Date: 2015-11-04
Type of information: Nomination
Compound:
Company: Actinium Pharmaceuticals (USA - NY)
Therapeutic area: Cancer - Oncology
Type agreement: nomination
Action mechanism:
Disease:
Details: * On November 4, 2015, Actinium Pharmaceuticals announced the appointment of Dr. Xin Du, Ph.D., to the position of Executive Director, Regulatory Affairs and Dr. Sri Srivastava, Ph.D., PMP, to the position of Associate Director of Project Management. Dr. Srivastava will have operational responsibilities for Actinium's Actimab-A program including the planned Phase 2 trial, planning and process optimization, management of external vendors and the coordination of all clinical trial related matters. Dr. Du will be responsible for managing Actinium's regulatory submissions, CMC efforts, interacting with regulatory agencies and developing the Company's regulatory strategy as pertains to both Iomab-B, Actimab-A and all future programs. Both hires are especially timely given the planned transformation of Actinium into a later stage product development company in 2016. Dr. Xin Du, Ph.D., is a senior regulatory professional with over 15 years of industry experience and a proven track record of product approvals, regulatory strategy and efficient regulatory submission management. He began his career at the FDA as Staff Fellow at the Center for Biologics Evaluation and Research. Following the FDA, he has worked for several global biopharmaceutical companies such as Aventis (acquired by Sanofi), Wyeth (acquired by Pfizer), Novartis, Bristol-Myers Squibb and NPS Pharmaceuticals (acquired by Shire) in regulatory affairs and CMC positions with increasing responsibility. Most Recently, Dr. Du was Senior Director and Global Regulatory CMC Head at NPS Pharmaceuticals, until the Company's acquisition by Shire, where he was instrumental in receiving approval for the Company's first BLA submission and in the successful launch of the Company's first product in Europe.
Dr. Sri Srivastava, Ph.D., PMP, has nearly two decades of successful project management and clinical operations experience with both large biopharmaceutical companies and as a consultant to emerging biopharmaceutical companies. His career includes tenures at Parke-Davis (now Pfizer), Purdue Pharma, Organon Pharmaceutical, Aestus Therapeutics, Janssen R&D and ClinTech Research. Dr. Srivastava spent a decade at ClinTech Research where he provided consulting services focused on clinical operations for emerging biopharmaceuticals including Aestus Therapeutics where he managed a randomized Phase 2 clinical trial. Dr. Srivastava has significant experience in clinical trial site and vendor oversight, developing study related documentation, designing clinical trial protocols, reviewing data management & monitoring plans, monitoring reports CSR.
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