- Email: [email protected]
Global Multidisciplinary Networks
C H A P T E R
28 Global Multidisciplinary Networks Torsten Zuberbier1, Ingrid van Hofman2 and Tamara Do¨rr1 1
Department of Dermatology and Allergy, Charite´-Universita¨tsmedizin Berlin, Berlin, Germany 2GA2LEN, Berlin, Germany
GA2LEN, the Global Allergy and Asthma European Network is a perfect example of how global multidisciplinary networks can encourage and support precision medicine to bring the results to our patients. GA2LEN was initiated in 2004 under the 6th Framework Program of the European Union as a so called Network of Excellence. This was possible through constant support and fostering of its “mother,” The European Academy of Allergy and Clinical Immunology, EAACI. Since then, the close relationship has remained with GA2LEN being a Network of Excellence of university departments in the field of allergy and asthma, and with EAACI, being its academic mother. The synergy is clear: EAACI is an academic society formed by now more than 10,000 engaged members, individuals interested in the field of allergy, and GA2LEN is a consortium of universities working in this field. A partnership of 27 members and 62 collaborating centers, originating in Europe but bringing specific programs and certified reference centers in clinical care also across the globe. As originally requested, the initially supported EU Network of Excellence has been a sustainable legal entity independent of financial support by the EU due to the high joint motivation of its centers. In the field of precision medicine, GA2LEN is a model project in the history of medicine. Paved out to originally overcome the fragmentation in research throughout Europe, GA2LEN has now delivered much more. Starting with experimental research and joining forces in collaborative projects, the clear benefits of GA2LEN result in the possibility that multi-center clinical trials can be performed on a large scale and very quickly, enabling translational research at an early level. The basic principle of research in precision medicine is to understand which patient or patient groups will profit best from which treatment option. Treatments may be individually tailored and do in a broader sense also include non-pharmaceutical interventions. In a certain sense, allergy immunotherapy has been one of the first areas in medicine where precision medicine has been applied. The selection of the chosen therapeutic SIT (Allergen Specific Immunotherapy) product depends on the individual state of sensitization. However, the level of precision in this example is not as precise as it could be. With molecular diagnosis becoming available, we are now able to understand better that the individual disease depends much more on the pattern of epitopes against which the individual patient is sensitized than on the crude allergen, for example, birch itself. This also helps to predict cross-reactivities and the possibility/intensity of pollen related food allergy. The development of the next generation of SIT strategies needs to address this knowledge by preparation of SIT solutions adjusted to the epitopes of the individual patient. Precision medicine on this level also brings along a new challenge in designing adequate trials for licensing these drugs. With the construction of the GA2LEN Mobile Pollen Exposure Chamber, GA2LEN has created a novel tool for this. Research in precision medicine also required to better understand the heterogeneity or homogeneity of different subtypes in diseases like atopic dermatitis or urticaria. Ideally, biomarkers are also found to discriminate them. For this purpose a large network is ideal as it allows a quick selection of also rare subgroups of patients when needed in trials. However, in precision
Implementing Precision Medicine in Best Practices of Chronic Airway Diseases. DOI: https://doi.org/10.1016/B978-0-12-813471-9.00031-1
203
© 2019 Elsevier Inc. All rights reserved.
204
28. GLOBAL MULTIDISCIPLINARY NETWORKS
medicine, research is only part of the necessity we face. As important as the research is rolling out the knowledge to health care professionals in the field and ensuring this knowledge is used for the better care of our patients. In this aspect, GA2LEN has worked in a groundbreaking strategy. Together with the European Academy, EAACI, many inter-disciplinary guidelines have been created. Strategies to ensure that the guidelines can be implemented into clinical care were developed in addition. The best current example is the urticaria guideline. The guidelines under the auspices of GA2LEN are updated every four years and have now, based on an originally European initiative with the EAACI, become a truly global endeavor. In the last guideline meeting in 2016, more than 40 international societies have been joining including all the major societies of the international regions and the world allergy organization. However, creating the guideline is only part of the work. Specialized centers of reference can help to build up local networks, ensuring that novel precision medicine and treatments really reach our patients. Apart from certified GA2LEN allergy centers covering all areas of allergies, a specific initiative has been started, creating centers of excellence and reference in fields of allergy. This group of initiatives is the so called UCARE centers [1]. Meanwhile, UCARE centers have been established globally (see Fig. 28.1). The centers are certified and regularly checked, but it is also assured that they are joining initiatives for registries and supporting each other to increase our knowledge in this field of allergy. GA2LEN created its CORE (Centres of Research and Excellence) project which includes the development, interaction and accreditation of centers of reference and excellence in special areas of allergy embedded in its overall quality management of allergy centers of excellence. The CORE project was successfully applied to 27 centers, showcasing their excellence in—among other things—quality management concentrating on patient needs, staff training and compliance to guidelines. The CORE Quality Management criteria consists of 23 basic requirements and is split into three levels: QM Level 1, 2 and an advanced level 1 and 2 combined. These requirements are reflected in the first specified area for CORE. Under the GA2LEN CORE framework, urticaria was the first area chosen to be investigated further. Centers of Reference and Excellence in Urticaria (UCAREs) can help to improve the management of hard to treat conditions such as urticaria. GA2LEN UCARE describes the aims, the requirements and deliverables, the application process, and the audit and accreditation protocol for its centers. The main aims of GA2LEN UCAREs, under the GA2LEN CORE umbrella framework, are to provide excellence in urticaria management, to increase the knowledge of urticaria by research and education and to promote the awareness of urticaria by advocacy activities. Urticaria centers that want to become a certified GA2LEN UCARE center have to apply and fulfill 32 requirements, defined by specific deliverables that are assessed during an audit visit. The GA2LEN UCARE program
FIGURE 28.1 World map of certified UCARE centers (copyright: GA2LEN/Google Maps).
