Invasive Mold Infections (IMI) - Real-World Evidence from Treatment Outcomes with Isavuconazole Grant

Pfizer Inc. is dedicated to advancing healthcare through innovative research and treatment options. The Invasive Mold Infections (IMI) program aims to bridge knowledge gaps regarding isavuconazole's effectiveness in real-world settings. The initiative seeks proposals that explore isavuconazole as a first-line therapy, its outcomes in various patient populations, and the management of drug interactions to enhance patient outcomes and reduce the burden of invasive mold infections.

Pfizer Inc.
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Competitive Grants Program
Pfizer supports the global healthcare community’s independent initiatives (e.g., research, quality improvement or education) to improve patient outcomes in areas of unmet medical need that are aligned with Pfizer’s medical and/or scientific strategies.
Invasive Mold Infections (IMI) - Real-World Evidence from Treatment Outcomes with Isavuconazole
This competitive program aims to support research proposals that address data gaps concerning Invasive Mold Infectionsin in real-world settings. This initiative seeks to advance clinical understanding of isavuconazole within the treatment landscape. The goal is to address critical knowledge gaps and develop evidence-based strategies to optimize treatment with isavuconazole, improve patient outcomes, and reduce morbidity and mortality associated with these infections. Proposals with the following areas of interest will be considered:
Isavuconazole as first line therapy and the burden of IMI disease in adutl and pediatric settings in onco-hematology, solid organ transplant, immunosuppressant usage, post-viral infections, intensive care settings, chronic obstructive pulmonary diseases, CAR-T cell therapy, and presence of coinfections between Invasive Aspergillosis and Invasive MucormycosisIsavuconazole usage outcomes for mould infections in the Central Nervous System (CNS)Isavuconazole use and therapeutic dosage monitoring (TDM) in severely ill patients and special populationsDrug-drug interactions management in real world settingsBreakthrough infections after azol treatment

Application Details

Overview
This competitive program aims to support research proposals that address data
gaps concerning Invasive Mold Infectionsin in real-world settings. This initiative
seeks to advance clinical understanding of isavuconazole within the treatment
landscape.
The goal is to address critical knowledge gaps and develop evidence-based
strategies to optimize treatment with isavuconazole, improve patient outcomes, and
reduce morbidity and mortality associated with these infections.
Project Types and Area of Interest
Proposals with the following areas of interest will be considered:

• • Isavuconazole as first line therapy and the burden of IMI disease in adutl and
• pediatric settings in onco-hematology, solid organ transplant,
• immunosuppressant usage, post-viral infections, intensive care settings, chronic
• obstructive pulmonary diseases, CAR-T cell therapy, and presence of co-
• infections between Invasive Aspergillosis and Invasive Mucormycosis
• • Isavuconazole usage outcomes for mould infections in the Central Nervous
• System (CNS)
• • Isavuconazole use and therapeutic dosage monitoring (TDM) in severely ill
• patients and special populations
• • Drug-drug interactions management in real world settings
• • Breakthrough infections after azol treatment
• Key Milestones
• Anticipated Grant Anticipated Project
• Submission Deadline
• Award Notification Start Date/Duration
• 29 July 2025 October 2025 January 2026
• Funding Range and Project Length
• Individual projects requesting up to $30,000 USD will be considered.
• Maximum project length is 10 months.

I. Eligibility
Geographic Scope:

• Australia, Germany, Israel, Italy, Spain, and Switzerland
• Applicant Eligibility Criteria:
• • The institution and Principal Investigator (PI) must be based in one of the eligible countries noted above.
• • Only organizations are eligible to receive grants, not individuals or medical practice groups (i.e., an
• independent group of physicians not affiliated with a hospital, academic institution, or professional
• society).
• • If the project involves multiple departments within an institution and/or between different institutions /
• organizations / associations, all institutions must have a relevant role and the requesting organization
• must have a key role in the project.
• • The PI must have a medical or postdoctoral degree (MD, PhD, or equivalent), an advanced nursing
• degree (BSN with a MS/PhD), or a degree in Pharmacy, Physiotherapy, or Social Work.
• • The applicant must be the PI or an authorized designee of such individual (e.g., PI’s research
• coordinator).
• • The PI must be an employee or contractor of the requesting organization.
• Requesting organization must be legally able to receive award funding directly from Pfizer Inc.

strongly recommend that applicants confirm this with their organization or institution prior to submitting
an application. Grants awarded to organizations that are subsequently found to be unable to accept
funding directly from Pfizer Inc. may be subject to rescission.
II. Requirements
Primary Area of Interest:

• Infectious Disease - Fungal - RES
• General Area of Interest for this RFP:
• Projects to be considered for Pfizer support will focus on the following areas:
• • Real-world evidence studies leveraging quality data sources for description and analysis of

Isavuconazole treatment outcomes. Data sources can be: demographics data, surveillance systems,
electronic health records, clinical and lab registries, patient reported clinical outcomes, wearables, or
any other good quality data types able to provide reliable results.

