Rheumatology 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 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, and maximizes patient education and patient-physician dialog. (top)
Who is eligible to apply for ASPIRE Research awards?
It is preferred that Applicants have a Doctoral degree (e.g., M.D., Ph.D., Pharm.D., Doctorate in Nursing, etc.) and relevant experience conducting the type of research proposed. However, other types of credentials will be considered (e.g., Nurse Practitioner, Physician Assistant, M.P.H., etc.), along with an appropriate track record, depending on the type of research proposed. Regardless of credentials, the Principal Investigator must reside and conduct the research in the United States. (top)
What is the role of Pfizer in the ASPIRE Rheumatology and Inflammatory Bowel Disease Research awards?
Pfizer is fully funding the ASPIRE Rheumatology and Inflammatory Bowel Disease Research awards. Additionally, Pfizer is providing the infrastructure and administrative support required to facilitate the application process. (top)
What are the specifics on the grant awards?
ASPIRE Rheumatology and Inflammatory Bowel Disease research awards are up to a maximum of $150,000 each. Research projects are expected to complete within 2 years of study start. Larger grants may be considered depending on scope and merit of proposal. (top)
Does the funding include Institutional overhead costs and indirect costs?
Yes, the maximum funding for each award includes direct and indirect costs, as well as institutional overhead costs. Final budgets of those studies awarded a grant will be reviewed for fair market value 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 administer 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. Pfizer guidelines limit institutional overhead to 28% of funding for ASPIRE grants. (top)
How are the funds dispersed?
The awards will be paid in milestones. There will be an Initial payment provided at the time of contract execution and receipt of required documents, followed by one or more interim payments triggered by achievement of progress milestones (a function of study design), and then a final payment upon receipt of study results, preferably in the form of a manuscript suitable for publication in a peer-reviewed journal. Details, including exact terms for final payment, will be finalized during contracting. (top)
How may the ASPIRE Rheumatology and Inflammatory Bowel Disease 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 registration and travel expenses to scientific meetings, software licensing fees, publication costs, etc.
An ASPIRE 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 other pending funding. ASPIRE Program grants cannot be provided to studies that are already in progress.
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 Review Committee be provided. If supplemental funding is required, it must be secured from government agencies or foundations outside of Pfizer provided there is no overlap. Similarly, an ongoing Pfizer supported standard IIR cannot apply for supplemental funding via a Pfizer supported competitive grants program.
ASPIRE awards cannot be provided to studies already in progress. (top)
Can ASPIRE Rheumatology and Inflammatory Bowel Disease Research funding be used to purchase capital equipment?
No. ASPIRE Research funds may not be used to purchase capital equipment, although the purchase of relevant laboratory supplies is allowed. (top)
Are the ASPIRE Rheumatology and Inflammatory Bowel Disease Research awards renewable?
No. Each ASPIRE Rheumatology and Inflammatory Bowel Disease Research award is a one-time, non-renewable research grant. Grants will be paid based on milestones to be determined during the contracting process. An Investigator funded in the past may apply to the program again with a substantially new proposal, which will be subject to the same competitive external review process. (top)
Are the ASPIRE Rheumatology and Inflammatory Bowel Disease Research awards open to researchers working outside the United States?
No. The ASPIRE Rheumatology and Inflammatory Bowel Disease Research awards are open only to researchers in the United States. (top)
What specific areas of research meet the criteria for ASPIRE Rheumatology and Inflammatory Bowel Disease funding?
Research proposals are should aim to further the understanding of selected rheumatologic disorders and diseases or inflammatory bowel disease. Specifically, proposals are sought that have the potential to enhance care for patients with selected rheumatology conditions or those with inflammatory bowel disease. Research areas of interest are as follows:
- Approaches to improving communication among patients and healthcare providers (e.g., enduring materials, technological advancements, or web-based teaching programs)
- Health economic and outcomes research related to selected autoimmune diseases
- Basic research in the etiology of selected autoimmune and inflammatory diseases in rheumatology or gastroenterology.
Rheumatologic Disorders and Diseases
Conditions of interest include, but are not limited to: RA, PsA, SLE, and ILD.
- Use of biomarkers, ultrasound and magnetic resonance imaging (MRI) in assessment and management of RA
- Comorbid conditions, such as diabetes, cardiovascular, pulmonary, or ophthalmologic, and increased risks with concomitant therapies used to treat these comorbidities (including, but not limited to, epidemiology, overlapping pathogenesis, assessment, and management of these conditions)
- Approaches to improving adherence to therapy
- Approaches to improving management such as: treating to a specific goal or target by monitoring response and adjusting therapy; evidence-based treatment algorithms; factors predictive of response to therapy
- Signaling pathways implicated in pathogenesis
- Kinase inhibitors and other small molecules that are not being studied currently by a company competing with Pfizer Inc.
Inflammatory bowel disease
- Exploration of the role of JAK/STAT pathways in pathogenesis of inflammatory bowel disease
- Use of biomarkers (of any type) to predict response to treatment, disease course, or to differentiate between Crohn's disease and ulcerative colitis
- Approaches to improving disease management (e.g. evaluation of sequencing of therapy, treating to a specific goal or target)
- Approaches to improving adherence to therapy (top)
Are there any specific research areas that are excluded from ASPIRE Rheumatology and Inflammatory Bowel Disease Research funding?
The following topics fall outside of the scope of the ASPIRE Rheumatology and Inflammatory Bowel Disease Research Program:
- General education and / or training
- Support for ongoing clinical programs that are part of an organization’s routine operations
- Proposals that do not focus on listed rheumatologic disorders and diseases or Inflammatory Bowel Disease except as specified above (top)
What project deliverables are required?
Projects are expected to yield results that will enhance the understanding of selected rheumatology conditions or inflammatory bowel disease and contribute to excellence in patient care, either directly or through patient and physician education. It is expected that the results will be presented at scientific meetings and published in peer reviewed journals. Therefore, consideration should be given to study design, size and statistical power to test hypotheses. Details regarding exact terms for final payment will be finalized during contracting (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) an FDA MedWatch Form, (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)
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-RA-GI-PsO@pfizer.com (top)
Is there a time limit for conducting the funded research?
Contracting must be completed within 4 months of award notification. Study results are expected within 2 years of receipt of initial payment. (top)
How do I apply for a ASPIRE Rheumatology and Inflammatory Bowel Disease Research award?
Applications are to be submitted to Pfizer through an online submission website. Please click on the link below to be routed to Pfizer’s global investigator-initiated research website. 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. UNITED STATES Applicants must select “2017 ASPIRE US Rheumatology and Inflammatory Bowel Disease” from the dropdown list of Competitive Grants Programs
Completed applications must be accompanied by the following documents:
- An abbreviated curriculum vitae (CV) (limited to 3 pages)
- Budget for proposed research
Other required documents. Due to uploading limitations, please condense the following information to no more than five (5) separate uploads:
- The 3 most relevant articles from the applicant’s scientific publications (if applicable)
- Description of available laboratory facilities (if applicable)
- Listing of other current research support with a description of potential overlap
- Listing of consenting collaborators (including CVs), if applicable. Signed Letter(s) of Agreement from all collaborators must be submitted with the application.
- Bibliography of relevant references (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
If my application is successful, when will the funding commence?
It is expected that awards will commence at the end of 2017, pending receipt of all required documents noted on the application form and full execution of the Research Agreement. Contracts that are unable to be executed by the end of the calendar year are subject to loss of funding. (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)