Clinical Guest Contributors

  1. Understanding The New U.K. MHRA 'Draft Guideline On Individualised mRNA Cancer Immunotherapies' 3/5/2025

    The U.K.'s MHRA has released a new draft guideline outlining best practices for drug product design, CMC, and manufacturing of mRNA cancer immunotherapies using LNP delivery systems. The public comment period ends March 31.

  2. Lessons Learned From Vivani Medical's Study Of GLP-1 Implant 3/5/2025

    Vivani Medical Cofounder and CEO Adam Mendelsohn, Ph.D. discusses the company’s first application of the NanoPortal, including its upsides for patient adherence, its optimized trial design,  and its reception among sites and patients.

  3. Should We Be Paying Clinical Research Participants? A Global Perspective 3/4/2025

    Eduardo F. Motti, MD discusses patient payment from a global perspective, arguing that patient payment isn't thought of the same way around the world as it is in the U.S.

  4. Breaking Down The FDA's Latest Guidance On Electronic Systems In Clinical Investigations 2/28/2025

    In October, the FDA took a significant step forward by releasing a new Q&A guidance clarifying the use of electronic systems, e-records, and e-signatures in clinical investigations.

  5. Are We On The Cusp Of A Quantum Revolution In Clinical Trials? 2/28/2025

    Though quantum computing is still in a nascent stage, life sciences companies are already investing in this technology to enhance predictive models, improve site selection, and find the right cohort.

  6. 4 Crucial Differences Between Early-Phase And Late-Phase Trial Site Selection 2/28/2025

    Learn the differences between early-phase and late-phase trial site selection, including what makes an ideal site for early-phase trials, where speed, precision, and adaptability are non-negotiable.

  7. U.S. Biosimilars Surge: Clinical Trials, Regulatory Shifts, And The Path To Dominance 2/28/2025

    Joseph Pategou asks and answers, "Where does the U.S. biosimilar market stand now?"

  8. Understanding Lupus Trial Participation And The Importance Of Patient Support 2/27/2025

    Lupus Therapeutics Director of Patient Engagement Caroline Donovan explores the challenges of patient enrollment and heralds the role of patient support in running successful trials for lupus patients.

  9. Is That Tech You're Eyeing Really Worth It? 2/26/2025

    Sage Therapeutics Head of Digital Health Jakob Alme discusses clinical trial technologies and the return on investment — financial or otherwise — when adopting a new technology. 

  10. Why A Positive Site Culture Can Have A Huge Impact — And How To Spot It 2/25/2025

    Curo Research CCO Amy Bland outlines the hazards of clinical research site turnover and offers tips for identifying and supporting positive workplace cultures.