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Frequently asked questions

What are the ASPIRE research awards?

The Advancing Science through Pfizer - Investigator Research Exchange (ASPIRE) program is a competitive grants program sponsored by Pfizer. ASPIRE seeks to support basic science, translational and clinical research that advances medical knowledge in the pathogenesis, treatment and prevention of selected diseases.

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Who is eligible to apply for ASPIRE Research awards?

The 2014 ASPIRE Awards in Vaccine Research are open to all investigators provided that specific eligibility requirements are met. Applicants must have a professional degree (MD, DO, PhD, PharmD or equivalent) and reside in the European countries including Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom. (top)

Define “junior investigator” and what is meant by “post-terminal training”?

To be considered a junior investigator, applicants must have a professional degree (e.g. MD, DO, PhD, PharmD or equivalent) and be within 5 years of terminal training or enrolled in a fellowship or postdoctoral program.
Post-terminal training attempts to better define that the applicant is no longer associated with a training program and in the early stages ( ≤ 5 yrs) of their research career.
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What is the role of Pfizer in the ASPIRE Vaccine Research awards?

Pfizer is fully funding the ASPIRE Vaccine Research awards. Additionally, Pfizer is providing the infrastructure and administrative support required to facilitate the application process.
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Who reviews the research proposals?

The ASPIRE applications will be reviewed by an independent, external review committee comprised of medical and scientific experts.
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When will the ASPIRE Vaccine Research awards for 2014 be announced?

The successful awardees will be notified in June 2014
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Is the funding a per-annum or per-study amount?

Each award funds the entire research period, and is not a sum paid per year
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Does the funding include institutional overhead costs and indirect costs?

Yes, the maximum funding for each award includes direct costs, and institutional overhead costs. Final budgets of those studies preselected for a grant  shall be  previously reviewed for fair market value before the attribution of the award.
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What are indirect costs?

Indirect costs are additional study expenses such as costs for publication, IRB/IEC review fees, supplies, software license fees, and travel.
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What are institutional overhead costs?

Institutional overhead costs, are costs to the institution for the support of your study. They are not easily identifiable in an economically feasible way as exclusively related to a particular project but are necessary to conduct the grant. Some examples of these costs are human resources department costs, payroll processing and accounting costs, janitorial services, utilities, property taxes, property and liability insurance, and building maintenance.
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How are the funds dispersed?

The awards will be paid in milestones. Initial payment will be up to 50% of the total grant and there will be payments made based on enrollment or other milestones depending on study type. Milestones will be determined during the contracting phase.
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Is formulated study drug or pure substance provided?

Pfizer support is typically provided in the manner of funding, and/or formulated study drug depending upon the type of research. Pfizer cannot provide funding for investigator to purchase a Pfizer formulated product.
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How may the ASPIRE Vaccine Research funding be used?

Funds may be used to cover the awardees’ salary and fringe benefits, as well as other direct expenses incurred during the research project. Direct expenses may include the salary of technical associates; the purchase of relevant laboratory supplies; direct expenses necessary for proper conduct of research (e.g. subject-related costs, study-related personnel costs, diagnostic fees/services, data management expenses). Indirect costs may include and travel expenses to scientific meetings, software licensing fees, publication costs etc. No other government, non-governmental, or industry-sponsored projects may cover the same work scope as the grant application to the ASPIRE Program. However, an ASPIRE Vaccine Research Program grant may be related to other funding from foundations or government agencies, as long as there is no direct overlap. It is the responsibility of the applicant to justify the novelty of the proposal and provide evidence that the application does not overlap with any current or pending funding.

Due to the competitive nature of these awards, Pfizer cannot provide any additional funding and/or drug support beyond what has been requested and approved by the external review panel.
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Can ASPIRE Vaccine Research funding be used to purchase equipment?

No. ASPIRE Vaccine Research funds may not be used to purchase equipment, although the purchase of relevant laboratory supplies is allowed. (top)

 

Are the ASPIRE  Vaccine Research awards renewable?

No. Each ASPIRE Vaccine Research award is a one-time, non-renewable research grant.
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Are the ASPIRE Vaccine Research awards open to researchers working outside Europe?

