Veena Rao
Director, Pdtl Vaccines R & d @Emergent BioSolutions
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WORK HISTORY
Director, Pdtl Vaccines R & d @Emergent BioSolutions
Veena\'s current role includes1. Drive program strategies across anthrax vaccine portfolio (early phase through post-licensure products) ensuring alignment with business goals, operational lines, and governance structure.2. Serve as a technical point of contact for all scientific communications with the U.S. Govt funding agencies and manage contractual expectations. Manage all internal and external stakeholder relationships (CMO, CRO) during project execution.3. Partner with project managers to deliver project milestones and deliverables within budget and timeline.4. Oversee technology transfer activities, qualification/validation of release assays (analytical and potency) in accordance with cGMP, ICH guidelines and FDA recommendations5. Oversee life cycle management activities for CYFENDUS and BioThrax.
EDUCATION
University of Maryland
Master of Chemical Engineering, Chemical Engineering
University of Mumbai
BE/BS, Chemical Engineering
ABOUT VEENA RAO
10+ years of experience in infectious disease research and product development along with program management leading early to post licensure vaccine programs within the medical countermeasures (MCMs) arena for biodefense application. 10+ years of experience in developing anthrax vaccine formulation, analytical and potency assay through validation, chemistry, manufacturing and controls (CMC) process validation, nonclinical and clinical study designs, FDA submissions (IND, BLA, responses to FDA IRs) Extensive project management experience in biopharmaceutical, aerospace and petrochemical industriesCurrently lead BARDA funded program on Ebanga (ansuvimab-zykl) monoclonal antibody (mAb) scale up development program (treatment for Ebola Zaire virus)Led to completion of two anthrax vaccines development programs- CYFENDUS (one of the two products ever to be licensed under the FDA Animal Rule) and Thermostable AV7909 IND (lyophilized aluminum based vaccine) for NIAID’s Phase 1 trial.
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