Cencora OUTPH Insights

1. Best Practices For Managing The Logistics And Distribution Of CGTs 2/23/2026

   Site infrastructure, formulary timelines, and storage capabilities create barriers between approval and patient access. Planning for these operational realities separates successful launches from stalled ones.

2. Navigating EU Regulatory Challenges With Cell And Gene Therapies 2/23/2026

   EU regulatory changes affecting advanced therapies demand new approaches to scientific advice, evidence generation, and health technology assessment for cell and gene therapy developers.

3. The Value Of Real-World Evidence In Canadian Drug Commercialization 2/18/2026

   Leveraging real-world evidence (RWE) across the product lifecycle enables manufacturers to fill the evidence gap beyond RCTs to help guide local commercial strategic planning and market access strategy.

4. Digitized Solutions To Increase Visibility And Streamline Communication Between A PSP And Manufacturer 2/18/2026

   When email-based escalation management creates compliance and visibility gaps, a centralized digital solution helps manufacturer and PSP teams act faster and with greater accountability.

5. Digital Twins And Hybrid Models In Biologics Production: A Model Comparison 2/17/2026

   Hybrid models outperform classical approaches in bioreactor prediction. See how combining mechanistic knowledge with machine learning builds process understanding that holds up beyond training conditions.

6. As eCTD 4.0 Adoption Inches Forward, A New ICH Guideline Puts It To The Test 2/17/2026

   Regulatory submissions are changing as eCTD 4.0 advances and the updated M4Q guideline reshapes how quality data is structured, cross-referenced, and reviewed across product lifecycles.

7. Unlock The Potential Of Pharmacovigilance Outsourcing 2/17/2026

   Outsourcing pharmacovigilance can reduce overhead, strengthen compliance, and free teams to focus on innovation. Examine what a well-structured global PV model actually looks like in practice.

8. EU HTA Implementation: Learnings From The First Year 2/13/2026

   The EU HTA regulation's first year reveals progress in harmonizing assessments alongside challenges in PICO consolidation, resource constraints, and patient engagement that require strategic adaptation.

9. The Growing Case For AI To Support Pharmacovigilance 1/14/2026

   Insights from the World Drug Safety Congress reveal how automation and AI streamline signal management and safety reporting while maintaining essential human oversight and ensuring regulatory compliance.

10. Why Flexible, Collaborative Distribution Partners Matter For CGTs 1/9/2026

    Learn how collaborative distribution models manage reimbursement hurdles and complex delivery requirements to ensure patient access and long-term commercial success.