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[Episode 18] Dr. Dave Williams Talks Flow Cytometers, Harmony, and KC BBQ!

In this episode of Molecular Moments, Scientific Officer Amanda Hays speaks with BioAgilytix colleague Dr. Dave Williams, Vice President of Operations. Dave has spent the last decade of his career supporting and leading bioanalytical programs at contract research organizations (CROs) in his pursuit of solutions for scientific problems.
 
They discuss what inspired him to study science, his career path to BioAgilytix, working with flow cytometers, and how he stays current with industry advancements. Dave shares why mentorship is only a part of the equation when deciding how to move forward in your career as a scientist. They also talk about how BioAgilytix has kept up with the complexity of cell and gene therapy research and how harmonization across CROs can help determine best practices to drive the science forward.
 
Originally from Kansas City, Dave also shares his thoughts on what kind of BBQ reigns supreme, his favorite sports team, and recent adventures in his Jeep! 

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Dr. Dave Williams Talks Flow Cytometers, Harmony, and KC BBQ!: Audio automatically transcribed by Sonix

Dr. Dave Williams Talks Flow Cytometers, Harmony, and KC BBQ!: this mp3 audio file was automatically transcribed by Sonix with the best speech-to-text algorithms. This transcript may contain errors.

Amanda:
Welcome to the Molecular Moments podcast. Welcome to the latest episode of Molecular Moments. I'm Amanda Hayes, scientific officer at Biopolitics. In today's episode, we sat down with our guest, Dr. Dave Williams, Vice President of operations at Biopolitics. Dave is an expert in large molecule bio analysis. He spent the last decade of his career supporting and leading bioanalytical programs at various contract research organizations. Dave is a leader, a mentor and a highly respected scientist in the field. So without further ado. Welcome, Dave.

Dave:
Thanks, Amanda. Thanks for that great intro.

Amanda:
So I'm actually going to start with how long I've known you. It's been a really long time, actually, since 2007, if you can believe that. So Dave and I went to grad school together. We both got our PhDs from the Farm Talks Department at the University of Kansas Medical Center. So I thought we'd start there. Dave What led you to science in the early years and to pursuing a degree in science?

Dave:
Yeah, so when I was an undergrad, I always like science. Even before that in high school, I was kind of inspired by some of my high school teachers to pursue a degree in science. So after I graduated, I went and took a job. I wasn't sure if I wanted to go into grad school yet or not. So I took a job at a clinical diagnostic company close to where I lived and just kind of out of happenstance that that clinical diagnostic company decided they wanted to get into drug support and they spun off kind of a little CRO company. So I was like the first, first employee in that CRO business at that diagnostic company and I really loved it. The ability to kind of see some something different than clinical diagnostic was, was neat to me and the group grew and the team got bigger and at some point I decided it was time to go back to grad school because I felt that that was what I needed to do.

Amanda:
Since I've known you for a while. So I know you spent some time after grad school kind of leading the lab for Dr. Isaac during those years. But what made you go back to the industry?

Dave:
Yeah. So, you know, that experience before grad school, that was kind of where I ultimately wanted to go. So grad school was kind of a means to an end for me, and that was kind of the main reason why I picked that graduate program Farm Talks. So some of my some of my mentors in that initial industry job said that, you know, if, if I wanted to go back into industry, toxicology degree would probably be most marketable for me. So in grad school, I was working mostly on liver toxicity. So, you know, as you well know, we were we were in a very liver centric department. So used to use that experience to kind of facilitate my my future career aspirations.

Amanda:
So since I've known you over the years, to me, you've always been kind of a jack of all trades scientists. So there's a lot of platforms that you're pretty knowledgeable about. Is there a specific scientific area or platform that you're most passionate about or stay most up to date on?

Dave:
Yeah. So in my current role at Bio Analytics, I oversee all of our cell based and molecular work here in our North Carolina lab. The thing that I've always been probably most passionate about is flow cytometry. So there's there's always been a little place in my heart for flow cytometry, and I'm actually still active in piece with the Flow Cytometry Action Planning Committee. So when I can make time to to join that group, it's something that I really enjoy and stand up on flow cytometry and especially the advances in that field are really exciting to me.

