Hearts Afire

Welcome to Hearts Afire, the podcast for the team working every day at BioBridge Global to save and enhance lives through the healing power of human cells and tissue.
We're happy you're listening and thank you for everything you do.
And now here's the host of Hearts Afire, Adrienne Mendoza.
Welcome to our next episode of Hearts Afire. Today my special guest is Amanda Whitelonis from GenCure, and I’m so glad to have you here Amanda as our guest.
I’m excited to be here.
So our audience is probably going to be really curious about what GenCure does to some extent because I know there's a lot of really cool things that go on there. You're really in the heart of it I think. Today I just want to get a chance for our audience to hear about you like get to know you as I do and also learn a little bit more about GenCure and how you work with the team.
So where are you originally from Amanda?
So I’m from San Antonio, I pretty much went to school here from all the way from kindergarten to high school and then after uh finishing high school I moved to Austin, Texas, went to UT, hook ‘em horns. That's my alma mater. And so I got a degree in biology from there.
So after that I did come back to San Antonio briefly, worked at the Health Science Center and did some stem cell research there, but then I did move back to Austin and worked for a molecular diagnostics company there for a couple of years, doing some analytical development, and then moved to Michigan shortly thereafter with my husband just both of us for work, me for another molecular diagnostics company. They were doing more analytical development there.
We were focused in developing genetic care screening assays. So that was I was there for about three years and then after two, three Michigan winters we were done, so we came back to Texas and and we've been here ever since.
By analytical development, I think that background is really, really cool. I've never been like a bench scientist or someone who's really behind the scenes behind the microscopes and like learning, but I know the process is to like validate and get a new test method. Speak a little bit about what that means.
Analytical development for those who are kind of curious about that so uh one example that I can give at least at my most recent experience there in Michigan because I did also do a bit of that here at QualTex. I was a research scientist uh in the R&D group for about two years here as well, but ultimately what we do is at least in that case we would take examples of assays actually from literature, run them in our lab, optimize the parameters to ensure that the sample types that we ultimately wanted to use could be tested reproducibly, all within an expected range.
In our case we were doing a next generation sequencing, so we were looking specifically for genetic mutations in these patient samples. So ultimately a pregnant woman would go in get her blood drawn we would extract the DNA, evaluate what markers were present to determine the likelihood of her passing on genetic disorders to her unborn child, and so based on what that looked like.
It wasn't diagnostic in the sense that it would say they're going to have this disease. This would just show the likelihood, so then this this person could then um work for the genetic counselor to just see you know what that would entail.
So I know that's kind of a higher-level overview, but those ultimately were the assays that we were developing. But the cool thing is if you get involved with working with some types of assays, that experience applies to so many others. While I was working with next generation sequencing there, I was able to move here and help develop some ELISA assays, and just you know it's it's very transferable experience.
So once you've been exposed to it, you can kind of get used to what that process is. You can apply it to so many different assays, and that's I see that's. What's happening at quality right now exactly I think that's really neat and so it really boils down to being able to look for something in someone's in a sample of some kind and in this case we're talking about blood.
But um any kind of assay is really just a test method to detect something inside of a sample and then you're looking for a range like you said you're looking for a specific marker and so the validation of the development of that is like really getting into understanding how to look for the presence of that thing and then validating it to make sure that it's within like you said that range.
So I mean that's really important work and just like you highlighted with it providing information that can then help someone make a decision. I mean when it boils down to it that's what so much of what we do.
In QualTex for example is is look at what's inside the sample to provide information to make a decision about whether or not a product a blood product or tissue product or any kind of product including cells if they can go on to the next step, if they can go on to help save someone's life, or if they should be taken out of that circulation. That may be researched further so it's really important work and I’m curious like how did that transition for you like doing that front line and like development and experimental stuff do you because your job now is more in the office and I think I always wonder how did that transition go? Do you do you look at it as the next step in your career? Do you miss that part of your work? Do you not miss it? So I’m just kind of curious about that.
It was a really big transition for me because as I mentioned you know I studied biology as an undergrad. I worked in the sciences for years and I expected my the next big step for me to take after working here at fall text for a couple of years, I assume that I would go for a PhD in the sciences. That's a logical next step. I ended up going for my MBA instead which was a really big shift and I just personally I felt that I could potentially make a bigger impact being in a role that would potentially be more client-facing or possibly leading teams and I sense that by going for an MBA that would prepare me a bit better for for that type of environment and that type of role.
Although going for PhD would have been awesome too and I definitely you know it was it was that was a tough decision to distinguish between the two, but I’m glad I went for the MBA after all um and then ultimately I moved to a different role in quality.
So that I as I moved into the MBA program I also moved into quality right around the same time after shortly after starting that uh program and that also was a tricky decision to make it was not easy because I thought I've never been in quality before, even though I've been involved in quality processes such as assay validations. It was a new world to me but it was exciting at the same time because it would allow for me to meet other individuals in the organization, including you, definitely more exposure to other departments, which is really valuable and just having a deeper understanding of the other workings in the organization that take place you know.
Because analytical development is very specific and you're looking at really my new details of things quality can be a bit it's broader and again it had a bigger reach to other parts of the organizations so yeah I'd say it was a good move overall but yeah it's it's it's very challenging to make a move like that.
It's not an easy decision to make for sure for sure and I think for me I was really glad that she joined our team because of your background in understanding the more analytical part of things and how uh methods need to be developed you had that background which really served you well in thinking about how do we break apart this process, how do we look for ways to improve it, what could go wrong what what ways to solve it.
