Marika Heinicke, Pharm.D. BCGP

Responsibilities & Activities

I represent NIDDK as a Sponsor's Authorized Representative (SAR) for extramurally funded NIDDK-sponsored investigational new drug (IND) applications and Investigational Device Exemption (IDE) applications. I manage INDs/IDEs and provide NIDDK staff and study teams with regulatory guidance. My focus is to ensure that NIDDK-sponsored trials are in compliance with applicable regulatory requirements and Good Clinical Practice (GCP). In the intramural program space, I assist investigators in projects related to the use of stable isotopes.

Prior to joining the NIDDK, I served as a clinical coordinator within the Office of Clinical Trials Operations and Management at the National Institute of Dental and Craniofacial Research (NIDCR). I acted as a liaison between the Data and Safety Monitoring Board (DSMB) and NIDCR and facilitated rigorous independent oversight of clinical studies of high risk or complex nature. In addition, I oversaw quality management activities for clinical sites.

Prior to joining the NIH, I served as a project manager and senior technical writer at a Clinical Research Organization (CRO) where I managed Human Factors (HF) studies for combination products. My responsibilities included assisting with the development of HF study protocols, writing study reports, and proposing strategies to reduce use errors or hazards of combination products.

I have a Doctor of Pharmacy degree from the Bernard J. Dunn School of Pharmacy - Shenandoah University. I am a Board Certified-Geriatric Pharmacist (BCGP) and previously served as a clinical pharmacist helping to optimize pharmacotherapy for patients with multiple comorbidities.