2021 Dutch Heart Foundation – Health~HollandPublic-Private Partnership (PPP) application form

I General information

1. Full project title:

2. Project acronym:

3. Contact details of main applicant (‘research leader’)If applicable, please list all co-applicants from one organisation under the same consortium partner in the designated table.

Consortium partner 1- Name of organisation:- Department:- Name of main applicant, title(s):- Male/female/other:- Position:- Address for correspondence:- Telephone:- E-mail:- Chamber of commerce number or equivalent:- URL of own web page:- (Scientific) excellence and expertise of the main applicant and added value of the main

applicant to the quality of the project:- Benefit of this project for the main applicant:

Other researchers involved from the same organisation as consortium partner 1Department Name of contact

person, title(s)(scientific) excellence and expertise and added value to the quality of the project

4. List of consortium partners Consortium partner 2- Name of organisation:- Department:- Name, title(s):- Address for correspondence:- E-mail:- Health fund/company/research organisation/other- SME (MKB): Yes/No- If you are an SME, please indicate if you are a medium-sized, small or micro enterprise

(for SME definition see Appendix A):- Chamber of commerce number or equivalent:- URL of own web page:- (Scientific) excellence and expertise of the consortium partner and added value of the

consortium partner to the quality of the project:- Benefit of this project for the consortium partner:

Other researchers involved from the same organisation as consortium partner 2Department Name of contact

person, title(s)(scientific) excellence and expertise and added value to the quality of the project

Consortium partner 3

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- Name of organisation:- Department:- Name, title(s):- Address for correspondence:- E-mail:- Health fund/company/research organisation/other- SME (MKB): Yes/No- If you are an SME, please indicate if you are a medium-sized, small or micro enterprise

(for SME definition see Appendix A):- URL of own web page:- Chamber of commerce number or equivalent:- (Scientific) excellence and expertise of the consortium partner and added value of the

consortium partner to the quality of the project:- Benefit of this project for the consortium partner:

Etc.

5. Consortium agreement and IPPlease describe the main aspects of the consortium agreement and the anticipated plan regarding intellectual property (IP) generated by the project.

6. Duration of the project (months):

7. Expected Start date (no later than 6 months after granting letter):

8. Total project costs:

9. Budget requested from DHF

10. Keywords (max. 5) … … … … …

11. Has this proposal been submitted elsewhere or do you intend to submit it elsewhere?Yes / No

If yes, please provide the following information: Funder: Title of the proposal: Application number: Expected month of outcome call:

12. Research category (see Appendix B)a. Please indicate per work package (if more than one) the applicable type(s) of research

(more than one option possible).

Types of research yes/no WP1. Fundamental research2. Industrial research3. Experimental development

Please give an explanation of the chosen research type(s). Make use of the phrasing that has been used to define the three types of research (see Appendix B).

13. Applicable categoriesa. Please indicate below which roadmap(s) (see Appendix C) is/are most applicable to the

project (max. 2 roadmaps).

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LSH Roadmaps yes/noa. Molecular diagnosticsb. Imaging & image-guided therapiesc. Homecare & self-managementd. Regenerative medicinee. Pharmacotherapyf. One healthg. Specialised nutrition, health & diseaseh. Health technology assessment, individual functioning & quality of lifei. Enabling technologies & infrastructurej. Global health, emerging diseases in emerging markets

b. Indicate on which of the seven LSH-related Dutch National Research Agenda routes1 the project applies to (max. 2 routes).

LSH-related Dutch National Research Agenda routes yes/no1. Healthcare research, sickness prevention and treatment2. Personalised medicine: the individual at the centre3. Regenerative medicine: a game-changer moving to broad areas of

application4. Creating value through responsible access to big data and its use5. NeuroLabNL: the ultimate living lab for brain, cognition and behavioural

research6. Sport and exercise7. Quality of the environment: game-changer ‘Exposome’

c. Indicate on which of the Key Enabling Technologies2 the project applies to.

