Breakthrough T1D
Breakthrough T1D is the leading global organization funding type 1 diabetes research, with the goal to accelerate life-changing breakthroughs to cure, prevent and treat type 1 diabetes and its complications.
ID: 623930744946-01
Lobbying Activity
Response to Targeted revision of the EU rules for medical devices and in vitro diagnostics
2 Oct 2025
Breakthrough T1D (formerly JDRF) appreciates the opportunity to provide comments on the targeted evaluation by the Commission on the EU rules for medical devices and in vitro diagnostics. ABOUT BREAKTHROUGH T1D As the leading global type 1 diabetes (T1D) research and advocacy organization, Breakthrough T1D helps make everyday life with type 1 diabetes better while driving toward cures. We do this by investing in the most promising research, advocating for progress by working with governments to address issues that impact the T1D community, and helping educate and empower individuals facing this condition. Since 2015, our organization has invested more than 57 million in European projects. In addition, 30 clinical trials are currently funded by Breakthrough T1D in Europe. COMMENTS Medical devices, especially insulin pumps, continuous glucose monitors (CGMs) and algorithms connecting them are essential tools for people living with T1D to be able to successfully manage their blood glucose and administer insulin. There have been continual improvements to these medical devices that have led to improved health outcomes, and we want to ensure that these advances continue and are able to be delivered to people with T1D without delay. Further, there are advanced therapies in development, such as cell replacement therapies, that may involve device components and will offer truly transformative curative solutions. Therefore, we recommend that the Commission look for ways to simplify the European regulatory ecosystem to accelerate development of new device technologies while maintaining the standards for quality and safety. Some specific examples for consideration in the targeted evaluation are: Decrease the Interplay Between Different Regulations in the Development of Cell Therapies: The rules for developers of novel technologies that use drug-device combinations, particularly for ATMPs, should be simplified. For example, developing cell therapy products requires compliance with several regulations, including the Medical Device Regulation (MDR), General Pharmaceutical Legislation, the ATMP Regulation (2007) and the Blood & Tissue Regulation and in some cases with the GMO regulation. These regulations have differing dossier requirements, review timelines and assessment divisions. Inconsistencies across multiple regulations adds complexity & delays the development of novel therapies. Align with emerging EU regulations: The lack of clarity on alignment between the MDR and other (horizontal) regulations, such as the AI Act, can lead to challenges regarding innovation in T1D management. Clear guidance is sought on how the different regulations (in this case MDR and the AI Act) would work together. Avoiding double regulatory requirements including conformity assessments is key to avoiding delayed access for people with T1D to new AI driven diabetes technologies. This would also be in line with the European Commission's ambitions as set out in the Draghi report and the Competitiveness Compass. Introduce an accelerated pathway for innovative/breakthrough devices: Type 1 diabetes requires an array of devices for diagnosis and management, such as continuous glucose monitors, insulin pumps, automated insulin delivery systems, islet autoantibody diagnostics, and assays for disease related biomarkers. The medical device and in vitro diagnostic regulations should introduce an amendment to fast-track novel/breakthrough devices for unmet medical needs such as those seen in T1D. This would bring more global alignment and faster patient access - given that other authorities e.g., FDA, have Breakthrough Device Designation programs. Such a pathway in Europe can expedite the development, review, and approval of medical devices to provide more effective treatments or diagnosis of conditions with unmet need.