The 2014 ASPIRE Vaccine Research awards are open only to researchers from Europe including Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom. 
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What areas of research meet the criteria for ASPIRE Vaccine Research funding?

The 2014 ASPIRE Vaccine Research Awards seek to evaluate the epidemiology and burden of pneumococcal disease in children and adults with underlying disease comorbidities and/or those living in long-term community settings.
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Are there any specific research areas that are excluded from ASPIRE Vaccine Research funding?

The following topics fall outside of the scope of the ASPIRE Vaccine Research Program:

  • General education and / or training.
  • Support for ongoing clinical programs that are part of an organization’s routine operations.
  • Proposals that evaluate populations outside of the defined European countries.
  • Interventional studies where13 – valent pneumococcal polysaccharide conjugate vaccine is given as an investigational vaccine
  • Proposals whose primary objective is to financially quantify outcomes as it relates to a Pfizer product(s) are outside the scope of the program.

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What project deliverables are required?

Projects are expected to yield results that will help to better understand the epidemiology and burden of pneumococcal disease in adults with underlying disease/ medical  comorbidities and/or those living in long-term community settings. It is expected that results will be presented at scientific meetings and published in peer reviewed journals.
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Will non-drug research proposals be considered?

Yes. Both drug and non-drug proposals will be considered for funding.
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If the study uses a Pfizer drug, what are Pfizer’s procedures for reporting of Serious Adverse Events?

For all studies using a Pfizer product and/or device:

Reporting of Serious Adverse Events Within 24 hours of first awareness of the event (immediately if the event is fatal or life-threatening), Principal Investigator will report to Pfizer by facsimile any Serious Adverse Event (“SAE,” as defined below) for which reporting is required under this provision (as described below). Such SAEs are to be reported for (1) Study subjects who are assigned or, in the case of a blinded Study, possibly assigned to receive the Pfizer Product or (2) individuals otherwise exposed to the Pfizer Product as described below. Principal Investigator should report SAEs as soon as they are determined to meet the definition, even if complete information is not yet available.

  1. Reporting Forms. Principal Investigator will report SAEs using one of the following forms: (1) a reporting form approved by the local regulatory authority, (2) a CIOMS form, (3) a Pfizer-provided Investigator-Initiated Research Serious Adverse Event Form, or (4) any other form prospectively approved by Pfizer. The Reportable Event Fax Cover Sheet provided by Pfizer must also be included with each SAE submitted.
  2. SAE Definition. An SAE is any adverse event, without regard to causality, that is life-threatening (i.e., causes an immediate risk of death) or that results in any of the following outcomes: death; in-patient hospitalization or prolongation of existing hospitalization; persistent or significant disability or incapacity (ie, substantial disruption of the ability to conduct normal life functions); or a congenital anomaly or birth defect. Any other medical event that, in the medical judgment of the Principal Investigator, may jeopardize the subject or may require medical or surgical intervention to prevent one of the outcomes listed above is also considered an SAE. A planned medical or surgical procedure is not, in itself, an SAE.
  3. Exposure During Pregnancy, Exposure During Lactation, Occupational Exposure, and Lack Of Effect. Even though there may not be an associated SAE, exposure to the Pfizer Product during pregnancy, exposure to the Pfizer Product during lactation, and occupational exposure to the Pfizer Product are reportable, and lack of effect of the Pfizer Product may also be reportable. These requirements are further explained in the training material provided by Pfizer (see Pfizer-Provided Training, below). As used in this Agreement, the term SAE will be understood to include exposure during pregnancy, exposure during lactation, occupational exposure, and reportable instances of lack of effect.
  4. Hy’s Law Cases. Cases of potential drug-induced liver injury as assessed by laboratory test values (“Hy’s Law Cases”) are also reportable to Pfizer. If a Study subject develops abnormal values in aspartate transaminase (AST) or alanine transaminase or both, concurrent with abnormal elevations in total bilirubin and no other known cause of liver injury, that event would be classified as a Hy’s Law Case. This reporting requirement is further explained in the training material provided by Pfizer (see Pfizer-Provided Training, below). As used in this Agreement, the term SAE will be understood to also include Hy’s Law Cases.
  5. e. Exclusions from SAE Reporting Requirements. Specifically excluded from the reporting requirements for SAEs under this provision is any SAE identified in the Protocol as anticipated to occur in the Study population at some frequency independent of drug exposure, unless the Principal Investigator assesses such an event as related to the Pfizer Product.
  6. SAE Reporting Period. The SAEs that are subject to this reporting provision are those that occur from after the first dose of the Pfizer Product through 28 calendar days after the last administration of the Pfizer Product, or longer if so specified in the Protocol. In addition, if Principal Investigator becomes aware of an SAE occurring any time after the administration of the last dose of the Pfizer Product, Principal Investigator should report that SAE to Pfizer if the Principal Investigator suspects a causal relationship between the Pfizer Product and the SAE.
  7. Follow-Up Information. Principal Investigator will assist Pfizer in investigating any SAE and will provide any follow-up information reasonably requested by Pfizer.
  8. Regulatory Reporting. Reporting an SAE to Pfizer does not relieve Principal Investigator of responsibility for reporting it to appropriate regulatory authorities, if such reporting is required.
  9. Pfizer-Provided Training. Pfizer will make available training material that provides information about the SAE reporting requirements for IIR studies. Principal Investigator will review this material and share it with any Study staff engaged in the reporting of SAEs.

