Tal Salz, Ph.D.

Dr. Salz came to Dark Horse after 6 years working for the FDA, during which she honed her regulatory experience in reviewing the Chemistry, Manufacturing, and Controls (CMC) information supporting development of cell and gene therapies (CBER/OTAT). Before that, she spent 7+ years working in cellular & molecular biology, genomics, epigenetic, immunology, and virology.

With DHC clients, Tal has focused primarily on CMC Regulatory authorship and review for FDA as well as other global regulatory bodies.  

Tal’s doctoral (University of Florida) and post-doctoral (Johns Hopkins) research was interdisciplinary, with a focus on genomic and epigenetics using wide variety of cellular and molecular techniques, bioinformatics, animal models, viral vectors, and various gene editing tools. Upon completing her post-doctoral training, Tal joined the FDA. Tal began her FDA regulatory career as a Commissioner’s Fellow in CBER, where she spent 2 years as a cell therapy product reviewer in the Cell Therapy Branch and led a regulatory project which focused on product comparability. Dr. Salz then joined the Gene Therapy Branch where she spent an additional 4 years as a gene therapy product reviewer.

During her time at the FDA, Tal reviewed a variety of cell and gene therapy products at all stages of the product lifecycle. She has significant experience with allogeneic and autologous genetically modified cell products such as Chimeric Antigen Receptor (CAR) T cells, CAR Natural Killer (NK) cells, T cell receptor (TCR)-modified T cells, genetically modified Induced Pluripotent Stem Cells (iPSCs) and CD34 cells, and genome editing products.

She also has experience with reviewing and advising on various regulatory submissions including INTERACTs, pre-INDs, INDs, BLAs, supplements, and designation requests. In addition to reviewing product information, Tal has also been engaged in FDA policy, including FDA guidance writing and international regulatory forums. Tal is a subject matter expert on management of manufacturing changes and product comparability. She advises on approaches to comparability study design and comprehensive submissions of comparability data to the regulatory agency.

• Late-stage CMC regulatory strategy
• Review of module 3
• BLA support
• Preparation of FDA meeting packages
• Comparability protocols and reports
• FDA comment resolution
• Ad hoc regulatory support/review

Tal was awarded the "Exceptional Athlete" award, allowing athletes to continue professional sport activities. Tal spent ten years as a professional basketball player, on the Israeli Women's National Basketball Team and in the Israeli division I professional basketball league. She also went to Murcia, Spain to play basketball for Israel as part of the 2001 European Youth Summer Olympic Festival.

FDA
Gene Therapy Reviewer (CMC)
Cell Therapy Reviewer (CMC)
Commissioner’s Fellow

The Johns Hopkins University School of Medicine, Center for Epigenetics
Graduate Research Assistant

University of Florida
Research Assistant

Public Health Research Institute of NJ
Conducted research in microbiology

The Johns Hopkins University School of Medicine, Center for Epigenetics
Postdoctoral Fellow

University of Florida
Doctor of Philosophy (Ph.D.), Medical Clinical Sciences/Graduate Medical Studies

Bar-Ilan University
Bachelor's Degree, Biotechnology