Amanda:
Yeah, I kind of staying within that vein. So, so the jack of all trades, I mean, how do you stay up to date in the industry with these different platforms, different drug therapies? Do you like carve out time to review literature or there are certain podcasts you listen to or.

Dave:
Yeah, it's funny because kind of the only thing that I read is scientific literature. You know, everyone kind of makes fun of me. Dave What's the last novel you read? And it's like, I can't even tell you. I don't know if I've read one and probably 20 years. It's all science for me. And I don't know, like I guess a lot of times I kind of look at just more, more general, you know, I look in the news and see what's happening. And if I see something that interests me, then I then I dig deeper and go back to the primary scientific literature and read that then. But yeah, I. Just. I don't know. It's what drives me, I guess. I always want to learn more and I'm always excited to read about new new advances and especially new drug modalities. That's awesome.

Amanda:
So big part of your career, you've spent a lot of times, you know, being an influential leader for scientists over the years and and you've had a hand in developing and overseeing pretty large teams of scientists. What would you say is the most rewarding aspect of that part of your career?

Dave:
Yeah. I mean, I think as scientists, we always want to learn more and grow. And as you kind of move into to leading larger groups, you just get to see more data. You get to be exposed to additional kind of strategies for how to tackle scientific problems. And that's my actually my favorite part of the job, you know, getting to dig into the data that the team generates and try to find solutions for scientific problems. But in terms of mentoring people, I really think that that's kind of an integral part of being a scientist. That's the only way that scientists science really advances by sharing knowledge and trying to help others answer questions that maybe you couldn't answer yourself. So it's really rewarding to me to to see young, excited new scientists join bio age clinics and and climb through the ranks, and then they're mentoring additional junior staff below them. So it's it's what drives us all as scientists.

Amanda:
I think that's a great point, actually. Right before this call, I had the opportunity to give a presentation at Temple University to the pharmacy school there, to their graduate students. And most of the questions that I received were about career path and kind of mentorship and that area. So I gave some, some pretty good nuggets of advice to those folks from, from my experience. But looking at your career and your path, what advice would you have for early scientists just getting started and maybe taking a career in the industry?

Dave:
Yeah, I think that when people are in academia, they're their mentors are academia focused, right? So most peers at the university want their most kind of promising students to remain in academia and kind of follow in their footsteps and continue their legacy. Right. But that's only part of the equation, I guess. So for people that are interested in industry, I think it's really important to not just rely on their mentor, but also to to talk to others. You know, like I think it's great that you were talking to some people at the university to get them exposed to other opportunities that they might not otherwise see at the university. For me, going into grad school, I kind of already knew where I wanted to go. I knew I wanted to go back to industry because I had already been there before. But for people that come straight out of undergrad into grad school, they might not know what they want to do. So when we interview people at biomedical optics that are also like, oh, well, you know, they finish their their PhD or they finish a couple of years of postdoc and they're like, I want to go into industry. And it's like, Well, why? And they're like, Oh, I'm done with academia. It's like, Well, why are you done with academia? What do you think industry is going to be like? And, you know, some of them have a clear picture of what they want and some of them just want something different and might not really even know why why they're saying they want to go into industry. But yeah, I mean, I think that keeping your options open and and talking to people and learning more about the opportunities are really, really important for young scientists.

Amanda:
Yeah, absolutely. And I know, you know, we have a ton of job openings right now as BIOPOLITICS continues to grow and expand and services and capabilities. What's the most exciting part of that to you for the future of Biopolitics and where we're headed?

Dave:
Yeah, I mean, the, the industry, the CRO industry in general is, is growing kind of leaps and bounds and you know, bio analytics, we try to try to grow even faster than that. So it really affords a lot of opportunities for, for our junior scientists to really grow with the company when the company's rapidly growing. We need people that want to step into the next role and and achieve more and do more. So it's a good time to be in science and it's frankly a good time to be in the CRO industry just because of those opportunities. So we have some people that that really like the bench work, some people that come in and they understand that they need to work on the bench, but then they want to move into more managerial roles so we can kind of support either, either growth path. And it's good that. People have the opportunity to do what they're passionate about.

