Young Investigators Award Program

Application Guidelines

I. Introduction

A. Mission
ENTELLIGENCE is a program designed to support basic science and clinical research related to pulmonary vascular disease. ENTELLIGENCE provides funding for young investigators to further our understanding of pulmonary vascular disease, and ultimately, to improve treatment of patients with pulmonary hypertension.

B. Description
ENTELLIGENCE was established by Actelion Pharmaceuticals US, Inc. in 2005. For 2011, Actelion is committed to providing the initial funding of $500,000 for up to a total of 5 competitive grants of $100,000 each. These grants will be awarded to qualified investigators who show promise in their investigations of basic mechanisms and/or vascular biology of PH. ENTELLIGENCE is run as a nonprofit program.

Applications will be considered for basic science, translation or clinical investigations specifically targeting pulmonary vascular disease in the following areas:

  • Pathophysiology
  • Pharmacology
  • Treatment
  • Genetics
  • Diagnosis
  • Epidemiology

The main focus of the project should be to develop a better understanding of and approach to disorders of pulmonary vascular biology, particularly PH.  Bridge funding, therapeutic drug trials and registries are not eligible.

C. Publication of results

Results will be shared with the scientific community through presentations at scientific congresses, online, and in publications. Award winners will also be required to share results with the Steering Committee during an annual ENTELLIGENCE meeting.

II. Structure

A. Steering Committee
The initial Steering Committee for the Young Investigators Award Program was selected by Actelion. Since the inception of ENTELLIGENCE, Steering Committee members have selected and approved all new and replacement members. The Steering Committee membership selection process ensures a wide variety of expertise, experience, and opinion as well as a geographic representation throughout the United States and Canada. There are currently 9 members on the ENTELLIGENCE Steering Committee.

The duties and obligations of the Steering Committee Chairperson include corresponding with Actelion regarding document finalization, supervising the grant process, and supporting public awareness of the ENTELLIGENCE Program. The ENTELLIGENCE Steering Committee members of the ENTELLIGENCE Young Investigators Award Program have the following duties and obligations:

  1. Review and rank Letters of Intent (LOI) and grant applications and decide on the final distribution and size of grants to the applicants
  2. Ensure a fair and timely grant application review, approval, and award procedure
  3. Guide strategic decisions and contributions to the improvement of the ENTELLIGENCE Young Investigators Award Program
  4. Participate in meetings and conference calls, as required, in support of the ENTELLIGENCE Young Investigators Award Program

III. Eligibility and conduct of the study

A. Eligibility

Eligible principal investigators must

  1. Be a United States (US) citizen, a permanent US resident, hold a temporary nonimmigrant visa, a Canadian citizen, or permanent Canadian resident.
  2. Be engaged principally in basic science and clinical research aimed at understanding the pathways and pathophysiology of pulmonary vascular disease
  3. Have experience in the research field proposed as of the date the completed Application Form is submitted
  4. Have no more than 5 years of experience in their tenure-track appointment or other comparable independent research appointment
  5. Be a junior faculty member (up to and including the rank of associate professor), post doctoral student, research assistant, doctoral candidate or fellow
  6. Submit only one research proposal per application round

Mentors must ensure the means for adequate funding to support necessary research and must see the project through to successful completion. Principal investigators must be given protected time to complete their research.

Grant funds cannot be awarded to principal investigators whose salaries are largely derived from commercial organizations in the pharmaceutical or allied industries. However, research support from commercial organizations is allowed.

Research projects must be carried out at an academic institution or research institute. Only submissions from the United States and Canada are accepted.

Grant funds are awarded to projects headed by the principal investigator, not to his or her institution. In the event that the principal investigator changes institutions during the course of his or her research project, the ENTELLIGENCE Young Investigators Award Program will fund remaining unfunded grant amounts only if the principal investigator can adequately establish to the ENTELLIGENCE Steering Committee that the project can be properly completed as planned at the principal investigator’s new institution.

Awards Ceremony: New award winners must attend the ENTELLIGENCE Awards Ceremony; travel and one-night hotel stay will be provided. Mentors are encouraged to attend. Their travel and one-night hotel stay will also be provided.

Prior award winners are required to present the progress/findings of their research. If a data embargo prevents the data from being presented, the study design and objectives should be presented at a return visit the following year to publicize data results and conclusions.

B. Start and end dates

Research should commence no later than 6 months after approval of the grant, unless an alternative date for commencement has been approved by the Steering Committee. Failure to initiate the research within this period may result in a withdrawal of the grant.