Key Enabling Technologies yes/no1. Advanced materials2. Chemical technologies3. Digital technologies4. Engineering and fabrication technologies5. Life science technologies6. Quantum technologies7. Nanotechnologies8. Photonics and light technologies9. Not applicable

1 https://wetenschapsagenda.nl/overzicht-routes/2 TNO: R11465

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II Summaries:

Overall scientific summary (max. ½ A4)

Short summary in Dutch (max. ½ A4)

Summary in Dutch (concise and to the point) (max. 2 A4)Deze samenvatting wordt gebruikt door de commissie maatschappelijke kwaliteit (CMK) en mogelijk ook voor communicatie- en fondsenwervende doeleinden richting het algemene publiek. Vermijd daarom het gebruik van IP gevoelige informatie. Neem de volgende punten op in de samenvatting: Beschrijf het gezondheidsprobleem Om welke ziekte gaat het? Hoeveel patiënten betreft het (incl. onderscheid tussen mannen en vrouwen)? Welke problemen staan een goede opsporing, behandeling of genezing in de weg? Welke oplossingen wilt u bereiken met het onderzoek? Hoe dragen ze bij aan het oplossen van het gezondheidsprobleem? Hoe worden de onderzoeksresultaten in de praktijk gebracht? Korte beschrijving van het werkplan (In begrijpelijke taal voor niet-medisch geschoolden)

III Impact (max 3 A4)Discriminate between men and women and include the following topics:

Theme, including health care problemDescribe your research theme and the context in which your research consortium or project operates. Describe the health care problem and its relevance.

SolutionDescribe the long term ambition that you envision. Be as specific as possible and be aware that this text will be used for publicity purposes after granting. Therefore avoid IP sensitive information.

Impact on cardiovascular burden of diseaseDescribe the impact of your solution on the cardiovascular burden of disease.

Main objectiveDescribe your short term ambition (to be reached by the end of the project).

Contribution to relevant research agenda'sDescribe how the solution to the health care problem contributes to the strategic agenda of the Dutch Heart Foundation, the Dutch CardioVascular Alliance and if applicable to other relevant research agendas such as NWA, NVVC knowledge agenda, etc.

Unique, innovative or distinguished elementsDescribe the unique, innovative or distinguished elements of the solution, plan of work and collaboration.

Contribution to the goal of this callHow does the proposal contribute to the specific goal(s) of this call?

IV Description of work (max 8 A4, excluding the Gantt chart) Has this proposal been submitted previously? If yes:

Grant application number of the previous applicationWhat revisions have you made compared to the previous application? Max ½ A4

Discriminate between men and women and include the following topics: General hypothesis

Describe the general hypothesis of the study Key objectives

Describe the key objectives of the study Does the current proposal build on results from previous studies? If yes: next

question:How does the current proposal build on results from previous studies?Describe how the current proposal builds on results from previous studies. Include relevant (pilot) data or references.

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. Overall scheme of the work packages

Describe the overall scheme of the work packages in terms of goals and hypotheses. Show the coherence between the various work packages.

Deliverables, milestones, Gantt chartProvide a timeline of deliverables and milestones using a Gantt chart

SWOT analysis and contingency planConduct a SWOT (Strengths, Weaknesses, Opportunities and Threats) analysis and describe a contingency plan

Description of work per work package (max 2 A4 per wp)Describe the plan of work per work package (if applicable). Include the involved consortium partners and their expertise and role (work package participants). Per work package specify objective, hypothesis, description of work, deliverables, milestones, task and time of delivery. Include HTA, valorisation and implementation activities. These can be part of a work package or described in a separate work package. Describe which partners are involved and their contribution. Recapture the innovative and unique elements. Include a statistical paragraph for your (pre-)clinical studies. Take diversity aspects into account in the description of work.

V Data management (max 0,5 A4) Data Management

Describe how the data is managed during the project. Re-use of existing data

Do you re-use existing data (sets)? Please elaborate which data sets and how the data will be reused.

VI Route to societal impact(Discriminate between men and women)Which steps will you take to bring the expected results further to clinical practice?

Valorisation (max 1,5 A4) Valorisation ambitionDescribe the valorisation ambition (in this application, valorisation is defined as the transformation of knowledge production to knowledge use, according to steps on the translational research pathway in terms of TRL), strategy and activities in time (during and beyond the timeline of the current project). Be specific in term of the TRL reached within this project, and which stakeholders and actions are important to reach this.Describe the actions to be taken after the project in order to achieve next steps. Include the person responsible for valorizationDescribe the interaction and collaboration with consortium partners and stakeholders outside the consortium. Describe the interaction and collaboration with end-users. Indicate which deliverables are foreseen in the valorisation activities.Describe the unique contribution of the consortium in the valorisation process, and describe what the consortium needs from other parties. Describe the funding strategy for the valorisation activities. Describe the strategy overall how HTA is included in your proposal. Include the person responsible for the HTA.

