INSIGHTS ON CELL & GENE CLINICAL TRIALS

• Adaptive By Nature: Modern Tools For Modern Trial Designs

  Adaptive platform trials (APTs) are reshaping clinical research by enabling multiple therapies to be tested simultaneously under a single, flexible protocol.

• New EDC Tools Enable Even Faster Self-Serve Study Builds

  Explore a powerful yet accessible EDC solution that enables faster, more efficient study builds without compromising data integrity or compliance, allowing clinical teams to focus on advancing research outcomes.

• Streamline Recruitment With Confidence

  Transform your clinical trial recruitment with a service that delivers faster, more cost-effective enrollment, particularly for hard-to-reach populations.

• Immunology's Next Frontier: High-Risk, High-Reward Innovations From EULAR 2025

  The 2025 European Congress of Rheumatology (EULAR) showcased a shift in immunology, highlighting a convergence of next-generation mechanisms and novel therapeutic modalities. Of note is the emergence of cell therapies as a treatment strategy.

• Leveraging Biomarkers In Early PK/PD Studies To Drive Smarter Drug Development

  Integrating biomarkers into early clinical studies is crucial to determine whether a new therapy engages its biological target, triggers the intended PD effects, and shows early signs of efficacy.

• Live Biotherapeutic Products: Unique Quality, Manufacturing And Nonclinical Considerations For Clinical Trial Entry

  Live biotherapeutic products (LBPs) represent an emerging frontier in therapeutic development, harnessing living microorganisms to prevent, treat, or cure disease.

• CMC Strategies For Cell And Gene Therapy Development

  The regulatory environment for cell and gene therapies (CGTs) is evolving rapidly, requiring sponsors to adopt a more strategic, integrated development approach.

• Project Optimus Explained: Shifting Away From Maximum Tolerated Dose

  Project Optimus represents a transformative shift in oncology, advocating for a more nuanced, evidence-based approach to dose selection, prioritizing patient safety alongside treatment effectiveness.

• Commercializing Your First Cell Or Gene Therapy (CGT): Developing Your Market Access Strategy

  Effectively commercializing cell and gene therapies requires a strong market access strategy. Learn key steps for ensuring your therapy reaches patients at the right time and place.

• Pushing The Boundaries In Cell Therapy: CAR-T Updates From EHA 2025

  The 30th European Hematology Association (EHA) Congress in Milan highlighted a more mature CAR-T therapy landscape, where rapid manufacturing, durable responses, and improved safety profiles are converging.