“Perfection is the enemy of progress.”
— Winston Churchill
Robert Blanks, MS RAC
Chief Regulatory Affairs & Quality Assurance Officer
Rob has served as our Chief Regulatory Affairs and Quality Assurance Officer since 2020. Before that, Rob served as our head of regulatory affairs and quality assurance since August 2013. Rob has more than 25 years of experience in the pharmaceutical industry in the quality, regulatory, and CMC areas. A majority of this experience has been with small biotech companies, where he has played a critical role in developing initial drug product candidates, including peptides, monoclonal antibodies, and small molecules, from the pre-clinical stage to commercial registration.
Prior to Ardelyx, Rob was vice president of CMC at Flexion Therapeutics, where he oversaw the manufacture of the company’s initial two drug product candidates and the company’s first commercial product, Zilretta®. Prior to Flexion, he was vice president of quality at Idenix Pharmaceuticals, overseeing all quality aspects of the commercial launch of the company’s first product, Tyzeka®. Previous to Idenix, Rob served as vice president of technical operations for Trine Pharmaceuticals and earlier was vice president of technical operations and founder of Phaedrus Pharmaceuticals. At GelTex Pharmaceuticals, subsequently purchased by Genzyme, he was a key participant in both the quality and regulatory areas in the development and registration of RenaGel® and Renvela®.
Rob earned a Bachelor of Science in biology from Bowdoin College and a Master of Science in chemistry from Boston College. Rob is regulatory affairs certified.
“Perfection is the enemy of progress.”
— Winston Churchill