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.
A Novel, Enhanced, and Sustainable Approach to Audit Trail Review
July 4th 2025Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.
Drug Solutions Podcast: Novel Drug Delivery Approaches: Refining AAV Vector Deliveries
May 30th 2025In this podcast episode, we discuss novel approaches to drug delivery, specifically regarding adeno-associated virus (AAV) vectors, as viewed by two industry experts who recently exhibited at the annual ASGCT meeting.
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.
