OVERVIEW
FOCUS AREAS
15+ years of translational experience in cell and gene therapy, spanning academia, industry, and regulatory review.
Cell and gene therapy CMC
Regulatory submissions and compliance
Process development and optimization
IND authoring and review
As a CMC Consultant at ELIQUENT Life Sciences, Dr. Chun-Chun Cheng draws on her deep scientific knowledge and regulatory experience to support life science clients with advanced CMC solutions for biologics, including cell and gene therapies.
Dr. Chun-Chun Cheng brings over 15 years of multidisciplinary experience spanning academia, industry, clinical settings, and regulatory agencies. She specializes in cell and gene therapy, with expertise in process development, regulatory strategy, and technical leadership from preclinical through commercial stages. Prior to joining ELIQUENT, she served as a CMC reviewer at the FDA, where she reviewed submissions involving CAR-T, CD34+ stem cells, MSCs, and iPSCs. At Novartis, Dr. Cheng was a CMC process lead involved in process development and technology transfer for gene-edited and stem cell-based therapies, contributing to an IND approval for a rare disease program. She is a published scientist with numerous peer-reviewed articles, multiple patents, and a strong record in regulatory writing and cross-functional collaboration.
-
EDUCATION:
- Postdoctoral Fellowship at MD Anderson Cancer Center (TX), UT Southwestern Medical Center (TX), and RIKEN BDR (Japan)
- Ph.D. in Biotechnology, National Taiwan University, Taipei, Taiwan
-
EXPERTISE:
- Regulatory CMC
- Cell therapy process development and optimization
- Technology transfer and CDMO collaboration
- Analytical method development and validation
- Gene editing and gene delivery (CRISPR, LVV, LNP)
- Clinical manufacturing oversight and staff training
AWARDS & RECOGNITION:
Two international patents granted for novel cancer diagnostics and stem cell tools; recognized with multiple publication awards and competitive research fellowships.