David R. Schoneker
David R. Schoneker is a Pharmtech editorial advisory board (EAB) member.
David R. Schoneker
Chair, IPEC–Americas and
Director of Global Regulatory Affairs, Colorcon
David R. Schoneker is the director of global regulatory affairs at Colorcon. His responsibilities include global coordination of Colorcon’s worldwide regulatory activities and raw material assessments. He received his BS from Ursinus College and MS in Chemistry from Villanova University. His previous position at Colorcon was director of quality assurance and quality control. He has been with the company since 1977.
Schoneker has been active in many professional organizations such as the American Association of Pharmaceutical Scientists (AAPS), RAPS, ASQC, ACS, AOAC and the Delaware Valley Chromatography Forum. He also is involved with a number of trade organizations such as the International Pharmaceutical Excipients Council (IPEC), the International Association of Color Manufacturers (IACM), the Council for Responsible Nutrition (CRN) and the Institute of Food Technologists (IFT). Schoneker is currently the chairman of IPEC Americas (his term ends Dec. 31, 2008), where he is actively involved with the development of excipient GMP and qualification-related guidelines to improve global supply chain security.
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.
