Cell and Gene Regulatory

  1. 3 FDA Approvals In 2025 That Shift The Landscape For 2026 1/20/2026

    In this presentation, Precision’s Chief Medical Officer and former FDA Director, Division of Oncology 2, Harpreet Singh, MD breaks down 3 FDA approvals from last year that are impacting 2026.

  2. Balancing Speed And Regulation In Cell Therapy 1/20/2026

    Rapid cell therapy development demands early planning for scalability, standardized platforms, and inspection‑ready operations to meet rising regulatory expectations and avoid costly rework in later clinical phases.

  3. Designing Cell Therapy Analytical Programs For Regulatory Success 1/20/2026

    Expedited cell therapy pathways demand early, reliable analytical development to ensure robust data, regulatory confidence, and smooth transitions from discovery through clinical stages without costly delays.

  4. What the FDA Looks For In Global Development Programs Today 1/16/2026

    Mastering the complexities of multi-regional clinical trials requires aligning global data with evolving regulatory expectations to ensure treatment consistency and successful drug approval.

  5. New Year, New Biopharma: Game Changers We're Betting On 1/15/2026

    Digital innovation and regulatory evolution are reshaping biopharma. From AI to breakthroughs in oncology and gene editing, discover the trends and challenges that could define the industry.

  6. Sterile Injectables: Why Innovation Matters More Than Ever 1/15/2026

    New technologies and regulatory changes are shaping safer, more efficient filling processes. Discover why innovation is key to protecting patients and advancing therapies.

  7. Three Tips To Put Your Viral Vector On The Path To Regulatory Success 1/15/2026

    Gene therapy regulations are evolving fast, creating uncertainty for developers. Discover three strategies to navigate approval challenges and keep pace with changing expectations.

  8. Navigating The Complex Regulatory World Of ATMPs/CGTs 1/15/2026

    Discover how shifting definitions for ATMPs and CGTs impact global development strategies, from CMC validation requirements to navigating the latest European pharmaceutical legislation and expedited regulatory pathways.

  9. Liberating Intelligence: The Industrial AI Orchestration Layer 1/15/2026

    Unlock predictive manufacturing by bridging IT and OT. The Industrial AI Orchestration Layer delivers real-time insights, compliance, and scalability, turning fragmented data into actionable intelligence.

  10. Host Cell DNA, Fragment Size Distribution By Quantitative Real-Time PCR 1/14/2026

    Quantitative PCR provides the sensitivity and precision needed to analyze fragment size distribution and ensure compliance with strict regulatory safety standards.