Funded projects should be completed within 12 months of commencement. Clinical follow-up after the 12-month limit is allowed, however, if properly justified by the applicant and corroborated by the outcomes and data delivered. A report must be provided after 12 months and the follow-up must be evaluated and approved by the Steering Committee. No further funding will be provided after the 12-month limit.

C. Progress and final reports

Start up of the Research Project - Within 90 days following the awards ceremony, an email supporting the start up of the research project with documentation should be sent to Jill Freeman, Program Director at jfreeman@medtelligence.net

Interim Progress Report - This report must be submitted 6 months from the start up of the research project. The completed report is to be uploaded to the ENTELLIGENCE Web site. Click here to access the Interim Progress Report template.  The payment of the second installment is contingent upon approval of the Interim Progress Report by at least two Steering Committe members.

Comprehensive Final Scientific Report/Final Reconciliation - At the end of the grant period, a comprehensive final scientific report summarizing the project's accomplishments as well as a final reconciliation must be submitted to the ENTELLIGENCE Steering Committee. This report must include copies of any reprints, abstracts, and/or manuscripts submitted, published or in press as a result of the research. The payment of the final grant installment is contingent upon approval of the final report by at least two Steering Committee members. All final reports must be submitted within 60 days of the termination date of the grant. Final reports are essential to the function of the award. Failure to submit final reports may affect eligibility for future funding. The completed report is to be uploaded to the ENTELLIGENCE Web site. Click here to access the Comprehensive Final Scientific Report template.

D. Study conduct and ethics

The ENTELLIGENCE Young Investigators Award Program is bound by its objectives to maintain and promulgate the highest ethical standards in clinical research and to maintain the highest standards in the conduct and assessment of such research.

All research involving human subjects should be performed in accordance with the latest version of the World Medical Association Declaration of Helsinki at the time of submission, as well as generally recognized standards of Good Clinical Practice in the United States of America. Research proposals for human cloning will not be considered.

E. Publication

Where a publication of the data and results generated by the grant-holder is foreseen, the full text of the manuscript or abstract shall be submitted to Actelion for consideration prior to submission to a scientific journal or prior to use in a public lecture or poster. Actelion shall have the right to provide comments on publication as mentioned in the agreement for grant awards.

F. Data and Intellectual property

Upon notification of the award grant; The applicant and Actelion will resolve issues in regard to ownership of data and intellectual property.

The grant-holder is required to make available to Actelion and the ENTELLIGENCE steering committee any and all data and the results of his/her work through a final study report, if performed through his/her ENTELLIGENCE Young Investigator grant.

G. Equipment

All equipment covered by the ENTELLIGENCE funds must be used for the purposes of the funded research. Applicants must give a full description of all equipment, including cost and technical data. The equipment will become the property of the host institution. The host institution will be responsible for related maintenance and accommodation, service and operation, and insurance costs.

H. Appropriate use of funds

The Steering Committee may demand reimbursement for funds that have been used in a manner contrary to the aims of the ENTELLIGENCE program or in contravention of the agreed-upon conditions.

IV. Grant Application Submission Process

A. Grants

Funds allocated to each competition cycle will be distributed to successful applicants. The amount of $500,000 is available in 2011/2012 for the competition cycle. Amounts available for the following competition cycles will be announced on the ENTELLIGENCE Web site (www.ENTELLIGENCEMD.org). Every project awarded will receive a maximum of $100,000.

B. Timelines

December 1, 2010: Letter of Intent Submission Deadline
December 2, 2010 - January 4, 2011: Letter of Intent Review
January 4, 2011 - February 19, 2011: Grant Submission
February 22, 2011 - March 15, 2011: Grant Review
April 12, 2011: Notify Applicants

C. Letter of Intent submission

The LOI must state the relevance of the application to pulmonary vascular disease. The LOI must be submitted electronically via the ENTELLIGENCE Web site (www.ENTELLIGENCEMD.org). Applicants will click on the LOI submission link and complete the form in accordance with the accompanying LOI application guidelines. The completed form should be submitted with the following documents to comprise the LOI submission packet:

  • Biographical sketch (principal investigator, the mentor, and the co-investigators, if applicable)

The LOI submission packet, including the required forms, should be submitted within the specified deadline and in accordance with the application guidelines presented on the ENTELLIGENCE Web site (www.ENTELLIGENCEmd.org ).

Once your LOI packet is submitted, you will receive an email confirming your submission. Please note that, LOI applications can be modified once up until the submission deadline. Confidentiality of data submitted is guaranteed; no personal data or scientific results will be provided to third parties.

