A Thémis x Institut Pasteur Initiative
Assessing the impact of sex and gender in clinical research
IMMUNE addresses a critical blind spot in biomedical research: the systematic under-integration of sex and gender variables in clinical immunology, despite clear scientific evidence of their impact on health outcomes.
Why This Matters
50%+
of the population are women
↑↓
Sex influences immune response
Rx
Treatment efficacy varies
⚠
Adverse events differ
Yet these variables remain inconsistently integrated in clinical research and regulation – resulting in avoidable health inequities.
IMMUNE exists to move from evidence to action.
What IMMUNE Delivers
- A shared, evidence-based state of the art
- Identification of scientific, regulatory, and ethical bottlenecks
- Two structuring questions that unlock system-level change
- A co-authored white paper validated by an independent scientific & ethical committee
- Operational recommendations for researchers, regulators, and funders
Roadmap – Phase 1
1. Stakeholder Mapping & Alignment (Jan-Feb)
Objectives
- Identify 20-25 key stakeholders across the research-to-policy continuum
- Align partnerships on scientific & policy ambition
- Establish shared language and scope
Deliverables
- Validated stakeholder map
- Scientific and policy framing note
- Shared state of the art bibliography
2. Online Framing Session (May)
2 hour online meeting
Objectives
- Present state of the art on sex and gender in immunology
- Identify scientific, regulatory, and ethical bottlenecks
- Prioritise 2-3 workstreams
Deliverables
- Synthesis of identified barriers
- Validated workstreams
- Formation of interdisciplinary working groups
3. Deep Dive & Pre-Lab Exercise (May)
Objectives
- Deep dive into each work-stream: scientific, regulatory, ethical
- Targeted expert hearings
- Integration of patient and citizen perspectives
Deliverables
- Briefs sent in advance
- Preliminary recommendations
4. In-Person Citizen Lab (early June)
1.5 days in Brussles
Objectives
- Consolidated presentation of state and barriers
- Small group work on core questions
- Development of transformation scenarios
Deliverables
- Key recommendations
- White paper production agreement
- Launch moment identification
- Leadership: Themis × Institut Pasteur
- Validation: Scientific & Ethical Committee
- Regulators: EMA & national agencies as active contributors
→ Structured, non-symbolic integration
→ Qualitative inputs collected via partner organizations
→ Lived experience interrogates frameworks, not illustrates
Target Stakeholders
Roadmap – Phase 2
July – Nov 2026
White Paper Writing
External Scientific Review + Immune Data Infrastructure
Unveiling of IMMUNE results at major scientific conference
Final drafting of White Paper
December 2026
White Paper launch – Brussels/Paris event
Distribution to DG Health, EMA, UNFPA, among other actors
Roadmap – Phase 3
Jan – March 2027
White Paper EU institutional tour – DG Health, European Parliament, WHO, EMA
April – June 2027
Integration into public funding criteria (Horizon Europe, ANR, etc)
Researcher training
July – Sept 2027
Impact assessment
Identification of next phase
New partnerships
Oct – Dec 2027
IMMUNE International Conference
2027 Impact Report
Phase 3/4 fundraising launch
Key Outputs & Milestones
Concrete Outputs
- Validated state of the art on sex & gender in immunology
- Mapping of scientific, regulatory, ethical bottlenecks
- Two documented structuring questions
- Co-authored white paper
- Recommendations for research teams, sponsors, regulators, funders
Expected Outcomes
- Alignment between science, regulation, and lived experience
- Reference framework for future clinical trials
- Credible evidence base for EU policy dialogue
- Themis positioned as structuring actor in women’s health research
Milestones
- White paper validated by Scientific & Ethical Committee
- Launch at major scientific congress or EU forum
- Targeted dissemination to policymakers
Funding & Imapct
IMMUNE continues to need financial support to guarantee the creation and launch of the White Papers, as well as the presentation of the results and their dissemination within regional institutions. If you would like to contribute to funding this new infrastructure for women’s health, please reach out to immune@themis.eu.
TAX DEDUCTIBILITY
Fondation Roi Baudouin
Thémis operates under the aegis of the Fondation Roi Baudouin. Donations are tax-deductible in Belgium, Luxembourg, and Denmark.