Actinium Pharmaceuticals Inc (NYSE American: ATNM), a company that says it is focused on improving patient access and outcomes to cellular therapies, announced yesterday that it has named Mamata Gokhale, PhD, RAC as vice president, global head of Regulatory Affairs.
In this role, Dr Gokhale will be responsible for developing and implementing a comprehensive clinical regulatory strategy across the company's portfolio of Antibody Radiation-Conjugate product candidates for targeted conditioning. These include the pivotal Phase 3 trial for Actinium's lead candidate Iomab-B, therapeutic and combination trials of Actimab-A, as well as potential next-generation ARC's resulting from its AWE or Antibody Warhead Enabling technology platform.
Dr Gokhale has more than 20 years of regulatory affairs experience that started at the US Food and Drug Administration (FDA) as a reviewer, before transitioning to industry where she worked at biotechnology and pharma companies including Amgen, Watson Pharma, Neumedicines Inc and global Contract Research Organisations including Voisin Consulting Life Sciences and Paraxel International. At Amgen Dr Gokhale successfully contributed to approvals and expansion of Prolia, Xgeva, Vectibix and Sensipar.
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