Cell and Gene Regulatory

41. Understanding Immunogenicity In AAV Gene Therapy 8/14/2025

    As adeno-associated virus-based gene therapies progress toward clinical use, effectively managing immunogenicity risk is critical to patient selection, therapeutic durability, and regulatory success.

42. How To Get Products To Patients Faster With A Connected QMS 8/14/2025

    BioBridge Global faced challenges with paper-heavy processes that risked errors and delays. Discover how digital solutions streamlined their operations and improved regulatory efficiency.

43. Defining Product Roles and Navigating FDA Approval with Monika Swietlicka 8/13/2025

    In Episode 2 of FDA Fridays, the special series from Cell & Gene: The Podcast, Host Erin Harris talks to regulatory expert Monika Swietlicka, Principal, Regulatory Strategy, Halloran Consulting Group to discuss key strategies and challenges in navigating FDA regulation for cell and gene therapies.

44. Regulatory Strategy And Submission Support 8/13/2025

    This Regulatory Operations Team enables biotech and pharmaceutical companies to focus on innovation while ensuring a smooth, compliant path to market entry.

45. Regulatory Strategy And Submission Support 8/13/2025

    Eliminate delays and ensure seamless regulatory alignment with an experienced toxicology services team.

46. Accelerate Your Drug Development With A Global Partner 8/13/2025

    With the right Chemistry, Manufacturing & Controls (CMC) consulting services, your organization can excel in early-stage strategizing, accelerate timelines, optimize processes, and reduce costs.

47. Developing An In Vivo CAR-T With Interius BioTherapeutics' Sianny Christanti and Babu Medi, Ph.D. 8/12/2025

    On this episode of Better Biopharma, Interius BioTherapeutics’ Sianny Christanti and Babu Medi, Ph.D., explain how the company is re-engineering a lentiviral vector to enable INT2104, its off-the-shelf, in vivo CAR T-cell therapy. They discuss the vector's design and its manufacturability, as well as the analytical and regulatory challenges of bringing this first-in-human therapy to the clinic.

48. Building A High-Quality IND From Scratch With Strategic Gap Analysis 8/12/2025

    A biotech sponsor lacking in-house regulatory expertise engaged a partner to obtain strategic regulatory review, medical writing, project management, and electronic publishing (eCTD).

49. NDA Success Strategy: Using Non-US Clinical Data In An NDA Submission 8/12/2025

    A sponsor acquiring a therapeutic asset from an overseas company sought assistance when including foreign clinical trial dat,a generated outside a U.S. IND, in a New Drug Application (NDA).

50. Advancing Oncology Innovation With Adaptive Trial Designs 8/12/2025

    When a biopharmaceutical company developing a novel therapy for solid tumor cancers became concerned with rapid over-enrollment from within a single region, they employed a CRO for assistance.