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Public Call for Proposals by the São Paulo Research Foundation (FAPESP) jointly with MedImmune, LLC (MEDIMMUNE)

FAPESP and MEDIMMUNE, a member of AstraZeneca Group for the global biologics research and development arm of AstraZeneca, make public this Call for Proposals and invite interested researchers, working within public or private Higher Education or Research Institutions in the State of São Paulo, to submit projects under the cooperation agreement between FAPESP, MEDIMMUNE and AstraZeneca, under the terms and conditions hereinafter set forth.

The conditions for participation in this call will be strictly enforced. Proposals that violate any of the conditions will be excluded. It is strongly recommended, therefore, their careful reading.

1. General Information

1.1 Purpose

The purpose of this Call is to define the conditions for the submission of proposals for research projects that generate knowledge about new techniques, methodologies, processes and technologies of interest from FAPESP and MEDIMMUNE, described below.

1.2 Fields of Knowledge

This Call for Proposals invites research proposals in topics described at item 1.2.b.

a) MEDIMMUNE’s Background

MEDIMMUNE is committed to enhancing its already robust pipeline by introducing New Molecular Entities through internal capabilities, or via partnering. The MEDIMMUNE Leadership Team strongly believes that the partnering with academia to identify and qualify new targets is the best way of addressing the challenges of our industry, and to provide solutions for unmet medical needs.

MEDIMMUNE is seeking scientific breakthroughs in applied and basic research that provide a deeper understanding of the pathophysiology of Cardiovascular and Metabolic Diseases that might form the basis of new drug discovery efforts. Inadequate glycemic control gives rise to diabetic complications including renal disease and cardiovascular disease, both of which are areas of high unmet need and focus areas for MEDIMMUNE drug discovery efforts.

b) Objectives

The epidemic of obesity and type 2 diabetes has enormous health consequences for our society and despite the development of new and novel therapeutics there is a need to continue research efforts in this area. The partnership between the industry and academia is critical in translating discoveries from bench to bedside.

The themes of interest shared by MEDIMMUNE and FAPESP for this call for research proposals are outlined below with a strong emphasis on technology and approaches that push the boundaries of science and applied research that has translational value for the development of novel therapeutics:

Metabolic Diseases

• Novel approaches to treat insulin resistance;
• Understanding molecular mechanism of hypertrophic obesity;
• Mechanisms promoting beigeing of the adipose tissue;
• Novel pathways regulating appetite;
• Modulating gut microbiota as a potential therapy;
• Mechanistic insight for diabetes resolution following gastrointestinal surgery;
• Approaches to increase functional pancreatic β-cell mass;
• Novel insights into the pathophysiology and treatment of diabetic nephropathy and chronic kidney disease and nonalcoholic steatohepatitis (NASH). 

Cardiovascular Diseases

• Understanding causes for endothelial dysfunction post myocardial infarction;
• Transplantation of stem and progenitor cells for the treatment of myocardial infarction.

2. Eligibility

In order to qualify for this Call for Proposals the proponent should satisfy the following requisites and norms in order to be eligible:

a) Meet the conditions and restrictions of the FAPESP Program for Cooperative Research for Technological Innovation (PITE), described at www.fapesp.br/pite, excluding those restrictions and conditions explicitly excepted in this CFP;

b) The proposals must be submitted by researchers from Higher Education or Research Institutions in the State of São Paulo.

3. Funds

a) The total amount available for this CFP is up to US$ 2.400.000,00;

b) FAPESP and MEDIMMUNE expect to jointly fund approximately 4-6 proposals under this CFP);

c) The appropriateness of the requested funding in relation to the proposal goals and qualification of the proposing team is a primary review consideration;

d) FAPESP and MEDIMMUNE reserve the right to propose lower funding levels for projects;

e) Proposals should include the indirect cost rate for the university, and if different, the indirect cost rate (as a %) for the proposed project;

f) Project award and funding will be confirmed only upon the agreement of key terms between FAPESP, MEDIMMUNE, AstraZeneca and the Host institution in subsequent Agreements;

g) Either FAPESP or MEDIMMUNE reserve the right to fund project separately if the projects does not meet JSC approval.

4. Research proposal characteristics

Proposals should target some or all of the following research goals:

a) Novel and Creative Solutions: The intention of the project is not to enable incremental engineering projects with a known outcome, but rather to explore and invent new technology and/or knowledge that will benefit underserved populations by addressing unmet medical needs aligned to the topics listed in the background section above. FAPESP and MEDIMMUNE encourage bold, novel, and unconventional approaches to the core science and technology challenges in the topics listed in section 1.2.

b) Immediate Relevance: FAPESP and MEDIMMUNE are seeking academic research projects that are highly complementary to a broad community need. Goals should be specific, measurable, and result-oriented with tangible metrics.

c) Intellectual property of Results: The intellectual property rights on the results will be subject of a specific clause in the Terms of Agreement between FAPESP, MEDIMMUNE, AstraZeneca and the Host Institution of each selected project.

d) Dissemination and Communication: Research results are expected to be widely communicated through relevant scientific communities using established academic channels, such as international conferences and refereed journals, according to the approval of the JSC members. All funded projects should result in a detailed web presence and relevant conference publications or presentations, respecting the opinion of Parties regarding relevant results identified as confidential. Other channels for community development may include regional workshops, graduate seminars, and curriculum components such as courses or course materials, necessarily after MEDIMMUNE or JSC formal approval. The conditions for communication and dissemination will be established in cooperation agreement to be signed by FAPESP, MEDIMMUNE, AstraZeneca and the Institution of each selected project to allow broad and rapid dissemination of knowledge while respecting the safeguarding intellectual property.

