy surfaces of indan, 3,3-dimethyl trans-stilbene on the Van der Waals forces of HCL and propanol and the Raman spectra and hydrogen bonding in—I forget what the name of the compound is. But actually, of them, the last one is probably the most quoted, or most referenced that I have because it’s used in the biochemical field where the hydrogen bonding can be determined based off the spectral properties. But the big questions at the time were, how do you utilize it? [laugh] You know?
We were developing information that was of interest and was advancing maybe the science in some degree in energetic states of molecules and how do you measure that. Maybe that’s had an effect longer-term on some of the things you're seeing now where you're using things such as an optical switch. Like I said, for 3,3-dimethyl trans-stilbene, you're looking again at the optical switching effect.
So I don’t know that there’s a good answer for that, as far as—it was really kind of very basic research. Very interesting. Nobody had done it before as far as the molecules I was looking at, or some of the particular challenges we were dealing with, with those particular compounds. But as far as a big-ticket, real-world application, I would argue it was a basic science research lab. I got exposure to high-end lasers that others didn't. I had exposure to, like I said, a variety of different spectral tools that were important in my future career. But the research itself, very basic. It led to some publications. Maybe somebody’s using it. I know, like I said, the one study that we did on the gas phase Raman of a surrogate for something found in DNA, or RNA. And the study that we did actually showed that the ratio between two bands was really key to understanding the hydrogen bonding and whether or not hydrogen bonding was there. And then they could translate that into the real-world application of looking at RNA in biological systems. And they were seeing instances where there was a lack of hydrogen bond. It was probably the most important stuff we did. It was also one of the easiest studies I did. [laugh]
Zane, given that you were sort of in pure basic science mode, getting back to this idea of career aspirations and things like that, as a graduate student, how much thought did you devote to ultimately the best way that you can apply your expertise to a career? In other words, were you starting to think about the health sciences at this point, or did that come later on?
No. Again, my life has been a little bit of luck. The health sciences didn't come in until much later. When I went into Dr. Laane’s labs, one of my big questions was, “Where do your people go?” And at that point in time, they were going to Dow. They were going to BASF. They were going to major chemical companies. You always need somebody who can go in and do spectral work or advance your spectral space for a variety of different reasons. And just having that baseline understanding of the physical aspects can help speed things along.
What about the academic track? Did you ever think about pursuing—becoming a professor yourself?
[laugh] Not your bag?
Nope! No desire, at all. Zero. Well, at the time. I mean, as I age, I do think at some point when I retire, maybe I might want to go that route. I do enjoy mentoring students and being in academic labs. When I was in grad school, I was trying to encourage my advisor to start looking at NIH for funding, because there was impact there, but also NIH at that point in time was also going through an explosion in their funding.
You know, NSF used to be the primary funding source for most research in the US, and that’s about the time that NIH suddenly came on the campus and just exploded, with their funding opportunities. But I was always an applied guy. I wanted to understand how I could utilize this in some other area, to advance my career, essentially.
What year did you defend?
I defended in 2001.
And at that point, what were you looking at? What were some of the most interesting opportunities you were considering?
Just a job in industry. [laugh] I was very non-specific in what I was looking for. I was looking for a job in industry. I knew that. I was not looking for academia. I was looking for an opportunity to grow and make money. You know, go out and make a contribution to big industry. And that’s primarily where I was focused, was big industry. It was really just focused on how could I go out and find a job that made money.
I hate to be so simplistic, but simplistic is beautiful at times.
That’s right, that’s right. And so what opportunities were most interesting to you? What offers were you considering at that point?
I didn't have that many offers at that point. That point was a little bit of a low. We were coming out of the ’98 crash due to the tech bubble. So, when I went in there were lots of opportunities, but 2001 wasn’t a great year to go find a job! [laugh]
Yeah, yeah. Even at blue chip companies like Dow? Even there, you felt it?
No. I mean, I just didn't have any offers. Some of it was the market in general was pretty poor. It was tough to get in, at that point in time. I had a hard time finding my first—well, I say a hard time; looking back, six months isn’t a hard time.
But it took me about six months post-degree to find a job. And, let’s be honest—I mean, I'll give you the history here, David, and I'll go a little further back: my wife’s dad died in July, my dad died September 6th of 2001.
9/11 was his burial, I defended the week after that, and I had my first kid the week after that. 9/11 hit, and the market just went to crap altogether. Nobody was hiring during 9/11.
Not to mention all the family stuff you were dealing with.
Yeah. I mean, the family stuff didn't affect the hiring aspects or me finding a job as much as 9/11 came in and every lead that you had just came to a standstill, because nobody knew what was coming. Everybody knew a crash was coming. And it did. There was a crash after 9/11. So that definitely put [laugh] a damper on the ability to go find a new job.
Was a place like the FDA—was that on your radar at all, at that point, or government service at all?
I had an opportunity to go to the Department of Defense. And if I were to aim at anything, I would have said the Department of Defense, and some form of weapons application, would have been where my heart was at that point in time. Really dug the opportunity to go apply these in weapons activities. But I also got an offer from Los Alamos National Labs at the same time I did from China Lake, the advanced air warfare center. But no, outside of the fact that—pharma was hiring at the time, but I didn't have any opportunities at pharma. So I just never even considered it.
What was the job at Los Alamos? What would you have been doing there?
I actually took the job at Los Alamos. I was a postdoc there. I was working in laser-induced breakdown spectroscopy. It was an interesting role. It’s something that I've had to deal with multiple times in my career, having two different bosses. I was actually brought in as a postdoc in the nuclear pits organization, but because of timelines for security clearances, they have to keep you busy with something as you're both learning the processes and procedures, but also getting clearances to go into the facility. So I was put with Dr. Dave Cramer and Dr. Roger Wiens. They were not my formal supervisors. [laugh] But that’s where I was doing my work.
And their big impact has been the LIBS use on the Mars rovers. I was getting to do some of the very early work on that, and actually we wrote a demonstration article on using it to analyze water ice, which was one of the key components they were looking for whenever they sent it up. It’s on Mars now, analyzing dirt and rocks and other stuff, using a laser-induced breakdown system. The beauty behind it is it can analyze things at large standoff distances. So for geography or geographic purposes, I can now aim my laser out 100 yards, not have to climb up, and I can actually ping that and then see what’s there. And geologists love that, because they can now determine what the age looks like, and what kind of rock surface is there, et cetera.
We were doing some of the early work on that. And they were talking about polar ice capabilities, of course, from the perspective of do things live in it. I don’t know that you can see that with a LIBS unit, but you could at least drill the hole and look at things that were embedded in that ice, down to a certain distance. Also did some work on Venus potential projects. A lot of it was space-based—could you stick one of these systems on a rover and send it to Venus, and then see what the rock is like on Venus at 400 degrees and in an atmosphere of sulfuric acid. [laugh]
Sounds like you had a great time at Los Alamos.
Yeah, it was a good—I enjoyed my time there. Again, breadth has always been my thing. I was doing the LIBS work. I had the ability to, or I was trained in the nuclear side, took a plutonium metallurgy class, which was really cool. I got to go back in the pit facility and actually do some work on equipment and work in the pits for a little bit. So, I was fully trained in the radiological aspects. I also got to do some explosives work. But quite honestly, I can’t talk about the explosives or nuclear work, because it’s all classified. But yeah, it was a good time. We would have stayed there.
But the environment—Los Alamos in general—some of the senior advisors that I had had there were down on it. They felt like the place was really not living up to what it used to be. My advisor, Dr. Laane, actually pushed me towards Los Alamos. He had done his postdoc there and really felt like it was a great place. I had an offer for a full-time position at China Lake at the same time as I had one at Los Alamos. So, whenever I got out and I had three different opportunities. If I had have just been on my own, I’d have probably taken my opportunity in China Lake. Although I had the two-body problem; my wife had a PhD, and there wasn’t great opportunity for her there. She found a job in Santa Fe. So, I shot off to Los Alamos as opposed to China Lake.
And what was the work? What would you have been doing at China Lake?
China Lake would have been spectral analysis of a variety of different things. It could have been anything from how do you utilize spectral capabilities in different war fighter applications to analyzing different samples that they might bring back from a variety of different applications. It was really spectral analysis and evaluation of systems, I think, more than anything else. To be honest, I can’t remember all the details of that job. I remember that they told me something about a helmet coming in and they had to analyze it to figure out some kind of deficiency or issue that it had. So I think it was a lot of troubleshooting, essentially, for the Navy, regarding their Naval air warfare systems.
