Dr. Arzu Selen joins FDA's Office of New Drug Quality Assessment (Rockville, MD, www.fda.gov/cder) as the associate director for biopharmaceutics.
Dr. Arzu Selen joins FDA’s Office of New Drug Quality Assessment (Rockville, MD, www.fda.gov/cder) as the associate director for biopharmaceutics. Since joining FDA in 1997, Selen has been in the office of clinical pharmacology and has been actively involved in several FDA initiatives related to pediatrics.
Dr. Julie Beitz has been appointed as the director for the Office of Drug Evaluation III (Rockville, MD, www.fda.gov/cder). Beitz has had a 12-year career at FDA involving both pre- and post-approval regulatory activities. Since January 2006, she has served as the acting director of the Office of Drug Evaluation III.
The Future of Cleanroom Construction: How Hybrid Solutions are Changing the Game
May 14th 2025Imagine a world where cleanroom facilities—essential for pharmaceutical manufacturing, biotechnology, and high-tech industries—are built with unparalleled speed, precision, and efficiency. That world is here, thanks to the hybrid construction approach. By blending traditional stick-built methods with modular and prefabricated solutions, companies are overcoming the limitations of conventional construction while ensuring compliance with stringent industry regulations. In this interview, we explore how hybrid cleanroom construction is transforming the industry, offering faster project timelines, improved quality control, and significant cost advantages. Join us as we delve into this game-changing approach with industry experts who are leading the charge in revolutionizing cleanroom infrastructure.
Mastering Antibody-Drug Conjugates
December 19th 2024In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.