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Shana Hardy Thomas, Ph.D. is listed as Associate Director, Regulatory Affairs at Kite Pharma | CGT Regulatory Strategist | Former FDA Reviewer at Kite Pharma, based in Charlotte, North Carolina, United States. AeroLeads shows a work email signal at fda.gov, phone signal with area code 334, 765, and a matched LinkedIn profile for Shana Hardy Thomas, Ph.D..
Shana Hardy Thomas, Ph.D. previously worked as Associate Director, Global Regulatory Affairs at Kite Pharma and Senior/Master Cell & Gene Therapy Reviewer, Pharmacology/Toxicology at Fda. Shana Hardy Thomas, Ph.D. holds Phd, Molecular Pharmacology from Purdue University.
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AeroLeads found 1 current-domain work email signal for Shana Hardy Thomas, Ph.D.. Compare company email patterns before reaching out.
I am an advanced therapy regulatory affairs professional focused on the development of cell and gene therapy (CGT) products and clinical programs. My areas of expertise included oncology-based therapies, genome-editing technologies and engineered autologous and allogeneic cell products. I have significant training and experience in the assessment and development of IND-enabling preclinical programs for complex products. In addition, I have burgeoning experience in the development of first-in-human clinical trials. Currently, I provide regulatory intelligence and strategy to the development of preclinical and clinical programs to support drug approval at Kite Pharma, a Gilead Company.My interests are the advancement of biotech-based treatment modalities, improvement of public health, and the agency and representation of minority scientists. When not thinking or working on these passions, you will find me traveling abroad or binging a Netflix series.
Listed skills include Research, Rna Isolation, Program Management, Project Scope Development, and 22 others.
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Santa Monica, California, Us
I provide regulatory intelligence, strategy, and leadership to cross-functional development teams to support CAR T cell product development and clinical research. In addition, I direct and manage regulatory activities to support drug product approval/licensure.
Silver Spring, Md, Us
Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT) I review and evaluate the toxicological and pharmacological data contained in INTERACTs, Investigational New Drugs (INDs), INDs, Investigational Device Exemptions (IDEs), 510(k) Premarket Notifications [510(k)s], Premarket Approvals (PMAs), Humanitarian Device Exemptions (HDEs), and Biologics License Applications (BLAs), as well as amendments and supplements, to support the safety of cell therapy, gene therapy, and tissue-engineered products that are regulated by CBER OTAT.
Gaithersburg, Md, Us
Selected by the National Research Council to receive an assistantship/fellowship from the National Academies of Sciences, Engineering, and Medicine to conduct research at NIST. Research focuses on developing tools, robust quantitative assays, and reliable measurement infrastructure to meet measurement assurance needs for the genome editing field and gene/cell therapeutics.Developed a biochemical single-cell-based assay for genome editing detection in application of reviewing and evaluating data for gene and cell therapy product development. And, evaluated current genome editing off target assays used for review processes in tissue, cell and gene therapy product development for measurement assurance and confidence. Participated in scientific conferences, symposia, and workshops featuring tissue, cell, and gene therapy. And, engaged company stakeholders, academia, and FDA/CBER for the advancement of current genome editing technology measurements and standards and participation in the NIST Genome Editing Consortium.
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Shana Hardy Thomas, Ph.D. works for Kite Pharma.
Shana Hardy Thomas, Ph.D. is listed as Associate Director, Regulatory Affairs at Kite Pharma | CGT Regulatory Strategist | Former FDA Reviewer at Kite Pharma.
AeroLeads has found 1 work email signal at @fda.gov for Shana Hardy Thomas, Ph.D. at Kite Pharma.
AeroLeads has found 3 phone signal(s) with area code 334, 765 for Shana Hardy Thomas, Ph.D. at Kite Pharma.
Shana Hardy Thomas, Ph.D. is based in Charlotte, North Carolina, United States while working with Kite Pharma.
Shana Hardy Thomas, Ph.D. has worked for Kite Pharma, Fda, and National Institute Of Standards And Technology.
You can use AeroLeads to view verified contact signals for Shana Hardy Thomas, Ph.D. at Kite Pharma, including work email, phone, and LinkedIn data when available.
Shana Hardy Thomas, Ph.D. holds Phd, Molecular Pharmacology from Purdue University.
Shana Hardy Thomas, Ph.D. is listed with skills including Research, Rna Isolation, Program Management, Project Scope Development, Cancer, Community Outreach, Immunoprecipitation, and Grant Writing.
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