Clinical Guest Contributors

  1. How Close Is The First FDA-Approved Full-Spectrum Botanical Drug For Autism? 5/6/2025

    AJNA BioSciences CEO Joel Stanley details his transition from helping to build one of the largest CBD companies to developing what he hopes will become an FDA-approved botanical drug to treat the symptoms of autism.

  2. EMA Issues Draft Reflection Paper On Accelerating Biosimilar Approval 5/5/2025

    In April, the European Medicines Agency issued a draft of a new guidance document titled Reflection paper on a tailored clinical approach in biosimilar development. The public consultation runs until Sept. 30, 2025.

  3. Understanding The Impact Of An RMP On Patient Risks Using Relational Risk Analysis 5/5/2025

    Using relational risk analysis, let's take a closer look at risk management plans for identifying and managing adverse reactions for administering a new therapy to a patient.

  4. DEI Was Never the Problem, The Way Pharma Did It Was 5/5/2025

    Consultant Denise Bronner details pharma's strategic rollback of DEI initiatives, roles, and even departments and explains why well-meaning but misguided intentions enabled their demise.

  5. What The Heck Are Financial Accruals? A Guide To Understanding The Mysterious Finance Brain 5/2/2025

    Clinical finance consultant Chris Chan helps clinical professionals understand financial accruals concepts and interpret requests from finance colleagues.

  6. AI In Medical Devices: Meeting The Regulatory Challenge Around The World, Part 1 5/1/2025

    This article explores the global regulatory landscape, examining how leading authorities in the U.S., EU, U.K., Canada, China, Brazil, Australia, and South Korea are approaching AI in medical devices. 

  7. 7 Steps For Clinical Investigators To Implement A Robust AI Governance System 5/1/2025

    In part two, Husch Blackwell LLP experts provide practical guidance for clinical investigators on overseeing the use of AI in clinical trials.

  8. The Risk And Reward Of Clinical Investigators Integrating AI 5/1/2025

    Husch Blackwell LLP experts discuss relevant regulatory frameworks and the risks and liabilities of clinical investigators using AI.

  9. The Evolving Landscape Of Data Integrity In Good Clinical Practice 4/30/2025

    ERA Sciences Andy O'Connor explores the growing focus on data integrity in good clinical practice (GCP) and how regulatory guidance is evolving to support a risk-based, system-life cycle approach.

  10. Medtech CEO Shares Lessons From FIH Implantable Glucose Monitor Trial 4/30/2025

    CEO and President Paul Goode, Ph.D., explores the implantable CBGM’s trial design, as well as the company’s approach to patient input, site selection, and more for its first-in-human trial.