Key principles

LFB and the Faculty Members are pleased to co-announce the launch of the 2024 edition of LFB Research Grant Program (“Program”) dedicated to healthcare professionals (“HCPs”) in the fields of immunodeficiency and immune-mediated neuropathy.

Proposals are sought for research projects, programs or initiatives (“Projects”) that aim to improve the management and/or quality of life of patients treated with intravenous immunoglobulin (exclusively within licensed indications).

Faculty Members - Committee

For the Projects in the immunodeficiency field, the Committee Members are as follows:

• Prof. Javier Carbone: Consultant Clinical Immunologist Clinical Immunology Department Hospital General Universitario Gregorio Marañon (HGUGM) – Madrid, Spain

• Prof. Francisco Espinosa Rosales: Consultant Clinical Immunologist Centro de Inmunología, Alergia y pediatría at Hospital Ángeles Lomas – Mexico City, Mexico

• Dr. Nizar Mahlaoui: Consultant Specialist in Paediatrics, Immunology-Hematology and Primary ImmunoDeficiencies Necker Hospital –  Paris, France

• Prof. Stephen Jolles:  FRCP, FRCPath, PhD - Department of Immunology, University Hospital for Wales - Immunodeficiency Centre for Wales - Hub Immunology Diagnostic Laboratory for Wales – Cardiff, United Kingdom

• Dr. med. Leif Hanitsch: Senior consultant at the Institute for Medical Immunology, Charité – Berlin, Germany

For the Projects in the immune-mediated neuropathy field, the Committee Members are as follow:

• Prof. Hans-Peter Hartung: Department of Neurology - Heinrich-Heine-Universität Düsseldorf – Düsseldorf, Germany

• Prof. Yeşim Parman: Department of Neurology - Istanbul Faculty of Medicine – Istanbul, Turkey

• Prof. Yusuf A. Rajabally: Aston Brain Centre, School of Life & Health Sciences, Aston University – Birmingham, United-Kingdom

• Prof. Jean-Marc Léger: Neurology Department. Neuromuscular Pathology Clinical Unit, Myology Institute. CHU Paris-GH La Pitié Salpêtrière-Charles Foix - Hôpital Pitié-Salpêtrière – Paris, France

• Prof. Steven Vargas: Department of Neurology at National Institute of Neurology and Neurosurgery - Laboratory of Neuro-immunology – Mexico City, Mexico

Eligibility

HCPs who are not Professors and are from the predefined countries (as described below) can apply with a Project that fulfills the aim of the Program.

Eligible countries are limited to the following: Austria, Belgium, France, Germany, Greece, Italy, Mexico, Spain, Turkey.

No LFB products nor placebo are part of the award and could not be requested as a replacement for the award.

Only financial support is available for a legitimate purpose that adheres to applicable laws, regulations and industry guides. Such financial support is not intended to inappropriately influence the approval, prescription, reimbursement, recommendation, or sale of LFB products, to influence the outcome of a clinical trial, or to otherwise improperly benefit LFB business.

The Project Scope should meet the following criteria:

• Increase the awareness of Immune-mediated disorders in terms of diagnosis or patient management.  

• Improve the overall quality of life of patients.

• Apply to patients treated within the licensed indications of Intravenous Immunoglobulins.

General Rules

The Projects are only financially supported by LFB; the candidates will develop the Project in their current departments.

The candidates must be responsible for the planning, strategy, content, development and execution of the Project.

A candidate can only present one (1) project per Program edition.

A candidate can present the same project over two (2) successive Program editions.

Projects’ duration should last maximum eighteen (18) months. The candidates must declare any foreseen difficulties for the Project to be completed within this timeframe.

The candidates must get the agreement of their Head of Department and their department’s allowance to use its facilities for the purpose of the Project.

Budget and Payment Process

Projects are funded by LFB up to EUR Fifteen Thousand (€15,000) for the whole project; only running costs/consumables and small equipment are allowed (no travel costs, no congress fees, etc.).

All awarded funds must be dispensed before the estimated end of the Project.

Funds are dispensed as follow:

• The first half (50%) at the signature of the contract.

• The second half (50%) at the beginning of the Project, that should not exceed six (6) months from the contract signature date. A document attesting the Project launch date should be sent to LFB in addition to the order.

Orders should be received according to previous dates (in accordance with administrative and financial incentive rules).

The support by LFB is provided on a non-exclusive basis. A Project could be supported by other institutions rather than LFB. In this case, the co-founder should be clearly identified. The total amount of the Project should be presented. The funded amount over €15,000 should be justified.