Read full responseResponse to EU cardiovascular health plan
15 Sept 2025
Breakthrough T1D, the worlds largest nonprofit funder of type 1 diabetes (T1D) research, welcomes the European Commissions commitment to a comprehensive EU Cardiovascular Health (CVH) Plan. However, we are concerned that a critical high-risk population - people with T1D - remains largely overlooked in cardiovascular screening, prevention, and care strategies. T1D is a chronic autoimmune disease in which the immune system destroys insulin-producing beta cells in the pancreas. People with T1D depend on insulin therapy to survive. T1D strikes both children and adults, and unlike type 2 diabetes (T2D), cannot be prevented through lifestyle changes. A growing body of longitudinal registry and population-level data clearly documents the disproportionate cardiovascular burden in people with T1D, offering the European Commission a strong evidence base to integrate T1D into the CVH Plan. We therefore urge the Commission to explicitly include T1D in the CVH Plan for the following reasons: 1) T1D is a major, under-recognized cardiovascular risk factor: Among autoimmune diseases, T1D carries one of the highest cardiovascular risksgreater than that of T2D. Gender disparities are significant: women with T1D face almost double the excess risk of cardiovascular events compared to men. 2) The atherosclerotic process begins early in T1D: Atherosclerosis begins in childhood or adolescence in people with T1D, highlighting the urgency of early prevention. Yet most current cardiovascular strategies focus on older adults or T2D, leaving young people with T1D underserved. 3) Adjunctive therapies for T1D can reduce cardiovascular risk, but remain inaccessible: Therapies such as SGLT inhibitors have been shown to reduce cardiovascular and renal risks in adults with T1D. Despite this, regulatory and reimbursement barriers across Europe limit patient access, while commercial incentives to pursue T1D indications remain weak. EU-level support is needed to close this innovation gap. 4) Opportunity for Public-Private-Philanthropic collaboration: The IHI iCARE4CVD project, the largest European initiative on personalized cardiovascular risk prediction, demonstrates the value of EU cross-sectoral partnerships. As a project partner, Breakthrough T1D is funding a clinical trial within iCARE4CVD targeting adjunctive therapies for T1D, showing how philanthropy can complement EU investment. Recommendations: A) Explicitly recognize T1D as a high-risk population in the EU CVH Plan. B) Develop EU-level guidance for age-appropriate cardiovascular screening and prevention in children, adolescents, and adults with T1D. C) Promote regulatory and reimbursement frameworks that enable access to adjunctive therapies reducing cardiovascular burden in T1D. D) Strengthen EU funding and cross-sectoral collaboration mechanisms to ensure T1D is included in cardiovascular research, registries, and innovation initiatives.
Read full responseResponse to Establishment of an expert panel on orphan and paediatric devices
16 Jun 2025
Breakthrough T1D (formerly JDRF) appreciates the opportunity to provide comments on the consultation for the draft implementing act on Medical devices establishment of an expert panel on orphan and paediatric devices. Breakthrough T1D supports the creation of an expert panel, which can provide scientific, technical, and clinical opinions and advice to support implementation of the EU Medical Devices and In Vitro Diagnostic Regulations. In type 1 diabetes(T1D) this could be especially important because the most advanced technology is often unavailable to children in Europe. Pediatric patients present unique challenges (e.g. device/cannula size, material compatibility, pathophysiological features) for devices, which the panel can advise on and/or source ad-hoc experts in specialties like T1D. Key issues in development of T1D tools include the appropriate clinical investigation and design of device components. For example, the size of the insulin catheter canula for very small children is an issue. Whereas some insulin pens have a very small needle of 3 or 4 mm, cannulas of such lengths are not always available in connection devices for pumps, and solutions need to be developed to accommodate the subcutaneous depth found in very young children. Here, an expert device panel in place can advise regulatory authorities such as the EMA and notified bodies. This initiative can address the lack of measures regarding pediatric medical devices in the current legislation, provide support to developers/EMA/notified bodies and complement other jurisdictions (e.g. FDAs guidance document on Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices, 2016). The Commission should also explore, as is the case for the Paediatric (2007) and Orphan Drug (2006) Regulations, obligations and incentives for device manufacturers to investigate device use in the pediatric setting. For example, some devices for diabetes are not approved for the youngest age group as there is no incentive for the manufacturer. About Breakthrough T1D As the leading global type 1 diabetes (T1D) research & advocacy organization, Breakthrough T1D helps make everyday life with type 1 diabetes better while drivingtoward cures.We do this by investing in the most promising research, advocating progress by working with the regional authorities to address issues that impact the T1D community, and helping educate & empower individuals facing this condition. Since 2015, our organization has invested more than 57 million in European projects. In addition, 30 clinical trials in Europe are currently funded by Breakthrough T1D.