Implementation (max 1.5 A4) Implementation ambitionDescribe the implementation ambition (In this application, implementation is defined as the use of new knowledge in health care practice), strategy and activities in time (during and beyond the timeline of the current project). Include the person responsible for implementation. Describe the interaction and collaboration with consortium partners and stakeholders outside the consortium. Describe the interaction and collaboration with end-users. Indicate which deliverables are foreseen in the implementation activities. Describe the unique contribution of the consortium in the implementation process, and describe what the consortium needs from other parties.

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Dissemination (max 1.5 A4, excluding the table) Communication StrategyPlease describe how results will be communicated to professionals and the public. Describe the strategy, activities and the target audience

End user involvementHow will patients, health care professionals and other stakeholders be involved in the project? What activities will take place to make sure their advice will be taken into account from the very beginning to the end of the project?

User-committee compositionDescribe to composition of the user committee. Who are the members, what is their expertise, role and task? Link to website if applicable

Company/Institute/other

Contact Full contact details Attendance user committeeyes/no

Name Dutch & English

Mr./Mrs title, initials, name

Postal addressZip City

yes/no/requested

VII CollaborationsInternal collaboration (max 1 A4) Governance of the consortiumDescribe the governance of the consortium. Please include an organisation chart

Management and operational structure. Describe the management structure and operational structure. Include the structure and role of advisory bodies, user committee, etcetera.

Multidisciplinary aspects of the consortiumDescribe the multidisciplinary aspects of the consortium and the added value of collaboration within this consortium.

External collaborations (max 1 A4) Consortium alignmentDescribe how the consortium ensures and maintains alignment and collaboration with (inter)national initiatives, consortia and projects. Describe the measure taken to avoid overlap with other (inter)national initiatives, consortia and projects

Collaboration with and contribution to the DCVADescribe the collaboration with and contribution to the DCVA and its pillars: infrastructure, implementation, valorisation, talent development

VIII References (max 1 A4)

IX Clinical studies/ studies with humans

1. Are experiments carried out on human:a) healthy subjects yes no if yes: number:b) patients yes no if yes: number: c) blood, tissue and/or DNA yes no

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d) Is ethical approval from a committee needed? yes noe) Do you already have ethical approval to perform the study? yes no

2. Short name of the intervention:3. Type of intervention (see appendix H):4. Development stage for this intervention (see appendix H):

X Studies with animals

1. Are experiments carried out on animals: Yes / NoIf yes, explain why and indicate in which work package.

Work package Species Sexe Numbers

a) Is ethical approval from a committee needed? yes nob) Do you already have ethical approval to perform the study? yes no

2. Total budget requested for the animal experiments: €

3. Justification for the requirement of experimental animals (max 0,5 A4) Why did you chose these animal models: Have experts been consulted and has a systematic review been performed: What is the justification of the sexe of the animals used:

4. Replacement (max 0,5 A4) Have alternative methods (besides experimental animals) been considered? What are the reasons that this project cannot be performed without experimental animals

(replacement)?

5. Reduction and Refinement (max 0,5 A4) What are the reasons that this project cannot be performed with fewer animals (reduction) or

with less distress and discomfort for the animals (refinement)? What are the reasons that this project cannot be performed with a lower species of animals?

XI BudgetPlease specify the project’s budget in the provided budget form. Use a separate line per consortium partner for their contribution. Do not forget to add the numbers in the ‘total’ column and rows.

Contribution cash 2020 2021 2022 2023 2024 Total

Research organisation

In cash          In kind

CompanyIn cash          In kind

Other partnersIn cash          In kind

PPP Allowance In cash

         Total funding (incl. PPP Allowance)

In cash          In kindTotal

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Total project costs Total

         

Deployment of PPP AllowancePlease indicate for each consortium partner 1) the total costs (incl. in kind contribution); 2) the amount of PPP Allowance that will be used; and 3) the activities that will be financed through the PPP Allowance. Note: each consortium partner must incur payroll costs (in kind) as part of the collaboration.

