Name:
Standardizing cell therapy processes with Josh Ludwig
Description:
Standardizing cell therapy processes with Josh Ludwig
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Duration:
T00H07M12S
Embed URL:
https://stream.cadmore.media/player/a9718770-6df9-4f54-a4d0-bc2830bbd47d
Content URL:
https://cadmoreoriginalmedia.blob.core.windows.net/a9718770-6df9-4f54-a4d0-bc2830bbd47d/ScaleReady - Josh Ludwig Interview - V1.mp4?sv=2019-02-02&sr=c&sig=bBEwK4Sqag8sT0wlWuc%2FsDO34h2ZpNdXMwkEPvWkuj4%3D&st=2024-05-10T11%3A26%3A13Z&se=2024-05-10T13%3A31%3A13Z&sp=r
Upload Date:
2023-07-28T00:00:00.0000000
Transcript:
Language: EN.
Segment:1 Standardizing cell therapy processes with Josh Ludwig.
[MUSIC PLAYING]
Segment:2 What are the benefits of collaborating in the cell and gene therapy space?.
JOSH LUDWIG: I think it's become obvious that, in order to drive the field forward and treat more patients, everybody's realizing that collaboration is key. And that's what our clients are realizing, as well, especially in this tough financial headwind time. Everybody is looking to collaborations to-- basically, can we, as a field, not spend the same money solving the same challenges over and over again? And that was ultimately the genesis for ScaleReady was each partner company had proven products working well.
JOSH LUDWIG: But could we help our clients move with speed if we gave them more of a whole product solution, as opposed to piecemeal, one technology here, one technology there? So that was the genesis. And I think it's been working incredibly well. And for me, having come from one of the partner organizations, Wilson Wolf, I always had blinders on. How does-- you know, help me with my cell culture.
JOSH LUDWIG: Well, it's pretty hard if they don't tell me what's going on upstream and downstream of that. And at ScaleReady, we now get to work on the full manufacturing workflow. [MUSIC PLAYING]
Segment:3 Why is it important to standardize cell therapy processes?.
JOSH LUDWIG: There's a lot of reasons. Critically, because we're in this information age and there's so many new technologies out there, it's very difficult for therapeutic developers to assess every single piece of technology and optimize them for their manufacturing process, again, back to this reinventing the wheel and solving the same problems over and over again.
JOSH LUDWIG: The field would benefit greatly by openly sharing best practices and saying 80/20 rule. 80% of the processes are essentially the same. And there's a lot of products that have been proven for decades, including most of the ones at ScaleReady that have been around for a long time. And if we can standardize the tools used and the basic architecture of a manufacturing protocol, no longer are companies spending years developing a process.
JOSH LUDWIG: It could be one year or six months. So we can shave years of time off. And then the point, too, there that I think oftentimes gets overlooked, everybody's struggling with staffing, and people that know cell and gene therapy, the business, the manufacturing, the CMC sections, which are your critical piece of the IND filings. The regulatory bodies are in the same boat. This is a new field.
JOSH LUDWIG: So they don't have experts. So when they get hundreds and hundreds of different INDs to review that are snowflakes and very different, it takes them much longer to review and approve for clinical treatment. So I think if we can standardize, we speed up the whole process, and we start to lower the barrier with this bottleneck of people and expertise.
JOSH LUDWIG: [MUSIC PLAYING]
Segment:4 How do we keep manufacturing processes consistent while also remaining flexible enough to cater for all cell therapy pipelines?.
JOSH LUDWIG: Well, standardization would help things become consistent. But I think we have to balance this inherent desire of a scientific innovator field to know every little thing about, and measure and get data points everywhere. But we also get kind of paralysis by analysis.
JOSH LUDWIG: There's too much information at times. So again, can we simplify? Can we standardize? And can that help us actually move with speed. And so that's a big one. And additionally, it's all about, again, if we take that aspect of simplify first and then look to automate and scale, I think we actually just get more drugs approved faster, and we can treat more patients.
JOSH LUDWIG: [MUSIC PLAYING]
Segment:5 What are the key challenges the industry is facing when it comes to the scale-up of cell therapies?.
JOSH LUDWIG: Yeah, we had a great breakfast briefing this morning at 8:00 AM. We had three phenomenal speakers that all have hands on cell culture experience. They've been manufacturing cells for decades now. Dr. Michal Besser has treated over 500 patients with cells that she has manufactured, which is phenomenal.
JOSH LUDWIG: They started with a very simple open manual manufacturing process. It works. It's kind of brute force. So it was stuck to these centers that had incredibly highly skilled PHDs to do the work. While transitioning those into automated or just in a sense of at least within ScaleReady's G-Rex Static Bioreactor.
JOSH LUDWIG: It's basically automatic. You just put the cells in. Fill it with media and nutrients, and the expansion works every time. And it's repeatable. That's allowing these centers now, when they incorporate these new technologies from the open manual processes, they go from treating hundreds of patients to thousands, and then eventually tens of thousands of patients.
JOSH LUDWIG: So it has to be about-- you have to simplify the process before you jump into these automated solutions. Otherwise, you're baking in the complexity. [MUSIC PLAYING]
Segment:6 How do you see the development and management of cell therapy products evolving over the next 5 years?.
JOSH LUDWIG: My hope, and I think that there's some-- every challenge is an opportunity. And I think right now with the financial headwinds, and groups needing to be more conscious about how they spend their money, and making sure that they can use the funds that they've raised to get to that next clinical inflection point, because it's not easy to raise funds, I believe our field is going to get back to the scientific roots and actually get back to sharing information, sharing best practices amongst centers and even commercial entities because-- And it's a bit altruistic.
JOSH LUDWIG: But ultimately, it's not just for the greater good, but those companies may be sharing a best practice. And being a leader in that, they're going to benefit by the other groups sharing their best practices, maybe that was on their docket to study and solve in the next six months. But actually, because they shared, somebody else is going to share something. And now the whole field is like, oh, there's a solution.
JOSH LUDWIG: We don't have to spend six months or a year and millions of dollars. It's already been proven. I think that's going to help us move faster and, ultimately, drive the cost down. [MUSIC PLAYING]