Twenty years of drug development experience primarily in oncology, but also in inflammation, metabolic, and infection diseases, seventeen of which have been in the pharmaceutical and biotechnology industry. The last ten years has been focused in Early Development, Translational Medicine, Regulatory Affairs and Clinical Development.
Regulatory and Clinical experience includes serving as member of Clinical Development team, responsible of designing IND-enabling GLP and non-GLP studies according to FDA guidelines, preparation and submission of regulatory pre-IND and IND documents, protocol design for phase 1and 2 clinical trials, PK/PD and biomarkers strategy for proof of mechanism, safety and efficacy data evaluation.
Worked for Abbott Labs, Amgen, Exelixis and University of Minnesota. Involved in development of cells, antibodies, proteins, peptibodies, peptides, peptidomimetics and small molecules as drug candidates.
Participated in 14 IND submissions, 3 open INDs, 2 NDAs and 1 BLA. Also well versed in project management, regulatory affairs, business development and working in a cross-functional team environment