Oncology/Hematology Research Awards Program FAQ Page
Frequently Asked Questions
What are the ASPIRE research awards
The Advancing Science through Pfizer - Investigator Research Exchange (ASPIRE) program is a competitive grants program supported 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. (top)
Who is eligible to apply for ASPIRE research awards?
Each ASPIRE research award program has established its own eligibility & research criteria. Check with the specific ASPIRE Oncology/Hematology Awards program for more information. (top)
What is the role of Pfizer in the ASPIRE Oncology/Hematology Research Awards?
Pfizer is fully funding the ASPIRE Oncology/Hematology Research Awards. Additionally, Pfizer is providing the infrastructure and administrative support required to facilitate the application process. (top)
When will the ASPIRE Oncology/Hematology Research Awards for 2017 be announced and how many awards will be issued?
The successful awardees will be notified in September 2017. Pfizer anticipates providing up to 6 awards to investigators in the United States. (top)
Does the funding include institutional overhead costs and indirect costs?
Yes, the maximum funding for each award includes direct costs, indirect costs and institutional overhead costs. Overhead is capped at 28% per Pfizer policy, and Pfizer will not pay overhead on indirect costs. Final budgets of those studies awarded a grant will be reviewed for fair market value in accordance with local policies and procedures before the contracting process begins. (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 may the ASPIRE Oncology/Hematology Research Awards 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 Oncology/Hematology 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.
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 grant program. ASPIRE awards cannot be provided to studies that are already in progress. (top)
Can ASPIRE Oncology/Hematology Research Awards funding be used to purchase equipment?
No. ASPIRE Oncology/Hematology Research Awards funds may not be used to purchase equipment, although the purchase of relevant laboratory supplies is allowed. (top)
Are the ASPIRE Oncology/Hematology Research Awards open to researchers working outside the United States?
NO. The 2017 ASPIRE Oncology/Hematology Research Awards are open to qualified researchers from United States only. (top)
What areas of research meet the criteria for ASPIRE Oncology/Hematology Research funding?
Each ASPIRE competitive grants program asset sets its own research criteria. Check with the specific ASPIRE Research award program and asset for more information. (top)
- Pre-clinical research (excluded for palbociclib only)
- General education and / or training
- Public health
- Support for ongoing clinical programs that are part of an organization’s routine operations
- Proposals that fall outside of the pre-specified research focuses (top)
What project deliverables are required?
Projects are expected to yield results that will advance the knowledge of palbociclib in the treatment and disease management of advanced breast cancer. It is expected that results will be presented at scientific meetings and published in peer reviewed journals. (top)
If the study uses a Pfizer drug, what are Pfizer’s procedures for reporting of Serious Adverse Events?
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 (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.
- 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.
Can an exception be made for certain applicants regarding the eligibility criteria to the ASPIRE Breast Cancer Research Awards?
Eligibility criteria have been carefully designed to attract appropriate candidates at a certain level in their professional development. In keeping with the purpose and intention of the ASPIRE awards, applicants must meet all the criteria in order to be considered for an award. 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. Email 2017ASPIREonc@pfizer.com (top)
2017 ASPIRE Oncology/Hematology Program is currently accepting research proposals. Please refer to ‘Apply’ tab on www.aspireresearch.org/onc.
What is the deadline for application?
Research proposals in the form of Letter of Intent (LOI) for the 2017 ASPIRE Oncology/Hematology Program are due March 31, 2017. Upon selection, investigators will be contacted individually to submit full protocol.
If my application is successful, when will the funding commence?
Awards will commence in the fourth quarter of 2017, pending receipt of all required documents noted on the application form. Contract must be executed by 1st quarter, 2018. All required documentation (including but not limited to: Final Protocol, IND approval, IRB approval and executed agreement) must be in place before study support is provided. (top)
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. Our objective is to keep our administrative costs as low as possible, preserving the bulk of our budget for actual grants. (top)
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)
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. (top)
How are the proposals reviewed?
Pfizer conducts a preliminary review to ensure proposals are within the scope of research topics. Then it will be reviewed by external review committee based on following criteria: scientific merit of the research proposal, qualifications of the applicant, relevance of proposed research to the program’s mission, evidence of the applicant’s commitment to an academic research career, and evidence of a suitable research environment. (top)