Read full responseResponse to Biotech Act
10 Jun 2025
Breakthrough T1D (formerly JDRF) appreciates the opportunity to give comments on the Call for Evidence for an Impact Assessment on the proposed EU Biotech Act. ABOUT BREAKTHROUGH T1D As the leading global type 1 diabetes (T1D) research & advocacy organization, Breakthrough T1D helps make everyday life with type 1 diabetes better while drivingtoward cures.We do this by investing in the most promising research, advocating progress by working with the regional authorities to address issues that impact the T1D community, and helping educate & empower individuals facing this condition. Since 2015, our organization has invested more than 57 million in European projects. In addition, 30 clinical trials in Europe are currently funded by Breakthrough T1D. COMMENTS ON THE CONSULTATION Overall, Breakthrough T1D believes the draft outlines meaningful areas in facilitating the expeditious development of biotechnology products, such as cell therapies as cures for T1D, by re-engineering the biotechnology R&D ecosystem in Europe. This should help new therapies reach patients faster. Specifically, our comments are as follows: #1 Speed & Streamlining: We support streamlining the regulatory environment for the development and approval of biotechnology products, especially cell therapies needed for autoimmune conditions like type 1 diabetes. The unmet needs in T1D, as well as for many other conditions for which biotechnology products will be developed, demand that product development and access be accelerated. Coordinated efforts are needed at the EU level to simultaneously advance research, development, regulatory, access, and adoption. The rules for developers of novel technologies that use drug-device combinations, particularly for ATMPs, should be simplified. For example, developing cell therapy products requires compliance with several regulations: the Medical Device Regulation, General Pharmaceutical Legislation, the ATMP Regulation and the Blood & Tissue Regulation and in some cases with the GMO regulation. These regulations have differing dossier requirements, review timelines and assessment divisions. Inconsistencies across multiple regulations add complexity and delay the development of novel therapies. This call for evidence should address the hard barriers between the legislative requirements. It should also consider improvements to the Clinical Trial Regulation. Despite the good intentions, serious concerns remain over regulatory fragmentation and operational complexity where there is no truly single application procedure (despite a reference member state leading the review) as national approval is needed from local regulatory and ethics committees where trials are to be conducted. #3 Scale: Supporting scaling up is essential to defragment and centralize high-tech biomanufacturing in the EU. Successful examples should be referred to both in Europe and other regions. For example, a centralized facility that can conduct early-stage ATMP manufacturing to support SMEs and researchers would be a great advance. This can be modeled using examples from other EU research centers such as the European Molecular Biology Laboratory and the European Commissions Joint Research Centers. Good national examples exist e.g. The Netherlands Organisation for Applied Scientific Research (TNO) a governmental research organisation that focuses on applied science with a hub and spoke research set-up. Further, some form of certification could be considered modelled on the FDAs new platform technology designation program. #5 Use of Data & AI in the Biotech Sector. In T1D, rich and diverse sources of data exist across the EU. Such data, which includes EHRs, clinical trial data, data from continuous glucose monitors and other contextual information would be of great benefit both for R&D and in the design of novel trials e.g. pragmatic trials, synthetic control arms given the recruitment difficulty for T1D participants.
Read full responseMeeting with András Tivadar Kulja (Member of the European Parliament)
4 Jun 2025 · Unmet needs ofthe T1D community
Meeting with Kasia Jurczak (Head of Unit Research and Innovation)
3 Jun 2025 · Presentation of Breakthrough T1D, the US based, tax-exempt nonprofit organisation that invests in type 1 diabetes research, and discussion on its role as a research funder supporting multi?country clinical trials within the EU
Meeting with Eero Heinäluoma (Member of the European Parliament)
2 Jun 2025 · Diabetes research
Response to EU Life sciences strategy
16 Apr 2025
As the largest global funder of type 1 diabetes (T1D) research, Breakthrough T1D is uniquely positioned to offer insights into how Europe can strengthen its life sciences ecosystem, particularly in translating cutting-edge science into life-changing therapies. Currently, Breakthrough T1D supports 313 million in active T1D research projects worldwide, including 58 million in European initiatives, among them 31 clinical trials taking place across Europe. Since 2015, we have also served as contributing partners in several IMI/IHI projects, with a total investment of 14 million. We strongly support the European Commissions ambition to boost innovation, build strategic autonomy, and reclaim global leadership in key areas such as advanced therapies and biologics. 1. Strengthen PublicPrivate Partnerships (PPPs) to Drive Translation Europe must build on models like the Innovative Health Initiative (IHI) to de-risk R&D, speed up translation, and engage the full innovation ecosystemfrom academia and industry to patient organisations. For chronic diseases like T1D: PPPs should fund cross-disciplinary consortia focused on disease-modifying interventions. Clear frameworks should support collaboration between nonprofit funders like Breakthrough T1D and EU-based SMEs or academic centres. Administrative burden should be reduced to allow faster cycles of innovation and participation by small biotech and startups. 