Pfizer and ICOSEP Announce a Quality Improvement Grant RFP

Improving the Care of Patients withDisorders of Impaired GrowthCompetitive Grant Program

I. Background
The International Coalition of Organizations Supporting Endocrine Patients (ICOSEP) and Pfizer
Global Medical Grants (Pfizer) are collaborating to offer a new grant opportunity seeking proposals toimprove the care of patients with disorders of impaired growth.
ICOSEP’s mission is to unite all types of endocrine groups, associations, societies and online entities,
into one comprehensive and cooperative global network. This centralized unification, hosted andcoordinated by ICOSEP shall, promote, facilitate and transparently share information among all
endocrine groups with the goal of uniting our voices regardless of the specific focus held by any one
unique organization. This consolidated umbrella of groups, shall enable rare endocrine voices to unite
as a cohesive presence and when necessary, take action for the improved care, health, and quality oflife for all patients with endocrine related health concerns. Endocrine united.
Pfizer Global Medical Grants (GMG) mission is to support the global healthcare community’s
independent initiatives to improve patient outcomes in areas of unmet medical need that are alignedwith Pfizer’s medical and/or scientific strategies.
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 ormonitoring of the quality improvement program.

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II. Eligibility
Geographic Scope:

GlobalApplicant Eligibility
Criteria•

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

•The following may apply: medical, dental, nursing, allied health, and/or
pharmacy professional schools; healthcare institutions (both large andsmall); professional associations; government agencies; and otherentities with a mission related to healthcare improvement.

•Pfizer believes that every person deserves to be seen, heard, and caredfor, and we work to further this goal by encouraging grant requestors withdifferent backgrounds, perspectives, and experiences to apply.

•Collaborations within institutions (e.g., between departments and/or interprofessional), as well as between different institutions / organizations /associations, are encouraged. Please note all partners must have arelevant role and the requesting organization must have a key role in theproject.

•For programs offering education credit, the requesting organization must
be the accredited grantee.

Date RFP Issued•June 1, 2022

Clinical Area•

Disorders of impaired growth

Specific Area of Interestfor this RFP:

•It is our intent to support projects that focus on direct patient care toimprove patient outcomes for those with pediatric disorders of impaired
growth. These may include quality improvement projects focusing on
appropriate diagnosis, treatment, management, and comprehensive
care of these patients. Proposals that include digital tools and eHealthare welcome.
Support the development of multidisciplinary care teams to ensure
health equity and address health care disparities for pediatric patientswith disorders of impaired growth.

III. Requirements••

Multi-disciplinary collaborations are encouraged when appropriate, but
all partners must have a relevant role.

•It is expected that projects will be evidence-based (education and/orquality improvement) and the proposed research/evaluation will follow
generally accepted scientific principles. During review the intended
outcome of the project is given careful consideration and, if appropriate
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based on the project goal, projects with the maximum likelihood to
directly impact patient care will be given high priority.
•There is a considerable amount of interest in receiving responses fromprojects that utilize system-based changes. Although educational efforts
for grantees and patients may be entirely appropriate components inresponses to this RFP, projects that include an overt description ofsystem changes will be given high priority.

It is not our intent to support clinical or fundamental research projects.
Projects evaluating the efficacy of therapeutic or diagnostic agents will not beconsidered. Projects to support existing registries or creation of newregistries are also out of scope.

Target Audience:•Pediatric patients with disorders of impaired growth and theprofessionals/multi-disciplinary teams that care for them.

Disease Burden
Overview:•Substantial health care burden is associated with impaired growth in thepediatric population1•

Impaired growth impacts multiple aspects of daily life for children withthe condition including their social and emotional well-being2, 3

Recommendations andTarget Metrics:

Related Guidelines and Recommendations•Consensus Guidelines for the Diagnosis and Treatment of GrowthHormone (GH) Deficiency in Childhood and Adolescence: SummaryStatement of the GH Research Society4•

Diagnosis, Genetics, and Therapy of Short Stature in Children: AGrowth Hormone Research Society International Perspective.5•

Clinical practice guidelines for the care of girls and women with Turner
syndrome: proceedings from the 2016 Cincinnati International Turner
Syndrome Meeting6•