Partner Total Costs PPP Allowance ActivitiesConsortium Partner 1

Consortium Partner 2

Consortium Partner 3

Etc.

Budget specificationPlease provide a justification/specification of the budget per work package or deliverable. Only referring to the budget form is not sufficient.

Have the consortium partners requested/received any additional grants for this project? Yes/No

If yes, please specify grant supplier(s), grant name(s), total amount requested/received per grant (in €) and status (applied/granted) in the TKI-LSH budget form.

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XII Signature

Please tick the boxes:

☐ By submitting this form, I declare that I have completed this form truthfully and I declare that I have informed the correct official(s) of my employing organisation of this submission.

☐ I hereby declare that I have read and agree to the agreements: the obligatory letter(s) of commitment of the other consortium partner(s) has/have been submitted separately.

Name and position of applicant:

Name of organisation:

Place: Date:

Signature:

The undersigned hereby authorise <name of main applicant> to submit the application form and to handle any further correspondence concerning this.

Co-applicant consortium partner 2

I hereby declare that I have read and agree to the agreements:

Name of organisation:

Name of contact person:

Place: Date:

Signature:

Co-applicant consortium partner 3

I hereby declare that I have read and agree to the agreements:

Name of organisation:

Name of contact person:

Place: Date:

Signature:

Attachments to be uploaded: budget form. Letters of commitment of all parties involved, each stating the parties’ in cash & in kind

(separately) contribution to the project. Only the main applicant does not need to upload a letter of commitment. See Appendix E for a template of a letter of commitment.

CV’s of all partners involved in the project (see appendix G) Reviewer suggestions (Appendix I)

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Appendix A: European Commission Recommendation 2003/361/EC regarding SME definition

Micro-enterprises are defined as enterprises that employ fewer than 10 persons and whose annual turnover or annual balance sheet total does not exceed EUR 2 million.

Small enterprises are defined as enterprises that employ fewer than 50 persons and whose annual turnover or annual balance sheet total does not exceed EUR 10 million.

Medium-sized enterprises are defined as enterprises that employ fewer than 250 persons

and either have an annual turnover that does not exceed EUR 50 million, or an annual balance sheet not exceeding EUR 43 million.

For more details ‘The revised User Guide to the SME definition’ can be downloaded here.

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Appendix B: Definitions of the three types of research3

Fundamental research means experimental or theoretical work undertakenprimarily to acquire new knowledge of the underlying foundations of phenomenaand observable facts, without any direct commercial application or use in view.

Industrial research means the planned research or critical investigation aimed atthe acquisition of new knowledge and skills for developing new products,processes or services or for bringing about a significant improvement in existingproducts, processes or services. It comprises the creation of components parts ofcomplex systems, and may include the construction of prototypes in a laboratoryenvironment or in an environment with simulated interfaces to existing systems aswell as of pilot lines, when necessary for the industrial research and notably forgeneric technology validation.

Experimental development means acquiring, combining, shaping and usingexisting scientific, technological, business and other relevant knowledge and skillswith the aim of developing new or improved products, processes or services. Thismay also include, for example, activities aiming at the conceptual definition,planning and documentation of new products, processes or services. Experimentaldevelopment may comprise prototyping, demonstrating, piloting, testing andvalidation of new or improved products, processes or services in environmentsrepresentative of real life operating conditions where the primary objective is tomake further technical improvements on products, processes or services that arenot substantially set. This may include the development of a commercially usableprototype or pilot which is necessarily the final commercial product and which istoo expensive to produce for it to be used only for demonstration and validationpurposes. Experimental development does not include routine or periodic changesmade to existing products, production lines, manufacturing processes, servicesand other operations in progress, even if those changes may representimprovements.

3 In case of drug development, pre-clinical research in animals falls within the research category ‘industrial research’. In principle, the clinical phases 1 and 2 fall within the research category ‘experimental development’. Phase 3 clinical trials (and beyond) are seen as competitive development and fall outside the scope of the PPP Allowance Regulation.

