Investigator Initiated Trials

Phathom's Support of Investigator Initiated Trials

As part of our passion for improving patient lives, Phathom is committed to the support of independent clinical research conducted by third-party sponsors (investigators) through Investigator Initiated Trials (IITs).

Learn more about Phathom's Support of IITs

IIT requests should focus on the following topics for one or more of our therapeutic areas of focus:

  • Increasing HCP awareness, including the prevalence, clinical manifestations of disease and associated complications, and diagnostic and treatment considerations
  • Educating on recent updates to treatment guidelines to improve their ability to identify patients who require appropriate diagnostic work-up and treatment
  • Increasing awareness of new therapeutic options and the risk/benefit profiles of current and emerging therapies to enable evidence-based decisions in treatment management

IIT requests in areas and diseases outside of our areas of interest will not generally be considered. The types of programs that Phathom supports are for the purposes of furthering objective and scientific discourse or healthcare provider and/or other healthcare-related personnel education and must be independent of Phathom’s influence.

 

Phathom will consider supporting grants for programs including, without limitation, the following:

  • Accredited Continuing Medical Education programs
  • Non-Accredited Medical Education programs

All grant requests should be submitted and completed in the Grants Portal at least 60 days prior to the activity start date.

IIT Frequently Asked Questions (FAQs)

Click the questions below to view answers to the most frequently asked questions (FAQs) on applying for an Investigator Initiated Trial (IIT) support.

Creating an Account

If you do not yet have a registered account for Phathom’s grant portal, click here to create an account.

Once registered on the Phathom grants portal, you can click on the “Access the Grants Portal” button above and you will be directed to our Phathom grants portal. You can alternatively visit the Phathom grants portal directly at https://phathom.medcompli.com.

Upon logging in to the Phathom grants portal, you can complete the online Grant Request Form as directed and upload the required documentation. You may request an Independent Medical Education (IME) grant or an Investigator-Initiated Trial (IIT) grant.

Note: Sponsorship requests should not be submitted through the grants portal. These requests should instead be directed to the Phathom Pharmaceuticals Commercial and/or Corporate Affairs team by sending a detailed email to Sponsorships@PhathomPharma.com.

Eligibility for IIT Support

Any medical or research institution, medical education company, non-profit professional association, or other qualified entity may receive support for both accredited education (CME) and non-accredited IME programs. Phathom prefers to fund educational programs that are organized by or through accredited, independent, third-party medical education providers.

Types of grants that Phathom will not fund include the following: educational activities that are designed to generate business for Phathom, grant requestor/recipient who is an individual or physician practice, grant requests for items that are promotional in nature, hiring of staff that are not dedicated to the proposed educational activity, political organizations, purchases of capital equipment unrelated to the educational activity or that would generate revenue, sponsorships, and construction funds to build new facilities.

Grant funds may not be used to subsidize recreational events or entertainment, travel or lodging or other personal expenses of non-faculty attendees, extravagant meals or receptions or other activities that are not incidental to the main educational goals of the program.

No, Phathom cannot provide speaker suggestions as per Phathom policies and Industry guidelines. Responsibility for and control over the faculty, content, and venue for an educational event belongs solely to the event organizer(s).

No, only the Phathom Grants Coordinator may assist you with your IME grant request or provide updates on its status. Commercial staff are not involved in the grant submission process or in decisions to fund educational activities.

Required Submission Materials, Timelines and Decision Making

  • Completed Educational Grant Request Form via the Grant Portal
  • W‐9 Form of your organization
  • Documentation of non-profit status, if applicable
  • Signed Letter of Request on your company letterhead, including description of program and amount of grant support sought
  • Accreditation Statement if event is to be provided by an accredited CME provider
  • Needs Assessment describing the educational need that the program is designed to address (should align with Phathom’s areas of therapeutic interest)
  • A description of the Intended Audience and Recruitment Plan for the Program, expected number of attendees, and how the audience will be recruited. May include this information in the Letter of Request and/or Needs Assessment if you would like to do so.
  • Agenda if applicable
  • Detailed Budget showing projected revenues (including learner/participant registration fees, industry support, etc.) and all program costs including live program costs as well as the costs of enduring materials and programs, if any
  • Supporting Documentation e.g., Program Brochure, Invitation, etc.

