Featured Insights

1. Sterility Assurance With Louise Ui Fhatharta 1/17/2025

   This discussion explores critical aspects of maintaining sterility in pharmaceutical manufacturing, from facility design and environmental monitoring to regulatory compliance and common misconceptions.

2. Essential Guide To Cell And Gene Therapy Commercialization 10/10/2023

   After devoting time, expertise, and financial resources to developing a transformative cell or gene therapy, it is essential to ensure patients can receive all of the benefits of your innovation.

3. A Comparative Guide To CGTs: Modalities, Landscape, And Logistics 2/29/2024

   Cell and gene therapies (CGTs) have the potential to revolutionize medicine. However, achieving therapeutic success requires advanced logistical consideration to ensure product safety and efficacy

4. Improving Access And Support For Cell And Gene Therapies 10/9/2023

   Although cell and gene therapies (CGTs) are potentially transformative, their effectiveness is undermined by difficulties with patient access and support, high costs, and a complex pathway to treatment.

5. Strategic Management Of The Mature Product Portfolio 4/7/2024

   Explore a new outsourcing paradigm that integrates expertise, regulatory knowledge, efficiency, and cost containment, moving beyond traditional low-cost offshore staffing models.

6. A Year Of Reflection And Preparation 1/3/2025

   The Trial Master File (TMF) landscape in 2025 will require companies to stay attuned to the evolving ICH E6(R3) guidelines and the full implementation of the CTIS.

7. Overcoming The Complex Logistics Of Autologous Cell Therapy Trials: A Deep Dive Into Challenges And Solutions 12/8/2023

   Explore critical logistical requirements in autologous cell therapies logistics and learn how to overcome challenges and achieve successful and timely autologous cell therapy trials.

8. Crafting An Effective Commercialization Strategy For CGTs 10/25/2023

   Patient access and manufacturing efficiency persist as barriers to widespread adoption of CGTs. An effective commercialization strategy is crucial to expand access to these life-changing therapies.

9. A Thoughtful Copay Program Design That Increased Patient Engagement 11/26/2024

   Learn how a partnership with a pharmaceutical company to redesign patient support materials resulted in increased patient engagement and copay program utilization.

10. How Patient-Centric Approaches Are Shaping The Future Of CGT 8/6/2024

    Emily Whitehead’s CAR-T cell therapy journey highlights the power of patient engagement in cell and gene therapies. Discover how her story and advocacy drive a patient-centric approach in innovative treatments.