Abstract:

In March 2012, Palo Alto based Affymax received FDA approval for OMONTYS® (peginesatide) Injection, a product for the treatment of anemia due to chronic kidney disease in adult patients on dialysis. It is the first Erythropoiesis Stimulating Agent (ESA), dosed once monthly, on the US market. Its drug development journey started with the rigorous selection of an erythropoiesis stimulating peptide with prolonged duration of action, and advanced through an odyssey of extensive preclinical and clinical testing.

In parallel with the drug development challenges, the company went public and entered into a worldwide development and commercialization partnership with Takeda Pharmaceutical. The regulatory environment also evolved due to increasing safety concerns about the ESA class. Yet, in spite of these developments and challenging Phase 3 results, Affymax successfully completed NDA review and received approval of OMONTYS® within the 10-month PDUFA timeline, positioning the company for its first commercial launch. The lessons learned in this "David vs. Goliath story" will address the importance of quality science, focus, transparency, and persistence.

Biography:

Dr. Duliege has over 20 years of scientific and leadership experience in the pharmaceutical industry. She joined Affymax in 2004 as VP of Clinical, Regulatory and Medical Affairs. She was instrumental in raising capital and taking the company public. Dr. Duliege was promoted to Chief Medical Officer in 2007. She lead her team through an extensive development program and obtained FDA approval for the company’s lead product, OMONTYS®. As a member of the executive team, Dr. Duliege is responsible for both clinical and non-clinical research. She helps set company strategies, contributes to investor relations, and supports business development activities.

Prior to joining Affymax, Dr. Duliege was a Senior Medical Director at Chiron Corporation where she directed Phase 1 through 4 clinical studies in pulmonary medicine, infectious disease and immunology. She has also been a Senior Research Physician at Genentech, Inc., working on an HIV treatment and vaccine, and an Epidemiologist at the National Institute of Science & Medical Research in Paris.

Dr. Duliege received her MD degree and her certification in Pediatrics from Paris Medical School. She also has an M.S. in Epidemiology from Harvard School of Public Health and an M.S. in Biostatistics from Paris Medical School. She continues to practice medicine as an Adjunct Clinical Assistant Professor at Stanford’s School of Medicine and Lucile Packard Children’s Hospital. She serves on the board of non-profit organizations focused on the prevention of HIV. She is personally committed to supporting public health efforts in developing countries.