es4

Mentoring for Translational Research

Expert, no‑cost mentoring to optimise translational feasibility and maximise patient benefit for ERDERA‑funded rare disease projects. This service is targeted to:

  • Principal Investigators (PI) planning or conducting translational rare disease projects, including at pre‑proposal stage and after funding.
  • Rare disease projects seeking guidance on topics such as translational feasibility, regulatory compliance, product classification, quality assurance and control, intellectual property, suitability of analytical readouts, manufacturing and therapy development.

What topics can I get mentored on?

  • Translational feasibility
  • Regulatory compliance
  • Product classification
  • Quality assurance and control
  • Intellectual property strategy
  • Suitability of analytical readouts
  • Manufacturing
  • Therapy development

In partnership with EATRIS, ERDERA offers expert mentoring to rare disease research projects. The aim is to maximise the impact and patient benefit of the excellent science supported under ERDERA. This mentoring provides early, project‑specific feedback from a panel of drug development, biomarker validation, methodological, and regulatory experts, focused on optimising the translational feasibility of each study.

The mentoring is offered free of charge and is delivered confidentially to help bridge the gap between promising research and tangible patient treatments.

How mentoring works

Before you meet

  • Kick‑off webinar: Shortlisted applicants are invited to a briefing on the mentoring process, common pitfalls, and how to submit a request.
  • Letter of Engagement (LoE): Sign to frame the collaboration and confidentiality. Indicate your priority mentoring needs. If a mentor is based outside the EU, consent for international data transfer under GDPR Article 49(1)(a) is requested within the LoE.
  • Availability: Propose several time slots for mentoring.

Your mentoring sessions

  • Onboarding meeting (60 minutes): Clarify your goals and questions.
  • Mentor team: Appropriate experts from its network will be identified; all mentors sign confidentiality and conflict‑of‑interest declarations.
  • Scheduling: Sessions are arranged based on your and mentors’ availability.
  • Preparation: To help mentors, you will be asked to provide specific questions plus any helpful information (including your abstract), as well as a concise project presentation.
  • Session format (45–60 minutes): Brief internal mentor huddle; introductions; PI presentation; focused discussion on gaps, options and next steps. Meetings may be recorded for accurate note‑taking.

After the session

  • Written report: You will receive a summary of recommendations and links to practical resources and tools.
  • Follow‑up: Additional focused meetings can be arranged if needed, and clarifications can continue via email.
  • Feedback: A short survey helps us improve the service.
  • Continued mentoring: If your first interaction was during proposal preparation and your project is funded, you may continue mentoring during implementation (frequency and topics agreed case by case).

Mentoring Templates

Here you can find a set of templates to be directly used for your own projects. It includes a Target Product Profile template, a reverse planning template and a project development plan template.

Each template can be easily downloaded and filled in to help creating a coherent development plan aiming at reaching clinical implementation.

These templates are designed as living documents to be updated as the project move forward and results gathered.

Target Product Profile template

Defines the intended clinical use, patient population, and value proposition of your project, serving as a vision document to guide development decisions.

Reverse Planning template

Outlines the key milestones and dependencies working backward from the project’s end goal, helping ensure realistic timelines and efficient execution.

Project Development Plan template

Details the scientific approach, objectives, and work plan, providing a structured overview of how your project will achieve its translational aims.

Confidentiality and independence

The mentoring service is independent of any formal review processes. Reviewers do not receive information from mentoring. Conflicts of interest are actively managed; mentors declare and avoid overlaps with active applications.

How to access

First, check available resources from the Innovation Management Toolbox to prepare targeted questions. Then proceed to fill this contact form. Please note that in order for us to provide a valuable service, enquiries should be made at least 1 month before a proposal deadline.

You might also be interested in

Eighteen international pre clinical therapy projects selected under ERDERA’s first Joint Transnational Call will accelerate treatment options for people living with rare diseases across Europe and beyond
More than 280 speakers from industry, regulators, patient organisations, investors and healthcare providers, and aims to showcase new science, technologies and policies that can accelerate orphan drug development and improve access to therapies for people living with rare conditions.
The European Conference on Rare Diseases & Orphan Products (ECRD) is the largest patient-led policy-shaping event on rare diseases in Europe.