Guest Column | January 7, 2025
Why The EU Biotech Act Matters To The U.S.: A Clinical Perspective
By Jessica Cordes, senior consultant, Clinical Excellence GmbH
The European Commission’s recently announced Biotech and Biomanufacturing Initiative, commonly referred to as the EU Biotech Act, marks a pivotal shift in the regulatory and industrial landscape for biotechnology in Europe. While much of the immediate attention has focused on how the initiative will benefit European life sciences companies, U.S.-based biotech sponsors should also take note, especially those involved in clinical development of advanced therapy medicinal products (ATMPs, also called cell and gene therapies), oncology therapies, or other high-complexity modalities.
Please read the full Clinical Leader Article.