Firas Younis

As DMPK nonclinical Lead at Teva pharmaceutical I managed 3 projects extended over different product development phases, including: Managing all preclinical DMPK/ADME activities of the project during development, starting from proof of concept, conducting and planning none-GLP and GLP IND-enabling PK studies at different CROs all over the world. Working closely with different functional groups including nonclinical safety, pharmacology and bioanalytics to ensure providing results within timelines while avoiding falling on project critical path. Worked with clinical pharmacology team, providing essential support for first in human studies/clinical phase 1; clinical dose selection based on preclinical obtained data, PK NCA analysis of clinical data and support decision making on dose escalation. Support advanced clinical phases 3 on PK sample transfers from clinical sites, samples bioanalysis, and data transfer. Nonclinical ADME regulatory documents writing and preparation; IND, IB, DSUR, and NDA. Preparation of briefing book (BB) for type B/C guidance meetings with FDA, mitigating with FDA, and participating in a type C meeting with the agency. additionally, have vast experience in PK/PD assessment of pharmacological agents in the treatment of various diseases; hypertension, diabetes, metabolic syndrome, multiple sclerosis, Alzheimer's, pain, close head injury, depression and anxiety. Developed in vivo models, as well as, assessment methods for such pathologies which included, behavioral and clinical manifestation, ADME and toxicological profiling of drugs, and assessment of gene modification at tissue levels. Experience at molecular pan of work included, PCR, RT-PCR, ELISA, RIA, and western blot. specialties: pharmaceutical drug development from preclinical upto first in human