Selection process

The Project proposals will be evaluated in 3 main steps:

1) The first step evaluation is made by LFB medical team based on the eligibility criteria outlined in this document and specifically taking into account the following:

• Have the candidates applied within the fixed deadline?

• Are the candidates from eligible countries?

An Excel file listing the eligible Project proposals and the non-eligible Project proposals is transmitted to the Committee Members for evaluation. The Committee Members have the right to reinclude a proposal initially not fulfilling the eligibility criteria within the final projects list.

2) The second step evaluation is made by the Committee Members individually. Each proposal will be scored based on 5 criteria. Each criterion is rated on a scale from 1 (the lowest score) to 15 (the maximum score that could be attributed)

• Originality of the Project and its interest within the chosen unmet need:  this criterion evaluates the innovation and significance of the Project in addressing the specified unmet medical need.  The score is based on the Sections “Type of project” and “Rationale” of the Project application sheet.        

• Relevance of the methodology: this criterion assesses the appropriateness of the Project’s methodology. The score is based on the Sections “Objectives”, “Population”, “Evaluation criteria”, “Statistical aspects” of the Project application sheet

• Feasibility of the project within the timeline and budget:  this criterion evaluates the practicality of completing the Project within the proposed timeline and budget. Although timelines and budget estimations are provided by the applicants, they could be challenged by the Committee Members based on their experience in managing research projects.

• Contribution to the field: this criterion assesses the potential impact of the Project’s results on increasing disease awareness, improving access to diagnosis, offering education, or enhancing patient care. The score is based on the section “Contribution to the field of science” of the Project application sheet.

• Experience of the team in the field of research: this criterion evaluates the qualifications and expertise of the team. The score is based on data provided in the candidate’s resume and publication list.  

3) The third step evaluation involves organizing a meeting to deliberate on the received Project proposals at least 15 calendar days after the submission deadline.

During this meeting:

• A LFB medical team member will be present as observer but will not be involved in any decision-making.

• The LFB medical team member will present all the individual sum scores provided by each Committee Member.

• All projects will be debated during the meeting.

• A final vote will be made by the Committee Members to decide on the best eligible Project.

• The Project receiving the 3/5 of the total votes will be chosen for the award. The LFB medical team member will contact the selected candidate to announce the award.

• If one of the Committee Members is unable to attend the deliberation meeting, then he/she must send his/her appreciation and scoring before the meeting. He/she will be informed about the decision of the rest of the group.

• If his/her vote confirms the already chosen Project with more than 3/5 of the total votes, then the LFB medical team member will contact the selected candidate to announce the award.

• If not, a second meeting should be held with the Committee Members as soon as possible to determine the best project.

Application file

The application should be completed and submitted in English language only.

The application file must be accompanied by the following documentation:

• A Curriculum Vitae document of the HCP (2 pages maximum)

• A short description of the team that will assist with Project execution

• A reference letter from the Head of the HCP Department supporting the Project

• Publication list of the HCP/team related to the Project and

• The “Data Protection Notice” document signed.

Application submission

To apply, please complete the application form and send it back as a pdf to immunology.grant@lfb.fr before November 15th, 2024, midnight, along with the required documentation.

An acknowledgment email will be sent to the applicant shortly after the file submission.

Timeline

• Application Deadline: November 7th, 2024 (0pm, Paris time) for immunodeficiency field, and November 15th, 2024 (0pm, Paris time) for immune-mediated neuropathy field.

• Announcement of Results and Funding Start Date: Early to mid-December 2024

• Budget Funding Deadline: February 15th, 2025

• Project Duration: 18 months

Conflict of interest

In the course of his application, the applicant declares any conflict of interest with LFB and one or more Committee member that may interfere or have an impact on his impartiality or independence (Such as professional or personal relationship with a Committee Member).

The applicant shall provide LFB with any additional information as requested by LFB. LFB is entitled to take all measures to avoid the occurrence of any conflict of interest. 

Pharmacovigilance

If the selected Project includes any LFB IVIg brand, applicants must follow the LFB pharmacovigilance procedures. A pharmacovigilance notice will be provided to applicants to inform them of the applicable pharmacovigilance procedures.

Transparency and Disclosure

The provision of support must be documented in a written agreement and be accurately recorded. To the extent required by law or regulation, the written agreement, along with the support details, may need to be disclosed to the competent regulatory authorities. 

Documentation and Recordkeeping

Documentation related to the provision of the support, such as internal review, the relevant agreement, proof of payment and other applicable documents must be retained in a LFB repository pursuant to applicable regulations.