• The burden of the disease across different populations, including onco-hematology, solid organ

transplant, immunosuppressant usage, post-viral infections, intensive care settings, chronic obstructive
pulmonary diseases, and presence of co-infections between Invasive Aspergillosis and Invasive
Mucormycosis.

• Isavuconazole as first line therapy in onco-hematology, solid organ transplant, immunosuppressant

usage, post-viral infections, intensive care settings, chronic obstructive pulmonary diseases, CAR-T cell
recipients, etc.) and presence of co-infections between Invasive Aspergillosis and Invasive
Mucormycosis.

• Isavuconazole and Central Nervous System (CNS) infections and outcomes.
• Isavuconazole and therapeutic dosage monitoring in severely ill patients and special populations such

as, but not restricted to: ECMO, Renal replacement therapy, obese, hypoalbuminemic patients, pediatric
(efficacy and safety beyond plasma levels).
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• Drug-drug interactions management with isavuconazole in real-world settings in adult and pediatric

settings.

• Breakthrough infections after azol treatment.

Expected Approximate Monetary Range of Grant Applications:

• IMPORTANT: Grants will be distributed following a fully executed agreement and submission of Final Protocol,
• Documentation of IRB/IEC Approval, Regulatory Approval (if applicable), Exemption or Waiver.
• Individual projects requesting up to $30,000 USD will be considered. The estimated total available

budget related to this RFP is $100,000 USD.

• Award amounts include direct costs, institutional overhead costs (capped at 28% per Pfizer policy), and

indirect costs.
Key Dates:

• Anticipated Grant Anticipated Project
• RFP Release Date Award Notification End Date
• 10 June 2025 October 2025 October 2026
• Submission Deadline* Anticipated Project
• 29 July 2025 Start Date
• January 2026
• IMPORTANT: Be advised applications submitted after the due date will not be reviewed.
• • *Please note the deadline is 23:59 Eastern Standard Time (e.g., New York, GMT -5)
• How to Submit:
• IMPORTANT: Please read this section carefully since applications submitted not following these
• instructions will not be accepted and will be cancelled.
• Please go to: www.cybergrants.com/pfizer/Research and sign in.

Note: there are individual portals for each grant application type. Please be sure to use the URL above.
First-time users should click “Create your password”.
Click the “Start A New Research Grant Application” button.
Requirements for submission:

• Complete all required sections of the online application
• IMPORTANT: Upload proposal (see Appendix) in the Proposal/Protocol field.
• In the application:
• For the question “Competitive Grant?” select “Yes”
• Select the following Primary Area of Interest: Infectious Disease - Fungal - RES
• Select the following Competitive Grant Program Name: 2025 I&I G Invasive Mold Infections Real
• World Evidence RES
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Questions:

• • If you encounter any technical difficulties with the website, please click here or the “Technical
• Questions” link at the bottom of the page in Cybergrants.
• • Please click here to view “Frequently Asked Questions” regarding the Competitive Grant Program.
• • If you have questions regarding this RFP, please direct them in writing to the Grant Officer, Talita
• Honorato-Rzeszewicz (Talita.Honorato-Rzeszewicz@pfizer.com ), with the subject line “Invasive Mold
• Diseases (IMD) - Real World Evidence from Treatment Outcomes 2025”
• Review and Approval Process:
• • Grant requests received in response to a general RFP are reviewed by Pfizer to make final grant
• decisions.
• Mechanism by which Applicants will be Notified:
• • All applicants will be notified via email by the dates noted above.
• • Applicants may be asked for additional clarification during the review period.
• Grant Agreements:
• • If your grant is approved, your institution will be required to enter into a written grant agreement with

Pfizer. Please click here to view the core terms of the agreement.

• Under Pfizer's competitive grant program, modifications to grant agreements will not be reviewed unless

a genuine conflict exists as between applicable law and the terms of the relevant grant
agreement. Applicant is encouraged to share the core terms with counsel for approval prior to
submitting an application.

• Except where prohibited by applicable law and, in any case, subject to review by Pfizer Legal, payment

of grant funding may only be paid to the grantee organization.

• This RFP is supported by Pfizer Inc. and, if approved, payment will be sent from the United States.

References:

• Bitar D et al. Emerg Infect Dis. 2014;20:1149-1155; 2. Webb BJ et al. Open Forum Infect Dis.

