Souzan Yanni

WORK HISTORY

EDUCATION

SKILLS

ABOUT SOUZAN YANNI

Souzan Yanni, PhD is pharmaceutical consultants, offers strategic and pragmatic direction on translational ADME/PK in support of preclinical and clinical studies in humans. She has 25 years of pharmaceutical experience in leadership with diversified discovery and development therapeutic programs such as oncology, antifungal, metabolic disease, cardiovascular, and CNS. Dr. Yanni possesses a special expertise on translational ADME/PK and drug disposition pediatrics,\"from bed side to bench\". • Plan and executed strategically designed ADME studies for predicting mechanism of drug disposition and PK parameters • Possess experience in drug design, bioanalytical, in vitro technologies, PK modeling for predicting ADME, drug transporters and models (drug absorption as well as hepatobiliary and renal elimination models) protein binding• Adhere to FDA/EMA guidelines in assessing DDI mediated by P450 and drug transporters and overall regulation for IND/NDA filing• Manage collaborations with teams from various disciplines and institutions in chemistry, biology, pharmaceutics, toxicology• Instruct workshops in ADME/PK/TK preclinical, clinical drug development, IND/NDA and translational medicine • Recently completed translational ADME for oncology drug towards NDA submission• Recently completed translational ADME investigations and submission of IMPD application of anti-progestine drug candidate• Frequently invited speaker at international conferences, AAPS, FDA, academic institutions, and pharmaceutical companies in the arena of ADME study design, pediatric drug disposition, and build of biotechs and outsourcing• Build operations and managed ADME teams, projects, budget under non-GLP/GLP guidelines• Demonstrate broad scientific track record: several peer-reviewed publications, review articles, book chapters, and in construction a text book in ADMET & pharmacology by WileySpecialties:*Preclinical and clinical ADME/PK/DDI leadership*Translational research experience, support the design of clinical studies in pediatrics and other special populations* Prediction of PK parameters and metabolism/transporters mediated drug disposition and clinical DDI.* Drug disposition and interaction of small molecules and biotherapeutics* Setting technical and scientific collaborations* Managing lab operations, staffing, and projects* Experience in Bioanalysis technologies