US WorldMeds is Committed to the Future
Ongoing Clinical Trials
Clinical trials are the cornerstone of furthering our mission to improving the lives of patients. US WorldMeds is committed to supporting safe and effective trials that help to better the lives of patients.
Grant & Research Support
As part of our goal to positively change lives through improved healthcare, we are strongly committed to supporting independent medical education activities and Investigator-Initiated Research (IIR). Please see the guidelines below for submitting Medical Education Grant Requests and IIR Requests. We look forward to reviewing your application.
Support by US WorldMeds of independent medical education activities is limited to only those that fall within the company’s specific areas of therapeutic focus.
The completed medical education grant request application should be sent electronically to our Medical Affairs Department at grants@usworldmeds.com.
A completed Medical Education Grant Request consists of the following:
- Cover Letter on institutional letterhead, including:
- Title of program/activity for which support is being sought
- Date(s) of program/activity (if applicable)
- Location of program/activity (if applicable)
- Type and amount of support requested
- Name and type of accredited provider(s)
- Contact person’s name, telephone number, fax number and email address
- Program/Activity Proposal (may also include Program/Activity brochure), including elements of the following:
- Needs Assessment: source(s) and methodology used to identify the medical educational need(s); identification of how the activity should lead or contribute to an improvement in patient care through the advancement of knowledge, medical skills, and/or disease awareness
- Design/type of activity (e.g., single/one-time live activity; enduring material; etc.)
- Program/activity learning objectives
- Intended metrics to measure the impact or behavior change of the educational activity
- Expected Outcomes
- Agenda, including faculty or tentative list (if known)
- Detailed budget, including how the funds (if requested) will be spent and how the requested amount was determined
- Copy of Tax ID letter and/or W-9
- Verification of CME accreditation (copy of provider’s status from accreditation website), if applicable
The contact person at the requesting organization will be notified within three months of receipt of the application with the approval or denial status. Therefore, funding requests must be submitted no later than three (3) months prior to the date of the event, as applicable, to ensure sufficient time for internal review.
Please check back periodically for any updates to current areas of therapeutic focus.
US WorldMeds recognizes that IIRs (also known as Investigator-Initiated Studies or IISs) enable research that has the potential to improve the lives of patients with challenging conditions and unmet medical needs. The program is offered to all institutional and community-based scientists and clinicians who are interested in conducting their own research, and support is awarded based on the scope of the proposal and its scientific merit.
In general, IIRs are smaller in scale than Phase IV Research and are "proof of concept" or "exploratory" in nature. US WorldMeds may provide funding and other forms of support, such as clinical trial materials, to support studies initiated and sponsored by outside researchers.
Research Interests/Requests for Proposal
US WorldMeds is seeking proposals in specific areas of interest including but not limited to High-Risk Neuroblastoma, Synovial Sarcoma, and Myxoid/Round Cell Liposarcoma (MRCLS) and for products Eflornithine (DFMO), Afami-cel (afamitresgene autoleucel), and Lete-cel (letetresgene autoleucel).
Request for Proposals: Investigator-Initiated Studies Evaluating Advanced Synovial Sarcoma Combination Treatment with afamitresgene autoleucel and letetresgene autoleucel. Click here.
Concept IIR Proposal
For consideration of support, a Concept IIR Proposal should be sent electronically to our Medical Affairs department at grants@usworldmeds.com.
A Concept IIR Proposal should include the following, (single PDF preferred):
- Name and contact information for Principal Investigator
- Curriculum Vitae for Principal Investigator
- Name and contact information for Other Investigators (where applicable)
- Study Synopsis (maximum 2-3 pages) including:
- Background and rationale
- Study objectives and endpoints
- Study design and methodology
- Patient population and key eligibility criteria
- Statistical considerations (as applicable)
- Estimated Study duration
- Requested Support
- Type of support (e.g., drug and/or funds)
- High-level Budget Outline, including justification
- Statement indicating whether support is being sought from other sources
- Institutional Capabilities Summary (optional but encouraged).
Complete IIR Proposal
If the Concept IIR Proposal is determined to be of interest to US WorldMeds, notification will be sent via email from grants@usworldmeds.com to the designated Principal Investigator informing them that they may now choose to submit a Complete IIR Proposal.
A Complete IIR Proposal should include the following:
- Full Study Protocol
- A curriculum vitae for each interested investigator and any co- and/or sub-Investigators (if applicable)
- A comprehensive and detailed proposed budget (in U.S. dollars), if applicable
- A 2-way Confidential Disclosure Agreement: In order to protect the ideas of those we work with, please fill out the highlighted fields in this 2-way CDA prior to submitting a complete proposal.
- Other supporting documentation
The Complete IIR Proposal should be sent electronically to our Medical Affairs Department at grants@usworldmeds.com.
If US WorldMeds is able to provide funding/support for the medical education activity or research trial, a Letter of Agreement (provided by US WorldMeds) must be signed by US WorldMeds and the Medical Education Provider or Independent Research Organization.
Any activity for which support is awarded is required to be compliant with and adhere to federal and state guidelines and regulations, including, but not limited to, the FDA Final Guidance on Industry-Supported Scientific and Educational Activities, the Accreditation Council for Continuing Medical Education (ACCME) Standards for Commercial Support, the American Medical Association (AMA) Ethical Guidelines for Gifts to Physicians from Industry, and the Pharmaceutical Research and Manufacturers of America (PhRMA) Code on Interactions with Healthcare Professionals, where applicable.
All grant and research support is awarded at US WorldMeds' sole discretion. Approval of grant funding or research support is never related to or conditioned upon past, promised, or potential future prescriptions or purchases of US WorldMeds' products. US WorldMeds does not offer or provide medical education grants or research support to encourage or to reward the prescription, purchase, ordering, or recommending of US WorldMeds products.
All Grant Requests should be submitted electronically to USWM Medical Affairs via email to: grants@usworldmeds.com
If you have any questions regarding independent medical education grants or IIRs, please contact our Medical Affairs Department at grants@usworldmeds.com.