Growth Hormone Research Society workshop summary: consensus
guidelines for recombinant human growth hormone therapy in PraderWilli syndrome7•

Management of growth failure and other endocrine aspects in patientswith Noonan syndrome across Europe: A sub-analysis of a European
clinical practice survey8•Causes of Disruptions in Children’s Growth: https://icosep.org/wp-content/uploads/2021/03/7-9-19-ICOSEP-Final-Compilation.docx

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Gaps Between Actualand Target, Possible
Reasons for Gaps:

Gaps in diagnosis and management of disorders of impaired growth:•Children with short stature may be evaluated inadequately•

Late diagnosis of treatable growth disorders 9•

Suboptimal referral of children with growth disorders10•Poor recognition10•

Lack of proper training and education of physicians regarding growthdisorders10•

Issues with long-term patient adherence to therapy11•

Lack of communication and collaboration between healthcare
providers/centers and patient advocacy organizations, to better informand accompany patients12•

Increase visibility and existence of patient advocacy organizations andstimulate collaboration with medical societies12•

Gap in general/large public information (schools etc), regular growth
curve measurements allowing early detection12•

Demographic differences in diagnosis and treatment rate and treatment
delay13•

Transitional care between pediatric and adult care15

Expected ApproximateMonetary Range ofGrant Applications:•Individual projects requesting up to $75,000 will be considered. The
total available budget related to this RFP is $300,000.

•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: June 1, 2022•

Full Proposal Deadline: August 3, 2022•

Review of Full Proposals by External Review Panel: September 2022•

Anticipated Full Proposal Notification Date: October 2022

•Anticipated Project Start Date: December 2022/January 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: 2022 RD Global3

3PediatricPatients with Disorders of Impaired Growth QI Initiative

Pediatric Disorders of Impaired Growth QI Initiative•Requirements for submission:o•Complete all required sections of the online application (seeAppendix).

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 by
the committee.

Questions:•If you have questions regarding this RFP, please direct them in writing
to the Amanda Stein [amanda.j.stein@pfizer.com] (Grant Officer,Pfizer), and with the subject line “2022 RD Global Pediatric Disorders of
Impaired Growth QI Initiative”

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 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 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.
A specific grant program RFP uses an expert review panel (ERP) tomake final grant decisions.
The panels are comprised of professionals from the medical community
with advanced degrees and expertise in particular clinical areas, or
speciﬁc needs of a geographic region/learner group, or expertise inresearch, continuing professional development or quality improvement•Review and ApprovalProcess•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.

References:
1. Economic burden of growth hormone deficiency in a US pediatric population Paul Kaplowitz, Janna
Manjelievskaia, Lorena Lopez-Gonzalez, Cynthia D Morrow, Pisit Pitukcheewanont, and Alden Smith
Journal of Managed Care & Specialty Pharmacy 2021 27:8, 1118-1128.
2. Brod, M., Alolga, S.L., Beck, J.F. et al. Understanding burden of illness for child growth hormone
deficiency. Qual Life Res 26, 1673–1686 (2017). https://doi.org/10.1007/s11136-017-1529-1
3. Philippe Backeljauw, Marco Cappa, Wieland Kiess, Lisa Law, Charlotte Cookson, Caroline Sert, John
Whalen, Mehul T. Dattani, Impact of short stature on quality of life: A systematic literature review,

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Patients with Disorders of Impaired Growth QI Initiative

