Toni Marie Nearing
Senior Director, Regulatory Strategy
Toni Marie Nearing, has 27 years of regulatory experience: 9 years as Senior Director in Global Regulatory Affairs at Quintiles, 13 years at FDA in regulatory affairs and legislative policy, primarily with the Center for Drugs Research and Review, and 5 years of Industry experience as Director of Regulatory Affairs at Johnson & Johnson’s (J&J) Liaison Office, and as Director of Regulatory Affairs at Solvay Pharmaceuticals.
Toni Marie’s main regulatory responsibilities while at Quintiles included acting as Authorized US Agent for many foreign sponsors interacting with the FDA for the first time, helping sponsors to prepare for FDA meetings (helping to prepare the deliverables [meeting requests, meeting information packages, and sponsor minutes], facilitating rehearsals and providing regulatory representation at the meeting), serving as the regulatory lead for IND applications to the Agency, coordinating IND maintenance submissions to the Agency once the IND was allowed to proceed into the clinic, and reviewing and helping to prepare IND specialty submissions, including fast track designation requests, pediatric study plan submissions, orphan drug designation requests, special protocol assessment requests, etc. Toni Marie has been involved in pre- and post-marketing global strategies in therapeutic areas such as (but not limited to): Oncology, Analgesics, Antivirals, Antidepressants and Antipsychotics.
Toni Marie holds a Bachelor of Sciences degree from the University of Maryland, College Park and has received numerous awards at Quintiles, FDA, and in Industry.