Regulatory Insights

1. Why Asia Should Be Your Next Trial Destination 10/17/2025

   Many U.S. oncology sponsors are expanding their late-phase trials into Asia to secure access to rich patient pools, leverage efficient regulatory pathways, and save time and money in the clinic.

2. The More We Know, The Better: The Benefits Of EMA Policy 70 10/17/2025

   Get ahead of EMA Policy 70 — start strategic compliance now to balance transparency, protect privacy, and accelerate your path to EU market access.

3. Top 5 Challenges In Psoriasis Trials (And How To Overcome Them) 10/15/2025

   Psoriasis trials face recruitment, endpoint, regulatory, and operational challenges. Identifying common hurdles early helps sponsors streamline processes, avoid setbacks, and prevent costly delays.

4. Conducting Early Phase Clinical Trials In Diverse Healthy Populations 10/14/2025

   Download our guide to learn proven strategies for designing early phase clinical trials that successfully enroll diverse populations and meet FDA diversity guidance.

5. Key Takeaways From ADCs In Oncology Trials Webinar 10/2/2025

   By aligning cutting-edge design with evolving regulatory expectations, sponsors can unlock the full therapeutic potential of ADCs and deliver transformative cancer treatments to patients worldwide.

6. Validation Beyond Just Meeting FDA Requirements Is Crucial 9/30/2025

   As the U.S. FDA is impacted by layoffs that threaten its oversight capabilities, the importance of robust software and manufacturing process validation has never been more critical.

7. Rapid Startup Phase 1 Cardiomyopathy CRISPR Gene Therapy 9/25/2025

   Hereditary transthyretin amyloidosis (ATTRv) is very rare, prompting a Phase 1 trial of in vivo CRISPR/Cas9 gene editing to reduce mutant protein and stop cardiomyopathy progression.

8. Conducting Autologous Cell Therapy Research With Zero Sample Loss 9/25/2025

   Autologous cell therapy trials require precision at every stage—and this biomarker-specific solid tumor study exemplified the challenge.

9. FDA Draft Guidance On Overall Survival in Oncology Trials 9/25/2025

   Historically regarded as the gold standard efficacy endpoint, Overall Survival (OS) in oncology trials is now positioned not only as a measure of therapeutic benefit but also as a critical safety endpoint.

10. Navigating Disclosure Complexity: The Power Of Human-Centered AI 9/25/2025

    Identify key regulatory hurdles that sponsors face when integrating Artificial Intelligence (AI), as well as the impact of AI on clinical trial disclosure and transparency.