Amanda:
Yeah, good point. You bring up about career path and wanting to move up. Is there a specific piece of advice that you would give a scientist who's interested in becoming more of, say, a biological project manager or moving into those roles where you kind of phase away from from the bench?

Dave:
Yeah. I mean, you know, always test the waters before you jump in. I guess so. You know, it's it's good to talk to your mentor or talk to your supervisor and try to just test out what they're doing before you decide that that's the way you want your career to go. And we have some people that, you know, once they get into it, they're like, I want to go back to the bench. I missed the bench. You know, I think at some point every scientist kind of misses the bench. Some days I miss the bench, too. But, you know, just being open to the opportunities and being communicative with with the management team to get those opportunities and figure out what they really want to do.

Amanda:
And kind of shifting the focus away from from individual growth. Just talking a little bit more about the growth of the industry. You mentioned the new modalities and cell and gene therapy kind of up and coming. That has really changed by analysis and force us to evolve with some of the technologies and tools that we use. In your opinion, how has the Bioanalytical lab kept up with the complexity of cell and gene therapy products?

Dave:
Yeah, I mean, I think that the industry as a whole is, you know, growing at leaps and bounds. Obviously, there's there's a lot of potential for rare and orphan diseases and, you know, in the future, a lot of potential for metabolic cardiovascular diseases. Obviously, immuno oncology and oncology in general, these new drug modalities are going to be huge. So when you look at growth year over year growth in these different drug modalities, you know, cell therapies, gene therapies are outpacing everything. You know, from a bioanalytical perspective, there are a lot of things that we have to try to keep up with to support these therapies. The guidance is normally the last thing that comes. So, you know, the the technology leads the way bioanalytical follows behind it and then regulatory is trailing behind. So hopefully those three things catch up and we get to steady state. But for now it's a very dynamic kind of place to work and really exciting to see what's coming, you know, even six months from now.

Amanda:
That's a good point. Speaking to technologies, driving that initiative, first let's dig into PCR a little bit and how that really has evolved as kind of a primary technology that we're using these days for cell and gene therapy.

Dave:
Yeah. So biology clinics, we were supporting cell and gene therapies for for multiple years now, honestly, but we didn't really support them completely until about two years ago when we added PCR. So for gene therapies that are using AVI or other viral vectors, we've been kind of well known for immunogenicity. So we've supported a V immunogenicity for for patient inclusion exclusion as well as for patient monitoring within study for multiple years now. But a couple of years ago we did add PCR and we added a couple of different platforms. So we had a PCR as well as PCR, which each kind of have their pros and cons and advantages and disadvantages I guess. But you know, in terms of of monitoring, bio distribution and drug products, all of those things, those are really essential tools and in the progression of of those drug modalities.

Amanda:
Interesting that you brought up the difference between the traditional PCR and digital PCR or digital droplet PCR. Let's dig into that a little bit more. So what are your thoughts on each platform? Let's talk about advantages, disadvantages, trend in the industry or more folks leaning one way or the other?

Dave:
Yeah. Yeah. I think that that's a it's a great point that we can compare those, those two different technologies. I would say probably in the the GMP, CMC Space Digital PCR is probably the front runner ahead of PCR at this point. I would say for bio distribution studies, it's kind of an even mix at this point. There is some legacy studies that are on PCR and those are generally staying on PCR and then newer studies, some will go to PCR, some will stay on queue in terms. Pros and cons. Probably the biggest advantage with digital PCR is the ability to to provide an absolute quantification. So with a lot of fancy math on the back end, you're able to to define the copy number per input without the use of a standard curve. That's a big advantage when early in tax studies or whatever, when the reference material is not super well characterized and the reference material isn't great. Right? So we can quantify without the need of a standard curve. Also, digital PCR is pretty resistant to matrix interference since digital PCR takes the reaction all the way to endpoint and then interrogates each one of those partitions for a positive negative call. The susceptibility of interference to to drop CT values that you would see in a PCR are kind of eliminated with with digital PCR. One of the biggest drawbacks, I would say, of digital PCR is is the cost. It's substantially more expensive. The partitioning of of each reaction can be expensive. So bio analytics, we use digital droplet PCR, so it uses an oil immersion to create the partitions. There are some other instruments that use microfluidic partitioning or a physical partitioning system.

