Investigator Initiated Studies

Investigator initiated studies (IIS) are clinical studies initiated, developed, designed and managed by a qualified sponsor who assumes sole responsibility for conduct and management of the study. We work with a broad range of sponsors including, but not limited to, the following:

• Academic medical centers
• Individual investigators / Researchers
• Collaborative study groups
• Networks and cooperative groups
• Healthcare providers and institutions
• Government research institutions

We support the following types of Investigator Initiated Studies:

• Clinical studies of approved and investigational uses of Genentech medicines, including medicines approved by the FDA or still in development (i.e. interventional studies phase I to IV).
• Clinical observational studies, real world evidence (i.e. non-interventional studies)
• Clinical studies requesting Genentech medicines only

Support for an approved IIS may come in various forms including supplying medicines, funding, material and/or information as allowed under local laws and regulations.

The following are not considered investigator-initiated studies:

• Non-clinical studies. Requests can be submitted here.
• Access to investigational medicines through compassionate use or expanded access. Program details can be found here.

There are three main steps in our IIS approval process and our medical science personnel are available to guide you each step of the way.

1. Discuss Concept with Your MSL
Your MSL can help with pre-approval by discussing your concept with the study review team and providing you with feedback

2. Submit Your Proposal
Access the IIS Portal and follow the instructions within the User Guide to complete your submission. Once you complete your submission, you will receive an email notification indicating that we have received the proposal. This notification will include the Submission ID and a link to a Diversity & Inclusion Questionnaire. We highly encourage you to complete immediately after submitting your proposal.

3. Submit Final Protocol
If your proposal is approved, you will be notified to submit additional details including a budget and protocol

Research proposals will be reviewed and approved based on scientific merit and alignment with our areas of strategic interest. We evaluate all funding requests against local fair market value. Funding requests for expenses not associated with the conduct of the study are strictly prohibited.

Investigator Initiated Studies are an important part of our R&D activities, and we hold all sponsors to the same high standards to which we hold ourselves. To be considered for support, a sponsor must fulfill the following requirements:

• Have the scientific, technical and operational capabilities to conduct the study including statistical support.
• Be able to fulfill all regulatory requirements (e.g. submit a IND/CTA and write the final study report and manuscripts) and comply with all relevant laws.

In accordance with the research agreement, sponsors must also:

• Provide regular study status updates to Genentech and deliver according to agreed timelines
• Provide Genentech and health authorities with safety reports
• Deliver a written report of the final study results to Genentech
• Publish the study results in a scientific journal

Before support can be initiated, the following documents must be in place:

• A fully executed IIS agreement between the sponsor and Genentech
• A fully executed IIS safety data exchange agreement between the sponsor and Genentech (or equivalent)
• An EC/IRB and/or Health Authority Approval.