Bridging Development and Regulation in CGT with Halloran Consulting Group's Monika Swietlicka

We love to hear from our listeners. Send us a message. 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, including stem cell therapies, mRNA, and nanoparticles. Dr. Remo explains why drug delivery platforms can help shape therapeutic design and development strategy, and how evolving FDA guidance is creating opportunities to streamli...

We love to hear from our listeners. Send us a message. On episode 139, Host Erin Harris talks to Jonathan Rigby, President and CEO of Sernova (and proposed CEO of BetaNova) and Will Rust, Ph.D., President and CEO of Seraxis (and proposed President and CSO of BetaNova). Sernova and Seraxis are coming together to form BetaNova, combining Sernova’s implantable Cell Pouch with Seraxis’ stem cell-derived pancreatic islet cells in an effort to develop a functional cell therapy for people living wit...

We love to hear from our listeners. Send us a message. In episode 138 of Cell & Gene: The Podcast, EA Weeks, J.D., Ph.D., Counsel at Troutman Pepper Locke talks to Host Erin Harris about the deal terms that matter most in CGT, including IP ownership, manufacturing capacity, CMC milestones, data rights, tech transfer, and more. They also discuss planning for what happens when a partnership does not go as expected. Subscribe to the podcast! Apple | Spotify | YouTube Visit ...

We love to hear from our listeners. Send us a message. In episode 137 of Cell & Gene: The Podcast, Host Erin Harris talks with Sylke Poehling, Ph.D., SVP and Global Head: Therapeutic Modalities, pRED; Roche Gene Therapy Center of Excellence about how the company selects the optimal modality by starting with disease biology. Dr. Poehling explains how an integrated Center of Excellence brings together discovery, safety, manufacturing, and development expertise to reduce technical risk and a...

We love to hear from our listeners. Send us a message. On episode 136 of Cell & Gene: The Podcast, Host Erin Harris welcomes back Dr. Panteli Theocharous, FIBMS, M.S., Ph.D., FRCPath to discuss why autoimmune CAR T is moving rapidly from an emerging concept toward a potentially transformative treatment approach. They talk about the very different benefit-risk calculus in autoimmune disease compared with oncology, the patient and caregiver burden of conditioning, apheresis and long-term mo...