ASPIRE Haemophilia Regional | FAQ

Frequently Asked Questions


What are the Regional Haemophilia Research Awards? 
The 2017 Regional Advancing Science through Pfizer Investigator Research Exchange (ASPIRE) Haemophilia Research Awards Programme is a competitive grants programme that reflects the commitment of Pfizer Haemophilia to support ongoing basic science and clinical investigation in haemophilia A and B. (top)


Who is eligible to apply for the Regional Haemophilia Research Awards? 
To be eligible for a Regional Haemophilia ASPIRE Research Award, applicants must have a professional degree (MD, PhD, PharmD or equivalent). Each Regional ASPIRE Haemophilia Programme awards (Wave 1, Wave 2 and Wave 3) has established its own eligibility and research criteria. Please refer to the eligibility tab for more information on how to apply for each Wave. (top)


What is the role of Pfizer in the Regional Haemophilia Research Awards? 
While Pfizer will fully fund the Regional Haemophilia Research Awards, the proposals will be reviewed and ranked by an independent, external expert panel. Pfizer will provide infrastructure and administrative support to facilitate the application and the review process as well as notify applicants and distribute awards. (top)


Who reviews, awards the research proposals?
The ASPIRE applications will be reviewed by an independent, external review committee comprised of medical and scientific experts. (top)


How many Regional Haemophilia Research Awards are available?
The number of awards available may vary each year. For the 2017 cycle, up to 5 awards will be granted. The amount of each award will be up to 60,000 euros, inclusive of institutional overhead (capped at 28%). Please refer to the Home page section Available Awards for more details. (top)


When will the winners of the Regional Haemophilia Research Awards for this year’s be announced?
The successful awardees are usually announced 4–6 months after the application deadline. (top)


Does the funding include institutional overhead costs and indirect costs?
Yes, the grant funding includes indirect costs, and 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 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. Initial payment will be up to 50% of the total grant and there will be payments made based on enrolment or other milestones depending on study type and country requirements. Final payment will be 15% upon receipt of study results. (top)


How may the Regional Haemophilia Research Awards 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 Programme. However, a ASPIRE programme 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. (top)


Can Regional Haemophilia Research Awards be used to purchase equipment?
No. The Regional Haemophilia Research Awards may not be used to purchase equipment, although the purchase of relevant laboratory supplies is allowed. (top)


Are the Regional Haemophilia Research Awards renewable?
No. Each Regional Haemophilia Research Awards is a one-time, non-renewable research grant. (top)


Are the Regional Haemophilia Research Awards open to researchers working anywhere in the world?
No. The 2017 Regional Haemophilia Research Awards are open to researchers working in Europe (including western and eastern countries), Australia, Japan and New Zealand. (top)


What areas of research focus meet the criteria for the Regional Haemophilia Research Awards? 
Pfizer will consider applications which address one of the following areas in haemophilia A and / or haemophilia:
 

  • Prophylaxis schedules / Individualised prophylaxis
  • Pharmacokinetics
  • Laboratory measurement
  • Joint assessment
  • Patient-reported outcomes
  • Cost of care (top)

 


Are there any specific research areas that are excluded from the Regional Haemophilia Research Awards?
The following topics fall outside of the scope of the Regional Haemophilia Research Awards:

  • General education and / or training
  • Support for ongoing clinical programmes that are part of an organisation’s routine operations
  • Proposals that do not evaluate haemophilia A or haemophilia B (top)

What project deliverables are required?
Projects are expected to advance medical knowledge of the fundamental mechanisms of disease and action of current and potential future treatments, and to optimise care for patients with haemophilia. 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. Both drug and non-drug proposals will be considered for funding. (top)


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

  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 (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
  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. Exclusions from SAE Reporting Requirements: i.e. 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, 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.

  1. 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.
  2. 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 3.7.b, SAE Definition). For this Study, only NS-AEs identified in the Study Protocol as reportable must be submitted to Pfizer.
  3. 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).
  4. 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.
  5. 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.
  6. Pfizer-Provided NS-AE Training: 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 3.7, 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 Regional Haemophilia Research Awards?
In keeping with the mission 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)


Is there a time limit for conducting the funded research? 
Study results are expected within 18 months of the grant being awarded. (top)


How do I apply for a Regional Haemophilia Research Awards?
Applications should be submitted through the online submission website. Please click here to be routed to Pfizer’s global investigator-initiated research website. After logging in, go to your Dashboard and click on “Create New Proposal” 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 the submission is part of a competitive grant programme, then select the appropriate programme name "Regional ASPIRE Haemophilia Programme:" (top)


Where can I get an application form?
There is no application form per se; applications are made online through the IIR portal referenced above (see http://www.aspireresearch.org). (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 ASPIRE Coordinator questions.europeaspire@pfizer.com (top)


What is the deadline for application?
Please refer to the Apply section for more information. (top)


When will I hear whether my application has been successful?
Successful applicants will be notified 3 months after submission. (top)


What if I have a question that is not covered here?
If you require clarification on an issue not addressed here, please contact the ASPIRE Coordinator.
E-mail: questions.europeaspire@pfizer.com (top)


Does Pfizer sponsor other competitive grants programmes?
Yes. Therapeutic areas, application dates, deadlines and eligibility vary between programmes. Please visit www.aspireresearch.org for more information (top)


Can I be notified when future Regional Haemophilia Research Awards become available?
Visit www.aspireresearch.org and complete the contact information section to receive future programme notifications. (top)


I'm a previous ASPIRE Award recipient; am I eligible to apply for another award?
The Regional Haemophilia ASPIRE Research Award winners may apply for awards in the future. Awards are based upon scientific merit commensurate with funding that is available. Please questions.europeaspire@pfizer.com  before applying. (top)