Blogs

  1. Essential Strategies For Mastering CMC And Avoiding CRLs For CGTs 10/16/2025

    CGT developers face rising regulatory challenges around potency, stability, and process control. Find out how proactive planning, expert guidance, and early FDA engagement are key to avoiding delays.

  2. PDABs: An Imperfect Solution To A Complex Issue 9/30/2025

    Prescription Drug Affordability Boards (PDABs) must clearly define goals, improve data analysis, and boost patient engagement to deliver on the promise of lower-cost medicines.

  3. Unlocking The Voice Of Patients: Are Engagement Initiatives Truly Transforming Canadian HTA Reviews? 9/30/2025

    The patient voice is now critical in evaluating new drug treatments. Learn how health technology assessment agencies incorporate patient-reported outcomes to move beyond traditional clinical endpoints.

  4. Changing Evidence Requirements For France's EAP: What Could We See In The Coming Year? 9/30/2025

    Financial pressures and unconfirmed efficacy are driving changes to France's EAP. Stricter evidence, RWE, and robust development plans will soon be required to secure early access for innovative therapies.

  5. Navigating Commercial Logistics: Key Considerations For Emerging CGT Manufacturers 8/27/2025

    A successful cell and gene therapy launch requires a logistics strategy that keeps patients at the center, plans for disruptions, and prepares for future growth and global expansion.

  6. Discover The Path To Oncology Success 8/22/2025

    The oncology landscape is brimming with innovative therapies and new treatment approaches. Successful commercialization requires a well-orchestrated strategy to bring these complex products to market.

  7. Navigating Global Health Policy In A Time Of Disruption 8/12/2025

    The healthcare industries in the U.S. and EU are undergoing significant regulatory and legislative changes. Learn how to better position yourself to navigate this complex environment.

  8. Patient Empowerment Through The European Health Data Space (EHDS) 8/12/2025

    A new regulation in the EU will give patients more control over their health data. Discover the opportunities and challenges this shift presents for the future of patient-centric healthcare.

  9. Unlocking Innovation: New Models And Next-Gen Tech For Success 8/12/2025

    AI and digital innovation are reshaping the pharmaceutical landscape. Learn how the industry is leveraging data and technology to enhance commercialization and improve patient outcomes.

  10. How PIE Streamlines Biopharma And Payer Communication 8/12/2025

    Navigating pre-approval information exchange (PIE) with healthcare decision-makers is essential for market success. Learn what information can be shared and the best strategies for communication.