How long did you end up staying at Los Alamos?
Year and a half.
And what were you thinking about doing afterwards? What kind of opportunities became available at that point?
Again, I'm opportunistic, David. You're going to hear this story over and over again. At that point, I've got a wife, I've got a kid, and my real thoughts were long-term employment. I wanted stability. That was the comment that I’d make at the time. I've come to realize from my career there is no such thing as stability. That no longer exists in the real world. You create your own. But at that point, as younger Zane, I wanted stability. I wanted someplace where I could depend on my paycheck every month and not have to worry about it. My dad had been laid off and couldn't find a job, and I was quite concerned that I would fall into that at some point in my career. It’s a recurrent reminder to stay up on your game. I just wanted a job. I really wanted to stay at Los Alamos. If Los Alamos could have come through with a long-term offer, I probably would be at Los Alamos. They couldn't.
I'm a believer that you interview once a year. China Lake had hired somebody, but they ended up letting them go. It wasn’t a good fit. They called me up and said, “Hey are you interested?” I was considering China Lake. I had put out a couple of applications. And I had an opportunity at Wyle Laboratories at Johnson Space Control. So, I had a couple opportunities on the table, but if Los Alamos had come forward with a long-term offer, I’d probably still be at Los Alamos. Even though the advisors there, like I said, were not high on Los Alamos anymore. A lot of the people I talked to who had been there for a while were like, “Yeah, this place just isn’t what it used to be scientifically.”
Well, of course the Cold War is over. That’s got to be part of the equation as well.
Cold War was over. They had had a bunch of issues.
I mean, Wen Ho Lee is not too far before when you arrived.
No, he was when I arrived.
I was there during Wen Ho Lee.
Well, actually, you are correct. He was just before I was there, but all of the issues came out while I was there. And then there was the lost hard drive and just a whole slew of issues. They were going to go through their first competition of the contract, ever. It had always been sole source to California. Now, they're going, “We have no idea who’s going to be our boss.” There mantra turned into “Safety, Security, and—” What was it? Didn't have anything to do with science. The base science that everybody was doing was getting further and further constrained, because the budgets just weren’t holding up to the cost point. I really was looking for the more applied stuff, but there just weren’t roles for me there at that point in time. And with a young kid at home, I needed a commitment of some kind for my time and effort. I tell the same thing to my grad students or my postdocs here at the FDA: “I don’t want to lose you, but after six months, you ought to be applying some place, because I can’t guarantee you a job.”
And that was the scenario I was in. So, I had to find something new.
What was that next opportunity for you? What did you do next?
So, I went over to Wyle Laboratories and Johnson Space Control, which again, if I had looked at things a little more financially. Wyle was servicing the international space station and human space factors for NASA. They had a $5 billion contract over five years to support all the various aspects of getting humans into space. The problem was that was after Columbia, there were no spaceships flying. They couldn't get one off the ground. And NASA’s spending $3 billion a year on a ship they can’t fly. So, there were all kinds of issues at that point in time with contracts and other things with regard to human space flight. But me being not as bright—and maybe I'm not as bright today either as I think I am—but I wasn’t looking at that aspect. NASA was really cool. I had always wanted to work for them. It was back home in Texas, so you know, we were less than an hour’s drive from the in-laws, and our house, and our brothers and sisters and all that. So, you know, it was Los Alamos or back out in China Lake. Again, China Lake, I’d probably still be in China Lake today if I had taken the role.
But ended up going to Wyle Laboratories for—and only spent about a year and a half, two years there.
And what was your work? What were you doing there?
It was pretty cool work. It was supporting the International Space Station. At the time, NASA was developing bioreactors for space-based activities. And a lot of our space exploration and having humans in space is based around what happened to the physiology of the human in a microgravity environment. That’s an expensive way of doing a study. So when you're sent up as an astronaut, to a degree, you're a test monkey. They want to know what’s happening to you as you're up there, to understand what happens in longer-term space exploration. And the problem that they face in that is, A, excessive cost, and B, you have to launch somebody into space.
So, they were trying to find means of doing that kind of work and looking at things on a ground-based type scenario. They were developing rotating bioreactors which actually mimicked in some degrees constant freefall for cell systems, and then you could utilize the changes that you were seeing in those systems to potentially predict what would happen in bigger systems, i.e. the human, right? So if you were growing pancreatic cells, you could actually get three-dimensional structures that would suddenly produce insulin. That’s unheard of in a normal bioreactor, although bioreactors have advanced a lot since I was at NASA. But they had bioreactors in space that were not—they had some that were just straight cell-based assay bioreactors. They also had the rotating bioreactors. Then they had the ground-based bioreactors.
The problem with space-based bioreactors is the cost for an astronaut’s time is measured in the hundreds of dollars a minute. So, if an astronaut has to do anything with that system, then that’s hundreds of dollars a minute to do the study or experiment. So what our job is, is to try to automate those bioreactors to where they did as much as they could on their own, as often as they could. So, I was responsible for doing things like developing glucose sensors, or lactose sensors, or other types of sensors that could be put onto that, which were mainly spectroscopy-based, that would then automate their systems in space and make sure that they were running appropriately, and limit the amount of astronaut time that was necessary. And then we would correlate that with ground-based experiments where we were also automating in our rotating bioreactors, to see if we were getting comparable results between top and bottom.
Problem was, you couldn't send a bioreactor up, because there wasn’t a spaceship! [laugh] But you had some problems there. And NASA eventually cut the program. They went through and looked and said, “You know, I don’t need bioreactors in space if I can’t launch a spaceship and I'm losing $3 billion a year.” So, they completely cut out all the bioreactor work. Fortunately for me, Wyle had another job for me, and I became the non-ionizing radiation safety specialist, and at that point started looking for really new jobs because I didn't feel that that was a long-term option for me.
And Zane, it sounds like, in terms of broadening your own areas of expertise, in that initial role at Wyle, you were working more in a biological realm than you had before.
Yeah. That’s where I probably got a little bit more biology-focused, primarily process analytics in biology. I had to learn a lot about keeping things sterile, how to build something, what the long-term needs were, what biological systems were putting off. But it was mainly just application of spectroscopy to a system. A special system. Some really cool stuff. I did get looped into running a lyophilization lab for a short period of time before the cut, which I was very proud to say we brought up from nothing to a fully functional lyophilization lab in under six months. And had some of the world’s experts out, and they were like, “Wow, y'all have really come along.” But I couldn't even spell lyophilization when I started. I didn't even know what that was. So I was really kind of getting outside of my core skill set. The explosives work I did at Los Alamos was also outside my core skill set. It really wasn’t spectroscopy. I was really interested in explosives. I still am. I think explosives are cool.
Most chemists do. And I should be very clear; I am not looking at exploding anything. I just think they're cool! [laugh] So those were opportunities to grow in spaces that I was not currently a specialist or an expert. The lyophilization, I was just told, “I don’t have anybody else. You're going to do this.” [laugh]
Could you have stayed on longer at Wyle if you wanted to, with the new job?
Oh, yeah. Actually, Vernon McDonald is the vice president, senior vice president at Wyle-something now. He contacted me just a couple months ago just to catch up. Great guy. Loved working for him. My biggest issue was—so, again, stability, right? I had just gone through a layoff, where 75% of my workforce was laid off—or the guys I worked with were laid off—in under two weeks. We were pulled in on a Friday and said, “There’s a problem. We're trying to work things out. But we're looking for other opportunities for you guys.” The next week, 75% of the workforce was gone. And they got a week’s pay; there wasn’t a severance package. So I'm looking at it going, “I'm the non-ionizing radiation safety specialist. I don’t even know what that is, globally.” I do now. And looking at it at the time, I was in a one-off position at NASA that was entirely dependent upon NASA’s belief of the need for that position, and I didn't see growth opportunity for me. I've always been—again, being financially motivated, I've always been growth-oriented, too. I've always been one who wants to see if I can move up to that next level up—that CEO, that next stage of the game.
So yeah, I could have stayed on. I think, actually, they still have that position. It took them a long time to fill it after I left. But it was a job where I felt like I was going to be doing that job for the rest of my career. Had it been a government job, I’d have probably stayed, because I’d have been on a government salary with a lot more protections in place. But with Wyle and what they had just gone through, I didn't feel comfortable. And again, young kid at home—second kid actually at home, at that point—really needed to make sure I could protect my salary, to some degree. Which you'll hear in my career, David, that has not been a successful thing. [laugh] I've been successful at doing it, but I've learned a lot of lessons over that time period. [laugh]
So what was your next move, after that?
