Please note that the application process has changed for 2010. Please allow time to attend to new procedures when submitting your proposal

Application Process

How to Apply:
 
For 2010, all applications will need to be submitted via the Pfizer Investigator-Initiated Research (IIR) portal via the following link: 

http://www.iirsubmission.pfizer.com

The following documents are required and must be completed in English (further details on each of these items are provided in the Application section of this page:
 
1. Itemized Budget
2. Full Proposal (limited to 5000 words excluding abstract, references, tables, or details about research facilities)
3. An Abbreviated Curriculum Vitae (CV) – Maximum 3-5 pages.
 
All submitted GRAND proposals must have “GRAND 2010” included in the title and be no more than 250 characters. Omission may cause significant delay in your submission confirmation.

Applications must be received by 5pm Eastern Daylight Time in the United States on:

May 12, 2009.
 
Applications must be submitted in English.

In 2010, research may be in the following areas:

• Human laboratory (eg, pharmacokinetics, pharmacodynamics, cravings, withdrawal)
• Pharmacotherapy of smoking cessation and relapse, and/or its interaction with behavioral support
• Characterization of subtypes of smokers and appropriate interventions.

The following topics fall outside of the scope of the GRAND Program for 2010:

• Animal studies
• Genetics
• Epidemiology (harm and prevalence of dependence)
• Tobacco policy
• Public health
• Community interventions
• Economic and social factors
• Educational programs.

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

It is anticipated that at least 6 Awards between US $50,000 and US $200,000 each (including direct costs, institutional overhead costs, and indirect costs) for a total of US $1.2 million will be granted in November/December 2010. These Awards are open to all researchers. If requested, Pfizer drug will be provided at no additional cost to Awardee. Drug supply will be provided in bulk bags, to be packaged for the study at the site.

Projects should yield results that would first merit submission as abstracts to scientific meetings and, subsequently, publication in peer-reviewed journals.
 
Key Dates
 
Application deadline: May 12, 2010 (by 5 pm Eastern Daylight Time in the United States)
Notification of Awards recipients: August, 2010
Announcement of Awardees: September, 2010
Start of Award: November/December, 2010
Study results are expected before November, 2012.
 
Eligibility
 
Applicants must meet the following requirements:
1. Academic Eligibility
An Applicant must hold an MD, a PhD, or the equivalent.
 
2. Research Requirements
An Applicant should have a strong academic career interest in one of the areas relevant to the mission statement:

• Human laboratory (eg, pharmacokinetics, pharmacodynamics, cravings, withdrawal)
• Pharmacotherapy of smoking cessation and relapse, and/or its interaction with behavioral support
• Characterization of subtypes of smokers and appropriate interventions.

3. Other Funding
No other government, non-governmental, or industry-sponsored projects may cover the same work scope as the grant application to the GRAND Program. However, a GRAND 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.
 
4. Citizenship
There are NO restrictions regarding citizenship. However, an Applicant must have legal status in the country in which his or her institution is located. 

Criteria for Selection
 
Applications will be reviewed by the GRAND Review Committee, who are all internationally prominent researchers listed in this brochure.
In their evaluation, the Committee members will consider:

• Scientific merit of the research proposal
• Qualifications of the Applicant
• Relevance of proposed research to the advancement of the understanding of the mechanisms of nicotine dependence and its treatment
• Evidence of a suitable research environment/feasibility.

Application
 
Applications must be submitted in English.

For 2010, all applications will need to be submitted via the Pfizer Investigator-Initiated Research (IIR) portal via the following link: 

http://www.iirsubmission.pfizer.com

Click on “Create New Proposal” and follow the online instructions to create a new IIR submission. If this is your first time visiting the portal, you must first “Create an Account”. For the online submission form, you will need to fill in all the relevant sections using the drop-down menus where appropriate. Please note the following guidance for these specific sections:
 
STUDY TITLE – All submitted GRAND proposals must have “GRAND 2010” included in the title and be no more than 250 characters. Omission may cause significant delay in your submission confirmation.

PRIMARY PFIZER THERAPEUTIC AREA – Select the most relevant area for your application.

SUBMISSION TYPE – Select “Full” (not concept).

STUDY TYPE – Select “Clinical” (not pre-clinical).

In addition to completing each box within every section of the IIR portal, the main proposal and other supporting documents are required for your submission and will need to be uploaded in the relevant sections:

FUNDING REQUEST SECTION
1. Itemized Budget – All costs associated with the conduct of the study, including institutional overhead costs and indirect costs should be identified in full in US $. All grants will be paid in US $. For guidance, the budget should be as detailed as possible and include (as appropriate):

• Direct Labor Costs – Indicate requested budget amount for Principal Investigator and other staff involved in study conduct
• Direct Study Costs – Please itemize to include procedural costs, ie, subject visits, X-rays, blood panels, data management and analysis, etc.
• Institutional Overhead Costs ¬– Please include applicable overhead percentage for the direct study costs
• Indirect Costs – Please include additional study expenses such as costs for publication, IRB/IEC review fees, supplies, software license fees, and travel.

**Please note that Pfizer does not pay overhead on indirect costs, or provide funding for capital equipment.
 
STUDY DETAILS SECTION
2. Full Proposal - The full proposal should be limited to 5000 words, excluding abstract, references, tables, or details about research facilities. Applications with proposals over this limit will NOT be reviewed by the Review Committee.