Dave:
So in terms of of which one is is best, it kind of depends on the Bioanalytical lab. So bio genetics, we decided on digital droplet PCR just from the regulatory compliance and it's kind of well established in the industry, especially like I said in the CMC side, the digital droplet PCR is pretty commonly used. So as a CRO, we want to be kind of early adopters of technology, not necessarily innovators of technology. So since that was the direction that the industry was going, we also stayed in that same direction. So like I said, the cost of digital PCR is is more also the throughput of digital PCR is less right now than it is for PCR. You know, the reaction, reaction time well. So you have to partition, you have to cycle the endpoint and then you have to interrogate each of those partitions. So what would take maybe an hour and a half in a PCR is probably going to take you close to 5 hours in a digital PCR. So I guess from a clinical or pre clinical study perspective, weighing those pros and cons is kind of the kind of the way to go. If you don't have a good reference material, you might want to stick with PCR. If you have a lot of samples you need to run, then maybe PCR is the way to go. So I don't say one is necessarily better or worse than the other. I think that they just have different applications and which one is better to use? Kind of depends on on the sponsor as well as on the study design.

Amanda:
And good point about Sierra's being the first adopters of these types of technologies. So one thing I kind of want to go back to is technology driving eventually the regulations. And one of the unique opportunities that you and I had last year was getting together with some colleagues at other Sierra Rose and talking about harmonizing how we develop and validate these PCR assays. So can you talk a little bit about how that group came to be and what you wanted to get out of that?

Dave:
Yeah. So like I said before, you know, we're kind of lacking industry guidance. So, you know, the CRO space is, is kind of unique in fact that we, we get to see a lot of different sponsors projects and we get to kind of dip our toes in in a lot of those different waters. So if what we discussed is if we can get kind of best practice and and harmonization across these Cros, then we can probably come to a fairly wide industry consensus about how to do some of these studies. It was really kind of neat to engage with Rafique and Katie to really go through and let's let's weigh the pros and cons. What do you guys do for best practice? How would you handle this? We've done it this way and we've seen it that way, but we also do it this way. So, you know, it was it was great to to really talk to our peers and, you know, competitor labs kind of coming together to decide what what's really the best way to drive science forward. And to me, that was kind of the coolest part of the whole thing is, you know, we're we're working with our direct competitor labs, but we're trying to trying to find out the answer for science. Right. I think that the workshop was was really well received this past summer and we got a lot of really good questions. So I think that the kind of the the summary paper that we wrote up for that meeting will hopefully, hopefully enlighten some people and if nothing else, kind of stimulate some discussion about what what should be best practice for some of these molecular assays in the bioanalytical space?

Amanda:
Yeah, I absolutely agree. Those those discussions were very instrumental. They were very enlightening. So going back to the workshop that you mentioned, so we actually had an opportunity to put together a two day workshop with the APS to talk about harmonizing best practices and our recommendations for developing and validating PCR assays. What was your biggest takeaway from the workshop questions that we received?

Dave:
Yeah, I mean, I think that the biggest takeaway was just general concepts like what? What do we need to demonstrate when we validate a bio distribution assay? We presented kind of what our consensus best practice was, but the attendees of that workshop, I think that they were mostly in lined, but there were there were some, you know, disagreements, conversations, recommendations. And I think that that that's great, that scientific discourse and that that actually helped us kind of round out the paper I feel on the back end. We took a lot of that feedback from the several hundred people that attended that workshop and really incorporated into into the final meeting summary.

Amanda:
And I think it's interesting that there are other global initiatives looking for the same thing, that harmonization, the best practices, recommendations for how to best use this technology.

