Questions and Answers

What are the ARISTA-USA research grants?

ARISTA-USA stands for the American ThRombosis InveStigator IniTiated Research ProgrAm and is a competitive research grants program supported by BMS and Pfizer.

ARISTA-USA’s mission is to encourage the generation of new data to improve patient care for those requiring oral anticoagulation treatment, specifically with apixaban, in relevant disease areas for approved indications or areas of unmet medical needs or special interest.

An external, Independent Review Committee (IRC) reviews proposals and decides on prioritization for funding based on area of interest, originality, scientific merit, and feasibility.

Who is eligible to apply for an ARISTA-USA research grant?

To be eligible, the principal investigator and institution must be based in the United States, hold a doctoral degree (e.g. MD, PhD, or PharmD).

Can an exception be made for certain applicants regarding the eligibility criteria to the ARISTA-USA research grants?

The eligibility requirements have been carefully designed. In keeping with the purpose and intention of the ARISTA-USA research grants and to be equitable between applicants, applicants must meet all the criteria to be considered for research grant support. Submissions outside these parameters will not be considered.

Is the ARISTA-USA program open to researchers working outside the United States?

No. The principal investigator and institution must be based in the United States.

What is the role of BMS and Pfizer in ARISTA-USA?

BMS and Pfizer provide the funding support for ARISTA-USA. All eligible submissions will be reviewed based on area of interest, originality, scientific merit, and feasibility by the external, Independent Review Committee (IRC), which will also decide on prioritization for funding support.

BMS and Pfizer will provide infrastructure and administrative support to facilitate the submission and the review process as well as notify applicants and distribute awards, as appropriate.

How many ARISTA-USA research grants are available this year?

The intent of the ARISTA-USA program in 2017 is to fund 5−8 individual research proposals up to $800,000 each (inclusive of institutional overheads) from a total fund of $3,000,000. Research grant monies will be distributed in milestone payments, in US Dollars.

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

Each ARISTA-USA research grant funds the entire study and is not a sum paid per year. All payments will be made according to a milestone-based payment schedule.

Is there a time limit for conducting the funded research?

The study must start within 6 months of contract execution and the duration of study treatment and follow-up should not exceed 2 years.

Are the ARISTA-USA research grants renewable?

Each ARISTA-USA research grant is a one-time, non-renewable research grant, to be paid in milestone-based progress updates.

How may the ARISTA-USA research funding be used?

Funds may be used to cover 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 travel expenses to present the study results at scientific meetings, software licensing fees, publication costs etc. ARISTA-USA research funds may not be used to purchase equipment, although the purchase of relevant laboratory supplies is allowed.

The principal investigator should not be receiving and will not receive funding from other pharmaceutical companies for the submitted research proposal. No other industry-sponsored projects may cover the same work scope as the research grant application to ARISTA-USA. However, an ARISTA-USA research grant may be related to other funding from foundations or government agencies. 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 ARISTA-USA research grant cannot be amended upwards with additional funding support from BMS/Pfizer (via the standard IIR process or separate competitive research grant program), nor can additional drug support above and beyond what is sufficient to complete the original study as reviewed and approved by the Independent Review Committee be provided. If supplemental funding is required, it must be secured from sources outside of BMS/Pfizer. Similarly, an ongoing BMS/Pfizer-supported standard ISR/ IIR cannot apply for supplemental funding via a BMS/Pfizer-supported competitive research grants program. ARISTA-USA research grants cannot be provided to studies already in progress.

Can ARISTA-USA research funding be used to purchase equipment?

No, ARISTA-USA research funds may not be used to purchase equipment, although the purchase of relevant laboratory supplies is allowed.

Does the funding include institutional overhead costs and other costs?

Yes, the funding award includes institutional overhead costs and other costs (e.g. costs for publication, IRB/IEC review fees, supplies, software license fees, and travel). Final budgets of those studies awarded a research grant will be reviewed for fair market value before the contracting process begins.

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 research project but are necessary to conduct the research 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 based on a milestone payment schedule, and in US Dollars.

What areas of research meet the criteria for ARISTA-USA research funding?

Please refer to Eligible Research.

Are there any specific research areas that are excluded from ARISTA-USA research funding?

Please refer to Eligible Research.

What project deliverables are required?

Research projects are expected to generate new data to improve patient care for those requiring oral anticoagulation treatment, specifically with apixaban, in relevant disease areas for approved indications or areas of unmet medical needs or special interest.

It is encouraged for ARISTA-USA awardees to present study results at scientific meetings and publish in peer-reviewed journals within 6-12 months of completing the study.

Will non-drug research proposals be considered?

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

I’m still not sure if my proposed research topic meets the criteria, how can I find out?

To request further information on the program please contact queries@arista-usa.com.

How do I apply for an ARISTA-USA research grant?

Please refer to How to Apply.

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

For technical support related to the BMS ISR Portal., send an e-mail to hd‐sci‐apps@bms.com, or call the ISR Hotline in the US +1 844 439 5499 FREE. For additional support, you may obtain the Investigator Guide for How to Apply on the main website from www.bms.com/israpplications.

What is the deadline for application?

Proposals must be received by Friday, May 19th, 2017, 11:59 pm EDT.

When will I hear whether my application has been successful?

Applicants will be notified of the Independent Review Committee’s final decision by October 31st, 2017.

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

Research grants will commence pending receipt of all required documents which will be provided to full applicants.

To request further information on the program please contact queries@arista-usa.com

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