5. Project duration

The duration of selected projects will be of up to 36 months.

6. Proposal preparation

Each proposal must contain the following items (to see the complete checklist of requested documents, please access the submission form):

a) FAPESP-MEDIMMUNE proposal submission form, in Portuguese and English (form available at www.fapesp.br/chamadas/2015/formAZ.docx)

b) FAPESP Summary of CV, in English, for the PI and each Associated Investigator, including those from MEDIMMUNE, when applicable (Instructions for elaborating the Summary of the CV are available at www.fapesp.br/en/6351).

c) Research team: listing of all researchers (Principal Investigator, co-Principal Investigators and Associated Investigators), in English. For each one, his or her role in the research project must be defined succinctly, as well as the weekly workload. Each participant must sign his or her agreement to participate in the project (www.fapesp.br/9539).

d) Research Proposal: proposals should be submitted in English. The proposal should cover items from d.1) to d.6) below in no more than 20 pages, using font Arial size 10 and double spacing. Section d.7) is not counted under this page limitation. Please address the sections listed below, from d.1) to d.6) under separate numbered headings:

d.1) Problem Statement: What is the problem addressed by the proposal and why is it important? What is the potential contribution to the field of the project if successful? Cite relevant work in the field as appropriate

d.2) Expected outcomes: What new science will be created or produced as a result of the proposed project? How will the results of this project be disseminating to others?

d.3) Scientific and technical challenges and the ways and means to overcome them: This is a critical part of the proposal. Describe the scientific and technical challenges that the project will face in order to reach the proposed goals. Describe the proposed methods and means. Cite references that can help reviewers to ascertain that such challenges were not yet overcome (or were not adequately overcome) and that they can be overcome with the proposed methods and means.

d.4) Schedule: When is the project to be completed? What milestones will be used to measure progress of the project and when will they be completed? If the project described is part of a larger ongoing research program, estimate the time for completion of this project only.

d.5) Dissemination and Evaluation: How will the results of this project be evaluated (if appropriate), and how will they be disseminated to others?

d.6) Other Support: List other contributions by the Host Institution to this project (cash, reduced indirect cost rate, goods, or services), if any, but not including items such as the use of university facilities otherwise provided on an ongoing basis. Note that authors of selected proposals will be required to present an original letter on university letterhead signed by the director of the Host Institution certifying the commitment of any additional support.

d.7) Fellowships: The proposed budget may include costs for Scientific Initiation, Masters or Post-Doctoral fellowships. The ending dates for each fellowship must happen at or before the ending date of the project. Fellowships will be covered with funds from MEDIMMUNE depending on the analysis of the proposal and the availability of resources, to be verified at the time of selection of proposals. For each requested fellowship a work plan with up to two pages must be submitted together with the research proposal. Work plans must include: Title for the Fellowship research project, Summary, and Description of the plan. It is not permitted to nominate the holder of the fellowship. If the grant is approved the Principal Investigator will be in charge of organizing a public selection process to select the appointees for the fellowships through a merit review process. In those cases, MEDIMMUNE must approve the candidate to each of the fellowships.

e) Requested budget description: proposals must include separate budget descriptions for the items requested to FAPESP and to MEDIMMUNE. It is desirable to keep the fraction of the total amount requested for each of the parties at around 50%. Such a balance is desirable but not mandatory, and may deviate from 50% due to specific circumstances to be justified.

e.1) The budget items that may be requested to FAPESP are those traditionally supported by the Foundation and described in www.fapesp.br/1656, with the exception of Technical Training Fellowships, not permitted under this CFP.

e.2) The budget items that can be covered with funds from MEDIMMUNE should be limited to:

i. Resources invested in capital equipment for the sole purpose of conducting the project. Capital equipment shall be defined as a tangible asset with a useful life of greater than one year and exceeding US$30.000 in value.

ii. Resources invested in Scientific Initiation, Masters or Post-Doctoral fellowships with values at least equal to the grants from FAPESP for these fellowships;

iii. Resources invested in consumables and services of third parties when directly associated with the project;

iv. Special cases documented by a detailed justification within the proposal, will be analyzed in each case by the Joint Steering Committee (JSC).

In all the cases above, the request is analyzed by the JSC and reductions in the budget may be proposed.

e.3) The budget request must be presented using specific spreadsheets (available at www.fapesp.br/9539) which include:

i. Consolidated Budget Request, classified by types of expense and sources of funding (FAPESP, MEDIMMUNE, and other sources);

ii. Separate Budget Request spreadsheets for FAPESP and MEDIMMUNE, by types of expense, following FAPESP standards;

iii. Spreadsheets for financial and physical schedule (FAPESP, MEDIMMUNE).

