Sue Manley has over 25 years of pharmaceutical industry experience and has been consulting for 5 years. Her most recent corporate experience was as Global Head of Regulatory Operations for Novartis Pharmaceuticals. She has a broad knowledge of the workings of the pharmaceutical industry with a focus on design and implementation of organizational processes to create harmony and efficiency across conflicting and inconsistent technical, cultural and geographic environments. Her experience includes managing transitions mandated by new regulatory requirements or company changes such as in or out licensing and mergers. She has directed staff to manage world-wide regulatory submission preparation, coordinate due diligence and legal depositions and oversee outsourcing. Her strong people skills have allowed success in team oriented “must do” environments. She has a MS degree from Seton Hall University in Biology/Business and a BS degree from Indiana University in Biology.
Officers
G. Alexander Fleming, MD
Executive Chairman
Thomas Seoh
President and Chief Executive Officer
Clinical Development
Regulatory Affairs
EU Regulatory
Clinical Operations/Project Management
Julie Waltz Gerlach, B.S.N., M.P.H., R.A.C.
Pre-Clinical
CMC, Formulation/Process Development & Sourcing
Medical Device
QA/QC
Julie Waltz Gerlach, B.S.N., M.P.H., R.A.C.
Medical Writing/Electronic Submissions
Process & Innovation Management
Elizabeth Whalley Buono, BSN, RN, MBA, JD
Commercializing and Business & Corporate Strategy
Founders