2. Boost and Sustain Strategic Research Funding Europes underinvestment in chronic autoimmune diseases is limiting its competitiveness. To close this gap, the EU should: Prioritise research into chronic autoimmune disease, under Horizon Europe and successor programmes. Ensure continuity of funding from early discovery through clinical validation and manufacturing readiness. Create co-funding mechanisms that leverage global nonprofit investment (e.g. from Breakthrough T1D) to maximise EU impact. 3. Enable Economic Models that Incentivise Drug Repurposing Repurposing existing drugs can accelerate time to patient impactespecially in autoimmune diseases, where promising immunotherapies exist but lack commercial incentives. The EU should: Develop IP or exclusivity incentives for companies repurposing off-patent or shelved compounds. Use milestone-based public funding to encourage SME and nonprofit-driven repurposing initiatives. Explore value-based procurement or outcome-linked rewards for therapies that delay or prevent disease progression. 4. Support Advanced Therapies Through Streamlined Regulation T1D is at the frontier of cell and gene therapy, but regulatory complexity threatens to slow innovation. Europe needs: A fit-for-purpose regulatory pathway for disease-modifying cell therapies and combination products. Harmonised frameworks to support multi-country clinical trials and scalable approvals. Clearer guidance on risk-adapted approaches for therapies with high potential but complex mechanisms. 5. Invest in European Manufacturing and Scale-Up Capacity Cell therapies for T1D and others ATMPs require GMP facilities, supply chain innovation, and specialist talent. To retain economic value in Europe: The EU should co-invest in manufacturing hubs and offer scale-up support to EU-based SMEs. Create loan guarantee and blended finance models to help innovators bridge the gap from clinical success to commercialisation. 6. Promote Patient-Centric Knowledge Networks Knowledge generation must be paired with inclusive, cross-sector networks that speed translation. We recommend: EU support for thematic knowledge hubs, particularly in autoimmunity, to connect research, clinical practice, and patients. Requirements for patient engagement across EU-funded R&I programmes. Integration of patient registries, natural history studies, and trial networks into innovation infrastructure.
Read full responseResponse to EU rules on medical devices and in vitro diagnostics - targeted evaluation
21 Mar 2025
Breakthrough T1D (formerly JDRF) appreciates the opportunity to provide comments to the targeted evaluation by the Commission on the EU rules for medical devices and in vitro diagnostics. ABOUT BREAKTHROUGH T1D As the leading global type 1 diabetes (T1D) research and advocacy organization, Breakthrough T1D helps make everyday life with type 1 diabetes better while driving toward cures. We do this by investing in the most promising research, advocating for progress by working with the government to address issues that impact the T1D community, and helping educate and empower individuals facing this condition. Since 2015, our organization has invested more than 57 million in European projects. In addition, 30 clinical trials are currently funded by Breakthrough T1D in Europe. COMMENTS Overall, the Commission should look for ways to simplify the European regulatory ecosystem to accelerate development of new device technologies while maintaining the standards for quality and safety. Some specific examples for consideration in the targeted evaluation are as follows: Decrease Interplay Between Different Regulations in the Development of Cell Therapies: The rules for developers of novel technologies that use drug-device combinations, particularly for ATMPs, should be simplified. For example, developing cell therapy products requires compliance with several regulations, including the Medical Device Regulation (MDR), General Pharmaceutical Legislation, the ATMP Regulation (2007) and the Blood & Tissue Regulation and in some cases with the GMO regulation. These regulations have differing dossier requirements, review timelines and assessment divisions. Inconsistencies across multiple regulations adds complexity and delays the development of novel therapies. For example, the COMBINE program, a cross-sector initiative started by the Commission in 2024 to streamline combined studies of medicines and medical devices, should be accelerated. This can not only address the current problems of bureaucracy, fragmentation, and inefficiency but the results can inform the legislative articles of the new General Pharmaceutical Legislation currently being debated by the EU institutions Align with emerging EU regulations: The lack of clarity on alignment between the MDR and other (horizontal) regulations, such as the AI Act, can lead to challenges regarding innovation in T1D management. Clear guidance is sought on how the different regulations (in this case MDR and the AI Act) would work together. Avoiding double regulatory requirements including conformity assessments is key to avoiding delayed access for people with T1D to new AI driven diabetes technologies. This would also be in line with the European Commission's ambitions as set out in the Draghi report and the Competitiveness Compass. Introduce an accelerated pathway for innovative/breakthrough devices: Type 1 diabetes requires an array of devices for diagnosis and management, such as continuous glucose monitors, insulin pumps, automated insulin delivery systems, islet autoantibody diagnostics, and assays for disease related biomarkers. The medical device and in vitro diagnostic regulations should introduce an amendment to fast-track novel/breakthrough devices for unmet medical needs such as those seen in T1D. This would bring more global alignment and faster patient access - given that other authorities, such as the FDA, have Breakthrough Device Designation programs. Such a pathway in Europe can expedite the the development, review, and approval of medical devices to provide more effective treatments or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
Read full responseMeeting with Tomislav Sokol (Member of the European Parliament)
14 Jan 2025 · Health policy