After that, I went to GlaxoSmithKline. I actually had—[scoffs]—I had four or five job offers at that point, after NASA. I can’t remember who all offered me jobs. I actually had an offer out of the Department of Army that I really, really, really wanted to take, but they just couldn't get it all together. And GlaxoSmithKline called me up on the phone. I had interviewed at Pittcon, at one of the major analytical conferences, which was actually the conference where I found all of my jobs except for my FDA job. I’d put my resume in there. Actually, I didn't even talk to them at Pittcon. I get a call on the phone; the guy says, “Hey, we're really interested in you. We’d like for you to come out and interview.” And at that point in time, I was talking to three different entities, all of them with offers on the table. I told the guy [laugh] I wasn’t interested. And he goes, “Man, listen, I can make you a really good offer. Just come out and talk to us. I'll get you on a plane tomorrow.” I flew out actually—do you remember Hurricane Katrina?
Oh, yeah! Sure.
Do you remember the Hurricane after that, called Hurricane Rita?
Rita came into Houston. I flew out the day Houston evacuated.
And we got out just ahead of the massive pileups on the highway, and you couldn't leave. I flew out on a plane to Philly [laugh] to go interview for the job, the day that they evacuated my entire side of the town. We were living in Friendswood, in Texas.
And Philly is where GlaxoSmithKline is?
Yep. So I flew from Friendswood to Philly on a Thursday, which is when they evacuated. I barely made my flight, because traffic was already building. My wife fortunately got to the other side of town where my in-laws were. I interviewed with GSK, and then flew back just before Rita hit, on a plane that was empty. It was the last plane coming into Houston. So it was a–yeah, fun trip!
But they offered me the job on the spot, with a pretty decent signing bonus. Gave me more money than anybody else was [laugh] going to offer me, short of the job that I was being offered in California. But California is so damn expensive that it just makes it almost impossible to live there. So, I ended up going to—again, financial motivation here; I'm an easy read—out to GlaxoSmithKline, where I spent 13 years.
I wonder if the work developing your biological skills at Wyle were part of the equation at GlaxoSmithKline. If that was something that you were considering.
Not the role that I was doing. Where I ended up in GlaxoSmithKline and spent seven of my 13 years was doing process analytical development. So what they were primarily interested in was my capability to take a system and integrate it into a processing system, which was what I was doing as far as my work with the International Space Station, was essentially taking advanced sensors and popping them into an advanced system, or into a system, so that we could monitor what was going on in it. GlaxoSmithKline had the same needs. At that point in time, the FDA had released a process analytical technology guidance, per se, or technical report indicating that there could be some flexibility in the processing allowed, if proper process analytical tools were put into the pharmaceutical process.
I mean, the pharmaceutical development aspects of drugs is well behind chemical companies. Massively behind, in their capability to monitor their product. And there’s a whole variety of factors that goes into that. One of the biggest ones, though, is regulatory oversight. The problem is, is that let’s say I come up with a new drug, and I develop my process for that drug off of today’s technology. Now, I'm trying to get that out as quickly as I possibly can, right? Because that drug, the base molecule that you take—you know, if you're taking cyclosporin—let’s use that as an example, and say that I patent that today. I come up with cyclosporin today and I patent it; my patent clock starts running on cyclosporin today. I haven't done anything to develop a chemical profile or a chemical development process yet. So I don’t know how to scale it. I don’t know how to put it into a tablet. I don’t know how to do that. I still have to do all my clinical trials to show that it’s safe. I've patented it, but I haven't shown you it’s safe yet and I can put it in people. All of that still has to occur, and under the 20-year timeframe of the patent.
So, you're in a massive rush. So, you come up with the best possible process you can, as quickly as you can, for developing ciclosporin at mass production. It may not be an efficient process, and it’ll make it, and it’ll make it pure. And then I stick that in the pharmaceutical development process which is all about powders, and how do I now mix this and make the little tablet you're going to take. And again, I'm going to rush that, and I'm going to make it right—you're going to get a good dose, but it’s probably going to be massively inefficient. And then I'm going to go through my clinical trials and I'm going to make damn sure it’s safe when you take it, so that you get a safe drug on market. And typically that takes me about 15 years of timeline. Right?
So now I've got five years of sales in which I'm stuck with a massively inefficient process for making it—[laugh]. You just had system checks in place to make sure that whatever got out the door was good product for the patient. You couldn't change that. Now I'm stuck with five years of patent life, and a really inefficient manufacturing process, because I had to put it together quickly to try to help patients. I mean, at the end of the day, the company was, yes, trying to make money. All companies are; let’s face it. That’s not an issue. But they were trying to make sure also that they were able to get this to a patient so that they could help patients, too. And now I'm stuck with these massively inefficient processes.
I can’t change them because now I have to go through bioequivalent studies. So the FDA was trying, or the view was the FDA was trying to get some regulatory flexibility to allow you to make changes to those processes without having to go through the full biocompatibility and expensive studies by truly understanding what your process was developing, and that when a change was made, it didn't make a subsequent change that was going to cause problems with your product. The primary test for a tablet is a dissolution test. Whenever you make the tablet—so you take your acetaminophen—you know how they do batch-to-batch variability? They take it and they drop it in a solution and watch how fast it dissolves, and look for how much acetaminophen came off. What sucks about that is that the dissolving process that they're using for that has to be developed to differentiate between batches that were made with slightly different compression forces or other things, to demonstrate that they can differentiate process changes. But what they’re dissolving it in is nothing like your stomach or gastric system that’s [laugh] actually going to do the work. So, you could have [laugh] massive variation and still have no biological effect, but still be tossing stuff out, because [laugh]—because of the dissolution results.
Zane, it’s amazing anything actually comes to market out of the pharmaceutical industry, based on what you're saying.
It was insane, the amount of work that goes into it. I had compounds where we dealt with them for years, and they're having to do the dissolution test at a pH level of—seven? It dissolves in the stomach at pH 3.2. You toss it into a dissolution bath at pH 3.2 no difference. You can’t differentiate any of the tablets. So you had to move your pH up to differentiate the tablets. But at that point, you're no longer biologically relevant. And it’s an excessively complex process to take something from inception, I've got a new molecule, all the way through to mass production of tablets people take. And what people don’t realize about the pharmaceutical market is there’s actually a break in the development process that does not occur in any other industry of which I’m aware. In any other industry, they would leave everything in the liquid phase as a final state, because it’s easy to deal with liquids. I can mix. I can process. Pharmaceutical companies can’t do that, because they have to prove purity of the compound. So they have to drop out the active ingredient, the API, into a solid form, and then from then on, it’s all solids processing, which is insanely difficult.
You don’t get the same mix ratios. You don’t get this. You don’t get that. So you have a whole slew of specialized equipment that’s utilized in the pharmaceutical industry for coming up with the final product that nothing else has. So chemical industry would assume purity, put it in, and mix it up, and you'd get a solid in the end. In the pharmaceutical market—and this is where my job actually was, was on the solids processing side—you have to drop out that product as a solid, and then you process everything else as a solid. So you have to go through six or seven different processing steps to get that final tablet that everybody sees. That includes granulation, where you're taking it and trying to make some fluffy stuff that doesn't mix and flow and doesn't have any good properties at all, into something that looks like sand, that you can pour through an hourglass, so you can actually fill it into a hopper on a tableting machine.
The problem is, what’s your end point on these things? And did I affect my API whenever I did that? If I toss my API down there, and I'm now tossing powders in, and I'm spraying it with water, and I'm mixing it real fast, does the heat of the system cause a problem? Does the water cause it to break down? [laugh] Whenever I toss it in the dryer, now I'm tumbling it around, so that I get this nice fluffy stuff; does that cause a problem? When I put it in a blender and I'm now trying to get proper concentration, how many times does that blender have to roll, and am I getting proper dispersion of the compound in that blender? All of those things are unknowns and essentially come with their own QA test. The key is, could you somehow automate that so that I understand what’s going on, and now I can make changes to that as I go? And also adjust to the API that’s coming in. Because API one day may be fluffy powder; the next day, it may be all rocks. [laugh] And both of them checked out with the exact same purity! [laugh]
Zane, this is a very clear exposition you're giving of all of your frustrations, in terms of the bureaucracy and the science at GSK. But over the course of 13 years there, you must have had some successes, some real moments of satisfaction where you moved the ball forward.
