Halloran Insights

1. ICH E6(R3) And A Risk-Based Approach As A Competitive Advantage  6/5/2025

   ICH E6 (R3) advocates for a streamlined, risk-informed trial design that enhances quality and participant experience, paving the way for more efficient and successful clinical research outcomes.

2. Halloran's Regulatory Lens – What We're Watching In 2025 6/5/2025

   As the regulatory environment evolves in 2025, product developers face increasing complexity driven by external pressures such as tariffs and internal shifts like FDA personnel changes.

3. Risk Mitigation Planning For Pharmaceutical Tariffs 5/7/2025

   Examine the potential ramifications of proposed tariffs on the pharmaceutical and biotechnology sectors, highlighting critical concerns regarding national security and supply chain stability.

4. Ticking Timeline: Tips For Effective Product Development Timelines 4/21/2025

   Biotech and pharmaceutical companies must establish clear product development objectives and well-designed timeline to navigate the drug development lifecycle effectively.

5. How The FDA Is Phasing Out Animal Testing Requirement 4/21/2025

   The FDA is embarking on a transformative initiative to phase out animal testing requirements.

6. Key Update On Guideline For Good Clinical Practice E6(R3) 4/21/2025

   Review details of the adoption of ICH GCP E6 R3 Principles and Annex 1, as well as what preparations and next steps your organization will need to undertake.

7. 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.

8. 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.

9. 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.

10. 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.