By submitting the completed LOI application form and packet, the principal investigator admits to having read and understood the Application Guidelines and the ENTELLIGENCE Grant Process, as these documents are presented on the ENTELLIGENCE Web site (www.ENTELLIGENCEMD.org), and acknowledges the content of these documents and the conditions stated.

The submission of a LOI does not guarantee approval or funding of a proposed research project. Submission of an LOI is the first step in the review and evaluation process. Grants are only awarded to those projects ultimately selected by the Steering Committee.

D. Letter of Intent review

The Steering Committee will evaluate submitted LOI applications according to the application guidelines. Submitted applications and evaluations will be discussed by the Steering Committee and ranked according to the Steering Committee discussion outcomes.

Selected LOI applicants will be sent an email invitation to submit a full grant proposal within 6 weeks from notification. The email will provide further detailed instructions for the grant proposal submission.

LOI applicants not selected will be notified via email accordingly.

E. Grant proposal submission and review

Selected LOI applicants will be sent an email invitation to submit a full grant proposal within 6 weeks from notification.

The grant proposal should be submitted within the provided deadline of February 19, 2011 and in accordance with the guidelines. The document can be modified up until the submission deadline.  Completed applications must include the following documentation (please adhere to specific font type and size, margins, and page limitations as indicated on the grant submission page, accessible with the link below):

  • Project title and research focus
  • Estimated start and completion dates
  • Institution and location where the project will be conducted (site of conduct)
  • Is there a need for drug transfer?
  • Will your proposed research involve laboratory animals?
  • Research abstract (provide an abstract of no more than 325 words outlining your proposed research)
  • The research proposal should be a clear and concise presentation of the applicant's proposed research. It is highly recommended that the applicant's mentor review the proposal before it is submitted. Proposal page limits:  no more that 10 consecutively numbered pages.  The proposal must include:
    • Introduction (no more than 2 pages)
    • Specific objectives and hypothesis (no more than 1 page)
    • Background
    • Methods
    • Inclusion and exclusion criteria
    • Statistical analysis section (figures and tables should be included in the body of text, where applicable) (no more than 1000 words)
    • Preliminary data (no more than 2 pages but no limit to the number of figures, charts, tables, and diagrams)

Literature Cited-All references (no limit on the number of literature references cited)

Budget

  • Budget specifications, justification, and availability of other sources of funding
  • Indirect costs of institution overhead of up to 10% of the awarded grant
  • Specify special resources, being careful to keep costs (eg, medications, devices, software, animals) within the limits specified (See Section V. Grant Awards; C. Budget)

Letter of Support from the Mentor is required for the grant application.  Mentors must ensure the means for adequate funding to support necessary research and must see the project through to successful completion.  Principal investigators must be given protected time to complete the research.  The letter should should detail the mentor's track record of productivity, funding, and success with prior trainees; available lab facilities; and proposed training plan for the applicant.  The letter must also assess the applicant's research competence, clinical proficiency, originality, perseverance, and ability to exchange ideas and organize scientific data.

Biographical Sketch for the PI, Mentor and Co-investigator (if applicable) 

  • No more than 5 pages per biographical sketch
  • Include career goals and objectives and career development and training activities
  • Personal details and details on academic and professional experience of the PI, mentor, and co-investigators-consider quality of postdoctoral training
  • List of publications (PI only)

Applicants should download the Grant Submission Form and Budget/Justification Form to their computer to complete. All completed applications must be re-uploaded to the www.ENTELLIGENCEMD.org site and submitted in PDF format electronically along with the documentation specified.

Once your grant proposal is submitted, you will receive an email confirming your submission. The document can be modified up until the submission deadline. All changes occurring after award are subject to approval by the Steering Committee.

Submitted full grant proposals will be evaluated and extensively discussed by the Steering Committee and ranked according to the Steering Committee discussion outcomes.

The number of awards will be determined according to the funds available for grants. The top-ranked projects will be awarded. Based on budget requests and available funds for grants, the Steering Committee will also decide on the size of the grants awarded, which can differ from the amount requested by the applicant.

To initiate the Grant submission process, please click here to access the Grant Submission page.

V. Grant awards

A. Notification

Applicants selected by the Steering Committee and those whose projects were not selected will be notified via email.

ENTELLIGENCE is under no obligation and is not obliged to provide details of the review process. In particular, ranking, qualitative and quantitative evaluations, names of reviewers and criteria for award or rejection will be communicated solely at the discretion of the ENTELLIGENCE Steering Committee.

The notification email may also include special terms or conditions that apply to all terms applicable.