I had plenty. I mean, I wasn’t even frustrated with that; that was just the fun part of understanding the problem. And that’s what I've found to be one of the keys to stability. I said earlier I was always looking for stability. I went through eight layoffs at GSK. Fortunately, I was never laid off, never asked to put in my papers. But what I started to learn at GSK was that understanding the drivers is a key component to gaining your own stability. If you understand the financial drivers, the business drivers, what’s going on underneath, what drives it forward, you can start creating your own stability, as opposed to depending on others. So yeah, I had tons of success with that. I mean, I spent my first six to seven years doing the process analytics work. And I pushed forward all kinds of new tools, got to redesign tools and put things into processing plants and visit a whole slew of different places. I was responsible at the time for our Pennsylvania, our Canadian sites, most of our contract sites. I got to install these devices and see just a whole breadth of different processing scenarios and issues that occurred.
But there were a ton of opportunities there to apply spectral sensors to these systems and make sure that you understood what was going on, and a ton of unknowns in those systems that were being generated. Then you had, on top of this, this big heavy weight of the FDA oversight and regulatory authority, and whether or not what you were doing was okay with the regulatory arm. I’d say about half of the really cool and cutting-edge stuff that I did there is not out in publication. You won’t find it. You might find a patent here, a patent there. Most of it was considered trade secret, or competitive advantage trade secrets. Everything from granulation and monitoring with particle—or particle sizers and how that works, to thermal imaging used in a roller compactor. We didn't publish a lot. We did a lot, though, and a lot of it was cutting-edge. I was reading a paper the other day—I've been gone from GSK for six years—I was reading a paper the other day on installing thermal imagers into a roller compactor; I have a patent on it, and I was doing it ten years ago. Quite honestly, there was no value to the company in publishing. So, we did it and we moved on. [laugh] I got to play with all kinds of neat toys and I had a huge capital budget. I didn't have enough personnel, but I had capital out the wazoo.
Zane, foreshadowing to the FDA a little bit, how much were you involved with the regulatory side of things? Did you get a sense of how the approval mechanisms worked to get a drug to market?
Some. But I wasn’t that heavily involved. A lot of my work early on at GSK was much more in the space of the R&D side. So, I knew some of the aspects, but the regulatory components I was dealing with at that point in time were much more aligned to processing concerns. How do you prove that your process is solid? Like I said, the dissolution test—how do you improve that? How do you ensure that I can predict that dissolution test coming out of something, because that’s what you have. Those were the types of things that I was dealing with in my first six years. I got more involved, to a degree, with the regulatory component towards my latter seven or six years, when I was dealing with my Center that I developed, in bioimaging. That was where I really got more of an exposure to some of the clinical sides of the regulatory review space.
Actually, that’s the first time I really got insight into it. I mean, you're always getting some of that in the background, right? You've been working on this project for a while. You're going through the regulatory review process. You hear about the various aspects of the clinical trials and what’s necessary. The company is constantly training you on it. There was a lot of I’d say transparency at GSK around various aspects of the development process. I was actually exposed a lot to the full mantra of what was going on, maybe not by being embedded in it, but at least being exposed to, how much does a clinical trial cost? How much time is spent in clinical trial? Why do we need these [laugh] different studies? Those were some of what you picked up by just being there.
And it sounds like if you wanted to, you were certainly on a leadership track at GSK.
To a degree. One of my issues, and one of the reasons I left GSK, was I was—my final job there, I had direct linkage with the senior vice president. I think the president knew my name, and the CEO knew of my program. But I was a strong technical resource. I was almost a one-off in a specialized area, a very important specialized area, and one that’s still going today at GSK, and going like gangbusters, and has made a massive impact on their organization. But I was a little bit pigeonholed there because I didn't have my own division, my own group. I hadn’t led a much larger component, which was going to limit my overall growth profile within the company, longer-term.
So you felt like you didn't have the support that you needed to grow in the way that you wanted to grow, with that program.
No, I was never going to get there with that program. So we can go into what I did next, because my next program is where I really got exposure to the senior levels of the company. That was when I took over a technical innovation program. It was originally a technical innovation program designed around looking at molecules in the eye. So, one of the dirty things about ophthalmology and one of the reasons you don’t see more drugs developed for ophthalmology is simply put, biomarkers are exceptionally hard to develop for an ocular drug. If you go into an ophthalmologist office, even today, the number one tool for determining whether or not your vision is degrading, is can you read an eye chart. They do the cool imaging and use OCTs in the back of your eye, they do all kinds of various testing, but I can’t take tissue out of your eye. I also can’t look at your bloodstream systemically and look and see, did my drug get to your eye?
So, there are no good tools for an ophthalmology exam. As far as a drug device is concerned, you're dealing with normally disease profiles that take years to develop. Now you're in a scenario where you're looking at the eye. You're taking years to develop at a cost point of a few hundred million a year in potential clinical trial costs. Depending on size—I mean, it could be anywhere from $10 million a year to $100, $200 million a year in clinical trial costs, depending on the size of your trial and where you are in the development process, on a patent that’s probably going to expire if I can’t get my answers quickly. So, I've got a massive issue when you're looking at ophthalmology drugs, because I can’t see the progression of the disease. I have no markers for the disease, and the only way I can tell if you're getting better or staying the same is have you look at an eye chart, over time. And if your disease is taking five years to develop to the point where I can make a conclusive diagnosis on that, my clinical trial has just ran out the window as far as the cost point with no possibility of ever making a buck off of it.
So, what we were looking at—if you look at the transitions I made, for the most part, it has been off my spectroscopy background that I developed in college. They needed to look at—there was a proposal made for a technology innovation workstream, what they called at the time, to develop spectral capabilities to look at the eye and envision drugs in the back of the eye. GSK had a fledgling ophthalmology program. They really wanted to know, could you utilize spectral capabilities to detect these drugs in the back of the eye so that I could actually show that it got there? So I give you your drug systemically and I can look in the back of your eye and see the drug there, I know it’s there, at least. And that was a step up on everything else they had. Some of the drugs were fluorescent.
There were some other means. The eye is easily accessible, visibly. You can look in it. You can see. You can shine light into it and get information back. So, I took over that technology innovation workstream, which most people thought was going to fail. I actually had the mass majority of people that I would talk to go, “You're insane. I don’t know why in the world you'd take that on.” But I saw it as an opportunity to get some exposure and growth. It was a management-level position. It was going to give me a bump up. It reported to a variety of people at very senior levels of the company as far as stakeholders were concerned. And I was given a leash that at least gave me a year, and I’d already been through seven layoffs at GSK, so a year was better than nothing.
I took over the program, and we started in ophthalmology, but it quickly became evident that ophthalmology was not going to be enough to justify this program. The cost point was going to go through the roof. The endpoints were exceptionally difficult to get. The ophthalmology group was running on a shoestring budget. Getting lucky, I discovered that a lot of the tools that we had were directly relevant to skin science and already being utilized. So the same things we were trying to develop for ophthalmology programs had already been used in skin science, but not by GSK. They were all fledgling. And our GSK had just gone through a major acquisition of Stiefel Laboratories, which was the number one dermal company in the world. So, I was able to roll in my dermal activities and develop a much different run on this, utilizing the spectral capabilities or these spectral systems to analyze people for dermal disease, where we had a huge portfolio and a lot of money going. And I was able to bring in my dermal people into the program and really justify the overall existence of it, because we were talking—you know, we ran one clinical study while I was there. GSK actually has since offloaded their dermal activities for the most part.
But that one study alone saved enough money for the company that we could fund our program for ten years. We ran six patients through a study, and due to the fact that we could, in a non-invasive way, see a lot of the information that would normally have required an invasive study, we could actually reduce our trial size by over tenfold. It was a massive reduction. And, we also reduced the amount of pain and effort that the subjects had to go through. So, we were able to take our clinical trial and do massively more than what we ever could, improving the patient outcome and also gathering more data than you would ever expect in these type of clinical trials. If you can make massive improvements there, you're talking tens to hundreds of millions of dollars of differential. My ROIs were measured in the thousands for that kind of study.
This is a quantum leap, really.
Oh, a quantum leap, yeah, as far as a difference in cost. Now, there were issues with it; don’t get me wrong. It was a non-validated methodology. It was purely a pharmaceutical development tool for determining whether we saw our drug, didn't see our drug; saw a change or didn't see a change. But the changes were not correlated to health at that point in time, because the data wasn’t there to validate that. But from our perspective of a clinical trial, “Did the drug get there?” is a critical question. [laugh] How deep did it penetrate? Critical question. Do you see change whenever it does that? Critical questions. And we could answer all those questions in a non-invasive way, in a very short time period. But that took me about six years of development to get the program from a conceptual idea, which was essentially I was handed some papers and, “Oh, by the way, we gave an organization $100,000, and they ran this, and what do you think, and here’s your office, and good luck.”
