In Episode 140 of Cell & Gene: The Podcast, Erin Harris speaks with Dr. Remo Moomiaie-Qajar of Axiom Biosciences about the company’s delivery-focused approach to developing regenerative and genetic medicines. Dr. Remo explains why drug delivery platforms can help shape therapeutic design and development strategy, and how evolving FDA guidance is creating opportunities to streamline preclinical requirements, leverage platform-based CMC data, and accelerate clinical development without compromising safety or quality. He also discusses the value of early regulatory engagement, clearer expectation...
What Erin Harris said
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Erin Harris interviewed Dr. Remo Moomiaie-Qajar, founder, chairman, and CEO of Axiom Biosciences, about the company's delivery-first approach to drug development and the impact of evolving FDA guidance. Moomiaie-Qajar described Axiom as a drug delivery company with multiple platforms developed over seven to eight years, focusing on delivery solutions before molecule design. He emphasized that different indications may require different modalities, and the platforms are interchangeable. He praised the FDA's evolution toward regulating drugs as platforms, noting it has expedited development pathways. He highlighted flexibility in preclinical work and the ability to cross-reference CMC data across platform candidates, citing mRNA and lipid nanoparticles as examples. He stressed that this efficiency does not compromise quality or safety, and that the FDA now acts as a partner in drug development.
Key takeaways
Axiom Biosciences is a drug delivery company with multiple interchangeable platforms developed over seven to eight years.
The FDA's platform-based regulatory approach has expedited development by allowing cross-referencing of CMC data across candidates.
The FDA's partnership approach has helped Axiom reduce time to regulatory clearance, with time being capital.
The evolution in FDA thinking is partly driven by the need for US competitiveness globally.
5:40It's a really important point where we are in the cell and gene therapy world and I think it's worth noting that this is an evolution of thought from the regulatory standpoint, right?
9:04Are we proving these in these surrogate models and animals?
Hey everyone, and welcome to episode 140 of Cell and Gene the Podcast. I'm Erin Harris. We talk a lot about delivery challenges and regulatory strategy across the Cell and Gene therapy sector and certainly on Cell and Gene. Because even the most promising science doesn't mean much if developers can't get therapies to patients efficiently and safely. And so today I'm talking with Dr. Remo Lumeia Gajar, founder, chairman, and CEO of Axiom Biosciences. And we talk about taking a delivery-first approach to drug development. We get into how platform technologies and evolving FDA guidance could really help developers cut unnecessary time and complexity without compromising safety or quality. And we talk about why in our industry time really genuinely is capital. And so I'm thankful to Remo for joining me, and I'm sure you'll find our conversation just as interesting as I did. Remo's up next. Enjoy.
Hi Remo, thanks for joining me on Cell and Gene the Podcast. It's wonderful to have you as a guest, and I'm happy you're here.
Oh, that makes me so happy. Wonderful. I'm glad you're finally a guest and to talk with our audience today. So, talk to us a little bit about Axiom Biosciences. So, the company is working across regenerative and genetic medicine. What are you developing today? What are the biggest, say, scientific development challenges you're working through? Talk us through a little bit about who you are and what you're doing.
Thanks. Um, I think I'd start by describing Axiom as fundamentally a drug delivery company based on several different platforms that we are developing for the last seven or eight years. And so, we take a very unique approach towards the problem of developing a drug in that we are really focusing in on delivery solutions and then back-ending into molecule design and moving then forward into, you know, the typical cycle of development starting from preclinical and then advancing into clinical stages. So, fundamentally, we are, I think, slightly different than most in that for a long period of time we've been focusing in on delivery solutions, understanding that we would get to a point where we could potentially have a plug-and-play opportunity and then, you know, move very quickly through the later stages of development, particularly clinical trials.
Great. Okay. So, we know that you're working across several different therapeutic modalities. So, as a drug development company, how does that development strategy change depending on what you're working on? So, you're talking regenerative medicine, cell-based approach, mRNA. What does that development strategy look like and how does it change across the different approaches?
Um, I think it's a very good question and it brings up an important point in my mind, which is that every solution and every indication has potentially a different solution and they may not be in one modality. So, really we're somewhat agnostic to the indications in which we're developing drugs for. What we started with was again going back to the concept of a delivery solution and back-ending that to figure out what are the major medical needs that would best fit this delivery solution. So, as we worked over the last 8 years across several different types of modalities from stem cells to nanoparticles and mRNA, the understanding is that it's not a one-size-fits-all approach, but that individually these platforms are truly platforms. So, they're somewhat interchangeable.
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Harris, E. (2026, October 21). Advancing CGT Delivery, Regulatory Strategy with Axiom's Dr. Remo Moomiaie-Qajar [Interview transcript]. Life Science Connect. CEOInterviews.AI. https://ceointerviews.ai/interview/3115908/
MLA
Erin Harris. "Advancing CGT Delivery, Regulatory Strategy with Axiom's Dr. Remo Moomiaie-Qajar." Life Science Connect, 21 Oct. 2026. Transcript, CEOInterviews.AI, https://ceointerviews.ai/interview/3115908/.
BibTeX
@misc{harris2026_3115908,
author = {Erin Harris},
title = {Advancing CGT Delivery, Regulatory Strategy with Axiom's Dr. Remo Moomiaie-Qajar},
howpublished = {Interview transcript, Life Science Connect. CEOInterviews.AI},
year = {2026},
month = {oct},
url = {https://ceointerviews.ai/interview/3115908/},
note = {Speaker-attributed transcript with timestamps}
}
