Insights On Drug Development

  1. A Brief Intro To CMC Compliance Through CDMO Collaborations 5/29/2025

    Chief Editor Louis Garguilo provides a brief introduction and background to our Outsourced Pharma Live Event: CMC Compliance Through CDMO Collaborations.

  2. Common Reasons For IND Rejections 5/29/2025

    Jumai Abioye, Pan Access Innovations, and Bikash Chatterjee, Pharmatech Associates, lay out for Outsourced Pharma readers the most common issues with IND submissions.

  3. Common CMC Compliance Pitfalls 5/29/2025

    Learn where biotechs encounter the most hiccups when it comes to meeting all the compliance processes and regulations with your outsourcing partners.

  4. You Need 'Brutal Honesty' When Outsourcing 5/29/2025

    Our Outsourced Pharma Live speakers were adamant: You need a clear and honest assessment of what both the sponsor and CDMO need and bring to the relationship.

  5. Where Are You In The Outsourcing Journey? 5/29/2025

    Prior to reaching out to CDMOs for potential partnerships, think hard about exactly where you are as a sponsor in the outsourcing journey.

  6. The 3 Models Of Outsourcing 5/29/2025

    Jumai Abioye, Ph.D., Founder and CEO, Pan Access Innovations, offers her three models of outsourcing and working with CDMOs, for biotechs of all shapes and sizes.

  7. Drug Development Outsourcing: The Devil Is In The Details 5/29/2025

    What you need and what a CDMO can offer specifically, the nuances of your development program, and the way both sides approach the outsourcing relationship will determine a successful development path.

  8. Navigating CMC Regulation For Plasmid DNA In Gene Therapy 5/28/2025

    Explore how evolving regulatory pathways and CMC innovation are shaping the future of gene therapy and viral vector production, plus what to consider when selecting a CDMO partner.

  9. Advancing Lentiviral Vector Manufacturing: A Platform For Commercial Cell Therapy Success 5/28/2025

    Explore how the LentiPeak™ platform can accelerate the development and commercialization of LV-based therapies, using GMP manufacturing, scale-down model validation, and a process design approach.

  10. Evaluating BACS For T Cell Isolation In CAR-T Manufacturing 5/28/2025

    Consider how Buoyancy Activated Cell Sorting (BACS) can streamline T cell isolation, reduce costs, and enhance CAR T and TCR cell therapy manufacturing — access the full study to learn more.