Christine Moore Bio
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Christine Moore Bio
Dr. Moore is the currently the Acting Director of FDA's Office of New Drug Quality Assessment. Christine has been with the FDA since 2004 and has been at the forefront of FDA's Quality by Design efforts including being a member of the expert working group for ICH Q8(R). Prior to joining the FDA, she worked for 10 years in API process development and scale-up at Pfizer and Searle/Pharmacia. Her background is in chemical and biochemical engineering, with degrees from Northwestern University and Massachusetts Institute of Technology.
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.
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.
