The Importance of Microstructure in Topical Drug Product Development
The interview will examine the importance of Microstructure in topical pharmaceutical drug development and how BASF is playing an integral leading role in this ‘hot topic’ in the Industry. Information will be provided that highlights the importance of this topic as it relates to the FDA and complex regulatory landscape. BASF will also describe its current work in this area as well as future steps.
The interview will examine the importance of Microstructure in topical pharmaceutical drug development and how BASF is playing an integral leading role in this ‘hot topic’ in the Industry. Information will be provided that highlights the importance of this topic as it relates to the FDA and complex regulatory landscape. BASF will also describe its current work in this area as well as future steps.
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
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.
