Name:
Ensuring quality in cell and gene therapy: Dave Lewandowski
Description:
Ensuring quality in cell and gene therapy: Dave Lewandowski
Thumbnail URL:
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Duration:
T00H07M29S
Embed URL:
https://stream.cadmore.media/player/6b99cb2d-ff76-460f-aa25-06e99e8ab3fd
Content URL:
https://cadmoreoriginalmedia.blob.core.windows.net/6b99cb2d-ff76-460f-aa25-06e99e8ab3fd/Dave Lewandowski - Interview - V1.mp4?sv=2019-02-02&sr=c&sig=BDNmSXZ%2B7LmoG9J4opHrSKz3eRq0GLM4N4E4x9jKNdw%3D&st=2024-05-04T13%3A03%3A12Z&se=2024-05-04T15%3A08%3A12Z&sp=r
Upload Date:
2022-06-29T00:00:00.0000000
Transcript:
Language: EN.
Segment:0 .
[MUSIC PLAYING]
SARAH REHMAN: We are at ISCT 2022. Could you please introduce yourself, and what you do, your career, today?
DAVE LEWANDOWSKI: Sure. My name is Dave Lewandowski. And I work with Azenta Life Sciences. I formerly worked in various companies in the life sciences industry, including working at companies like Genentech. About 20 years ago, I remember working at that organization, and we were delivering monoclonal antibodies to the clinic. And it was the first time that I realized that the cold chain and maintaining the ultimate quality of these therapies require special handling.
DAVE LEWANDOWSKI: And just after that, I also heard that cellular material required even colder handling, and even more precision. So I guess I've been on a quest since maybe 2010 to really be involved in sample management and therapeutic management, and realizing that it's the critical nature of it, and delivering these great therapies to patients.
SARAH REHMAN: Wow, so what would you say in your experience so far is the greatest challenge within your line of work?
DAVE LEWANDOWSKI: Well, I think as everybody is learning more about this industry, there's not a lot of standards. It's a nascent industry. So people have a lot of questions, and they also are looking for guidance in an industry which isn't yet well defined. So it's a real challenge when people are asking for standards, and we maybe don't even have best practices set up yet. So in our industry, you have a lot of groups who are looking to define critical quality attributes of their product.
DAVE LEWANDOWSKI: You hear this a lot lately. They're looking to take products from the research area, and perhaps research area, and make that tech transfer into a GMP environment, into a clinical environment. And that's not an easy thing to do, right? So the earlier people can employ great rigor and process, it's going to make that tech transfer a little bit easier. So I say in the marketplace right now, I think that's one of the biggest challenges people are having, is how to implement those processes which are going to be able to scale as their programs, and as their products become successful.
SARAH REHMAN: Yeah. I think that's definitely like a hurdle with scaling up, but also keeping things standardized. Just, yeah, interesting.
DAVE LEWANDOWSKI: Yeah, it reminds me. I did spend time at an international society, the International Society for Biobanking, as a matter of fact. And this society spent a lot of time around managing materials of all different kinds that required maybe temperature, specific temperature requirements, but barcoding, documentation that might support GMP-like practices, like 21 CFR 11 documentation.
DAVE LEWANDOWSKI: But when I worked with the biobank, it didn't matter what the material was. It was very precious, had special handling requirements, and to do it on a small scale is actually pretty-- you can do it, right? One person. You've got a small project. But as your projects start to scale, it becomes really difficult.
DAVE LEWANDOWSKI: So at Azenta, right, for instance, when groups are in early stage preclinical phases, we're trying to provide them with scalable solutions. So today, they might not need, you know, one certain product, but earlier stages, you have products that you want to step into, so that when your program grows, that tool or that service that you've written in can scale and grow with it. So a perfect example, GMP Storage.
DAVE LEWANDOWSKI: People have to manufacture and store ancillary supplies and cell and gene therapy, right? This can be plasmids, various other ingredients that go into manufacturing these great therapies. Well, you have to not only manufacture them, but you have to store them, and you have to maintain ultimate integrity of those products. And so what we find is most people would rather focus on bioprocessing, the analytics.
DAVE LEWANDOWSKI: And when it comes to building up facilities to maintain collections, it might be a good opportunity to outsource, and it enables people to go a little bit faster, right? So yeah. I don't know if that answers your question.
SARAH REHMAN: Oh, no, it does. It does, it's very good. And my next question is, where do you see the future of the field going? Big question.
DAVE LEWANDOWSKI: Yeah, I think the future, what I'm hearing most about is that we're going to have to break it down into bit-sized pieces. So instead of going from zero to standards, I think we need to look at from zero to specific sections of the workflow. So it could be apheresis, it could be data, it could be cryopreservation. Each one of these subjects deserves its own best practices and guidance to get people closer to the end line, realizing that things aren't all the way defined yet.
DAVE LEWANDOWSKI: So I see the market really learning from those leaders who have, I guess, maybe crossed the chasm a little bit to begin with, and building on what they've learned along the way. Yeah, I think the future is, it's really bright. I couldn't believe the statistics that people are showing about the number of new therapies that are going to come to the market and things like this. But I think the process and the best practices and the standardization, I think that's the next horizon.
SARAH REHMAN: Even just seeing like the sheer amount of people here today really gets [INAUDIBLE] the industry as a whole, I think. It's really cool.
DAVE LEWANDOWSKI: Yeah and to build on that, at ISCT 2022 this year, the mix of people, right? You've got great suppliers who are providing great services and products to the companies that need them. And then you've got scientists who are pushing further and sharing what new therapies and new modalities might look like. And then you've got the manufacturers, who are really trying to bring that to the market, and get it to the patients.
DAVE LEWANDOWSKI: So it's a really exciting time to be ISCT, and in cell and gene therapy.
SARAH REHMAN: So my final question is--
DAVE LEWANDOWSKI: Uh-oh.
SARAH REHMAN: What is your favorite part of ISCT so far?
DAVE LEWANDOWSKI: Specifically ISCT. I think the way that ISCT is, again, structured to bring in so many voices. It's a global organization, so I'm always amazed when I come to this meeting, meeting people from around the world, that want to have a say, that want to be learning, to have a voice, and bring that information back to their own home regions, I think is-- I think that's the most exciting part about ISCT in particular.
SARAH REHMAN: Definitely, definitely. So that's the end of my questions. Do you have any final takeaways you want to say?
DAVE LEWANDOWSKI: Let's see, final takes. I would just say keep going, keep pushing. It's very not an easy field to be in, but a really fun one. And I think the part that makes this great right now is that people are still all learning together. So they're very open to sharing and being collaborative. And that's what makes the environment so fun right now. So keep pushing and find partners that are going to support your cause, and help you reach your next goals.
DAVE LEWANDOWSKI: Yeah.
SARAH REHMAN: Amazing. Thank you. It was really nice to talk to you.
DAVE LEWANDOWSKI: Thank you. [MUSIC PLAYING]