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Appendix C: Definitions of the ten roadmaps

The roadmaps are designed to address priorities in health outcomes (age-related, chronic, acute, infectious, orphan and neglected diseases) and along the healthcare chain (from prevention through diagnosis to cure and care). The roadmaps represent the areas in which public and private parties are committed to co-innovate and ask the government to co-invest. Companies, research institutes, practitioners, patient organizations, health foundations, health insurers, regulators, and many others have contributed and endorsed these roadmaps. Seven roadmaps (1 through 7) are product-oriented. They are supported by two that deliver health technology assessment (8) and enabling technologies & infrastructure (9). The latter also links to other Top Sectors with a strong life sciences component, such as Agro-food, Horticulture and Chemistry. A final roadmap (10) is centred around diseases that cause a high burden mainly in the developing world, but for which the developed world can make strides in solving.

1. Molecular diagnostics: Development of candidate biomarkers into validated molecular diagnostics for clinical use

2. Imaging & image-guided therapies: Development of imaging applications for more accurate and less invasive diagnosis and treatment

3. Homecare & self-management: Development, assessment and implementation of technologies, infrastructure and services that promote clients’ abilities to live independently and manage their own care, adequately supported by healthcare professionals

4. Regenerative medicine: Development of curative therapies for diseases caused by tissue damage and ensuing organ dysfunction, through repair or renewed growth of the original tissue or replacement by a synthetic or natural substitute

5. Pharmacotherapy: Discovery, development and stratified use of new, safe and (cost-)effective medicines in order to cure or prevent progression along the healthcare chain

6. One health: Development of solutions like vaccines, optimized antimicrobial use and early warning systems that improve health status of humans and animals by coupling the know-how and infrastructure available in the human and veterinary/agricultural domains

7. Specialized nutrition, health & disease: Researching specialized nutrition for nutritional intervention as part of integrated health solutions in terms of prevention, cure and care of chronic, acute and rare diseases

8. Health technology assessment, individual functioning & quality of life: Development of methods and knowledge for health technology assessments in which the impact of health innovations on quality of life, cost-containment and productivity is assessed

9. Enabling technologies & infrastructure: Development and offering of expertise and infrastructure in cutting-edge molecular life science technologies (e.g. next generation sequencing, proteomics and bioinformatics), in biobanks and in ultramodern research facilities, all readily accessible to industry and academia, and with existing, strong links to other Top Sectors (Agro-food, Horticulture, Chemistry, Biobased Economy and High Tech Systems and Materials)

10. Global health, emerging diseases in emerging markets: Development and delivery of solutions to diseases associated with poverty, which affect more than 2 billion people in the developing world

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Appendix D: Technology Readiness Levels

TRL level Definition Type of research *TRL 1 Basic principles observed Fundamental researchTRL 2 Technology concept formulated Fundamental researchTRL 3 Experimental proof of concept Fundamental researchTRL 4 Technology validated in lab Fundamental/industrial

researchTRL 5 Technology validated in relevant environment (industrially

relevant environment in the case of key enabling technologies)

Industrial research

TRL 6 Technology demonstrated in relevant environment (industrially relevant environment in the case of key enabling technologies)

Industrial research

TRL 7 System prototype demonstration in operational environment

Industrial research/experimental development

TRL 8 System complete and qualified Beyond the scope of the PPP Allowance Regulation

TRL 9 Actual system proven in operational environment (competitive manufacturing in the case of key enabling technologies; or in space)

Beyond the scope of the PPP Allowance Regulation

*The TRL is an indication of the type of research but the definition of type of research (Appendix B) prevails.

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Appendix E: Letter of commitment template

[Use headed paper of party]

[Name and address of the main applicants' duly authorised representative (“bestuurlijk verantwoordelijke”)]

[Date]

LETTER OF COMMITMENTfor the

[name of] PROJECT

Dear [main applicants’ duly authorised representative],

I, [first name and family name], in my capacity of [position in the organisation (has to be a duly authorised person)] at [name legal entity] hereby confirm that [legal entity] is committed to contribute to the [project name] project, on the condition that the Heart Foundation grants the PPP Allowance as applied for by the main applicant, [first name and family name], [position] at [name organisation].

[Name legal entity] will contribute € [•] in cash towards the project costs in accordance with the budget in the project proposal and budget form.

[Name legal entity] will provide an in kind contribution of [description of the contribution], representing a monetary value of € [•] and further detailed in the project proposal and budget form.

