Barbara Testa

Biography

 Over 20 years of experience in CRO organization and biopharmaceutical R&D in multiple therapeutic areas. Key activities: Contributed to NBE entry (Oncology) in Clinical phase 1/2 (2012) by providing supportive pre-clinical data. Contributed to NBE clinical development (Osteoarthritis and Cartilage Injury) providing DMPK support to pre-clinical package (2007-2012). Repeated Due Diligence conductions successfully concluded. Translation from preclinical to clinical of NBEs.

Research Interest

 Excellent knowledge of pre-clinical development, acting in multi-functional research and development teams. Broad therapeutic expertise including oncology, endocrinology, and autoimmune disease. Experience in successfully negotiating with national and international health authorities. Strong leadership skills and excellent interpersonal communication skills. • Responsible for the development of New Biological Entities from clinical candidate through NDA. Design, conduct and/or implement non-clinical metabolism, PK and PK/PD studies under GLP guidelines, if appropriate.  • Perform PK data evaluation. Review and provide interpretation of experimental results to teams and project leaders. Integrate in vivo PK, metabolism and bioanalytical data with information from other disciplines (pharmacology, toxicology, clinical, formulations, PD, modeling and simulation). Provide input on design and implementation of pharmacology, toxicology and clinical studies. Prepare and review scientific data reports and summaries suitable for internal program review and regulatory submission. Bioanalytical experience: LC/MS, GC/MS, HPLC, AAS, SDS-PAGE electrophoresis, RIA, ELISA.