I was reporting to one of the vice presidents, who’s still one of my mentors. I see him regularly. He left the company. [Said] “Tell me what you need.” The first year was a matter of developing the overall business dynamics of it. What did we need to do? What’s necessary? Figuring out who the key players were, where the money was. Understanding what the senior vice president is [laugh] really looking for. And the beauty behind that was the exposure I got to the senior levels of the organization, because I quickly learned what I thought they wanted, and what they really needed, were very, very different things.
My first presentation to the senior vice president, I walked in with a 47-page slide deck of technical information. He looked at me and said, “I want to see page blah-blah-blah,” which was the only page that we looked at the entire time, which was financials. And all the other stuff is—and that’s where he started mentoring me, to a degree, of—“All the other stuff, I get it. You're a technical guy. But you gotta understand, I trust you as the technical guy; I need the other information. Stuff to base this on and grow it.” And had to learn over time how to interface with those people who I guess are like me now, that have moved up in the chain and really have to think about it at a different level. I know that it’s good science. But you're not necessarily entitled to do good science. Now you have to show me why that good science is going to make a difference for my bottom line.
So it sounds like in addition to the science for you, this was extraordinarily formative and important in developing your skills in learning how to execute a strategic mission, and how to be a team leader, a significant team leader and be effective to an organization that’s quite complex.
Absolutely. It was a step-change. I mean, I was doing that before. Just when I was doing the process analytics, I was responsible for a pretty big portion of GSK’s process analytics portfolio and catalog, and a big portion of our footprint. But the level of exposure that I had at that point in time to the real needs was a step-change different. It was eye-opening to see—and now, whenever I'm looking at things, I look at it much differently. A company like GSK goes out and they buy a company, and they spend all this money, and you go, “Well, that was a really crappy investment. Technically that makes no sense.” There’s always some other information that’s being played into that decision-making. Maybe they went against their technical advisors, but because of the other things going on, they feel like there’s still a shot that it’s going to be successful and they're going to get a massive pay bump in their stock price. There are other factors that you have to play into the game that are more financial-related than they are to the purely technical and scientific political game side of it, that have to be evaluated. So, you know, it’s physics, but it’s at a different type of level.
The push and pull aspects are still there. There are still dynamics that are in place that are actually largely physics, but harder-to-predict physics. [laugh]
Zane, on that push and pull question, when did you start thinking about new opportunities beyond GSK?
Well, so—I said this earlier, David—I'm a believer that everybody should interview once a year, period. And that's not a hit on GSK. It’s not a hit on any company. It’s that I'm progressive in my leadership style and my beliefs because I've been through a bunch of companies and I've seen the ups and downs and the instability there. And like I said earlier, you create your own stability. But I encourage all of my staff, even at the FDA, I encourage them to interview, because you never know what’s going to come. Congress could come in tomorrow and do a RIF. I mean, they're not, and it’d take a lot longer than that, but it’s always a possibility you could have a layoff. You should always be up to speed on your interview skills, period. Because you never know when you're going to have to use them, and those who are out of shape typically are the ones who walk in and completely flub it. And three, you never know what you're going to get offered. And the reality is, I had zero intention of taking the FDA job the day I walked in and interviewed.
Not a single intention at all. And I told people this. I'm brutally honest about everything, David, or try to be, and be as transparent as I can. If I'm told I can’t be transparent on something, I'm not—I'll hold back. But if I'm not, [laugh] I'm transparent.
Now what was the point of connection at FDA? Did somebody reach out to you? Was there an open position that looked attractive to you?
No, so I'll go back a little bit in history on this. So, GSK—I’d been there for about six years. Like I said, I felt like I was probably capped at where I was going. I was really good at running the program I was running. The program is still running. That is probably the biggest thing I can take is a program I was running is still running, and running successfully three years after I left. And I'm a big believer that it’s what you leave behind and what happens to it that’s a bigger key to whether you were successful or not.
It’s a legacy. It’s a legacy, and it’s a point of pride.
Right. You know, legacy indicates that you did something right that continued. Because legacies don’t exist whenever you're doing it wrong, because they'll kill it. [laugh] Right? I mean, that’s how it works. So it’s not even a sense of pride to me. It’s just an indicator that I was moving in the right path. I established a very unique center between the University of Illinois and GlaxoSmithKline while I was there. Even in that center, I was just—I knew where my growth profile was in GSK. I knew that I was probably capped. I probably was going to have a very, very difficult time with the level I was at in the company, and the level that I needed to get to, to see further growth. Making that transition, just due to the size and the fact that I was seen as a very strong technical person there. Even though I've been successful at building my business, and maybe there would have been other opportunities.
So, I started to just look around and interview on a once-a-year basis, which is what I always did. I actually interviewed at Bayer Pharmaceutics, and for a process analytics position that was a director-level role, or director-ish-level role. And they offered me the job, but it was Berkeley, and the cost point was too high, and I told them no. But in the discussion, they were actually like, “Man, you know you're qualified for a job above”—the guy that was trying to hire me! He’s like, “You ought to look around for higher-level jobs [laugh] than this.” So I’d play on USAJobs every once in a while and just keep my eye on what’s available. And saw this director-level role pop up in Biomedical Physics, and applied.
And got a response and asked if I’d come in and interview. Now, I had just interviewed, or I had just gone to Bayer. My center out at Illinois is going like gangbusters. We had just got another bolus of cash. I'm in a good position. I have no belief at all that my position was going to be cut anytime in the next two years. So I said, “Sure, why not? I'll come out and interview with you guys.” Now, understanding that when I got contacted, my brother had just had back surgery. And he lives in DC; he’s at GAO. So I was going to be there in town anyway, that day. [laugh] I came to town the night before my brother’s back surgery. I stayed the night with them. My sister-in-law looked at me and she goes, “Do you even know what they do?”
My response, in all honestly, David—I had no idea. None! I hadn’t even looked at their website. I was going to go in cold and just see how it goes. So, I popped open my iPad and just started cycling through, and went, “Wow. They have a lot of problems.” [laugh]
And, you know, just cycling through. The Division was about 35 people; I had 24 web pages for 35 people!
Individual projects. Or programs. Walked into the interview the next day, and quite honestly had zero desire. I did not believe the government could afford me, period. I had done all my research the night before. I walked into the interview entirely convinced that I'm not taking the job. Just sat and had a discussion with them and was just cold on it [laugh] as far as—or very blunt with them. Not cold. “I think you got a problem.” You know? [laugh] This, this, and this. And they asked me all the questions—you know, the standards—“How do you handle this? How do you handle that?” Which was fairly easy to answer, because I had quite a bit of experience of the strategic aspects of building my own organization. I will say, again, GSK was a great place to work. They developed me in a whole variety of different ways. From team building to management to strategic development, they actually did a pretty good job of developing me, I think, over time. I get a call from them saying, “Hey, we want you to come work for us.” [laugh] I told the lady on the phone, I said, “Sorry, y'all can’t afford me.” [laugh]
And this was in the GS range, or you were looking in the SES range, at this point?
The job was advertised in the GS range. They had to go to a Title 42. And even then, I took a pay cut. Now, I'll give you a little history also on my personal family aspects. But I was willing to take some pay cut. The reality is, David, I have a daughter who’s 18, and my daughter has an undiagnosed disease. She developed it about five years ago now. No doctor has been able to touch it. And quite honestly, I had already spent 13 years in the medical field; I know what a mess it is. And having had to go through three years of testing and a variety of different things, I can tell you how bad the medical field is. As a matter of fact, the first day at FDA, I stood up and told them, “Today’s world in medical device space sucks. That’s our starting point. It’s not as good as you think.”
You know, you get an MRI to determine you have cancer; you're going to die. That’s your outcome. You might die a little later, maybe six months, but I'm not giving you years in most instances. Because by the time we catch that cancer, it’s already two centimeters in size. That means 100 million cells, it’s already vascularized, and it has already moved. That’s why whenever you have surgery for these cancers, most of the time they blow up. It doesn't work. Our capabilities to do this are not good. Sticking a pacemaker in somebody’s heart—yes, it will help them, and it will give them longevity, but it’s not a great solution. It’s just a solution. And we as a country and society in general are not moving as fast as we think we are. There’s a lot of issues out there. And some of it is created by the regulatory hurdles that we create, and some of it’s by the fact that people don’t know how to get through the regulatory hurdles.