Because kind of quality is in a way looking for the solution and solving the riddle through and testing new ideas out so I think it's it probably lent itself really well to you know a transition for you and you were just you know such a pleasure to work with us we had so much fun in global quality and what we were also really really excited about what you had in store next when you got a chance to look at your new opportunity which is where you're working now in GenCure.
So tell us what GenCure does and what you do with GenCure and for the people who are not as familiar with it so at GrenCure?
I am the director of program management, so I am responsible for the onboarding of client projects into our organization just seeing them all the way through from process development phases of their project and into GMP production so that's the ultimate goal we work with a lot of clients that are developing new therapies groundbreaking therapies life-changing therapy. So it's really motivating and really exciting to onboard new client projects into our group but ultimately once once a contract is signed they have a certain statement of work that they intend to work with us on once that's signed we hit the ground running we start the tech transfer process and we onboard their projects into our group and ultimately we help them with scale up.
I think that's a big component of what we offer typically these companies have very small scale processes that they're using to generate these therapies we help see them through into large-scale production so that they can not only have safe quality protein products but they can be applied to clinical trials.
So typically most of our clients have products that are intended to be used for phase one through phase three clinical trials, so that's ultimately what we manufacture for so we manufacture both uh cell banks um cell-based products. We also have some media supplements that we manufacture there.
So never a dull moment over there always fun, very dynamic, and we have an amazing team.
It's just it's a really fun dynamic place to work. I think that's so cool because you know that's an area of the industry that when you think about it you know there's a group of researchers somewhere out there it's just like an example of a project that are really looking at providing a new drug product that's going to help save lives or really improve lives someone who's really suffering from a disease and they need a treatment that doesn't exist right now or doesn't exist in a way that's really helping them.
So researchers get together they put something together in a lab they are excited about they see some preliminary incredible results but they can't take it to the next level and they know that they need to be able to produce this for a lot more people potentially so that they can go through the the trials required to really validate that drug products effective and safe for people to use so to get to them to that next level.
That's when the tech transfer happens. It sounds like when they come over and they say OK, I have this product I need to have it I need that technology of the manufacturing process we developed in our little you know research lab to now be scaled up and made available in a setting that's going to bring that product that drug to fruition in a way that they can have multiple patients receive it .
And I think that's so important because without that things would not progress from that basic research level to something that's viable for people to use and can save lives and so I think it really goes back directly to our mission and I think it's some of the more fascinating work we do.
It's really interesting for people and you get to bring that that along through your program management by working directly with the companies that are developing those drugs and saying what's the next step tracking that through helping make sure that everything's running on time giving them report outs and really seeing it through so that it can be successful and I think that is so important is that a way to describe it to people who you know I i think maybe not have the same experience with GenCure in a nutshell I think you covered it that's exactly right.
So I think I heard you're working on a really cool project outside of work. Tell us about that, like something that I wish I could do, you've got this unique opportunity.
So it's a house.
I understand yes.
So when I’m not working here, I’m working there um yeah so it's a family house that my husband and I uh purchased uh not too long ago. I was approached by my my mom and she was like ‘hey we're getting ready to sell your grandparents house would you be interested?’ and at first, I mean, it needs so much work. It needed so much work and I thought there's no way we can do all of this.
But I thought about it and we've spent every Halloween, New Year's Eve, Easter so many holidays and memories were there. I just couldn't imagine that home leaving our family and so we decided you know we just got to do it.
So it took some time for us to decide to do that, but things fell into place um so we were able to buy it and start working on it. So we're still working on it. That's going to be ongoing indefinitely but it needs a lot of work.
We've done some foundation work we hired that out there's no way we can do foundation work ourselves. Plumbing, electrical, AC, pretty much the whole nine yards but again it's a labor of love and it's actually been really exciting and not as much of a I guess.
We were thinking I was going to be such a huge burden but in reality it's actually been a nice distraction, you know, sometimes especially at work if you're dealing with a challenge at work you're trying to kind of navigate and troubleshoot and do things sometimes it's nice to step away do something else for a while. And then come back to it with a fresh perspective and that's something that I've seen just from doing this housework it's actually really it's a neat stress reliever surprisingly.
Yeah I had a project like that in California. So we bought this 1942 bungalow in California, my husband and I. It was really like small it was our first home together, 600 square feet, it was tiny but it was so super cute and when we were renovating, so there was the kitchen had been renovated in like the 1980s. It was a bad renovation but it was it was there when we were tearing apart we decided we're going to like really make it come back to the 1940s or 1950s stylistically. So my husband and I decided to do this all ourselves. We demolished the kitchen cabinets and as we were doing that we found a little treasure left over from when the kitchen was renovated in the 80s.
It was a tile that from the original, late 1940s tile in the kitchen underneath the cabinet and where you couldn't like see it unless you demolished the cabinet and I think it was there left by the person who renovated the kitchen to say ‘this is what used to be there.’ So awesome it was so much fun we took that original tile that the one piece of tile that was loose it was actually obviously placed there and we designed around that and brought the kitchen back to the way we thought it was originally.
And it was so much fun and we left a little memento of what the kitchen looked like a picture of what the kitchen looked like before we renovated it and a picture of the tile on the floor for whoever is going to renovate it next time to find it.
I gotta see pictures of this, please tell me you got some pictures of it.
I think I do. I need to see the documentation.
Well it was great to have you Amanda. I’m so excited you were able to join us on Hearts Afire and please come back to to host or to visit and be a guest again.
Thanks for having me.
Executive producers of Hearts Afire are Heather Hughes and Jay Podjenski. Your director is David King with technical assistance from Matt Flores. Our logo was designed by Roberto Esquivel. Our host is Adrienne Mendoza. If you have an idea for Hearts Afire, please feel free to email us: HeartsAfire@biobridgeglobal.org.