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ASPIRE-AR_US Linezolid 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.

Who is eligible to apply for ASPIRE Research awards?

The 2012 ASPIRE Awards in Antibacterial Research are open to all investigators (senior & junior) provided that specific eligibility requirements are met. Applicants currently enrolled in a residency, fellowship or postdoctoral program are NOT eligible.

Define “junior investigator” and what is meant by “post-terminal training?

To be considered a junior investigator, applicants must have a professional degree (e.g. MD, PhD, PharmD) and must be no more than 5 years post terminal training.

Post-terminal training attempts to better define that the applicant is no longer associated with a training program and in the early stages (≤5 yrs) of their research career. Applicants currently enrolled in a residency, fellowship or postdoctoral program are not eligible.

I will complete my professional training shortly after the application deadline, am I eligible?

2012 ASPIRE awards will be administered no earlier than July, 2012. Given the application deadline and the timing of the official award overlaps with the completion date of most training programs, applicants may apply as long as they:

  • Provide evidence that the applicant will be officially employed by the university
  • Provide evidence that the applicant will have a faculty appointment
  • Have their award nominator state within their nomination letter that the applicant will have completed training and will not be associated with a training program after July, 2012.
What is the role of Pfizer in the ASPIRE Antibacterial Research awards?

Pfizer is fully funding the ASPIRE Antibacterial Research awards. Additionally, Pfizer is providing the infrastructure and administrative support required to facilitate the application process.

Who reviews, awards the research proposals?

The ASPIRE applications will be reviewed by an independent, external review committee comprised of medical and scientific experts.

When will the ASPIRE Antibacterial Research awards for 2012 be announced?

The successful awardees will be notified in July 2012.

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

Each award funds the entire research period, and is not a sum paid per year.

Does the funding include institutional overhead costs and direct costs?

Yes, the maximum funding for each award includes direct 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.

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.

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.

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 enrollment or other milestones depending on study type.

Is formulated study drug or pure substance provided?

Pfizer support is typically provided in the manner of funding, and/or drug (either formulated or pure compound) depending upon the type of research. Pfizer cannot provide funding for investigator to purchase a Pfizer formulated product.

How may the ASPIRE Antibacterial 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 Antibacterial 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.

Due to the competitive nature of these awards, Pfizer cannot provide any additional funding and/or drug support beyond what has been requested and approved by the external review panel.

Can ASPIRE Antibacterial Research funding be used to purchase equipment?

No. ASPIRE Antibacterial Research funds may not be used to purchase equipment, although the purchase of relevant laboratory supplies is allowed.

Are the ASPIRE Antibacterial Research awards renewable?

No. Each ASPIRE Antibacterial Research award is a one-time, non-renewable research grant.

Are the ASPIRE Antibacterial Research awards open to researchers working outside the United States?

The 2012 ASPIRE Antibacterial Research awards are open only to researchers from the United States

What areas of research meet the criteria for ASPIRE Antibacterial Research funding?

Each ASPIRE competitive grants program sets its own research criteria. Check with the specific ASPIRE Research award program for more information.

Are there any specific research areas that are excluded from ASPIRE Antibacterial Research funding?

The following topics fall outside of the scope of the ASPIRE Antibacterial 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 linezolid (top)
  • Investigators may consider evaluating additional clinical measures (e.g. length of stay, readmission, ventilator days, etc.). However, proposals seeking to financially quantify outcomes are outside the scope of the program. Studies designed to address how patients / payers use evidence about our products to make coverage and reimbursement decisions are prohibited.
What project deliverables are required?

Projects are expected to yield results that will advance the medical knowledge of linezolid’s role in the treatment of complex adult patients within approved indications. It is expected that results will be presented at scientific meetings and published in peer reviewed journals.

Will non-drug research proposals be considered?

Yes. Both drug and non-drug proposals will be considered for funding.

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

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.
Can an exception be made for certain applicants regarding the eligibility criteria to the ASPIRE Antibacterial 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.

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: [email protected]

Is there a time limit for conducting the funded research?

Study results are expected before December 31, 2013.

How do I apply for a ASPIRE Antibacterial Research award?

Applications are to be submitted to Pfizer through an online submission website. Visit www.aspireresearch.org and click on “2012 Antibacterial Research Awards – United States”. From there you will choose “Narrow Spectrum Antibiotics for the Treatment of MRSA: Clinical Evaluation in Complex Adult Patients”. Click on “Apply” and you will be routed to Pfizer’s global investigator-initiated research website. Click on “Submit an IIR Request” and follow the online instructions.

Completed application forms must be accompanied by the following information:

  • Cover letter on institution letterhead
  • The 3 most relevant articles from the applicant’s scientific publications (if applicable)
  • An abbreviated curriculum vitae (CV) (limited to 4 pages)
  • Description of available laboratory facilities (if applicable)
  • Listing of other research support available with a description of overlap and, if applicable, a listing of consenting collaborators (including CVs)
  • Bibliography of relevant references
  • Budget for proposed research
  • A letter of nomination from the sponsoring department chairman (junior faculty only).
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 [email protected]

I’m having difficulty submitting my application online, who do I contact for assistance?

Receive assistance by contacting [email protected] or call the IIR Hotline in US: 877-IIR-5670/877-447-5670 (Mon – Fri 9:30am to 3:30pm EST);
Outside the US, call: 203-316-9059.

What is the deadline for application?

Applications must be received by May 1, 2012, 11:59pm EST.

When will I hear whether my application has been successful?

Successful applicants will be notified in August 2012

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

Awards will commence on or around November/December, 2012, 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.

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.

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: [email protected]

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.

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.