TTRFAP 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 GLOBAL ASPIRE TTR Amyloidosis Research award program for more information. (top)
I will complete my professional training shortly after the application deadline, am I eligible?
2016 ASPIRE awards will be administered no earlier than October, 2016. If the application deadline and the timing of the official award overlaps with the completion date of your training programs, applicants may apply as long as they:
- Provide evidence that the applicant will be officially employed by the university/host institution
- Provide evidence that the applicant will have a faculty appointment (top)
What is the role of Pfizer in the GLOBAL ASPIRE TTR Amyloidosis Research awards?
Pfizer is fully funding the GLOBAL ASPIRE TTR Amyloidosis Research awards. Additionally, Pfizer is providing the infrastructure and administrative support required to facilitate the application process. (top)
Who reviews the research proposals and are the reviews blinded?
The ASPIRE applications will be reviewed by an independent, external review committee comprised of medical and scientific experts. The reviews are completely blinded. No one on the committee will have access to investigator/institution identifying information. Instructions for preparing the study protocol and accompanying documentation in a manner to preserve the blinded reviews are provided in the application guide. Regardless, all submissions will be carefully reviewed by program staff prior to sharing them with the committee to ensure any identifying information can be redacted in advance of their review of your application. (top)
When will the GLOBAL ASPIRE TTR Amyloidosis Research awards for 2016 be announced and how many awards will be issued?
The successful awardees will be notified in July 2016. Pfizer anticipates providing up to 4 awards. (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. Overhead rates are capped at 28% per Pfizer policy and will not be negotiated beyond this cap. Pfizer also will not pay overhead on indirect costs. 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 GLOBAL ASPIRE TTR Amyloidosis 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, a GLOBAL ASPIRE TTR Amyloidosis 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 GLOBAL ASPIRE TTR Amyloidosis Research funding be used to purchase equipment?
No. GLOBAL ASPIRE TTR Amyloidosis Research funds may not be used to purchase equipment, although the purchase of relevant laboratory supplies is allowed. (top)
Are the GLOBAL ASPIRE TTR Amyloidosis Research awards open to researchers working outside the United States?
YES. The 2016 GLOBAL ASPIRE TTR Amyloidosis Research awards are open to qualified researchers from around the world in the following regions: United States, Europe, Latin America and Asia Pacific. (top)
What areas of research meet the criteria for GLOBAL ASPIRE TTR Amyloidosis Research funding?
Each ASPIRE competitive grants program sets its own research criteria. Check with the specific ASPIRE Research award program for more information. (top)
- Studies involving requests for formulated study drug or pure substance
- Public health
- Support for ongoing clinical programs that are part of an organization’s routine operations
- Studies designed to address how patients / payers use evidence about our products to make coverage and reimbursement decisions are prohibited
- Studies focused on progression of disease with attention to burden of disease and health outcomes
- Head to head drug studies
- Anything outside of TTR amyloidosis
- Dose-response or combination therapy studies
- Pediatric investigations
- End stage disease (Stage 3-4 TTR amyloidosis)
- Pre-clinical studies (except requests for pure substance only)
- Post-transplant investigations (top)
What project deliverables are required?
Projects are expected to yield results that will advance the understanding of the epidemiology, basic science and early diagnosis and treatment of TTR amyloidosis. It is expected that results will be presented at scientific meetings and published in peer reviewed journals. (top)
Will non-drug research proposals be considered?
Yes. Post-hoc exploratory and well-designed retrospective or prospective evaluations to generate and/or test hypotheses or studies to validate new assessments will be considered for the 2016 ASPIRE TTR Amyloidosis program provided the study is designed to generate data to better understand important diagnostic and clinical management issues relevant to treating patients with TTR Amyloidosis. Evaluations may include standardized assessments as well as surrogate biomarkers that may define or predict clinical response and to identify novel diagnostic strategies. (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.
In addition, for any non-interventional study with sites in the EU, the following requirements also apply:
Reporting of Non-Serious Adverse Events. Certain Non-Serious Adverse Events (“NS-AEs,” as defined below) must also be reported to Pfizer. The NS-AEs that are reportable to Pfizer are those that (1) were specified in the Protocol as being reportable and (2) occur during the NS-AE reporting period (as defined below). Within 24 hours of first awareness of the event, Principal Investigator will report to Pfizer by facsimile any such NS-AE. Principal Investigator should report these NS-AEs as soon as they are determined to meet the definition and reportability criteria, even if complete information is not yet available.
