Pfizer Announces a Quality Improvement Grant RFP

Quality Improvement Grants to Support the Delivery ofGene Therapies to Patients with Rare Disease by aMultidisciplinary Team
Competitive Grant Program - internal Pfizer review process
I. BackgroundPfizer 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 are aligned with Pfizer’s medical and/or scientific strategies.
Pfizer’s GMG competitive grant program involves a publicly posted Request for Proposal (RFP) thatprovides detail regarding a general area of interest, sets timelines for review and approval, and uses aninternal Pfizer review process to make final grant decisions. Organizations are invited to submit anapplication addressing the practice gaps as outlined in the specific RFP.
For all independent quality improvement grants, the grant requester (and ultimately the grantee) is
responsible for the design, implementation, and conduct of the independent initiative supported by thegrant. Pfizer must not be involved in any aspect of project development, nor the conduct or monitoringof the quality improvement program.

3 Grants to Support Delivery of Gene Therapies to Patients with Rare Disease
QIII. Eligibility
Geographic Scope:

GlobalApplicant Eligibility
Criteria•

The following may apply: medical, dental, nursing, allied health, and/or
pharmacy professional schools; healthcare institutions (both large andsmall); professional associations and medical societies; medicaleducation companies; and other entities with a mission related tohealthcare professional education and/or healthcare improvement.

•If the project involves multiple departments within an institution and/orbetween different institutions / organizations / associations, all institutions
must have a relevant role and the requesting organization must have akey role in the project.

III. Requirements
Date RFP Issued

14 July 2022

Clinical Area

Gene Therapy- Rare Disease

General Area of Interestfor this RFP:

•Projects that will be considered for Pfizer support will focus on
operationally preparing and/or optimizing multidisciplinary care teams
for the integration of recombinant Adeno-Associated Virus (rAAV) genetherapy into the treatment armamentarium for patients with a RareDisease.

•Support is available for the development of initiatives that will result inoperational preparedness, needs-assessment, development ofleadership, standards of care, best practices, SOP development, site
readiness, support and/or operational training of HCPs within amultidisciplinary team environment 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)
oProposals tailored to a specific rare disease or group of rarediseases will not be considered.

oProposals 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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3 Grants to Support Delivery of Gene Therapies to Patients with Rare Disease
QI

Target Audience:•Members of multidisciplinary care teams for gene therapy including butnot limited to Medical Geneticists, Genetic Counsellors, Pharmacists,
and Specialist Nurses.

Expected Approximate
Monetary Range ofGrant Applications:•Individual projects requesting up to $50,000 will be considered. Pfizer
anticipates supporting up to 2 projects.

Key Dates:•RFP release date: 14 July 2022•

Grant Application due date: 20 September 2022•

Anticipated Grant Award Notification Date: October 2022•

Grants will be distributed following a fully executed agreement. Theagreement is expected to be signed by both parties within 2022 andwithout change.

•Anticipated Project Start Date: on or after January 2023

•Please go to www.cybergrants.com/pfizer/QI and sign in. First-timeusers should click “Create your password”. [Note: there are individual

How to Submit:

portals for each grant application type. Please be sure to use the URL above.]•Click the “Start A New Quality Improvement Application” button.

•In the application:oo

For the question “Competitive Grant?” select Yes
Select the following Competitive Grant Program Name: 2022 RD
G QI Delivery of Gene Therapies to Patients with RareDiseases•

Requirements for submission:
Complete all required sections of the online application and upload yourproject proposal (see Appendix) in the Full Proposal Submission field.

•

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 after the due date will not
be reviewed by the committee.

Questions:•If you have questions regarding this RFP, please direct them in writing
to the Grant Officer, Amanda Stein (amanda.j.stein@pfizer.com), withthe subject line “2022 RD G QI Delivery of Gene Therapies toPatients with Rare Diseases”

Grant Agreements:•

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.

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3 Grants to Support Delivery of Gene Therapies to Patients with Rare Disease
QI•

Pfizer has drafted the terms of these agreements to be balanced andreasonable and to further the goals of both parties. Negotiating grantagreements 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.

Review and Approval
Process:•Grant requests received in response to a general RFP are reviewed byPfizer to make final grant decisions.

Mechanism by which
Applicants will beNotified:••

All applicants will be notified via email by the dates noted above.
Applicants may be asked for additional clarification during the review
period.

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Appendix A

Quality Improvement Project Full Proposal
Applications will be accepted via the online portal. Full Proposal documents should be no longer than 1012 pages in length (12-point font and 1-inch margins) excluding Organization Detail and References.
When uploading your Full Proposal please ensure it addresses the following*:

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 applicant
organization(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 adescription 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•

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, orongoing projects developed either by your institution or other institutions
related to this project.

•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, and timeline of patient impact,expected from this project in terms of your target audience.

Innovation

Evaluation andOutcomes4

3 Grants to Support Delivery of Gene Therapies to Patients with Rare Disease
QI•

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.

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
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.

oThe inclusion of these costs cannot cause the amount requested
to exceed 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.

*The online application also includes the fields noted above. The text in those fields should be the same textthat is included in your Full Proposal document.

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