Design and manage IND-enabling pharmacology and toxicology studies (non-GLP/GLP) to support all phases of global development

Led cross-functional project team to develop novel, first-in-class gene therapy for the treatment of Huntington’s Disease

Provide regulatory guidance to cross-functional product development teams on nonclinical, clinical and CMC strategy

Center for Drug Evaluation and Research (CDER)Office of Drug Evaluation (ODE III)Division of Gastroenterology and Inborn Errors Products (DGIEP)

Center for Biologics Evaluation and Research (CBER)Office of Cellular, Tissue and Gene Therapies (OCTGT)Pharmacology Toxicology Branch (PTB)- Lead and oversee the day-to-day operation of a team of Pharmacology/Toxicology reviewers- Provide scientific and regulatory oversight on regulatory submissions (preIND, IND, IDE)- Preceptor in the FDA Commissioner's Fellowship Program, CBER-CDRH fellowship in Regenerative Medicine (2013-2015)

Center for Biologics Evaluation and Research (CBER)Office of Cellular, Tissue and Gene Therapies (OCTGT)Pharmacology Toxicology Branch- Perform regulatory review of biologics, medical devices and combination products (IND, IDE, and BLA submissions) to the Office of Cellular, Tissue and Gene Therapies- Leverage technical expertise as well as knowledge of FDA laws, regulations, and policies to provide scientific and regulatory guidance on pharmacology and toxicology study designs, as well as product development and preclinical testing strategiesKey Accomplishments:* Primary Pharmacology/Toxicology reviewer for the first cell-device combination product and first allogeneic cell-based therapy licensed by CBER (Gintuit, March 2012)* Co-chair FDA planning committee for FDA Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) on cellular and gene therapy products for the treatment of retinal disorders. June 29, 2011* FDA Lead in organizing NIH-FDA Workshop: Pluripotent Stem Cells in Translation: Preclinical Considerations. July 11-12, 2012* Delivered 10 external presentations to stakeholders regarding US regulatory considerations in the preclinical development of cell and gene therapy products

- Developed a novel technique to quantitatively and non-invasively monitor tumor cell proliferation and metastasis in animals- Conducted research on the combined use of gene and cell therapy approaches to generate functional blood vessels in vivo

- Assisted in assay development for an adenovirus-based HIV vaccine and conducted study to reduce assay cost