Regulatory Insights

41. 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.

42. 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.

43. 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.

44. 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.

45. 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.

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 FDA Draft Guidance On Overall Survival in Oncology Trials 9/25/2025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

47. 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.

48. Ensuring Compliance In Gene Therapy Trials: IRB And IBC Views 9/23/2025

    Explore ethical and regulatory challenges in neurological gene therapy trials, with expert insights on IRB/IBC collaboration, consent protocols, and oversight for vulnerable populations.

49. The Hidden Problem In Early Phase Oncology Trials 9/23/2025

    Integrating patient-reported outcome measures (PROMs) can enable improved capture tolerability and optimize dosing decisions.

50. Expand Bandwidth With A Trusted Regulatory Writing Partner 9/18/2025

    Find out how a mid-size biotech lacking the bandwidth, expertise, and resources to independently handle its regulatory writing requirements overcame this challenge.