Growth Hormone & IGF Research, Volumes 57–58, 2021, 101392, ISSN 1096-6374,
https://doi.org/10.1016/j.ghir.2021.101392.
4. Growth Hormone Research Society. Consensus guidelines for the diagnosis and treatment of growth
hormone (GH) deficiency in childhood and adolescence: summary statement of the GH ResearchSociety. GH Research Society. J Clin Endocrinol Metab. 2000;85(11):3990-3993.
doi:10.1210/jcem.85.11.6984
5. Collett-Solberg P, F, Ambler G, Backeljauw P, F, Bidlingmaier M, Biller B, M, K, Boguszewski M, C, S,
Cheung P, T, Choong C, S, Y, Cohen L, E, Cohen P, Dauber A, Deal C, L, Gong C, Hasegawa Y,Hoffman A, R, Hofman P, L, Horikawa R, Jorge A, A, L, Juul A, Kamenický P, Khadilkar V, Kopchick J,J, Kriström B, Lopes M, d, L, A, Luo X, Miller B, S, Misra M, Netchine I, Radovick S, Ranke M, B, Rogol
A, D, Rosenfeld R, G, Saenger P, Wit J, M, Woelfle J: Diagnosis, Genetics, and Therapy of Short
Stature in Children: A Growth Hormone Research Society International Perspective. Horm Res
Paediatr 2019;92:1-14. doi: 10.1159/000502231
6. Gravholt CH, Andersen NH, Conway GS, et al. Clinical practice guidelines for the care of girls andwomen with Turner syndrome: proceedings from the 2016 Cincinnati International Turner Syndrome
Meeting. Eur J Endocrinol. 2017;177(3):G1-G70. doi:10.1530/EJE-17-0430
7. Deal CL, Tony M, Höybye C, et al. GrowthHormone Research Society workshop summary: consensus
guidelines for recombinant human growth hormone therapy in Prader-Willi syndrome. J Clin Endocrinol
Metab. 2013;98(6):E1072-E1087. doi:10.1210/jc.2012-3888
8. Edouard T, Zenker M, Östman-Smith I, et al. Management of growth failure and other endocrine
aspects in patients with Noonan syndrome across Europe: A sub-analysis of a European clinicalpractice survey. Eur J Med Genet. 2022;65(1):104404. doi:10.1016/j.ejmg.2021.104404
9. Savage MO, Backeljauw PF, Calzada R, Cianfarani S, Dunkel L, Koledova E, Wit J-M, Yoo H-W. Early
Detection, Referral, Investigation and Diagnosis of Children with Growth Disorders. Hormone Researchin Paediatrics 2016; 85, 325-33
10. John M, Koledova E, Kumar KM, Chaudhari H. Challenges in the Diagnosis and Management ofGrowth Hormone Deficiency in India. Int J Endocrinol. 2016;2016:2967578. doi:10.1155/2016/2967578
11. Marini MG, Chesi P, Mazzanti L, Guazzarotti L, Toni TD, Salerno MC, Officioso A, Parpagnoli M,Angeletti C, Faienza MF, Iezzi ML, Aversa T, Sacchetti C. Stories of experiences of care for growth
hormone deficiency: the CRESCERE project. Future Sci OA. 2016 Feb 25;2(1):FSO82. doi:
10.4155/fso.15.82. PMID: 28031934; PMCID: PMC5137913.
12. EndoERN patient survey on their perception of health care experience and of unmet needs for rareendocrine diseases. Susan M. Webb,et al.. Endocrine. 2021 Mar;71(3):569-577. doi: 10.1007/s12020021-02625-0.
PMID: 33544353
13. Kaplowitz P, Manjelievskaia J, Lopez-Gonzalez L, Morrow CD, Pitukcheewanont P, Smith A. Economic
burden of growth hormone deficiency in a US pediatric population. J Manag Care Spec Pharm.
2021;27(8):1118-1128. doi:10.18553/jmcp.2021.21030
14. Davidse K, van Staa A, Geilvoet W, Eck JV, Pellikaan K, Baan J, Hokken-Koelega ACS, Van den Akker
ELT, Sas TCJ, Hannema SE, Van der Lely AJ, de Graaff LCG. We mind your step: understanding andpreventing drop-out in the transfer from paediatric to adult tertiary endocrine healthcare. EndocrConnect. 2022 Apr 1:EC-22-0025. doi: 10.1530/EC-22-0025. Epub ahead of print. PMID: 35521816

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Appendix A
Proposal Requirements
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 adescription of your plan to obtain this information. Include regional orlocal needs related to your project.

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/age limits of yoursample 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 institutionsrelated 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.

Innovation

Evaluation andOutcomes6

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

•Describe how the project outcomes will be broadly disseminated andapplicable to different centers.

Anticipated ProjectTimeline•

Provide an anticipated timeline and milestones for your project including
project start/end dates

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 and coordination of the proposed project. Articulate thespecific role of each partner in the proposed project. Letters of support
from partner organizations.

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 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 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.

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