International Pharmaceutical Federation (FIP) and Pfizer Announce aQuality Improvement Grant RFP

Gene Therapy Site-Preparedness
Competitive Grant Program

I. Introduction
This Request for Proposals (RFP) is for initiatives that span multiple rare disease areas. The International
Pharmaceutical Federation (FIP) and Pfizer Global Medical Grants are collaborating to offer a new competitive grant
opportunity focused on Pharmacy teams and the integration of gene therapy into the treatment armamentarium forpatients with a Rare Disease. The focus is the roles of pharmacy in ensuring gene therapy site preparedness in themanagement of rare diseases, and then by sharing learnings and experiences more widely.
About the International Pharmaceutical Federation (FIP):
The FIP mission is to support global health by enabling the advancement of pharmaceutical practice, sciences andeducation. Our vision is for a world where everyone benefits from access to safe, effective, quality and affordable
medicines and health technologies, as well as from pharmaceutical care services provided by pharmacists, incollaboration with other healthcare professionals. Evaluating the role that pharmacists play to ensure site
preparedness in this important area of gene therapy in rare disease is an important development, to provide
guidance, toolkits and support for the profession in the logistics required in this area. FIP will provide technicalassistance and support to grantees, establishing a learning community for grantees.
About Pfizer Global Medical Grants (GMG):
Pfizer Global Medical Grants (GMG) 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 arealigned with Pfizer’s medical and/or scientific strategies.
Pfizer’s GMG competitive grant programme involves a publicly posted Request for Proposal (RFP) that provides
detail regarding a specific area of interest, sets timelines for review and approval, and uses an expert review panel(ERP) to make final grant decisions. Organizations are invited to submit an application addressing the specific gaps
in practice as outlined in the specific RFP.
For all quality improvement grants, the grant requester (and ultimately the grantee) is responsible for the design,
implementation, and conduct of the independent initiative supported by the grant. Pfizer must not be involved in any
aspect of project development, nor the conduct or monitoring of the quality improvement program.

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II. Eligibility
Geographic Scope:

GlobalApplicant EligibilityCriteria•

Applicant must be a FIP Member Organization or collaborate with a FIP
Member Organization or constituency.

•

Only organizations are eligible to receive grants, not individuals or
medical practice groups.

III. Requirements
Date RFP Issued

15 November 2022

Clinical Area

Gene Therapy- Rare Disease

Specific Area of Interestfor this RFP:

•Projects that will be considered for support will focus on operationallypreparing and/or optimizing Institutional Pharmacists for the integrationof recombinant Adeno-Associated Virus (rAAV) gene therapy into thetreatment armamentarium for patients with a Rare Disease.

•Support is available for the development of initiatives that will result in
operational preparedness, needs-assessment, development ofleadership, standards of care, best practices, SOP development, site
readiness, support and/or operational training of pharmacists to improve
the site’s readiness for rAAV gene therapy delivery.

•Proposals should be related to rAAV gene therapy operational quality
improvement that is therapeutic area and disease area agnostic (i.e.,
not related to a specific rare disease or group of rare diseases)•Proposals tailored to a specific rare disease or group of rare diseases
will not be considered.

•Proposals that are primarily related to gene therapy medical andscientific education will not be considered.

It is not our intent to support clinical research projects. Projects evaluating
the efficacy of therapeutic or diagnostic agents will not be considered.

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Target Audience:

Pharmacists / pharmaceutical scientists.

Background:

Pharmacists have a key role in the proper handling and generalmanagement of gene replacement therapies, identifying risk level,
establishing infrastructure, and developing adequate policies andprotocols.1, 2

Expected Approximate
Monetary Range ofGrant Applications:•Individual projects requesting up to $50,000 will be considered. The
estimated total available budget related to this RFP is $150,000.

•The amount of the grant Pfizer will be prepared to fund for any projectwill depend upon the expert review panel’s evaluation of the proposal
and costs involved and will be stated clearly in the grant agreement.

Key Dates:•RFP release date: 15 November 2022•

Application Deadline: 18 January 2023•

Review of Applications by Expert Review Panel: February 2023•

Anticipated Full Proposal Notification Date: March 2023•

Grants distributed following execution of fully signed Grant Contract•

Anticipated Project Start Date: May 2023•

Please go to www.cybergrants.com/pfizer/QI and sign in. First-timeusers should click “REGISTER NOW”. [Note: there are individual portals for

How to Submit:

each grant application type. Please be sure to use the URL above.]•

Click the “Start A New Quality Improvement Application” button.

•For the question “Competitive Grant?” select Yes•

Select the following Competitive Grant Program Name: 2023 RD G FIP Gene Tx Site Preparedness QI•

Requirements for submission: Complete all required sections of theonline application (see Appendix).

•If you encounter any technical difficulties with the website, please click
the “Technical Questions” link at the bottom of the page.

