Industry Insights

  1. Impact Of JCA And Project Orbis On The European Revenue Potential Of An Oncology Product 6/12/2025

    Contrary to concerns about price erosion, new analysis suggests Joint Clinical Assessment and Project Orbis will likely increase European oncology product revenue by enabling faster market uptake.

  2. A Look At Elsa, The FDA's New AI Digital Assistant 6/12/2025

    The U.S. FDA recently launched its very own generative AI tool called Elsa. It's designed to assist FDA employees across various functions, from scientific reviewers to investigators.

  3. Creating A Compliant And Scalable CGT Logistics Launch Plan 6/12/2025

    As cell and gene therapies advance to commercialization, biopharma companies face immense logistical hurdles. A customized, end-to-end strategy is crucial for ensuring product integrity and market success.

  4. A Roadmap To Expedited Review Pathways 6/12/2025

    Accelerated development and manufacturing timelines provide developers with paths to move new therapies to market quickly while still maintaining a balance of risk/benefit assessment. 

  5. J&J Survey Of Oncologists Reveals Challenges With Awareness & Access 6/12/2025

    J&J President, U.S. Solid Tumor Biljana Naumovic discusses the company's Oncology Care Index, which revealed issues with oncology provider awareness of and access to clinical trials.

  6. Huntington's Disease Clinical Trials: Innovation, Challenges, And The Road Ahead 6/11/2025

    The Huntington’s disease (HD) landscape is undergoing rapid transformation driven by breakthroughs in gene-targeted therapies, small-molecule modulators, regenerative medicine, and digital innovation.

  7. How Strategic Resourcing Accelerates Biotech's Path From Preclinical To FIH 6/11/2025

    Explore how strategic resourcing, particularly through FSP models, empowers biotech sponsors to overcome common hurdles transitioning when from preclinical research to first-in-human (FIH) trials.

  8. Improving Recruitment Needs More Than Transactional Fixes To Earn Patient Trust 6/11/2025

    Driving patient recruitment and retention in clinical trials isn't always about scheduling, transportation, or even reimbursement. Often, and especially for marginalized communities, it begins with trust.

  9. EHR-To-EDC Success In A Complex Oncology, Adaptive Platform Trial 6/10/2025

    The I-SPY 2 Trial represents a groundbreaking approach in oncology, with a key component of the trial's success being the integration of EHR with EDC via OpenClinica's Unite platform.

  10. U.S. Tariffs And Their Tenuous Impact On Clinical Trials 6/10/2025

    RSM US LLP Life Sciences Senior Analyst Amanda Laskey discusses Trump administration tariffs and how they're expected to impact the pharma world, specifically clinical research.