There’s a lot the FDA can do to improve that space. And me personally, with my own personal life, I've got a daughter who’s had a disease for four or five years; nobody knows what the hell it is. Although now, we think we might have a track. I've been through the medical system. I've been to Mayo. I've been to New York. I've been to Boston. I've been to [laugh] Children’s Hospital of Philadelphia, to DuPont. I've been to some of the best medical centers the US has to offer. And I can tell you all but one suck! [laugh] And that was a problem for me. So I was willing to take a pay cut for altruistic reasons.
There’s also, Zane, the stability aspect that you keep referring to, as well. And a government job, that’s about as stable as it gets.
There is, but I no longer look at jobs from a stability standpoint. I mentioned this earlier; one of the things that I've learned through my career is you create your own stability. You create it by knowing what’s going on and knowing how you're being impactful. By measuring that impact and talking in a way and showing that impact in a way where the people who are paying you understand that and make an investment in you. My job at GSK—I actually went through a layoff where I really thought I was gonna get hung, and it was my last one there. Because I was two years into this technical innovation program, we hadn’t gotten off the ground yet, and GSK cut 20% of their headcount. And I'm going, “I'm in a technology innovation workstream, no results yet, and you're gonna have to invest in my program [laugh] to see this move. And you're cutting 20% of your headcount.”
I survived because I had created my own stability. I had already shown them the financial metrics that would justify the longer-term investment, and they felt that that was warranted. I mean, it could have gone either way, I'm sure. But what I found over time in my career is, is understanding what people need and want, and understanding your customer, the stakeholder, is the most important part of stability. I have no intent—and I'll say this—again, I'll say it on record—I have no intent on being at the FDA for 20 years. I mean, I will need to grow, and I will need to find some way where I can move up. I have not finished my growth path. I'm not going to become a guy that’s here for 30 years with no growth, who sits at the top of the Division of Biomedical Physics because it’s comfortable and easy. That’s just not my style.
What was your game plan when you got in and you realized that you had to wrangle all of these inefficiencies into something that would turn around effective results?
The strategic planning on this is the same as it is with anything. I mean, you can go to any book you want—Leading Change is my favorite one, because it has a kind of stepwise approach that you want to look at. The first step is always understanding what you have. Why is it this way? Are there drivers here that I don’t understand? Do I not understand the stakeholders? Listening is a lot of the first part of it. I spent my first six months really doing nothing other than occasionally spitting out, “This doesn't feel right, guys” and trying to figure out where the problem was. Was it my division? Was it the office? Was it the center? Where was my lack of communication, or where were things lacking in all this? So my first six months, and I put this down—I told them at the interview—I said, “My first six months will be figuring out what is really needed, as opposed to coming in here and trying to tell you how to do your job without understanding it.”
It became very evident to me very quickly that our office had a major issue. We had no identity. Nobody understands the stakeholder. We don’t know how to talk our own narrative. Again, I'm being very blunt with you, David, and I know this is going to be public record—when I took this job and I said I was going to go lead a division that does research and development at the FDA, my colleagues and my mentors and peers went, “The FDA does research?” They had no idea. We publish a lot of papers, which is a very important outcome of our work, but that doesn't get the visibility, notoriety, and other things that we need in order to do our jobs successfully. So, we have a massive identity issue that we've been dealing with, that bled into a focal problem, in the fact that we had no means by which—if I don’t know my identity, I can’t actually focus all my work around my identity.
I've led several different strategic initiatives here in the office. One of them—the first ones that I did was a SWOT analysis—strengths, weaknesses, opportunities, threats. And they had done this before, but the problem with SWOT analyses are that most people never go back to them. They never look back and see, “Did I address anything?” And more importantly, most SWOT analyses never actually get you to a root cause. They tell you all the ancillary information that you're seeing out here, and then people start slapping lipstick on pigs, and saying, “Okay, that’s fixed. That’s fixed.” And it never fixes the problem; it just makes it look a little prettier.
So, we actually did a SWOT analysis early on, and we then reduced that down to our root causes, which came out to eight different things. Top of the list—we had no strategy, mission, or vision for our office. Well, if I don’t have that, I can’t fix my division. My people didn't understand what they were supposed to be doing. They had no idea who our stakeholders were. We came out with about eight other things that—and most of them actually fit right into the mission, vision, et cetera. So I led an effort to redefine our mission and vision statement. Which was quite hilarious at the beginning, because I went into my office leadership team, and I flashed up the current mission and vision statement; they were actually reversed on our web pages and nobody had any idea. I couldn't even tell which was a mission and vision statement. So we've redefined that. And in doing that, we've also been looking at how can we develop a more programmatic focused method of figuring out what we're going to need to do. Again, looking at our stakeholders.
Now I have a mission statement. I know what I'm doing. I have a statement I can now stand up and say, “Does that fall within my mission? Is that best-in-the-world regulatory science? Is that advancing patient access? Is that developing something that’s going to prove a device safe and effective?” Our entire mission statement is now one sentence “Advance patient access to innovative, safe, and effective medical devices through best-in-the-world regulatory science.” That’s the entirety of our entire mission statement now. So I can hold every program, every project I have in the office, up to that and say, “How can you tell me that this is part of it? And if you can’t, I don’t need to do it.” I can’t recite the vision statement quite yet, but it’s also one sentence. We got rid of the long, bulky—I mean, the one we had before just encompassed everything we could do, and you could drive a truck through it. Now we have something that is very specific in what we're aiming at as far as our programmatic goals. These were critical things that had to be figured out before I could start addressing the real needs in my division.
So, I've been leading a variety of different strategic initiatives that are really office-level strategic initiatives, with the help of Ed and the other division directors. But really redefining our office in a way that is quite different. I have people who have been here 52 years, and they're going, “This is a lot different than anything we've ever tried before.” So that’s a good thing. We're not just reinventing the wheel. Some of it, they look at and go, “Oh, this is just going to go away.” But, it’s not going away. We now have program charters, where everything is defined as far as gaps that we want to address. Every gap has a timeframe on it. We're looking to close that gap. It’s no longer just, “I'm going to work in this space until—for 20 years, and every year come back and tell you that I'm still justified because that gap is still open, or there’s still a need here.” Specificity in the need, so that I can actually go out, and I can start talking to NIH, NSF, DOD, Congress, my brother—[laugh] my stakeholders here—and say, “This is what I'm doing, this is how I'm getting it done, and this is when we're going to deliver something on this.” And science changes. We all know that. Science will continue to change.
But by doing this, we give ourselves very concrete deliverables that we can now demonstrate to people what the value of the organization is, above and beyond, “We published 100 papers last year.” That is not solving a healthcare problem; that’s publishing a paper. We are working on our narrative. How do we better tell you what that paper is supposed to make you do? So, you know, I don’t want papers out there just because I can publish stuff. Somebody might pick it up and reference it. But it’s probably not going to make anybody do anything very different. The work we do at the FDA is about making you do it different, giving you a guideline, a method, an opportunity to improve your process so that you can move through the FDA faster.
We have to get to where our narrative around our paper is really, “Who’s my intended audience, and what is it I expect them to do if they read this paper? How would they apply this to their research now to ensure that they have a better method and capability to prove the point that we're trying to get?” Which is reasonable assurance of safety and effectiveness. So, we are now at a point where we can point to that. And we're getting to the point where our narrative is changing. People have stopped saying, “I'm writing a paper.” “I've made a method on XYZ, and I'm going to disseminate that in the form of a paper.” It’s such a nuance in how you're talking, but it’s a major nuance in how you sell it. And that’s one of the things science organizations are pathetic at!
And it doesn't matter where you are. At GSK, in my process analytics days, the one thing I learned when I made that transition to the next step up was, we did not know how to sell it. At all! We were doing really critical work, but a lot of it people felt were entitled. And I would say even back then, when I was doing that work—I was complimented at times on my capability to actually sell what I was doing as opposed to come in and go, “We've really got to do it, because it’s really critical.” That doesn't sell. And scientists have that mindset—“It’s a cool scientific question. Nobody has answered it. I need to do it.”
Zane, it sounds like your vision on implementing a strategic vision, talking about from GSK to the FDA, there sounds like there’s more continuity there than change in terms of the transition from a corporate environment to a government environment. In other words, no matter where you are, good leadership is good leadership.