IMPORTANT: Be advised applications submitted through the wrong
application type and/or submitted after the due date will not be reviewed bythe committee.

Questions:•If you have questions regarding this RFP, please direct them in writing
to the Pfizer Grant Officer, Amanda Stein (amanda.j.stein@pfizer.com)
or to Carola van der Hoeff (carola@fip.org) at FIP.

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[Title/Clinical Area]

Grant Agreements:••

Review and Approval
Process

Mechanism by which
Applicants will beNotified:

••

•
•

If your grant is approved, your institution will be required to enter into awritten grant agreement with Pfizer. Please click here to view the coreterms of the agreement.
Pfizer has drafted the terms of these agreements to be balanced andreasonable and to further the goals of both parties. Negotiating grant
agreements requires significant resources, so please ensure that yourinstitution (including your legal department) is able and willing to abideby these terms before proceeding with submission of your application
as they will need to be accepted in their entirety.
A specific grant program RFP uses an expert review panel (ERP) to
make final grant decisions.
The panels are comprised of professionals from the medical community
with advanced degrees and expertise in particular clinical areas, orspeciﬁc needs of a geographic region/learner group, or expertise inresearch, continuing professional development or quality improvement
All applicants will be notified via email by the dates noted above.
Applicants may be asked for additional clarification during the review
period.

References:
1. Petrich J, Marchese D, Jenkins C, Storey M, Blind J. Gene Replacement Therapy: A Primer for theHealth-system Pharmacist. Journal of Pharmacy Practice. 2020;33(6):846-855.
doi:10.1177/0897190019854962
2. Myers CJ. Preparing pharmacists to manage gene therapies. J Am Pharm Assoc (2003).
2021;61(3):e78-e82. doi:10.1016/j.japh.2020.11.018

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Appendix A
Proposal Requirements
Applications will be accepted via the online portal. The main section of the full proposal
document should be no longer than 12 pages in length (12-point font and 1-inch margins)
excluding Organization Detail, References, and Budget Narrative. The full proposal should beuploaded in the portal as a single document.
Goals and Objectives•

Briefly state the overall goal of the project. Also describe how this goalaligns with the focus of the RFP and the goals of the applicantorganization(s).

•List the overall objectives you plan to meet with your project both in termsof learning and expected outcomes. Objectives should describe thetarget population as well as the outcomes you expect to achieve as aresult of conducting the project.

Assessment of Needfor the Project•

Please include a quantitative baseline data summary, initial metrics (e.g.,quality measures), or a project starting point (please cite data on gap
analyses or relevant patient-level data that informs the stated objectives)in your target area. Describe the source and method used to collect thedata. Describe how the data was analyzed to determine that a gap
existed. If a full analysis has not yet been conducted, please include a
description of your plan to obtain this information.

Target Audience•Describe the primary audience(s) targeted for this project. 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 andMethods•

Describe the planned project and the way it addresses the establishedneed.

•If your methods include educational activities, please describe succinctly
the topic(s) and format of those activities•

Please describe how the project submitted supports diversity, equity, andinclusion either through the study population targeted or through theproject team that is directly involved•

Explain what measures you have taken to assure that this project idea isoriginal and does not duplicate other projects or materials alreadydeveloped.

•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.

Innovation

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[Title/Clinical Area]

Evaluation andOutcomes•

In terms of the metrics used for the needs assessment, describe how you
will determine if the practice gap was addressed for the target group.
Describe how you expect to collect and analyze the data.

•Quantify the amount of change expected from this project in terms ofyour target audience.

•Describe how the project outcomes will be broadly disseminated.

Anticipated ProjectTimeline•

Provide an anticipated timeline for your project including project start/enddates

Additional Information•

If there is any additional information you feel Pfizer should be aware ofconcerning the importance of this project, please summarize here

Organization Detail•

Describe the attributes of the institutions / organizations / associations
that will support and facilitate the execution of the project and theleadership of the proposed project. Articulate the specific role of eachpartner in the proposed project. Letters of support from partnerorganizations will be required at the Full Proposal stage only and should
not be included with the LOI.

Budget Detail•

While estimating your budget please keep the following items in mind:•oGeneral organizational running costs such as insurances, heating,lighting, rent, building maintenance may be included. Pfizer does notprovide funding for capital purchases (infrastructure expenses suchas equipment, purchases of software or software licenses,
technology or bricks and mortar). Equipment hire/leasing isacceptable and may be included in project budget. The inclusion ofthese costs cannot cause the amount requested to exceed thebudget limit set forth in the RFP.

oThe inclusion of these costs cannot cause the amount requested toexceed the budget limit set forth in the RFP.

oIt should be noted that grants awarded through GMG cannot be
used to purchase Pfizer therapeutic agents (prescription or nonprescription).

Pfizer maintains a company-wide, maximum allowed overhead rate of
28% for independent studies and projects. Please click here for details.

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