ASPIRE Gene Therapy for Hemophilia 2017 | FAQ

Frequently Asked Questions


What are the ASPIRE HEMOPHILIA Research Awards?

The U.S. Advancing Science through Pfizer: Investigator Research Exchange (ASPIRE) Gene and anti-TFPI Therapies for Hemophilia Research Awards Program is a competitive grants program that reflects the commitment of Pfizer Hemophilia to support ongoing basic science and clinical investigation in gene and anti-TFPI Therapies for hemophilia. In an era of increased competition for research funding, the 2018 ASPIRE Gene and anti-TFPI Therapies for Hemophilia Research Awards Program is designed to support laboratory and clinical research in pathogenesis, complications, management, and clinical outcomes of gene and anti-TFPI therapies for hemophilia. The ASPIRE Gene and anti-TFPI Therapies for Hemophilia Research Awards Program utilizes an independent, external expert panel to review and rank the successful grant applications.top


Who is eligible to apply for ASPIRE Gene Therapy for Hemophilia Research awards?

To be eligible, applicants must have am advanced professional degree (e.g. MD, PhD, PharmD, DNP, etc. or its equivalent). Mid-career or Senior Investigators are encouraged to apply; however, in order to stimulate the careers of young investigators, preference will be given to those investigators who are currently conducting postdoctoral PhD research or within 5 years of fellowship completion. Applicants currently enrolled in a residency or fellowship program are not eligible.top


What is the role of Pfizer in the ASPIRE Gene and anti-TFPI Therapies for Hemophilia Research awards?

While Pfizer will fully fund successful ASPIRE Gene and anti-TFPI Therapies for Hemophilia 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


How many ASPIRE Gene and anti-TFPI Therapies for Hemophilia Research Awards are available and what is the monetary amount of each award?

For the 2018 cycle, up to 3 awards will be granted. The amount of each award will be up to approximately $125,000 per year, for up to 2 years, inclusive of institutional overhead (capped at 28%).top


What is the deadline for application?

Applications must be received by Monday, 31 May 2018, 5:00PM New York Eastern Daylight Time.top


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

Awards will commence on or around November/December 2018, pending receipt of all required documents noted on the application form. Contracts that are unable to be executed by the end of the calendar year are subject to loss of funding.top


Will I receive a copy of the Review Committee’s evaluation of my grant proposal?


A summary review of the independent expert review panel’s comments will be provided on request to unsuccessful applicants in order to assist them in further refining their grant proposals for possible future submissions.  top


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


Yearly grant monies will be distributed on a per-annum basis.  top


Does the funding include Institutional overhead costs and indirect costs?


Yes, the funding award 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?


Examples of 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. Note: These are capped at 28%. top


How are the funds dispersed?


Yearly grant monies will be distributed at up to 50% at the beginning of the award year and up to 50% upon a subsequent milestone such as submission of the yearly grant progress/final report.  top


How may the ASPIRE Gene and anti-TFPI Therapies for Hemophilia 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, an ASPIRE Gene and anti-TFPI Therapies for Hemophilia 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.top


Can ASPIRE Gene and anti-TFPI Therapies for Hemophilia Research Award funding be used to purchase equipment?

No. ASPIRE Gene and anti-TFPI Therapies for Hemophilia Research funds may not be used to purchase equipment, although the purchase of relevant laboratory supplies is allowed.top


Are the ASPIRE Gene and anti-TFPI Therapies for Hemophilia Research awards renewable?

No. Each ASPIRE Gene and anti-TFPI Therapies for Hemophilia Research award is a one-time, non-renewable research grant.top


Are the ASPIRE Gene and anti-TFPI Therapies for Hemophilia Research awards open to researchers working outside the United States?

Yes, the ASPIRE Gene and anti-TFPI Therapies for Hemophilia Research awards program is global.top


What areas of research meet the criteria for the ASPIRE Gene and anti-TFPI Therapies for Hemophilia Research Awards?

