FDA Announces Top Personnel Changes
US Food and Drug Administration (Rockville, MD) Commissioner Lester M. Crawford has solidified the agency’s temporary management structure as one of his first actions in his new post.
Most significant for drug manufacturers, the commissioner made Janet Woodcock, MD, his permanent deputy commissioner for operations and chief operating officer, ending any speculation that she might return to her old job as the head of the Center for Drug Evaluation and Research (CDER). Steven Galson, MD, gets that position at CDER on a permanent basis as a result. Galson has been CDER’s acting director for almost two years, since Woodcock was detailed to the commissioner’s office. Galson was appointed CDER deputy director in 2001, coming from the Environmental Protection Agency, where he was involved with product safety and risk management activities. He faces the daunting task of overseeing CDER’s move to White Oak, Maryland, and other related organizational changes.
Crawford also named Murray Lumpkin, MD, the permanent deputy commissioner for international and special programs, which includes pediatric therapeutics, combination products, and public health issues. Associate Commissioner for Legislation Patrick Ronan becomes Crawford’s chief of staff and liaison to the Department of Health and Human Services. Scott Gottlieb, MD, who served as a deputy to former commissioner Mark McClellan, MD, and followed McClellan to the Center for Medicare and Medicaid Services, returns to FDA as deputy commissioner for medical and scientific affairs. Gottlieb is well positioned to help FDA access Medicare drug safety data and deal with drug coverage and cost issues.
–Jill Wechsler
Transformations in Drug Development for Cell and Gene Therapies
March 28th 2025As a recognized leader in immunophenotyping for clinical trials, Kevin Lang from PPD discusses how spectral flow cytometry is transforming drug development, particularly in cell and gene therapies like CAR-T. He also dives into his award-winning research, including his 2024 WRIB Poster Award-winning work, and his insights from presenting at AAPS PharmSci360.
Advancing Clinical Trials with Spectral Flow Cytometry: A Conversation with Kevin Lang
March 28th 2025As a recognized leader in immunophenotyping for clinical trials, Kevin Lang from PPD discusses how spectral flow cytometry is transforming drug development, particularly in cell and gene therapies like CAR-T. He also dives into his award-winning research, including his 2024 WRIB Poster Award-winning work, and his insights from presenting at AAPS PharmSci360.
Adding SYLOID® Mesoporous Silica to Improve Run Time and Yield for Micronization Processes
May 9th 2025A must-read for anyone in the industry looking to enhance their micronization processes. Discover how adding low percentages of SYLOID® mesoporous silica can significantly improve the run time and yield of jet milling processes for hard-to-process Active Pharmaceutical Ingredients (APIs). Imagine achieving a more consistent feed rate and a homogenous final product simply by pre-blending SYLOID® mesoporous silica with your APIs. Grace & Microsize conducted experiments that reveal substantial improvements in both run time and yield, making this paper an essential guide for professionals aiming to optimize their manufacturing processes and boost efficiency and feed rate consistency.