Regulatory

1. U.S. Tariffs And Their Tenuous Impact On Clinical Trials 6/10/2025

   RSM US LLP Life Sciences Senior Analyst Amanda Laskey discusses Trump administration tariffs and how they're expected to impact the pharma world, specifically clinical research.

2. Bracing For The Impact Of The Federal Workforce Reduction 6/9/2025

   The federal workforce reductions pose significant challenges for the life sciences industry, particularly for R&D, supply chain oversight, and industry workforce development.

3. The Potential Impact Of U.S. Tariffs On The Biotech Sector: Manufacturing, Funding, And Clinical Trials 5/12/2025

   Syner-G Biopharma Group's Raymond Forslund, Ph.D., MBA explores how U.S. tariffs might affect biotech manufacturing, funding, and clinical research.

4. Navigating Tariffs: Implications And Strategies For Pharmaceuticals Manufacturers 4/17/2025

   The U.S. tariffs on trading partners bring a whole new set of challenges, but there are tactics and strategies companies can deploy to help offset the cost and operational impacts. 

5. How HHS Budget Cuts And Vaccine Hesitancy Threaten Clinical Trial Operations — And What Leaders Can Do 4/10/2025

   Prof. Stacey B. Lee, Ph.D., examines how the recent Department of Health and Human Services (HHS) staffing cuts and vaccine hesitancy combine to make clinical research much more challenging.

6. Biopharma R&D Faces Productivity And Attrition Challenges In 2025 1/29/2025

   Evaluate VP of Thought Leadership Daniel Chancellor discusses trends for 2025 as the surge in R&D, coupled with rapidly evolving industry dynamics, presents a productivity and attrition challenge for the industry.

7. Navigating The CGT Landscape: Key Takeaways From The FDA's New FAQ 1/6/2025

   The FDA's new FAQ on cell and gene therapy offers a roadmap for developers. Review key insights from the document, including the importance of early engagement with the FDA, CMC considerations, and more.

8. Unraveling The Complexity Of Cell Therapy: Advancements And Challenges 11/26/2024

   Cell therapy has emerged as a powerful tool for addressing critical medical challenges, but its rapid evolution necessitates a clear regulatory framework and consistent terminology.

9. Navigating The Cell And Gene Regulatory Landscape 10/3/2024

   Navigating the complex regulatory landscape is essential for cell and gene therapy success. Explore key considerations, challenges, and best practices for companies operating in this space.

10. AI Is A Tool — Not A Replacement — For Human Innovation In Drug Discovery 9/4/2024

    This attorney provides practical advice. Can artificial intelligence (AI) make drug discovery easier? Yes! Will we lose the human component essential to the innovation culture? No.