7. Submission of proposals

a) Proposals should be submitted in on one paper copy accompanied by a CD with one unique PDF file of the complete proposal.

b) Proposals that are incomplete, inaccurate, that request funds in excess of the maximum award available, or are otherwise not responsive to the terms and conditions of this CFP will be excluded from consideration.

c) The envelope containing the proposal should be addressed to:

PROPOSTA DE PESQUISA CHAMADA FAPESP- MEDIMMUNE 2015
FAPESP – Fundação de Amparo à Pesquisa do Estado de São Paulo
Rua Pio XI, 1500 - Alto da Lapa
CEP 05468-901 - São Paulo - SP

d) Proposals will not be accepted by any other means.

e) All submitted proposals under this CFP will not be returned to the proponents. For record-keeping and administrative purposes, the copy will be archived by FAPESP.

f) For Calls for Research Proposals issued by FAPESP as a result of this Agreement with the Parties, such proposals will be forwarded to the Joint Steering Committee to examine their compliance with the terms of the Call for Proposals.

8. Information and clarification

All questions related to this CFP must be directed to: chamada_azmedimmune@fapesp.br.

Please, put “CFP FAPESP-MEDIMMUNE” in the subject line of your e-mail to ensure a prompt and proper response

9. Analysis and selection of the submitted proposals

All received proposals adherent to the terms of this Call for Proposals will be analyzed.

The selection process is based on merit review and comparative analysis. To this end FAPESP will use reports from reviewers indicated by FAPESP and MEDIMMUNE.

The Foundation’s Area and Supervising Panels will provide input and analysis to the JSC. After receiving feedback from reviewers, the JSC will make the final recommendation to the Scientific Director, who will make a final decision, taking into account the recommendation provided.

All comments and discussions of the recommended proposals can be provided to the Scientific Director.

The criteria used will be that applied to the selection of proposals in the FAPESP Program for Cooperative Research for Technological Innovation (PITE), with the addition of the analysis by the JSC.

Researchers participating in any submitted proposal will not take part in the analysis and selection process.

All proposals will be analyzed and selected using the following criteria:

a) Adherence to the terms of this CFP;

b) Novelty and Ambition of the proposed academic research project, as it relates to the goals of this CFP;

c) Qualification of the research project, in the specification of clear goals, of the challenges to be overcome and the scientific, technical and material means and ways for this, in relation to the state-of-the-art in the field, including interface definitions, testing methodology, and plans for experimental deployment;

d) Adequate existing institutional infrastructure and support, offered by the Hosting Institution;

e) Qualifications of Principal Investigator and his team, including previous history of work in areas relevant to this CRFP, successful completion of previously funded projects, teaching awards, and publications, all of those items being demonstrated in the Curricular Summaries Summary of the CV of the Principal Investigators;

f) Ability to complete the project, including the adequacy of available resources available, institutional support, reasonableness of timelines, and number and qualifications of identified contributors; value, which encompasses the efficient use of requested resources and funding;

g) Potential for publication and intellectual property;

h) Training of new researchers and professionals, as a result of the execution of the Project;

i) Potential for technological innovation involving market analysis, potential difficulties for industrial implementation and ways to overcome them, comparisons with competing technologies and the reasons for the technology appears to be more beneficial than we currently use.

10. Schedule

Event	Date
Launching of the CFP at FAPESP Web site	March 19th, 2015
Last date for receiving proposals	June 26th, 2015
Publication of the selected proposals	October 7th, 2015

11. Announcement of results

The results of the selection process will be announced in FAPESP’s Web Site at www.fapesp.br , including Project Title, Process Number at FAPESP and PI´s name and Host Institution, and by communication to the proponents.

12. Contracting of the selected proposals

For each research proposal selected, the relations between FAPESP, MEDIMMUNE, AstraZeneca and the Principal Investigator’s Host Institution will be determined by an agreement which will be defined but not limited to:

a) Schedule of disbursements and financial reporting on the amounts disbursed;

b) Adherence of the project proposal to the desired themes by MEDIMMUNE;

c) Definition and timing of expected results at each stage of the project;

d) Intellectual property, confidentiality and possible exploitation of project results, including publication rights;

e) Confidentiality;

f) Publication;

g) Term;

h) Termination rights for individual projects and FAPESP, AstraZeneca, MEDIMMUNE, and Host Institution contract;

i) Legal venue.

13. Cancellation of the award

The award might be canceled by MEDIMMUNE and FAPESP by mutual agreement, in the event of justifiable cause, on the basis of evaluation by the Scientific Director of FAPESP and MEDIMMUNE. Cancellation does not preclude other measures that might be deemed necessary.

14. Grants, progress analysis and evaluation

If the application is approved, a Grant Contract will be made, which will be signed by the Principal Investigator and the Host Institution´s representative.

The results will be evaluated by progress reports and financial reports that should be submitted on the dates established in the Grant Contract.

15. Agreement to Terms and Conditions

By submitting an application under this CFP, applicants confirm that they have read, understood and agreed to the terms and conditions of the CFP and the conditions attached to any successful awards.

 

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