Pfizer will ONLY consider applications which address one of the following areas of focus for this year’s program

Areas of Research Focus:

  • Basic Science of Gene Therapy for Hemophilia
    • Basic science, tropism, transduction efficiency & tolerability of Adeno-associated virus
    • AAV antibody Titer assessment, reduction, tolerance
    • Role of immunosuppression in managing transaminitis
  • Basic Science of TFPI & Anti-TFPI Monoclonal Antibodies
    • Regulation of Coagulation
    • Basic biology of TFPI interactions with Protein C, ATIII, & Protein S
    • Cross talk among regulators (e.g. Protein S being a co-factor for both Protein C and TFPI)
    • Role of different TFPI pools in regulation of coagulation
    • Pharmacology resulting from concomitant treatments (especially antifibrinolytics) added to anti-TFPI
  • Patients with MILD Hemophilia A or B
    • Patients with MILD Hemophilia A or B
    • Arthropathy: presence, development, clinical burden & Joint damage in mild Hemophilia
    • Quality of Life/Work analysis in mild Hemophilia
    • Clinical profile & healthcare utilization in mild Hemophilia
    • Cost of Care, including non-hemophilia related healthcare utilization in mild Hemophilia. top

Are there any specific research areas that are excluded from ASPIRE Gene and anti-TFPI Therapies for Hemophilia Research Awards?


The following topics fall outside of the scope of the ASPIRE HEMOPHILIA Research Program:
 

  • General education and / or training
  • Public health
  • Support for ongoing clinical programs that are part of an organization’s routine operations.
  • Proposals that do not evaluate subject matter in the Areas of Focus as specified above.  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?


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



For All Studies Using a Pfizer Product and/or Device: Pfizer requires that, within 24 hours of first awareness of the event (or immediately if the event is fatal or life-threatening), the principal investigator will report to Pfizer by facsimile any Serious Adverse Event (SAE) that occurs during the SAE reporting period in a study subject assigned to receive the Pfizer Product. In addition, for studies using a Pfizer device or Pfizer product packaged with a device, reportable events include not only SAEs but also Device Incidents and Device Near-Incidents.

  • Reporting Forms: The principal investigator will report such SAEs using the Pfizer IIR SAE reporting form or the approved local regulatory form (i.e., FDA MEDWATCH form, CIOMS, etc.) and the Reportable Event Fax Cover Sheet provided by Pfizer. SAEs should be reported as soon as they are determined to meet the definition, even if complete information is not yet available.
  • Reporting Period: The Reportable Events that are subject to this provision are those that occur from after the first dose of the Pfizer product through 28 days after discontinuation of the Pfizer product.
  • Follow-up Information: The institution and/or 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 the institution and/or principal investigator of the responsibility for reporting it to the FDA or local regulatory authority, as required.  top

Can an exception be made for certain applicants regarding the eligibility criteria to the ASPIRE Gene and anti-TFPI Therapies for Hemophilia Research awards?


The eligibility requirements have been carefully designed to attract appropriate candidates. 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


What is the ultimate expectation of projects that receive funding through the ASPIRE Gene and anti-TFPI Therapies for Hemophilia Research Awards Program?

Projects are expected to yield results that will advance the medical knowledge of Gene Therapy and anti-TFPI therapy for Hemophilia. It is expected that results will be presented at scientific meetings and published in peer-reviewed journals.top


Is there a time limit for conducting the funded research?


Interim of final study results are expected before each 31 December commencing the year after the award is made. top


How do I apply for an ASPIRE Gene and anti-TFPI Therapies for Hemophilia Research Award?

Applications are to be submitted to Pfizer through an online submission website. Visit www.aspireresearch.org, and click on “Awards in Hemophilia, United States”, and click on the “Apply” tile in the blue bar at the top of the page. From there you will be routed to Pfizer’s global investigator-initiated research website. Click on “Submit an IIR Request” and follow the online instructions. Select“ASPIRE-Gene and anti-TFPI Therapies for Hemophilia 2018”” from the drop down list of the online submission portal.

Completed application forms must be accompanied by the following documents:

  • Cover letter on institutional letterhead
  • Relevant articles from the applicant’s scientific publications (if applicable)
  • Description of preliminary work in proposed research topic
  • An abbreviated curriculum vitae (CV) (limited to 3 pages); NIH biosketch format will be accepted
  • Description of available research facilities
  • Listing of other research support with a description of overlap with ASPIRE application, if any, and, if applicable, a listing of proposed collaborators (including CVs)
  • Bibliography of relevant references
  • Itemized budget for proposed research  top

What if I don’t fully understand the ASPIRE application process?

Please refer to the application guide. If you still have questions, please email the coordinator at Questions.Aspireresearch-Hemophilia_Gene_aTFPI_therapies@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 programs become available?


Visit www.aspireresearch.org and complete the contact information section to receive future program notifications. top


I'm a previous ASPIRE Award recipient; am I eligible to apply for another Award?

ASPIRE Hemophilia award winners may apply for awards in the future. Awards are based upon scientific merit commensurate with funding that is available. Please inquire Questions.Aspireresearch-Hemophilia_Gene_aTFPI_therapies@pfizer.com before applying.  top