- Reporting Forms. Principal Investigator will report NS-AEs on 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 Non-Interventional Study Adverse Event Report 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 NS-AE submitted.
- AE and NS-AE Definitions. An Adverse Event (“AE”) is any untoward medical occurrence in a Study subject receiving the Pfizer Product or an individual otherwise exposed to the Pfizer Product, without regard to whether there is a causal relationship between the Pfizer Product and the medical occurrence. A Non-Serious AE (“NS-AE”) is any AE that does not meet the definition of an SAE (see Section b above, SAE Definition). For this Study, only NS-AEs identified in the Study Protocol as reportable must be submitted to Pfizer.
- NS-AE Reporting Period. Unless the Protocol specifies a longer period, the NS-AEs that are subject to this reporting provision are those that occur from after the first dose of the Pfizer Product or the Study subject’s enrollment in the Study (whichever is later) through 28 calendar days after the last administration of the Pfizer Product or the subject’s last Study visit (whichever is earlier).
- Follow-Up Information. Institution will assist Pfizer in investigating any NS-AE if Pfizer considers it necessary and will provide any follow-up information reasonably requested by Pfizer.
- Regulatory Reporting. Reporting an NS-AE to Pfizer does not relieve Institution of responsibility for reporting it to appropriate regulatory authorities, if such reporting is required.
- Further information about the NS-AE reporting requirements for non-interventional IIR studies conducted within the European Union is provided in the Pfizer-provided training referenced in Section i above. Principal Investigator will review this material and share it with any Study staff engaged in the reporting of NS-AEs. (top)
Can an exception be made for certain applicants regarding the eligibility criteria to the GLOBAL ASPIRE TTR Amyloidosis 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: questions.aspireresearch-TTR-Amyloidosis@pfizer.com (top)
How do I apply for a GLOBAL ASPIRE TTR Amyloidosis award?
Applications are to be submitted to Pfizer through an online submission website. Visit www.aspireresearch.org and click on “2016 Global TTR Amyloidosis Research Awards”. Open the “Apply” tab on the top of the page and click on link “To Apply for a 2016 ASPIRE Award Click Here”. This will direct you to Pfizer’s online submission portal www.iirsubmission.pfizer.com
Click on “Submit an IIR Request” and follow the online instructions. If this is your first time visiting the portal you must first “Create an Account”.
When starting the online submission form, select “yes” when asked if you are applying for a competitive program. A dropdown menu will appear. Select "2016 GLOBAL ASPIRE TTR Amyloidosis" to ensure the submission is tagged and routed appropriately.
Completed applications are to include only two files:
- Study Protocol (this is a single document including the study protocol, reference list, description of the overall research environment, qualifications to conduct the proposed research, and the study budget).
- An abbreviated curriculum vitae (CV) (limited to 3 pages) for you and any collaborators; CVs are to be combined into a single document for submission
Note: when the system prompts you to submit the budget, just submit the Study Protocol again. You do not need to prepare a separate budget document as it should be part of your study protocol. See the application guide for complete details preparing the Study Protocol. (top)
Where can I get an application form?
Please see the above question and answer for how to apply for an award. An application guide is available at www.aspireresearch.org under the link to the 2016 Global ASPIRE TTR Amyloidosis. Once you get to the site for the 2016 Global ASPIRE TTR Amyloidosis, click on the tab at the top that says “Apply”. From there see: Application Guide For an APPLICATION GUIDE click here (top)
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 questions.aspireresearch-TTR-Amyloidosis@pfizer.com (top)
What is the deadline for application?
Applications must be received by May 9, 2016, 11:59pm EST. Late or draft submissions will not be accepted under any circumstances. You must completely submit your application by the May 9th deadline to have your grant application considered. Addenda, supplemental materials, changes, or updates will not be accepted after the deadline. (top)
If my application is successful, when will the funding commence?
Awards will commence on or around October-November 2016, pending receipt of all required documents noted on the application form. Contracts that are unable to be executed by December 30, 2016 are subject to loss of funding. (top)
Will I receive a copy of the review committee’s evaluation of my grant proposal?
Yes as long as you request it. The review committee’s comments will be provided as a courtesy upon request. However, please note that Pfizer is not able to discuss the reviews further nor is there a mechanism for reconsideration or resubmission. Applicants are not to contact committee members or Pfizer directly regarding the reviews.(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: questions.aspireresearch-TTR-Amyloidosis@pfizer.com (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)