The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Geulah Livshits - Chardan Capital - Analyst
: All right. Yes. So you mentioned that Solid has transitioned programs from HSV to the transient transfection processes. Can you elaborate a little
bit more on that and walk us through the factors underlying that decision?
Question: Geulah Livshits - Chardan Capital - Analyst
: And can you talk about what you've learned from working with these different processes and also different capsids as well as from prior experience
in the clinical gene therapy space?
REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us
consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies.
APRIL 24, 2023 / 6:00PM, SLDB.OQ - Solid Biosciences Inc at Chardan Genetic Medicines & Cell Therapy
Manufacturing Summit (Virtual)
Question: Geulah Livshits - Chardan Capital - Analyst
: So in terms of scale, what is your current process scale? And [when] do you expect that to be sufficient for commercial use across your different
programs?
Question: Geulah Livshits - Chardan Capital - Analyst
: Okay. So you mentioned analytics earlier. Can you elaborate a little bit in discussing your approach to assessing the purity potency and the other
quality attributes of your gene therapies?
Question: Geulah Livshits - Chardan Capital - Analyst
: Got it. And so from your perspective, how clear are the FDA and the other regulators' expectations regarding what they're looking for with respect
to CMC?
Question: Geulah Livshits - Chardan Capital - Analyst
: Got it. And you talked a little bit about the next-gen capsids that you're working with. Can you expand a little bit on how CMC and manufacturability
tie into the capsid discovery at work that Solid is doing?
Question: Geulah Livshits - Chardan Capital - Analyst
: That makes sense. And just in terms of the process itself that you're using, is that a suspension process?
Question: Geulah Livshits - Chardan Capital - Analyst
: Got it. And so I think in the current financing climate, there's a lot of discussion about costs issues there. How is the current financing climate
influencing Solid's decisions regarding what to invest in on the CMC front?
REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us
consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies.
APRIL 24, 2023 / 6:00PM, SLDB.OQ - Solid Biosciences Inc at Chardan Genetic Medicines & Cell Therapy
Manufacturing Summit (Virtual)
Question: Geulah Livshits - Chardan Capital - Analyst
: Got it. That makes sense. So what do you see as the major challenges with respect to CMC in the gene therapy space?
Question: Geulah Livshits - Chardan Capital - Analyst
: Got it. And -- so on the flip side, are there innovations that you're excited about that can either address the challenges or kind of take the manufacturing
in a new direction?
Question: Geulah Livshits - Chardan Capital - Analyst
: So on those topics, I guess as you get greater understanding of the -- what it takes to build a viral particle and as the analytics still continues to
develop, to what extent do you expect the standards, so what a gene therapy should be to kind of evolve from either a regulatory standpoint or
from a functional standpoint?
Question: Geulah Livshits - Chardan Capital - Analyst
: Got it. So what do you think you might be missing regarding Solid's current manufacturing capabilities as the company is in 2023 after evolution
that it has gone through?
Question: Geulah Livshits - Chardan Capital - Analyst
: Okay. And one last question in the last couple of minutes, in recent years of field-testing considerable supply chain constraints that have affected
manufacturing time lines in the cell and gene therapy space. Just wondering what you're seeing these days and how Solid approach is to supply
chain for it's program.
Question: Geulah Livshits - Chardan Capital - Analyst
: Great. So as you're just at the end of the session, so I'd like to thank all of you again for your participation.
|