Toni Marie is a highly experienced regulatory professional who joined Quantum in June 2023 as a Principal Regulatory Strategist. Toni Marie brings over 30 years of regulatory affairs experience: 16.5 years as a Senior Director in Global Regulatory Affairs at CROs, 13 years at FDA in regulatory affairs and legislative policy, primarily with CDER, and 5 years as Director of Regulatory Affairs in mid-size and large pharma. A key focus of her efforts has been in the development of regulatory strategy from proof of concept through successful product registration, launch, and lifecycle management. This has resulted in a successful registration track record, including 505(b)(1) and 505(b)(2) applications and a biologics marketing application. Toni Marie has been involved in pre- and post-marketing global strategies across numerous therapeutic areas including oncology, dermatology, antivirals, antidepressants, and antipsychotics.