That’s right. No, I mean, and people tell me all the time—people come into the government, and they go, “Oh, man, the government and industry are so much different.” No, they're not. Now, this gets back to what I've talked about. I'm very basic, David. I made that statement many times. And I'm very [laugh] transparent. I've said many times that I'm financially motivated. Part of my financial motivation is, I don’t care if you're in the government, I don’t care if you're industry, I don’t care if you're in healthcare—I don’t care where you are—money talks. Money is where you're looking. You got to figure out where the money is, and then you got to figure out how to influence it.
And that comes across harsh, because FDA, we're public healthcare. Public healthcare has a cost, same as everything else. There’s only so much money to go around. I'm trying to encourage somebody in a zero-sum game. There’s not more money being made—although there is. [laugh] I've got to encourage somebody that what I'm doing is more important than what they're doing over there, and what that cost point is, and make that transition from a financial perspective. The game is still the same. I mean, there are special things about the FDA and working in government that are a little different than in industry, in how you have to go about things. But you're right—the continuity there, end of the day, government wants outcomes. They want a product of some kind, something they can sell to the public—that we did this with your money.
Whenever I come out and I say, “We published 100 papers”—you or anybody else that I talk to is going to go, “Okay, and? I spent how much money at the FDA on this, and I got 100 papers.” I come out and I say, “Hey, that new neurostimulator that they have out, we published papers on it that allowed that company to conclusively show that they're safe devices and can be used for five years. By the way, we did that in a paper.” That’s a much better argument, if I'm trying to go out and have a discussion around this. Again, scientists are really poor at sales. Marketing is not our thing. And people don’t get that the marketing is a massive component. They see it as the political game—“My science is important; you ought to see that upfront.” We don’t know how yet, and we're working on this, of writing our narrative in a way where it’s visible and something somebody wants to read, and wants to see, and wants to have more of.
Zane, in terms of executing this vision, how much buy-in and support did you need, and how much buy-in and support did you get, up the chain of command at FDA, to make the changes that you wanted to make?
I had to have buy-in. Up the chain of command, Jeff’s fairly hands-off with our office. Ed has fully bought in. Now, one thing that we have to be careful about in our offices is, Ed is ex-industry, I'm ex-industry, one of our other new division directors is ex-industry. So, you know, the government is unique. Our activities are unique. We don’t make product. I don’t get a sell sheet at the end of the year. I don’t have to write out my end-of-year summary for the SEC. [laugh] So there are some differences in our deliverables. We are public healthcare. There are some things that I may want to invest in that are not purely financially driven. Although I've talked a lot about financial-driven decisions, there are some areas where you go, “Well, that’s just a big public health need, even if—” But even then, public health needs always come up with big dollar signs.
But primarily, I needed Ed’s buy-in as well as my peers on the Office leadership team. I had to, over the time period that I've been here, help develop the sense of urgency in my fellow colleagues as my peers. That we really did need this change. My peers have been awesome and I don’t want to take anything away from them as I think they had been trying to change our direction for a long time. I think between Ed being hired to lead the Office and my hire to lead my division we just provided the critical mass and change in perspective to help move the changes along. But again, being in a government entity—you said it earlier—stability, right?
Next year, what’s OSEL’s budget gonna be? I can tell you. It’s 2021. I just got my budget. I can guarantee you, I will be within 5% right now if I did nothing. If the office just continued as it was, I bet I could predict, within 5%, what my office budget will be next year. Which is almost the same as this year, and the year after that. Again, I can predict that one, too. And short of some kind of cataclysmic event, I bet I could even guess it five years from now, if the office just continued doing what it is today. What people don’t understand is, our budget actually has been going down over that time period. Because it’s essentially a flat line, but inflation looks like this [moves hand upward]. [laugh] So our flat line actually is not, “Oh, we're doing all right.” Our flat line means we're being paid less year on year, to do this work. And that means that somebody someplace isn’t getting the message and isn’t realizing what the impact of that change in cost is. And we're in an exceptionally high-cost area. I use this example all the time—the last program I ran at GSK, I had more capital budget a year for an eight-person program than I do for 173 people in my office right now.
[laugh] Wow. [laugh] There’s a sense of scale for you.
That’s the sense of scale. That’s my capital budget. Now, I will say, our biggest expense, of course, is the 173 people. That’s a big capital line item. I only had eight people working on it. But the capital scale, I'm talking—last year, NIH’s National Institute of Bioimaging and Bioengineering budget increase was four times what our normal yearly operating costs are as far as capital. Just their increase! Three percent increase! And we're supposed to be the people who are making sure that their translation occurs! I can’t survive on no increase on a yearly basis, or only a 3% increase, on a budget that is that massively out of whack with what’s going on elsewhere. And our colleagues at NSF and NIH are going, “Yeah, you guys are a little underfunded.” But they can’t do anything about it because we're another government agency. So, we've got to figure out how to close that gap financially and improve that, year on year. And that has been part of our big strategic initiative and where our sense of urgency is coming from, is the fact that when you look at it, we are not healthy. We need more money than we have, and we need more investment in this.
So Zane, I want to ask sort of a bird’s-eye view of your tenure at the FDA. Given your laser focus, even from the outset, on the change that needed to implement, and your clarity on what exactly the mission of the organization is, all within the context of this big boulder that you keep on rolling up the hill, in terms of the bureaucracy, the legacy issues, all of those things.
So, you put all those together—what are those wins for you? What are those things where you've identified the problem, you've overcome those problems, and you can say, “This is where we've moved the ball forward. This is where we've helped with patients in this regard. This is where we've streamlined these processes”? What are those areas that you can point to, at your tenure of the FDA, and said, “I came in, I saw these problems. I'm proud of what I've achieved”? And to get back to that legacy thing, at GSK, where you can look back with satisfaction even after you've gone, the ball continues to be pushed in the right direction because of your efforts.
We're not there yet. So the transition we're going through right now is a long one. It’s a three-year-plus plan. We're probably two years into the major component of it. Right now, where we are I don’t expect people yet to see the massive change that’s ongoing. Within the next year, we will start seeing stabilization in our own organization. So from that perspective, having program charters, clear deliverables, clear lineage of where we're going as far as what—when I put a dollar in, what do I expect out—will be a massive improvement upon our operations. Because at that point, I can now start having much different conversations with other organizations about, “OK, you invest this money; this is what you're going to get.” As opposed to, “You invest this money, and we'll put it in this little area, and we'll hope something comes out.” We will have very clear strategic direction as to what our deliverables and outcomes are. And even in that category, what is an output from the U.S. government? How do I define my product catalog and portfolio? But, you know, we have one now.
That’s one of the things that my division, and I’d argue my leadership, has led to. We have a catalog of tools you can look at right now on the OSEL website that says, “These are the things we've done.” It’s not a very good one yet, and it’s still got a lot of refining to do, but we at least got to the point we can say, “We produce methods. We produce software. We produce this.” So we have products that I can now say, “Hey, you go on our site, you look this up, and you use this, and you're going to have better outcomes than you would if you don’t.” That’s helpful, and that’s one of the things that we can take away. Our programs are moving forward. We're finally getting to the point where they're starting to be established. But we're still at the point where the rock could go either way. If we don’t continue pushing, that rock’s just going to roll back over us, and we're gonna [laugh] watch our organization move right back to where it was. It’s probably one of the reasons I'm not ready to leave yet—I've not got to the point yet with this organization that I feel comfortable that the things that we have changed have taken hold. They're getting there.
But we also have to have some wins. We need some financial wins. We need to have some money come in. But we're just getting to the point where we can actually go out and have those types of discussions in a way where it’s structured in a way where it makes very clear what your money is going to buy you. You know, MDUFA is coming up this year. Hopefully we can get some funds through MDUFA. Penultimately, what we want is Congress. We want to be as visible to them, what the FDA is doing, or almost as visible, as what NIH does. NIH sits in front of the Congressional healthcare team once a year and gives an update on all the great things NIH has done. We need to get to the level where we have Ed Margerrison sitting up in that chair giving testimony to the Congress about the great things that we're doing, and how their money is being spent. We're not there yet. So ultimately that’s where we want to be, and that’s where we'll see our success, is whenever we get to the point where we have that visibility.
And Zane, just to bring the conversation right up to the present, I wonder in what ways—COVID has made us all reinvent the wheel in every aspect of how we run our lives, personal and professional. So I wonder, in thinking about how you continue to push forward on innovation and change in your office and the mission of the work that you're doing, even if the work is not directly related to COVID, in what ways has COVID offered opportunity for you to work the system better?
It hasn’t offered opportunity to work the system better, although we have been able—I guess—hard question—
I mean, we hear about fast-tracking, just for an example, in terms of new ways of doing things, because the time demands it.
