Fiona Stavros, Ph.D.

Fiona Stavros has over 20 years of industry experience in the design, implementation, management and regulatory submission of nonclinical drug development from lead optimization to market approval. She has extensive knowledge and expertise in strategic nonclinical development program design and execution, GLP compliance, clinical bioanalysis and pharmacokinetic assessment, contract research organization (CRO) selection and management, and in the writing and submission of the nonclinical regulatory documents (foreign and domestic). Fiona has the unique experience of having personally taken a small molecule from target identification, through lead optimization, into first in man studies and on to market approval. 

Previously, Fiona was Senior Director of Nonclinical Development at Encysive Pharmaceuticals, Houston, Texas where she oversaw the strategic development, execution and regulatory submissions of the nonclinical development programs for 4 therapeutic areas. She has extensive experience monitoring outsourced GLP studies (safety pharmacology and acute, subchronic, reproductive, genotoxic and carcinogenicity toxicology, analytical assay development and validation (dose formulation and nonclinical/human bioanalysis); and in vivo and in vitro ADME (animal species and man). She also was responsible for clinical bioanalysis, reporting and pharmacokinetic evaluation and wrote the clinical drug-drug interaction plan.  During her tenure she successfully filed 8 IND’s and 1 NDA. One drug, Thelin®, has gained approval in the EU, Canada and Australia, and approval is pending in the US. 

Prior to Encysive, Fiona worked as a manager at Immunopharmaceutics Inc., an early development pharmaceutical company and Synbiotics Corp., which specialized in veterinary diagnostics.  

Fiona obtained a Bachelor of Science (Hons) degree and Ph.D. in Pharmacology from the University of Edinburgh. She has over 30 peer reviewed scientific publications.