Yes. Please submit a budget for all costs associated with the entire program (not just a portion for which funding is sought from Phathom) including a breakdown of per person costs for each line item available, as well as all projected revenues. Phathom has provided a budget template should you wish to use the template.

To upload documents within a request submission, navigate to the upload component within the form.

Here, you will see text that reads, “Drop files to attach or browse.” To drag and drop and file into the upload box, drag the file from an external window into the upload box window within the form. Alternatively, select “browse” to upload from your device files. Select your document for upload from the list. Select “Upload.” To review your document, select the link created once uploaded. Be sure to allow pop-ups so the document may open in a secondary window.

All grant requests should be submitted and completed on the website at least 60 days prior to the activity start date.

Phathom will consider every grant request received within the therapeutic areas of interest (as noted on our website and grants portal). Grant requestors and/or their education partner(s) must be providers in good standing to be eligible for review. Grant requests must comply with Phathom policies as well as relevant laws, regulations, and industry guidance. Criteria for awarding grants include educational strategy and goals, scientific merit, addressing an unmet educational need, anticipated outcomes, target audience, availability of funds, adequate review time, and past performance.

Between 15-45 days after submission of your application, Phathom will notify you via email if your request is approved or declined. If your request has been approved, you will receive further instructions for executing a Letter of Agreement (LOA) with Phathom that is a required prerequisite to final approval and to receiving your grant funding. Grant review may take longer if any required information is not received with your application or additional information is required from the applicant.

All contact is made via email to the address entered during the application process on the Phathom grants portal (https://phathom.medcompli.com). For questions regarding a submitted grant funding request, please communicate through the grants portal. For general questions not related to a funding request, contact Phathom directly at Grants@phathompharma.com.

Decline decisions are final. A declined request cannot be re-submitted.

Contracts and Payments

No, a Letter of Agreement (LOA) must be signed by all relevant parties prior to being eligible to receive grant funding from Phathom. The LOA outlines the responsibilities of the parties with respect to the provision of the grant funding and any related activities. Phathom reserves the right to withdraw funding if the LOA is not signed by the applicant within an acceptable time frame prior to the program date.

You will receive notification that your grant request has been approved via email. At or around the same time, the Letter of Agreement (LOA) will be sent for your review.

Phathom’s Letter of Agreement (LOA) has been created to meet applicable industry guidance and to protect the interest of providers and Phathom. Most LOAs are executed without any changes. Nevertheless, Phathom recognizes that certain government-affiliated and other institutions may require specific language or revisions to certain provisions in our standard LOA. To that end, Phathom Legal counsel will work with you to negotiate requested changes. Phathom reserves the right to reject changes and decline a grant request if terms acceptable to Phathom cannot be achieved. Negotiations to language may lead to increased time to process and provide funding.

After the execution of the Letter of Agreement, a request to submit an invoice will be sent. Once an invoice is received, it generally takes up to 30 days to receive funding. A check in the approved amount will be issued and mailed to the grant requestor.

Reconciliation and Close-Out

The Education Provider will complete the final budget report, including actual expenditures and revenues as submitted with the original grant request within 60 days of the Program, and will return to Phathom all Grant Funds not used for the Program. If there was an outcomes assessment conducted with the attendees, please submit that report as well.

No, any funds provided are to be used for the specific Program for which the applicant was awarded an IME grant. Unexpended funds cannot be applied to another Program. Unused funds must be refunded to Phathom within 90 days of the final Program.

Additional Questions

For questions regarding a submitted grant funding request, please communicate through the grants portal. For general questions not related to a funding request, contact Phathom directly at Grants@phathompharma.com.

*Any info to add here?