We've had some areas of that. Although you gotta be really careful in that, with respect to the FDA and how we're changing with respect to COVID. I say that because fast-tracking is good, and fast-tracking is bad. If I'm fast-tracking it today, what did I miss yesterday? Or what am I missing now that I was getting yesterday? And that has been the key question here. There are some learnings coming out of this, as to how we could improve and move things forward. I mean, standards are moving through at a rapid rate now. Why didn't they before? Because everybody was arguing and, you know, wanted their little itty-bitty change. And now you've got COVID out there, and they're not as inclined to fight for the little stuff. It really hasn’t changed us that much. It reduced our research for a while. We're getting spun back up. We have some different targets now, and some research areas that we may be interested in, with respect to emergency response and preparedness, that we may not have had before.
But the FDA, we're put between a rock and a hard spot on this, of, you know—I said reasonable assurance of safety and effectiveness, right? Well, ‘reasonable’ is always a question. And when you put COVID into that equation, “Reasonable to who?” [laugh] is the next question. And then you start asking questions about whether reasonable assurance is absolute assurance, and how much can I give up on that reasonable assurance of safety, for example, because I have a massive pandemic, versus normal times.
For example, a ventilator. How safe does that ventilator have to be? Normal times, most of these devices may not make it through the process. But because we've now got a new factor in there, we have a reasonable assurance question that’s now pushing things out that may not have met muster. But because of the need, the specific need today that’s driving it. I suspect over time, you will see us have some learnings in the face of, how can we speed some of this stuff up? Which obviously we've done. But there’s also going to be some learnings in how do you respond to a pandemic, and not necessarily put some things out that shouldn't be out there.
Zane, I want to ask, for my last question, looking forward, glad to hear that you have a very clear vision of the problems that remain, and that you're not willing to go anywhere until you get some effective solutions to those problems. So I want to ask, in the next—whatever it is for you—x number of years—let’s just say five years, nice even number—what are those feedback mechanisms or benchmarks that you're looking for now? Because I can tell you're a mission statement guy. You know what success looks like.
Where do you want to be before you even start to think about—as you were saying before—that one interview a year? Starting to think about your next opportunity. As you consider your legacy at the FDA, what are those feedback mechanisms and benchmarks where you can say, “Okay, I came, I did what I needed to do, I'm satisfied with it; now it’s time to look to the next opportunity”?
It’s a fair question. And it’s a difficult question to ask. First off, I'll say… If you want me to put out on there what I'm looking for as far as our wins—
And that’s also—just to interject—like we were saying before about the momentum thing, the legacy thing, these are things that you put in the train; you don’t necessarily have to be here to watch them come to fruition.
That’s true. No, and that’s where I was going to get with this. Over the next year, it’s going to be seeing the local changes that we've made take and start becoming part of our culture, as opposed to—and that’s always going to be a battle, as long as I have people with 52 years experience, right? My newer people buy into it a lot faster, because that’s the culture they come into. But even our newest director, some of the questions he’s asking, I just giggle at times, ‘cause I'm like, “You've got some time before you're going to be able to make that change.” Because culture has to change. He’s coming in and he’s seeing where we're going. He’s seeing what we've put in place. And he’s asking the right questions. And he’s going to be a great director here. He knows what he’s doing. But our culture isn’t there yet. And what he’s seeing is the movement we've made to move the culture, but our people aren’t there yet. And he’s going, “Well, why aren’t they doing this already?” And it’s because that—we've got to embed. So you know, over our next year, it’s embedding this cultural shift, this change in our mantra and mindset, where everything revolves around those deliverables—that gap that you've identified, that thing that you're going to deliver, that you're going to change healthcare with, that I can go talk about.
That’s the biggest change over the next year that I'm going to be looking for and trying to foster. When I came in, we have internal proposals that we submit every year. And every year, I go, “Well, we want to do this and this and this.” And when I started here, I had no clear mission to build this around. I didn't have programs to build it around. It was essentially a free-for-all, whatever you wanted to do. And it was very scientifically interesting, and related to healthcare—“Well, let’s go do that, toss that in.” Now this year I'm looking at these very differently and I'm going, “Okay, next year, I want a process in place that builds in my programs as a foundation.”
This year, I said, “You will not have a critical path proposal that is not already built into your program charters.” Next year, I need a process that says, “Okay, we're going to go through step one, two, three. And the top of that is going to be, has this already been discussed with your program charter?” Because now I'm starting to get to a point where, in the past, I’d have 20 different proposals pitched at me, and then we would just go through and go, “These are our six best, and that’s all I'm putting forward. And the rest, I'm not going to put that overhead in, because I'm only going to get five of these anyway.” Now, I'm going to hit a point next year where every one of them is aligned with a program charter, every one of them which should be justified. How do I rank them now, because I'm no longer just saying “best”; I need to look at where my resources are. So that's one of the key components that I'm going to be looking at in the next year, is how can we start embedding in our processes and other things the changes that we're putting in place, so that they stick? So, they become a routine part of our operating procedures.
When I started, there were clearly some things in place, but it wasn’t readily evident to me as to how that related to everything that we needed to get done. That’s the first year. As we're moving through that year, I'm going to be expecting to start seeing some more wins, because we're able to talk more outside the office about the criticality of the work that we're doing and what that impact is. So financially, what I expect to see in the next two years—actually, we've already set it as part of our strategic initiative, is an increase in our budget. Within the next two years, I need to start seeing that budget go from flatline to starting to shift up. That’s going to be critical, because that starts showing feedback loop into the system to get people to buy in. “Hey, Joe last time went after $100,000; he just got two million.” People raise their ears up.
We've hired a business director, essentially. So, integrating him into the system to make sure that we are taking advantage of the right opportunities, and we stop going fishing for the small fish and start hunting the sharks. I'm not saying $100,000 is bad, but I’d much rather go after $2 million, $5 million investments. That’s much more in line with what somebody externally is getting. So we've got to get to a point where we're seeing some financial wins. Press-wise, you're going to see more out of us. It’s no longer gonna be, “I released a paper.” If that paper has real impact, I want to see it someplace. I want to see a press release on it. I want to see somebody talking about it. Not just release the paper and hope that it—and go give a talk at a scientific conference and hope that it takes. We're going to start talking about what we do externally. Ultimately, that’s going to lead to us being able to talk externally to the bigger dogs—the NIHs and the NSFs where there is more money.
But ultimately Congress, taking more notice of the work that we're doing here, and making it a line item in their budget, as opposed to a, “Oh, we give the Center of Devices and Radiologic Health x number of dollars, and some of that money might go to research and development.” Make it a line item that’s very specific and driven, there. Those are the kind of key things that I'm looking for over the next three to five years. Not an easy task. We've got to continue changing. Although we're now to the point in the change where we're beyond the need now for a massive strategic shift. We've made that shift. We've bought in. As an office leadership team, as a division—I'll even say, my division, I probably have in my leadership team some holdouts, still.
But the shift has been made. Now we have to buy it and live it and make smaller changes. It’s now reforming the process to ensure that we're getting what we want out of it. We know what we need to say. We're going to need more marketing. Like I said, more visibility of the work we're doing. Those are the types of things I'm looking for as success, which ultimately leads to people recognizing the work and then investing more in it. And I'm not saying we need the world in investment, but my little budget right now [laugh] just isn’t there. It’s just too small. Especially whenever you're dealing with a multibillion-dollar industry. Our entire office budget is probably on the order of about $4 million. That’s a pittance. That’s enough to stay a little engaged. But seeing that identity build over the next couple of years—I gave you our mission statement. At the end of it is “best-in-the-world regulatory science.” We want to be known for that. We're the only organization in the world that has regulatory science built in. We should be best in the world. So, we want to be known for that. That’s going to take some extra effort.
Well, Zane, it has been so fun talking with you. And a theme of this talk has been, as you said, create your own stability. But I would add to that, create your own clarity. Because this conversation has been unique in the fact that this has been really a no-BS zone. You've sort of given it to me straight from your difficulties in childhood to the issues you're facing today. And you've done it with remarkable clarity and grace. You explained everything from the science to the bureaucracy to the politics, and there’s going to be so many people from so many different backgrounds who are going to gain such insight from our conversation. So, I thanked you at the beginning for all the work institutionally that you supported, and now I want to thank you for spending this time with me this morning and giving me all your recollections and insight. It has been fantastic. So, thank you very much.
No problem, David. It has been fun. I hope none of it gets me in trouble.
But like I said, most of what I put on the record today is probably already on the record someplace. I believe in transparency. Hopefully somebody can get some value out of it. [laugh]