Former FDA reviewer with experience in CMC review for cell and gene therapy (CGT) products at CBER/OTP. Expertise in cellular and molecular biology, genomics, epigenetics, immunology, and virology.
CMC
品質とコンプライアンス
薬事
ビジネスアナリティクス
Dr. Salsitz joined Dark Horse after six years at the FDA, where she served as a regulatory reviewer for Chemistry, Manufacturing, and Controls (CMC) information supporting the development of cell and gene therapies (CBER/OTAT). Prior to her time at the FDA, she spent over seven years in research, specializing in cellular and molecular biology, genomics, epigenetics, immunology, and virology.
At DHC, she focuses on the preparation and review of CMC regulatory documentation for the FDA and other global regulatory agencies.
Dr. Salsitz earned her PhD from the University of Florida and completed her postdoctoral training at Johns Hopkins University, where she engaged in interdisciplinary research. Her work spanned cellular and molecular biology, bioinformatics, animal models, viral vectors, and various gene-editing tools, with a focus on genomics and epigenetics. Following her postdoctoral training, she joined the FDA as a CBER Commissioner’s Fellow. She began her regulatory career as a reviewer in the Office of Tissues and Advanced Therapies (OTAT), where she spent two years reviewing cell therapy products and leading regulatory projects on product comparability. She subsequently moved to the Division of Gene Therapy, where she served as a reviewer for gene therapy products for an additional four years.
During her tenure at the FDA, she reviewed a diverse portfolio of cell and gene therapy products across all stages of the product lifecycle. She possesses extensive experience with both allogeneic and autologous genetically modified cell products, including CAR-T cells, CAR-NK cells, TCR-engineered T cells, gene-edited iPSCs, CD34+ cells, and genome-edited products.
She has extensive experience reviewing and providing guidance on various regulatory submissions, including INTERACT, pre-IND, IND, BLA, supplemental applications, and designation requests. In addition to product review, she has contributed to FDA policy development, including the drafting of FDA guidance documents and participation in international regulatory forums. She is an expert in manufacturing change management and product comparability, providing strategic advice on the design of comparability studies and the preparation of comprehensive comparability data packages for regulatory agencies.
タルは「優秀アスリート」賞を受賞し、プロスポーツ活動を継続する資格を得ました。タルは10年間プロバスケットボール選手として、イスラエル女子代表チームおよびイスラエル1部プロリーグで活躍しました。また、スペインのムルシアで開催された 2001年ヨーロッパユース夏季オリンピックフェスティバルにイスラエル代表として出場しました。
FDA
遺伝子治療審査官（CMC）
細胞治療審査官（CMC）
コミッショナーズ・フェロー
ジョンズ・ホプキンス大学医学部 エピジェネティクスセンター
大学院リサーチアシスタント
フロリダ大学
リサーチアシスタント
ニュージャージー州公衆衛生研究所
微生物学の研究に従事
ジョンズ・ホプキンス大学医学部 エピジェネティクスセンター
博士研究員（ポストドクトラル・フェロー）
フロリダ大学
博士号（Ph.D.）、医学臨床科学／大学院医学研究
バル＝イラン大学
学士号、バイオテクノロジー
