In my position, I provide comprehensive regulatory support, guidance, and education services to investigators active in FDA-regulated clinical research.
- Investigational New Drug (IND)/Investigational Device Exemption (IDE) application preparation and submission to the FDA
- IND/IDE Consultation & Development; provides support for research involving investigational agents (drugs, devices, and biologics).
- IND/IDE Lifecycle Maintenance offers support for all submissions that may be required by an active IND or IDE.
- Clinical protocols development, review and editing
Pharmacy School Attended: University of Michigan (1992)
Areas of Interest
Protocol development and review (oncology), Patient education –investigational drugs, Regulatory (IND submission and support, expanded access)
Published Articles or Reviews
- SidenR, ModlinJ,Lee-Gabel L,RedicKA.Handout for research subjects receiving investigational oral chemotherapy. Am J Health-Syst Phar.2019; 76:2009-12.
- Hertz DL, Siden R, Modlin J, Au L, Lee-Gabel L, Wong SF. Frequency and Description of Drug Interaction Screening within Southwest Oncology Group (SWOG) Clinical Trials. Am J Health-Syst Phar. 2018; 75:607-12.
- Siden R, Redic K.Are you involved in a clinical trial: Here’s how to take your medications safely. ASHP SafeMediation website.