ASPIRE-Sicklecell Faq

Frequently Asked Questions


What are the ASPIRE Sickle Cell Disease Research Awards

The US Advancing Science through Pfizer: Investigator Research Exchange (ASPIRE) Sickle Cell Disease Research Awards Program is a competitive grants program that reflects the commitment of Pfizer Rare Disease to support ongoing basic science and clinical investigation in sickle cell disease. In an era of increased competition for research funding, the 2016 US ASPIRE Sickle Cell Disease Research Awards Program is designed to support laboratory and clinical research in pathogenesis, complications, management, and clinical outcomes of sickle cell disease. The ASPIRE Sickle Cell Disease Research Awards Program utilizes an independent, external expert panel to review and rank the successful grant applications


Who is eligible to apply for ASPIRE Sickle Cell Disease Research Awards?

To be eligible, applicants must hold a doctoral degree (e.g. MD, PhD, PharmD, or equivalent). top


What is the role of Pfizer in the ASPIRE Sickle Cell Disease Research Awards?

While Pfizer fully funds the ASPIRE Sickle Cell Disease research grants, applications will be reviewed and grant awardees will be ranked by an independent, external expert panel (External Review Committee). Pfizer will provide infrastructure and administrative support to facilitate the application and the review process as well as notify applicants and distribute awards. top


How many ASPIRE Sickle Cell Disease Research Awards are available?

The intent of the 2016 ASPIRE Sickle Cell Disease program is to fund at least two grants of up to US $55,000 (inclusive of institutional overheads). Grant monies will be distributed in milestone payments, in US Dollars, with up to 50% at the beginning of the award. top


When will the ASPIRE Sickle Cell Disease Research Awards for 2016 be announced?

The successful awardees are scheduled to be notified in November 2016. top


Is the funding a per-annum or per-study amount?

Each Research Award funds the entire research period and is not a sum paid per year. top


Does the funding include institutional overhead costs and indirect costs?

Yes, the funding award includes indirect costs, and institutional overhead costs (up to 28%). Final budgets of those studies awarded a grant will be reviewed for fair market value before the contracting process begins. top


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. top


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. top


How are the funds dispersed?

The awards will be paid in milestones, and in US Dollars. Grant monies will be distributed with up to 50% at the beginning of the award top


How may the ASPIRE Sickle Cell Disease Research Award 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 travel expenses to scientific meetings, software licensing fees, publication costs etc. ASPIRE Sickle Cell Disease research funds may not be used to purchase equipment, although the purchase of relevant laboratory supplies is allowed.
 

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 Sickle Cell Disease Research Award 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.
 

Once awarded, an ASPIRE grant cannot be amended upwards with additional funding support from Pfizer (via the standard IIR process or separate competitive grant program), nor can additional drug support above and beyond what is sufficient to complete the original study as reviewed and approved by the External Review Committee be provided. If supplemental funding is required, it must be secured from sources outside of Pfizer. Similarly, an ongoing Pfizer supported standard IIR cannot apply for supplemental funding via a Pfizer supported competitive grants program. ASPIRE Program Research Awards cannot be provided to studies that are already in progress. top


Can ASPIRE Sickle Cell Disease Research Award funding be used to purchase equipment?

No. ASPIRE Sickle Cell Disease research funds may not be used to purchase equipment, although the purchase of relevant laboratory supplies is allowed. top


Are the ASPIRE Sickle Cell Disease Research Awards renewable?

No. Each ASPIRE Sickle Cell Disease Research Award is a one-time, non-renewable research grant, to be paid in milestones based upon progress updates. top


Are the 2016 ASPIRE Sickle Cell Disease Research Awards open to researchers working outside the United States?

No. The 2016 ASPIRE Sickle Cell Disease research grants are open to researchers from the US. It is possible that in future years the program will be open to applicants from other countries. Applicants should also confirm with, and/or secure appropriate approval from their institution if there is any conflict of interest by receiving research award funding from Pfizer. top


What areas of research meet the criteria for ASPIRE Sickle Cell Disease research funding?

Pfizer will consider applications for research projects which address laboratory investigation or clinical research in Sickle Cell Disease. Examples of research topics are listed for guidance; however, other applications will be considered. top
 

Innovative research may be in any of the following areas:

  • Biomarkers of Sickle Cell Disease
  • Phenotypic differences in clinical course and/or response to therapy
  • Clinical trial endpoint validation
  • Patient Reported Outcomes (PRO), Health Related Quality of Life (HRQOL)
  • Improving care of specific complications of Sickle Cell Disease
  • Improving clinical care delivery models
  • Improving acute pain management

 


What project deliverables are required?

Projects are expected to yield results that will advance knowledge and innovation in Sickle Cell Disease research. It is expected that results will be presented at scientific meetings and published in peer reviewed journals within 1-2 years of study start. top


Will non-drug research proposals be considered?

Yes, non-drug proposals are encouraged. top


If the study uses a Pfizer drug, what are Pfizer’s procedures for reporting of Serious Adverse Events?

Reporting of Serious Adverse Events is a key responsibility of the Research Award Principal Investigator 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.
 

  • 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.
  • 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 (i.e., 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
  • 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.
  • 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.
  • 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.
  • 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.
  • Follow-Up Information. Principal Investigator will assist Pfizer in investigating any SAE and will provide any follow-up information reasonably requested by Pfizer.
  • 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.
  • 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. top

Can an exception be made for certain applicants regarding the eligibility criteria to the ASPIRE Sickle Cell Disease Research Awards?

The eligibility requirements have been carefully designed to attract appropriate candidates. In keeping with the purpose and intention of the ASPIRE grants and to be equitable between applicants, applicants must meet all the criteria in order to be considered for a grant. Submissions outside these parameters will not be considered. top


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. Please email


Is there a time limit for conducting the funded research?

Research is expected to be completed and submitted for presentation/publication within 1-2 years of study start. top


What is Pfizer’s policy on inventions?

Any Invention made solely by one or more employee or contractor of Institution will be solely owned by Institution. Inventions related to Pfizer product will be subject to negotiation in regards to licensing rights. top


Where can I get an application form?

The Application Form can be found here (click here). Alternatively, email IIR@pfizer.com. top

 


What is the deadline for application?

Applications must be received by Monday, October 17, 2016, 11:59 PM Eastern Daylight Time.


When will I hear whether my application has been successful?

The final decision on applications is scheduled to be communicated in November 2016. top


If my application is successful, when will the funding commence?

Grants will commence by early 2017, pending receipt of all required documents which will be provided to full applicants. Contracts that are unable to be executed by early 2017 are subject to loss of funding. top


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: IIR@pfizer.com


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. top


I'm a previous ASPIRE Grants Winner, am I eligible to apply for another grant?

Previous ASPIRE grant winners may apply for ASPIRE awards in the future. Grants are based upon scientific merit commensurate with funding that is available every year. top