Halloran Insights

  1. Pathway To Success: How De-Risking Life Sciences Companies Leads To Investment Growth 3/7/2025

    De-risking in clinical development is essential to optimizing trial success and ensuring regulatory approval and strategic decision-making at critical points in a study’s lifecycle can minimize uncertainties.

  2. Groundbreaking Rare Disease Drug Approval (OGSIVEO [nirogacestat]) 1/16/2025

    Strategic guidance helped SpringWorks Therapeutics, a biopharmaceutical company dedicated to advancing precision medicine, to refine their regulatory strategy for late-stage development.

  3. Bridging Continents For Clinical Development 1/16/2025

    By leveraging Australia's ecosystem as a launchpad, organizations managing both early-stage and advanced development can enhance trial quality and position themselves for success.

  4. Turning Your Inspection Fears Into Actionable Readiness Steps 1/9/2025

    Inspection readiness is a vital component of achieving FDA approval for drugs and devices, yet even seasoned clinical research professionals can face challenges in navigating the evolving regulatory landscape.

  5. Disrupting The Clinical Trial Ecosystem 1/9/2025

    Clinical research advances healthcare, but access, opportunity, and technology are vital to overcoming barriers and improving outcomes.

  6. Moving Through Obstacles On The Path To Commercialization 1/9/2025

    Leaders in the clinical trials field answer questions about transitioning from clinical development to commercialization and the strategic foresight, operational excellence, and adaptability required.

  7. Three Ways To Accelerate From Trial To Market 1/9/2025

    Moving from pre-IND to IND involves preparing for FDA interactions with a focused pre-IND meeting request and package, Selecting the right CRO, and ensuring data integrity.

  8. Successfully Managing The Transition From Research To Development 1/9/2025

    When transitioning from research to development it's important to thoroughly understand FDA requirements and engage the FDA early on, and create an efficient integrated development plan.

  9. 483 Issues To Sites – Indicators Of Sponsor Oversight Effectiveness 10/17/2024

    Explore how effective oversight is critical for companies addressing Form 483 observations identified during clinical study site regulatory inspections.

  10. Three Key Impacts Of ICH E6(R3) On RBQM And Oversight 9/16/2024

    The drafted guideline ICH E6(R3), introduces significant updates impacting Risk-Based Quality Management. Explore three major ICH principles and key insights related to this guidance.