Halloran Insights

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.