Dr. Dawn Toronto is a CMC and regulatory compliance professional with 20 years of international experience within the pharmaceutical industry. Throughout her career, she has been responsible for developing the CMC control strategy for more than 50 clinical drug candidates and has contributed to the development of several commercially approved drugs. She has worked with regulatory health authorities including FDA and Europe National Competent Authorities (ANSM, BfArM, FAMHP, SUKL, FIMEA, MHRA) and across multiple indications such as oncology, UI, CNS, neurodegenerative disorders, sensorineural disorders, IBSC, ESRD. In the last 5 years she has collaborated on several fast-track pediatric development programs which have received ultra-rare and orphan designation from the FDA. Dr. Toronto’s education includes a PhD in Chemistry from UC Davis and two post-doctoral fellowships in French research institutions.