2018;5:ofy187; 3. Skiada A et al. J Fungi (Basel). 2020;6:265; Bongomin F et al. J Fungi
(Basel). 2017;3:57; 2. Bitar D et al. Emerg Infect Dis. 2014;20:1149-1155; 3. Prakash H, Chakrabarti A.
J Fungi (Basel). 2019;5:26; 4. Denning DW. Lancet Infect Dis. 24;7:428-438

• Liu, F., Panagiotakos, D. Real-world data: a brief review of the methods, applications, challenges and

opportunities. BMC Med Res Methodol 22, 287 (2022). https://doi.org/10.1186/s12874-022-01768-6
About Pfizer Grants:

• • Pfizer supports the global healthcare community’s independent initiatives (e.g., research, quality
• improvement or education) to improve patient outcomes in areas of unmet medical need that are
• aligned with Pfizer’s medical and/or scientific strategies.
• • Pfizer’s competitive grant program involves a publicly posted general Request for Proposal (RFP) that
• provides detail regarding a general area of interest, sets timelines for review and approval, and uses an

internal Pfizer review process to make final grant decisions. Organizations are invited to submit an
application addressing the research gaps as outlined in the specific RFP.

• For all Investigator Sponsored Research (ISRs) and general research grants, the grant requester (and

ultimately the grantee) is responsible for the design, implementation, sponsorship, and conduct of the
independent initiative supported by the grant, including compliance with any regulatory requirements.
Pfizer must not be involved in any aspect of study protocol or project development, nor the conduct or
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monitoring of the research program. An ISR grant request cannot be submitted for a study that has
already commenced and was not originally supported by Pfizer.

IMPORTANT: RFP Submission Requirements
Applications will be accepted via the online portal listed in the How to Submit section. Project
Proposals/Protocols should be single-spaced using Calibri 12-point font and 1-inch margins. Note there is a
15-page limit exclusive of references. When uploading your Full Proposal please ensure it addresses the
following sections:

• Goals and Objectives
• Provide the main goal of the study and the study population. Provide a detailed definition that is directly

linked to the primary objective.
Assessment of Need for the Project

• This should reflect your study rationale. Provide a brief description of the medical/scientific question and

the rationale of how this trial or study addresses the question.
Study Population

• Describe the study population for this project. Please specify all clinically relevant characteristics,

including the age, gender and other demographic information for the study population.

• Also indicate whom you believe will directly benefit from the project outcomes. Describe the overall

population size as well as the size of your sample population.
Project Design and Methods

• Describe concisely the research design and methods for achieving the stated goals. Describe the data

source, potential sources of bias in the data and methods to deal with bias or missing data;
inclusion/exclusion criteria, sample size, and statistical plan.
Innovation

• Explain what measures you have taken to assure that this project idea is original and does not duplicate

other projects. Describe how this project builds upon existing work, pilot projects, or ongoing projects
developed either by your institution or other institutions related to this project.
Evaluation and Outcomes

• Specify type and frequency of safety, efficacy, and/or outcome measures. Also indicate the method(s)

used to assess measures.

• Provide a publication plan describing intended submission of abstracts to (a) congress(es) or intended

submission of (a) publication(s) to peer-reviewed journals.
Anticipated Project Timeline

• Provide an anticipated timeline for your project including project start/end dates.
• An ISR grant request cannot be submitted for a study that has already commenced and was not

originally supported by Pfizer.
Additional Information

• If there is any additional information you feel Pfizer should be aware of concerning the importance of this

project, please summarize here.

• Early-career applicants: Letter(s) of support from mentor(s) and collaborators describing how the award

will advance the applicant’s career.
Organization Detail

• This information is used to assess the capability of the organizational resources available to perform the

effort proposed. Identify the facilities to be used [laboratory, animal, clinical and “other”]. If appropriate,
indicate their capacities, pertinent capabilities, relative proximity and extent of availability to the project.

Budget Detail

• The budget amount requested must be in U.S. dollars (USD).
• While estimating your budget please keep the following items in mind:
• • General organizational running costs such as legal fees, insurance, heating, and lighting etc. should be

included in an Institutional Overhead (if required). These costs are not specific to a grant request and
therefore, should not appear as line items in budgets. However, costs that are specific to the study (e.g.,
some countries require insurance to be taken out on a per-study basis for clinical research) would be
acceptable to be included as line items.

• The inclusion of these costs cannot cause the amount requested to exceed the budget limit set forth in

the RFP.

• Pfizer does not provide funding for capital purchases (infrastructure expenses such as equipment,

purchases of software or software licenses, technology or bricks and mortar). Equipment hire/leasing is
acceptable and may be included in project budget.

• It should be noted that grants awarded through GMGP cannot be used to purchase Pfizer therapeutic

agents (prescription or non-prescription).

• Pfizer maintains a company-wide, maximum allowed overhead rate of 28% for independent studies and

projects. Please click here for details.
• Initial Study Protocol

• Organizations must obtain approval from an Institutional Review Board (IRB) for their proposal to be

eligible to receive the grant award, if the study design requires IRB approval. It is not mandatory to have
IRB approval at the time of proposal submission. However, organizations are anticipated to secure an
IRB evaluation subsequent to the award notification and must ensure that the approval is in place prior
to 19 December 2025.