Dave:
I also think that, you know, right now we're at a point where where people are trying to use the current guidance, right? Like so do we apply ligand binding assay guidance to this molecular assay or do we apply chromatographic guidance to this method? And I think that we're going to land somewhere in between. And that's kind of what what our recommendations ended up being. So applying the ones that that make scientific sense, there really isn't a one size fits all like this type of method doesn't directly fit with with LBA and it doesn't directly fit with chromatographic. So where is the overlap? Where are the differences and where is it just really unique from from both of those two technologies?

Amanda:
Exactly. And in keeping the context of use in mind, you know, we use this technology for a host of different assays. Thinking about how the data is going to be used is also another important aspect of how the assays themselves are validated.

Dave:
Yeah, absolutely. And you know, another kind of interesting conversation that came out of that workshop was what's what's really a critical reagent for these assays, probes and primers, master mics, obviously the reference material. And if those are critical reagents, what do we need to do as as a bioanalytical laboratory to qualify to bridge to to say that those reagents are fit for purpose and able to to perform as expected as required within the assay.

Amanda:
Thanks, Dave, for your insight on PCR. Let's switch gears a little bit and talk about hobbies. So both of us are Kansas City natives. We hail from the Kansas City area in Kansas. Now that you've spent a number of years in North Carolina, do you still follow hometown sports?

Dave:
Yeah, I'm still a huge Chiefs fan. So this this year was a little rough for me, the monumental meltdown in the championship game. But, you know, we can't go to the Super Bowl every year, I guess. But, you know, there aren't many Jayhawks fans here in our team either. It's, you know, a lot of Duke, it's a lot of you and see, it's a lot of NC State. So I'm kind of the oddball here. But yeah, definitely, definitely. Still a Kansas Kansas City sports fan for sure.

Amanda:
Right. And speaking about North Carolina. So I know you you enjoy being out in nature and hiking and sightseeing with your family. What is your favorite spot that you have been to in that area?

Dave:
Yeah. So the great thing about the RTP area is we're about like 3 hours from the mountains or 3 hours from the beach. So the fun thing about North Carolina Beach is, especially on the Outer Banks is you can drive on them. So I take my Jeep out and drive on the beach. Can you find your spot you want and park and the kids pull all their stuff out. And if you want to move to another spot, you just throw it in the jeep and drive to the next spot. So it's it's fun. You know, the weather here is obviously a lot better than it is in Kansas City. You know, it'll be 60 here and it'll be six there. So I'm.

Amanda:
Jealous.

Dave:
But yeah, I mean, in terms of the city and, you know, being in North Carolina, we really like it here. One thing I definitely do miss is the barbecue, though, so I know it's kind of blasphemous that somebody in North Carolina says that they don't like the North Carolina barbecue. But I was born and raised in Kansas City barbecue and it's just not the same here.

Amanda:
Yeah, I believe that I'm with you on that one. What's your favorite barbecue place in Kansas City?

Dave:
It has to be Joe's. It has to be Joe's.

Amanda:
I agree with you on that as well. So outside of North Carolina, do you have any travel bucket list spots?

Dave:
Oh, that's a good question. I mean, so we really like to travel, you know, with over the past couple of years with COVID, you know, we haven't really wanted to put our kids on planes. So most of our travel has been, you know, in the general vicinity where we can do it by car, definitely at some point are going to want to want to go to Europe and let the kids explore there. But for now, we're keeping it local. Hopefully COVID will be done soon, but who knows?

Amanda:
Awesome. Thank you, Dave. This has been a wonderful conversation. I appreciate you taking the time out of your busy schedule to sit down and talk with us. And thank you.

Dave:
Absolutely. Thanks for having me, Amanda.

Amanda:
The Molecular Moments podcast sponsored by Biology Olympics, is an ongoing conversation about the various nuances of drug development and bio analysis. In each episode, we sit down with a different industry leader to explore their area of expertise, the industry as a whole, and the mentors who help them become the scientists they are today. It's a podcast for scientists by scientists. Listen and subscribe to molecular moments today on Spotify, Apple Podcasts, or wherever you like to listen. Thanks for listening to the Molecular Moments podcast.

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