Uyen Dinh, PhD
Consultant and Scientific Writer
Toxicologist with over 8 years of experience in nonclinical pharmacology and toxicology for cell and gene therapies, biomaterials, and small and large molecules with experience at development stages from discovery to approval.
Background
Uyen Dinh received her PhD in Biomedical Sciences from NC State College of Veterinary Medicine. Uyen has experience in drug discovery and development, regulatory nonclinical studies, and translational development of therapeutic programs including cell and gene therapies, miRNA, exosomes, extracellular vesicles, biomaterials, and small and large molecules. Uyen has supported toxicology program planning, study monitoring, data analysis, and interpretation. Uyen has authored or co-authored over 30 peer-reviewed publications in high impact journals and has expertise in technical writing and review of study reports and regulatory submission documents. Uyen has supported regulatory filings for traditional and investigator led INDs, NDAs, BLAs, and 505(b)(2)s.
Uyen has also served as principal investigator, consultant, and subject matter expert in supporting drug development programs from discovery through clinical trials and licensing. Uyen participated in founding two university-based biotechnology start-ups focused on stem cell and exosome therapies with two lead candidates progressing to first-in-human Phase 1 trials. She has been active in professional organizations, including the American Society of Cell and Gene Therapy, the American Thoracic Society, the American Heart Association, and the American Association of Extracellular Vesicles.
Practice Areas
- Nonclinical Development Strategies for:
- Cell and Gene Therapies
- Biologics (tissue-based therapies and biomaterials) and Large Molecules
- Small Molecules
- Toxicology Study Design and Interpretation
- Nanotechnology including:
- Extracellular vesicles (exosomes)
- Nanoparticles
- Lipid-based particles
- Inhalation Toxicology (nebulizer and DPIs)
- Stem Cell Therapy and Regenerative Medicine
- Nonclinical Animal Model Development (injury induced and transgenic models)