CHIESI GLOBAL RARE DISEASES ACADEMIC REQUEST FOR PROPOSALS 2024

FOR INNOVATIVE TECHNOLOGIES TO TREAT RARE METABOLIC DISEASES

Collaborating with Chiesi

We look forward to hearing from researchers and physician-scientists who are keen to collaborate with a global pharma company with a strong track record of translational R&D in rare diseases.

Our objective is to award funds to validate early-stage projects with clear therapeutic potential. Successful applicants will be funded through sponsored research, with up to 2.8M SEK available per project for 2 years duration.

This should enable researchers to generate relevant pre-clinical data or demonstrate preclinical proof of concept for technologies to treat rare metabolic disorders, for example Inborn Errors of Metabolism, including Lysosomal Storage Disorders. Specific focus on macromolecules and areas of interest are e.g. :

• difficult to reach organs (CNS, bone, skeletal and cardiac muscle)
• Gene editing
• Gene therapy
• RNA technologies
• Cell therapy

The technology might be brought into the Chiesi Global Rare Diseases pipeline and ultimately benefit patients.

What We Are Looking For

We are seeking new technologies with key attributes including some of the following:

1. Potential for platform development (for example to address multiple indications)
2. Preliminary pre-clinical evidence to support feasibility of technology
3. Innovative models for technology validation (e.g. organoids lab on a chip, in silico solutions)
4. Strong potential for clinical impact

Therapeutic Areas of Interest for 2024

Technologies that can be applied to treat rare metabolic diseases, for example inborn errors of metabolism, including lysosomal storage disorders.

APPLICATION GUIDELINES

Key Dates

• October 31, 2024 – Pre-Proposal submission deadline
• January 10, 2025 – Full Proposal submission deadline* (Full Proposal solicitations by invitation only)
• March 2025 – Awardees will be notified. Chiesi will work with the investigator’s institution to enter into a Sponsored Research Agreement (SRA). The research project may begin once the SRA is complete. *Investigators will be given at least one month to prepare for Full Proposal submission.

Eligibility Criteria

To be eligible for funding, the applicant must be a research scientist or physician-scientist at an accredited university, academic medical center or research institution in Sweden.

Proposal Submission Process

The first step in the process is submission of a Pre-Proposal (deadline October 31, 2024). This must include only non-confidential information. If you are unsure, please consult with your Technology Transfer Office (TTO) or Office of Technology Development (OTD), or equivalent institutional representative prior to submission of the Pre-Proposal.

Following a favorable review of the Pre-Proposal, selected investigators will be invited to submit a more comprehensive Full Proposal (deadline January 10, 2025). Awardees will then be chosen from a shortlist of promising Full Proposals and will be notified in March 2025.

Pre-Proposal Template Instructions

Please download the Pre-Proposal template here and submit completed applications by October 31, 2024. Please follow the submission instructions to be found in the template.

Selection Criteria

Proposals will be reviewed by the Scientific Review Committee, members of which are selected from Chiesi R&D. The research projects will be judged on several criteria, including:

• Potential for platform development (for example to address multiple indications)
• Preliminary pre-clinical evidence to support feasibility of technology
• Innovative models for technology validation (e.g. organoids lab on a chip, in silico solutions)
• Potential to qualify for orphan drug designation and intellectual property protection;
• Strength of prospective clinical impact.

Additional Information

For selected shortlisted Full Proposal submissions, Chiesi will communicate with the appropriate office at the investigator’s institution (Office of Technology Development, TTO, Office of Sponsored Programs, or equivalent) to discuss terms of the Sponsored Research Agreement (SRA) and work on the agreement. Awardees will be notified in March 2025 and enter into an SRA with Chiesi.

An SRA is a contract between the investigator’s institution and the sponsor (here Chiesi) for the purposes of funding and conducting research at the institution. The SRA will include the scope of the work to be performed by the investigator, the project budget, and will provide Chiesi with an option to intellectual property (IP) that may be generated during the awardee’s research project.

For questions about the RFP program please contact: AcademicRFP@Chiesi.com

FAQs

How much funding is available for a project that is awarded funding by Chiesi?

The total funding per project will not exceed 2.8M SEK.

If an investigator is awarded the funding, will indirect costs (a.k.a. overhead) be added to the funding?

No, the total funding to be awarded includes all costs such as indirect costs (a.k.a. overhead). The total funding per project will not exceed 2.8M SEK.

How long will the research project and funding last?

The research project duration will be two years. Total funding will not exceed 2.8M SEK. Payments will be made during the two years project duration according to agreed milestones.

What is the proposal submission process?

Please see the Proposal Submission Process in the Guidelines above.

Where can I find the Pre-Proposal templates?

Please download the Pre-Proposal template here and follow the submission instructions to be found in the template. Please note: completed applications must be submitted by October 31, 2024.

What is a Sponsored Research Agreement (SRA)?

An SRA is a contract between an investigator’s institution and the sponsor for the purposes of funding and conducting research at the institution. The SRA typically includes the scope of the work to be performed by the investigator, the project budget, and provides the sponsor with an option to intellectual property (IP) generated during the research project.

Which therapeutic areas are you considering for the Chiesi Rare Disease Academic RFP 2024?

Enabling technologies and therapeutics that can be applied to treat rare metabolic diseases, for example inborn errors of metabolism, including lysosomal storage disorders.

Which therapeutic areas are excluded in the Chiesi Rare Disease Academic RFP 2024?

Non-rare and oncological diseases are excluded.

What therapeutic modalities is Chiesi considering for the Chiesi Rare Disease Academic RFP 2024?

Macro-molecules (e.g. nucleic acids, proteins and mAbs) are the therapeutic modalities being considered for this RFP, and include: Gene editing, Gene therapy, RNA technologies, and Cell therapy.