Mining Electronic Health Records

  • Partnership with the Institute for Healthcare Policy Innovation (IHPI) Data Methods Hub
  • Access to de-identified electronic health record data sets to make associations between drugs and diagnosis codes, lab results
  • Can establish safety for IND submission to the FDA for drug repurposing projects and can generate new associations between drugs and diseases.

FDA regulatory support for drug repurposing projects with the MICHR-MIAP team

  • We have developed specific FDA regulatory strategies for drug repurposing with the MICHR IND/IDE Investigator Assistance Program (MIAP)
  •  Provides consultation on research involving investigational agents (drugs, devices, and biologics) that includes:
    •  Determination of regulatory pathway and need for an IND (Investigational New Drug) or exemption, IDE (Investigational Device Exemption), orphan disease designation, or humanitarian use device (HUD).
    • Protocol and informed consent review and assistance.
    • Assistance with FDA meeting requests, preparation, and support.
    • Expertise and guidance on navigating investigational agent regulation and compliance.
  • An Investigator IND is submitted by a physician who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed.  A physician might submit a research IND to propose studying an unapproved drug, or an approved product for a new indication or in a new patient population.
  • Emergency Use IND  allows the FDA to authorize use of an experimental drug in an emergency situation that does not allow time for submission of an IND in accordance with  21CFR , Sec. 312.23 or Sec. 312.20.  It is also used for patients who do not meet the criteria of an existing study protocol, or if an approved study protocol does not exist.
  • Treatment IND is submitted for experimental drugs showing promise in clinical testing for serious or immediately life-threatening conditions while the final clinical work is conducted and the FDA review takes place.