From The Editor

  1. Leveraging Directed Evolution To Optimize AAV Vector Design 12/18/2024

    4D Molecular Therapeutics (4DMT) CEO and co-founder, David Kirn, MD, talks about the company’s approach to vector optimization, its product development, and its stage-appropriate buildup of internal GMP manufacturing.

  2. Inside Interius' Global Regulatory Strategy 12/13/2024

    Interius BioTherapeutics' lentiviral gene therapy INT2104, which creates CAR T and CAR NK cells in vivo, headed to clinical trials in Australia where the company dosed a first patient with a B-cell malignancy. CEO Phil Johnson, M.D. gave us a look inside the company's global regulatory strategy.

  3. Internalizing Nanoparticle Therapeutic Development 12/3/2024

    De facto approaches to treating immune-mediated diseases aren’t very kind to the immune system itself. COUR Pharmaceuticals is leveraging nanoparticles, a purpose-built platform and in-house expression systems to build antigen-specific therapies that treat the root cause of autoimmune diseases.

  4. Coya Therapeutics On Developing A Combination Biologic 10/31/2024

    Coya Therapeutic’ executive chairman, Howard Berman, Ph.D., discusses the company's approach to developing a combination biologic and the challenges that multi-targeted therapeutics present.

  5. Inside J&J's Many-Indication mAb 10/30/2024

    Leona Ling, Ph.D.’s relationship with the investigational monoclonal antibody nipocalimab is defined by curiosity, perseverance, and commitment. She discovered the molecule while working for Momenta Pharmaceuticals, and she continues to shepherd it long after J&J's $6.5 billion bid for it in 2020.

  6. How Cidara Got Its Molecule Back 10/30/2024

    In a dramatic turn of events that makes for some great storytelling, Cidara's novel drug-Fc conjugate, once locked up in a deal with J&J, is now squarely back in the biotech's hands and moving forward with an aggressive phase 2b study.

  7. Suppliers Pushing Novel Analytical Methods Testing Forward 10/17/2024

    The urgency to develop novel therapeutics must be balanced by rigorous safety testing, but cell and gene therapy testing protocols, of which there are many, have to date been neither standard nor quick. What role are outsourced testing service providers playing to change that paradigm?

  8. Tune Therapeutics On Clinical Readiness, Technology Adoption 10/16/2024

    Heidi Zhang, Ph.D., explains Tune Therapeutics' epigenetic approach to gene therapy and how the company is preparing its lead candidate for the clinic, as well as it's modular approach to automation.

  9. Discovery vs. Hypothesis-Driven Cell Line Development 10/8/2024

    Susan Sharfstein, Ph.D., explains how discovery-driven research can further our understanding of cellular biology and ultimately inform cell line development.

  10. How Platform Technologies Are Shaping The Gene Therapy Landscape 9/30/2024

    Leading experts in gene therapy discuss CMC strategy for platform technologies, product lifecycle management, and the role CDMOs play in moving the space forward.