Yours sincerely,

______________________

Name:Position:Date:

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Appendix F: Checklist application form

☐ The consortium must consist of at least one research organisation and one for-profit enterprise☐ The main applicant is located in the Netherlands☐ The project has a duration of a maximum of 42 months☐ The starting date is within six months after the awarding letter will be received ☐ The chamber of commerce number or equivalent is listed for all consortium partners☐ Effective collaboration takes place. This means, for example, that the project is realised at joint

cost and risk ☐ All consortium partners should make an in kind contribution. This means, for example, that all

consortium partners should at least incur payroll costs☐ Dutch SMEs and other Dutch private parties may finance a maximum of 25% of their in kind

costs (e.g. man hours, consumables and the use of equipment)☐ Depending on the type of research, a for profit enterprise must contribute at least 15%, 30% or

45% of the total project costs☐ At least 2/3rd of the required minimum contribution of a large enterprise must consist of a cash

contribution☐ The research organisation must contribute at least 10% of the total project costs☐ All parties, with the exception of the main applicant, must submit a letter of commitment; a

letter of intent is not sufficient☐ The budgeted costs are directly related to the R&D activities, and do not include for example:

bench fee costs, travel within the Netherlands, supporting/project management tasks that are not directly related to the project’s R&D activities

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Appendix G. Curriculum Vitae

Provide the following information of all partners in the consortium. State relevant information for the application. Maximum of 1 A4 per CV.

Name:Year of birth:Education/Academic background: (Specify degree, year of completion, field of study, and which institution)Current job title:Affiliation: (mention all institutions/organisations to which you are affiliated)Role in the consortium: (e.g. research leader, WP leader, consortium partner, end user representative etc)

Profile (max 5 sentences)Introduce yourself in short. Explain which qualities and expertise do you add to the consortium. Think of this summary as a snapshot of your skills, knowledge, accomplishments, and ambition.

A. Scientific track record

1. Best 5 selected peer-reviewed scientific publications, relevant for this proposal2. Number of publications: 1) total, 2) as first author and 3) as second last and last author3. Scientific honours and awards4. Scientific grants

B. Professional track record

1. Relevant professional positions and activities: (e.g. management, board or advisory tasks, clinical tasks, teaching etc.) Please indicate how the different positions are proportionate to each other.

2. Other Experience and Professional Memberships (e.g. membership of a scientific society, membership of boards, participation in user committees, etc.)

C. Societal track record

1. Relevant societal positions and activities: (e.g. advisory role, volunteer work, organisation of events, collaboration with patients, communication activities for a broad public etc)

2. Best 5 selected non-scientific outputs, e.g. policy documents, guidelines, newspaper articles, etc.

D. Valorisation track record

1. Relevant positions and activities for valorisation of research: (e.g. collaboration with industry, IP rights claimed, contribution to start-up companies, seed money/valorisation grants, etc.)

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Appendix H. Additional information for two questions in the part: Clinical studies/ studies with humans

Use at ‘Type of intervention’ one of the possibilities below: · Diagnostic Tool – Imaging· Diagnostic Tool - Non-Imaging· Therapeutic Intervention - Drug· Therapeutic Intervention - Vaccines· Therapeutic Intervention - Cellular and gene therapy· Therapeutic Intervention - Medical Device· Therapeutic Intervention - Surgery· Therapeutic Intervention - Radiotherapy· Therapeutic Intervention - Psychological/Behavioural· Therapeutic Intervention - Physical· Therapeutic Intervention - Complementary· Preventative Intervention - Behavioural risk modification· Preventative Intervention - Physical/Biological risk modification· Preventative Intervention - Nutrition and Chemoprevention· Management of Diseases and Conditions· Health and Social Care Services· Support Tool - For Fundamental Research· Support Tool - For Medical Intervention· Products with applications outside of medicine· Other Use at ‘development stage’ one of the possibilities below:· Initial development· Refinement. Non-clinical· Refinement. Clinical· Early clinical assessment· Late clinical evaluation· Market authorisation· Small-scale adoption· Wide-scale adoption

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Appendix I : Reviewer Suggestions

It is obligatory to provide suggestions for experts to review your application. Please provide names for three national reviewers, specifying their speciality and contact details. The reviewers you suggest should have no conflict of interest such as active collaborations or joint publications with you, or any of the other consortium partners for the past three years.

M/F Title Name E-mail address

Expertise Institute

NationalNationalNational

Exclude

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