Regulatory Affairs Personnel

Neehar Bhatia, PhD

Director of Regulatory Affairs

Neehar Bhatia, Ph.D. is the Director of Process Development and Manufacturing and interim-Director of Regulatory Affairs at the Laboratory of Cell and Gene Medicine (LCGM), Stanford University. Dr. Bhatia received a Ph.D. in Biochemistry from the Central Drug Research Institute, India. Dr. Bhatia is responsible for development and manufacturing of cGMP compliant cell and gene therapy products at LCGM. Dr. Bhatia oversees manufacturing for multiple projects such as CD19/CD22 bi-specific CAR-T and other T cell based therapies, CD34 HSPC transplant and manufacturing of AAV6 for gene correction in HSPC.

Dr. Bhatia has lead multiple projects which include banking  of ESCs, iPSCs, MSCs and iPSC derived differentiated cells, development of GMP process for translational projects and manufacturing cell therapies for Phase I/II clinical trials. Dr. Bhatia has also lead efforts in quest for serum-free chemically defined culture medium for MSCs and development of platform technology for AAV production. Dr. Bhatia’s focus is on development of cGMP compliant manufacturing process for “bench to bedside” cell and gene therapies.

Selected Publications:

David M Gamm, Neehar Bhatia, Anna Petelinsek, Jee Min, Elizabeth E Capowski, Travis Cordie, Diana Drier, Connor Lyons, Derek Hei, Joe Phillips. (2015) cGMP production of neural retina from hiPSCs. ARVO Annual Meeting Abstract. Investigative Ophthalmology & Visual Science June 2015, Vol.56, 3170.

Bloom DD, Centanni JM, Bhatia N, Emler CA, Drier D, Leverson GE, McKenna DH Jr, Gee AP, Lindblad R, Hei DJ, Hematti P. (2015) A reproducible immunopotency assay to measure mesenchymal stromal cell-mediated T-cell suppression. Cytotherapy. 17(2): 140-51.

Neehar Bhatia, Tony Z. Xiao, Kimberly A. Rosenthal, Imtiaz A. Siddiqui, Saravanan Thiyagarajan, B. Smart, Qiao Meng, C.L. Zuleger, Hasan Mukhtar, Shannon C. Kenney, Mark. R. Albertini and B. Jack Longley. (2013) MAGE-C2 promotes growth and tumorigenicity of melanoma cells, phosphorylation of KAP-1, and DNA damage repair. J. Invest. Dermatol. 133(3):759-67.

Neehar Bhatia, Tara A. Demmer and Vladimir Spiegelman. (2008) Inhibition of β-TrCP function potentiates UVB-induced apoptosis in hTERT-immortalized normal human keratinocytes. Photochemistry and Photobiology, 84(2): 376-381.

Felicite K. Noubissi, Irina Elcheva, Neehar Bhatia, Andrei Ougolkov, Toshinari Minamoto, Jeff Ross, Serge Y. Fuchs, and Vladimir S. Spiegelman.(2006) CRD-BP mediates stabilization of β-TrCP, and c-myc mRNA in response to β-catenin signaling. Nature, 441(7095): 898-901.

Neehar BhatiaSaravananThiyagarajanIrina Elcheva, Mohammed Saleem, Andrzej Dlugosz, Hasan Mukhtar, and Vladimir S. Spiegelman.(2006) Gli2 is targeted for ubiquitination and degradation by β–TrCP ubiquitin ligase. Journal of Biological Chemistry, 281(28): 19320-19326