Russell E. Madsen
Russell E. Madsen is a Pharmtech editorial advisory board (EAB) member.
Russell E. Madsen
President, The Williamsburg
Group, LLC
Russell E. Madsen is president of The Williamsburg Group, LLC, in Gaithersburg, Maryland, which is engaged in pharmaceutical consulting in the areas of CGMP compliance and auditing, quality systems, design review, aseptic processing and sterilization technology, sterile filtration, due diligence evaluation, process validation, regulatory liaison and general technical services. Most recently, he had served PDA as acting president and was senior vice-president of science and technology, responsible for the overall scientific, technical and regulatory affairs activities of the association.
Before joining PDA, he was employed by Bristol-Myers Squibb as director of technical services, providing technical and general consulting services to Bristol-Myers Squibb pharmaceutical, medical device, nutritional, and cosmetic operations worldwide. He currently is vice-chairman of ASTM E55.03 General Pharmaceutical Standards, serves as a member of the USP Parenteral Products-Industrial Expert Committee, is a member of Pharmaceutical Technology’s editorial advisory board, and is senior technical documents advisor to ISPE. Madsen holds a BS from St. Lawrence University and a MS in Chemistry from Rensselaer Polytechnic Institute.
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.
Understanding the Variability in Bioburden Test Results in Biomanufacturing
May 7th 2025This article explores the impact of test volume, microbial distribution, and dilution errors on bioburden testing variability. It presents statistical approaches to estimate percentage error and discusses strategies to optimize microbial enumeration techniques in biopharmaceutical quality control.
