“I worked closely with Amanda on the Qualification of the iBOX, a composite biomarker endpoint in kidney transplantation, by EMA and the Qualification Plan submission and acceptance by FDA. She is results-oriented, rolls up her sleeves, and gets the work done with a sense of urgency. Uniquely, she also balances the needs of colleagues and connects with team members in a personally meaningful way.

Few regulatory professionals have her experience with EMA endpoint qualification with EMA and Qualification Plan with FDA.”

— Bill Fitzsimmons, PharmD, MSc                                                                                                                                  Founder, Tutela Pharmaceuticals Inc.; Adjunct Professor, Colleges of Pharmacy and Medicine at University of Illinois at Chicago, Former Executive Vice President, Regulatory Affairs, Clinical and Research Quality Assurance, Astellas Pharma Global Development, Inc