Direct Access Program

The Direct Access Program is designed to provide commercial or investigational drug only. No additional funds will be provided to conduct Pre-Clinical or Clinical Research. We review each request regarding use of our drugs for content, value, and consistency with La Jolla’s direction for the requested drug. For approved requests, La Jolla requires a Material Transfer Agreement (MTA) to provide the drug to a third party to conduct the agreed upon study. We require a final manuscript or report of the conclusions to bring closure to the study.

When requesting drug, please follow the guidelines below and provide a study outline:

Study outline (2-page maximum):

  • Study hypothesis (medical/scientific question to be addressed)
  • Background & rationale
  • Study objectives
  • Inclusion/exclusion criteria (Clinical studies)
  • Study design/schedule (including treatments/procedures) (Clinical studies)
  • Patient population criteria (Clinical studies)
  • Study endpoints with statistical justification for the end points
  • Publication plan
  • Drug accountability/use plan
  • Please indicate if Government funding is used to conduct research
  • Literature cited
  • Principal Investigator CV will be needed with Submission to process your request

Submit Direct Access applications/proposals to MAresearch@ljpc.com