Marijke Adams has over 22 years of pharmaceutical industry experience and has been a consultant since 2006. She earned her BS Pharmacy degree from the University of Florida, and PharmD and PhD degrees from Virginia Commonwealth University. Her professional experiences include clinical drug development, clinical study design and management, pharmacokinetics study design and data analysis, project management, medical/regulatory writing, pharmacy practice, teaching, and scientific review for an institutional review board.
Services provided by Dr. Adams mainly include:
Design, management, and reporting of clinical and nonclinical pharmacokinetic studies
Analysis of pharmacokinetic data from clinical and nonclinical studies
Authorship and/or editorial review of all regulatory documents (eg, IND, clinical protocols, NDA)
Authorship of briefing or pre-meeting packages for meetings with regulatory authorities
Authorship and/or editorial review of standard operating procedures
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
Defense & National Security Practice
Commercializing and Business & Corporate Strategy
Kinexum Associate
Founders