B. Further conditions to funding

Only projects that meet the Eligibility Requirements for the ENTELLIGENCE Young Investigators Award Program, as outlined above, will be evaluated and considered for funding.

Applicants shall be deemed the “sponsor” of the research project, including without limitation for purposes of compliance with all legal or regulatory obligations imposed on study sponsors under applicable law. To the extent that the research project involves human subjects, the applicant will be responsible for obtaining from each study participant proper informed consent, which shall state that the applicant is the sponsor of the research project.

Drugs, if used in the submitted studies, must be approved in the country where the study will be conducted. ENTELLIGENCE is funded by an independent grant by Actelion Pharmaceuticals US, Inc. All decisions to fund protocols are solely decided by the ENTELLIGENCE Steering Committee. Receipt of a grant in no way requires the recipient nor implies that the recipient, is obligated, to recommend or prescribe any Actelion products.

Any changes in the protocol will need to be reviewed and approved by the ENTELLIGENCE Steering Committee.

Award winners will be asked to provide supplementary documents, including but not limited to, the following: Institutional Review Board or ethical committee approvals for the submitted study; complete clinical study protocols; samples of informed consent documents; authorities' approvals to conduct animal trials (if applicable). Changes occurring after the grants are awarded are subject to approval by the Steering Committee.

Award winners and the institution where the study will be conducted must sign the ENTELLIGENCE Agreement for Grant Awards. A completed W-9 form from the institution will also be required to process funding. This must be completed within 90 days from the date of notification.

The signed agreement and requested documents are to be returned, as specified in the notification letter, no later than 90 days after communication of the award. No funds will be disbursed prior to complete submission of the requested documents. Failure to submit requested documents as specified and within the given deadline may result in a withdrawal of the award.

C. Budget

Budgets are to be submitted in US dollars and should reflect realistic estimates of the funds required for the proposed research. Awards are made without assurance of continued support beyond the term designated.

The award is not necessarily designated to cover the total cost of the proposed research. The grantee institution is expected to provide the required physical facilities and administrative services normally available in a research institution. However, each grant may include an indirect cost of up to 10%  for institution overheads, the disposition of which is the responsibility of the host institution and the applicant. This amount is included in the total grant awarded.  When applying, overhead costs should be included in the submitted budget at the time of submission. It is assumed that the institution will permit the overhead allocation to be spent on the research project.

The ENTELLIGENCE program provides funds for the following items:

  1. NEW research
  2. Indirect costs of institution overhead of up to 10% of the awarded grant
  3. Travel, related directly to the research project to communicate research findings, is allowable up to a maximum of $1,500 (as a part of the submitted budget)
  4. Maximum equipment: $5,000

The ENTELLIGENCE program does not provide funds for the following items:

  1. Institutional overheads above the 10% flat rate
  2. Purchase of journals and books
  3. Purchase of office furniture
  4. Payments of dues and membership of professional societies
  5. Recruitment and relocation expenses
  6. Construction and maintenance of buildings
  7. Payment of nonmedical or personal services to patients
  8. Purchases of reprints/copies

The ENTELLIGENCE program relies on the integrity of the applicants insofar as assessing overlap between the grants proposed and the other grants held or being requested by the applicant. The ENTELLIGENCE program intends to fund independent research projects. Any overlap between grant proposals submitted and research already being conducted by the applicant must be specifically acknowledged by the applicant.

If a project designated for funding by the ENTELLIGENCE program is also funded by another agency, the applicant must choose which grant to accept. If funding is awarded later by another institution, notification must be made to the Steering Committee, and the ENTELLIGENCE program will be entitled to withdraw the grant or the remaining part of it.

D. Funds disbursement

The Steering Committee will decide the manner in which an award will be disbursed. The research project must be initiated within 90 days of the Awards Ceremony in which the grant term commences and funds are to be disbursed. Award winners must submit all requested documentation and send an email documenting that research has been initiated within the 90-day period of award acceptance. Funds are scheduled to be distributed in the following three installments: 33% paid upon receipt of signed contract and necessary paperwork; 33% at the time of the interim report; and 33% at the completion of the research and receipt of final reconciliation. If more than three installments will be paid, further progress reports may be requested before proceeding with payment.

The ENTELLIGENCE Young Investigators Award Program is a 12-month mentored grant. However, special consideration will be given to allow an additional period of time—up to 12 months—to conduct research, but not to supply additional funding. This will be on an individualized basis only, subject to the final approval of the Steering Committee.

All funds are disbursed in US dollars.

To begin Letter of Intent process, please view the LOI Submission page.