The following sections should structure your proposal:

• Abstract (Please limit to 250 words) – Describe your study rationale and synopsis, and how it relates to the 2010 Grant mission. Be sure to include the primary objective(s), hypotheses, and techniques you will use to achieve these goals
• Objectives – A statement of objectives, specific aims, hypotheses, and relevance of the study to the advancement of the understanding of the mechanisms of nicotine dependence and its treatment
• Methodology – A description of the study methodology including: experimental design, sample size, potential problems and possible approaches for overcoming them, ethical issues relating to the involvement of human subjects, and methods of data analysis. Figures and tables must be included in the body of the text
• A description of relevant past work by the Applicant and other investigators involved in the study
• References
• Research facilities (in brief).

PRIMARY SITE INFORMATION SECTION
3. An Abbreviated Curriculum Vitae (CV) – Maximum 3–5 pages.
 
As additional guidance, please note the following:
 
APPLICATION DEADLINE: May 12, 2010
 
Applications must be received by 5 pm Eastern Daylight Time in the United States on May 12, 2010. Addenda, supplemental materials, changes, or updates will not be accepted after the deadline.
 
Applications must be submitted in English
 
Prior to submitting your application via the IIR portal, please notify the GRAND coordinator of your intention to apply via email at enquires@grand2010.org so that the GRAND coordinator can help to expedite and track the processing of your application.
 
If you do not receive formal acknowledgement of your application via email within 1 week of your submission, please contact enquiries@grand2010.org.
 
 
Conditions of the Award
 
Each Award is subject to the following conditions, which must be agreed to by the Awardee and host institution through a Letter of Agreement with Pfizer before any funds will be disbursed.

A. Financial Administration
The GRAND Program grant will be awarded to the host institution on behalf of the Awardee. It is anticipated that at least 6 Awards will be granted in November/December, 2010 between US $50,000 and US $200,000 each, for a total of US $1.2 million. The amount of each Award includes direct costs (labor and study costs), institutional overhead costs, and indirect costs (additional expenses such as publication, software license fees, and travel costs). The institutional overhead costs cannot exceed 28% of the direct costs. Pfizer does not pay overhead on indirect costs. Each payment will be made in instalments according to milestones, with a maximum of 50% of the funding delivered at the beginning of the project. The last instalment of 15% will be made when the final results of the study are available. Final budgets of those studies awarded a grant will be reviewed for fair market value before the contracting process begins.
 
B. Use of GRAND Program Funding
Funds from the GRAND Program may be used to support the Applicant's salary and fringe benefits, technical salaries, and supplies. 
 
C. Financial Record Keeping
A separate financial record must be maintained by the Awardee.
 
D. GRAND Program Awards Progress and Final Reports
The Awardee must submit a final report on study results to the GRAND Program within 6 months after the finalization of the study.
Reprints of articles, published or in press, should be included with all reports.
From time to time, the GRAND Program may ask prior Awardees for information on study progress.
 
E. Required Documents if Proposal is Selected for Funding
Required additional documentation if your proposal is selected for funding by the independent review panel (further guidance will be provided):

• Original letter documenting acceptance of support, written on institutional letterhead, signed by the Investigator
• Two copies of the Signed Research Agreement, which will be provided to the site by Pfizer
• Final Protocol
• IRB/Ethics Committee approval documentation, if applicable
• IND documentation (for US) or response from regulatory authorities, as applicable per country regulations
• W-9 form for your institution (US Applicants Only).

F. Publications
Awardees are expected to present their findings at scientific meetings or to publish them in scientific journals. All publications that result from a project supported by the GRAND Program must carry the following acknowledgement: "This research was supported by the Global Research Awards for Nicotine Dependence Program grant, an independent competitive grants program supported by Pfizer, to (name of Awardee).”
Awardees will provide to the GRAND Program the opportunity to view manuscripts or abstracts 60 days prior to submission for publication or other public disclosure.
 
G. Patents and Licensing
If the conduct of the research results in any invention or discovery by the Awardee that relates to a Pfizer product, the Awardee will grant to Pfizer a perpetual, royalty-free worldwide, non-exclusive license to each such invention.
 
H. Stipulations
1. Should the Awardee discontinue the research project or leave the designated host institution, the GRAND Program must be notified without delay.
2. The GRAND Award may be transferred to another institution at the sole discretion of the GRAND Program, acting on the recommendation of the Review Committee. If a transfer is requested, letters from the Awardee and the new institution must be submitted to the GRAND Program at least 3 months before the date of the proposed transfer.
3. If the host institution or the Awardee wishes to terminate the Award before its completion, an agreement between the host institution and the GRAND Program will be arranged. Termination will be made with the understanding that all unexpended funds will be returned to the GRAND Program and any unpaid balance of the Award will be cancelled.
 
I. Serious Adverse Events (SAE) Reporting (As Applicable)

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 (ie, 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 a 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. 
   
   

Review Committee
 
The Review Committee will consist of the following internationally renowned researchers in the field of smoking cessation:
 
Karl Fagerström, PhD, Co-chair
Fagerström Consulting AB
Helsingborg, Sweden
 
Scott Leischow, PhD, Co-chair
University of Arizona
Tucson, Arizona, USA
 
Jonathan Foulds, MA, MAppSci, PhD
University of Medicine and Dentistry of New Jersey
New Brunswick, NJ, USA

Peter Hajek, PhD
Queen Mary’s School of Medicine and Dentistry
University of London, London, UK
 
John R. Hughes, MD
University of Vermont,
Burlington, Vermont, USA
 
Maxine Stitzer, PhD
Johns Hopkins University
Baltimore, Maryland, USA
 
Philip Tønnesen, MD
Gentofte University Hospital
Copenhagen, Denmark
 
Serena Tonstad, MD, PhD, MPH
University of Oslo
Oslo, Norway
 
Robert West, PhD
University College London
London, UK