Missiratch (Mimi) Biable, M.S., has 18 years of experience in the biotech industry, which includes over 10 years of experience in regulatory affairs with the U.S. Food and Drug Administration (FDA) and Astrazeneca/Medimmune LLC. She joined DataRevive in February 2021. Prior to joining DataRevive, Ms. Biable was a Regulatory Health Project Manager (RPM) for five years, a Regulatory Project Manager Team Leader for two years, and a Chief Project Manager in 2020 with the US FDA in the Office of at the Center for Drug Evaluation and Research (CDER) as part of the Office of Regulatory Operation (ORO), Division of Oncology 2 (DO2).


Ms. Biable earned her B.S, and M.S., degrees in Combined Science (Biology) and Bioscience Regulatory Affairs respectively. Early in her career, she worked as an associate scientist, and served as a clinical supply specialist in Medimmune LLC.


During her time at Medimmune LLC/ Astrazeneca, from 2009 to 2012, she delved into regulatory affairs and worked as a Regulatory Affairs associate. In this role, she helped developed strategies in support of investigational drug development submission to the US FDA and Rest of World. This included collection, evaluation, preparation, and assembly of documentation required for regulatory submissions (INDs, CTAs and IMPDs) to the US, Canada, EU, and Japan. During her time at FDA, from 2012 to 2017, she was a RPM and managed 150+INDs along with numerous marketing applications, including

Approvals of few new molecular entities (NMEs). As a RPM Team Leader from 2018-2020 she continued to manage applications, including approval of NMEs and supplemental applications, while also training and mentoring the regulatory project management staff.


From 2020-2021, she served as a Chief Project Manager, where she staffed up the Regulatory Project Management team, and lead in supporting and executing regulatory milestones for the Division of Oncology 2 (DO2). In that role, she worked in conjunction with the Division Director, Cross Discipline Team Leaders, and Discipline Team Leader at the FDA, to oversee the day-to-day management of a broad range of application reviews while ensuring timely completion of projects and timely resolution of regulatory conflicts to avoid delays in achieving goals.