In addition, Pfizer requires reporting of all non serious adverse events for any non-interventional clinical study with at least one study site in the European Economic Area.

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I’m still not sure if my proposed research topic meets the criteria, how can I find out?

Please contact the ASPIRE coordinator with a brief description of your proposed research area.
Email: euaspirevaccinesaward@pfizer.com
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Is there a time limit for conducting the funded research?

Study results are expected before December 31, 2015.
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How do I apply for a ASPIRE Vaccine Research award?

Applications are to be submitted to Pfizer through an online submission website. Visit www.aspireresearch.org and click on “2014 Vaccine Research Awards – Europe”. Click on “Apply” and you will be routed to Pfizer’s global investigator-initiated research website. Click on “Submit an IIR Request” and follow the online instructions.
Completed application forms must be accompanied by the following documents:

  • Cover letter on institution letterhead
  • An abbreviated curriculum vitae (CV) (limited to 3 pages) or a NIH biosketch (no more than 4 pages)
  • The 3 most relevant articles from the applicant’s scientific publications (if applicable)
  • Description of available laboratory facilities (if applicable)
  • Listing of other research support available with a description of overlap and, if applicable, a listing of consenting collaborators (including CVs)
  • Bibliography of relevant references
  • Itemized budget for proposed research
  • For Junior investigators (within 5 years of terminal training or those enrolled in a fellowship or postdoctoral program) the following documents are required:
    • A letter of endorsement from the applicant’s sponsoring department chairman, division director or equivalent which clearly identifies the applicant’s mentor for the project
    • A letter of commitment from the applicant’s mentor

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What if I don’t fully understand the ASPIRE application process?

Please refer to the application guide. If you still have questions, please e-mail the coordinator euaspirevaccinesaward@pfizer.com
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I’m having difficulty submitting my application online; who do I contact for assistance?

Receive assistance by contacting iir@pfizer.com
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What is the deadline for application?

Applications must be received by 11:59pm EST on April 9, 2014.
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When will I hear whether my application has been successful?

Successful applicants will be notified in June 2014.
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If my application is successful, when will the funding commence?

Awards will commence on or around October/November, 2014, pending receipt of all required documents noted on the application form. Contracts that are unable to be executed by the end of the calendar year are subject to loss of funding.
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Will I receive a copy of the Review Committee’s evaluation of my grant proposal?

Unfortunately, we are not able to provide applicants with comments by the ASPIRE Review Committee.
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I have a question that is not covered here?

If you require clarification on an issue not addressed here, please contact the ASPIRE Coordinator, email: euaspirevaccinesaward@pfizer.com
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Does Pfizer sponsor other competitive grants programs?

Yes. Therapeutic areas, application dates, deadlines and eligibility vary between programs. Please visit www.aspireresearch.org for more information.
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Can I be notified when future ASPIRE competitive grants program become available?

Visit www.aspireresearch.org and complete the contact information section to receive future program notifications.
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