VI. BRINGING PRECISION MEDICINE TO THE CLINIC
REFERENCE
205
has and still is resulting in a strong network of urticaria specialists, promotion urticaria research and harmonization and improvement urticaria management on a global scale. A GA2LEN UCARE audit visit and meeting makes sure that an urticaria center complies with the rules and fulfills the requirements to become a GA2LEN UCARE center. The audit visit is also intended to strengthen the interaction between UCAREs and to promote the discussion of urticaria management, the organization of urticaria centers and joint urticaria projects between GA2LEN UCARE centers in the future. GA2LEN CORE is now focusing its attention on Atopic Dermatitis (ADCARE) and is the newest project currently in planning, following on from the success of UCARE. ADCARE will be equipped with the 23 requirements from CORE and will address areas, among other topics, such as guidelines, impact, treatment and control for patients.
Reference [1] Maurer, et al. Definition, aims, and implementation of GA(2) LEN urticaria centers of reference and excellence. Allergy 2016;71 (8):1210 18.
VI. BRINGING PRECISION MEDICINE TO THE CLINIC
28 Global Multidisciplinary Networks Torsten Zuberbier1, Ingrid van Hofman2 and Tamara Do¨rr1 1
Department of Dermatology and Allergy, Charite´-Universita¨tsmedizin Berlin, Berlin, Germany 2GA2LEN, Berlin, Germany
GA2LEN, the Global Allergy and Asthma European Network is a perfect example of how global multidisciplinary networks can encourage and support precision medicine to bring the results to our patients. GA2LEN was initiated in 2004 under the 6th Framework Program of the European Union as a so called Network of Excellence. This was possible through constant support and fostering of its “mother,” The European Academy of Allergy and Clinical Immunology, EAACI. Since then, the close relationship has remained with GA2LEN being a Network of Excellence of university departments in the field of allergy and asthma, and with EAACI, being its academic mother. The synergy is clear: EAACI is an academic society formed by now more than 10,000 engaged members, individuals interested in the field of allergy, and GA2LEN is a consortium of universities working in this field. A partnership of 27 members and 62 collaborating centers, originating in Europe but bringing specific programs and certified reference centers in clinical care also across the globe. As originally requested, the initially supported EU Network of Excellence has been a sustainable legal entity independent of financial support by the EU due to the high joint motivation of its centers. In the field of precision medicine, GA2LEN is a model project in the history of medicine. Paved out to originally overcome the fragmentation in research throughout Europe, GA2LEN has now delivered much more. Starting with experimental research and joining forces in collaborative projects, the clear benefits of GA2LEN result in the possibility that multi-center clinical trials can be performed on a large scale and very quickly, enabling translational research at an early level. The basic principle of research in precision medicine is to understand which patient or patient groups will profit best from which treatment option. Treatments may be individually tailored and do in a broader sense also include non-pharmaceutical interventions. In a certain sense, allergy immunotherapy has been one of the first areas in medicine where precision medicine has been applied. The selection of the chosen therapeutic SIT (Allergen Specific Immunotherapy) product depends on the individual state of sensitization. However, the level of precision in this example is not as precise as it could be. With molecular diagnosis becoming available, we are now able to understand better that the individual disease depends much more on the pattern of epitopes against which the individual patient is sensitized than on the crude allergen, for example, birch itself. This also helps to predict cross-reactivities and the possibility/intensity of pollen related food allergy. The development of the next generation of SIT strategies needs to address this knowledge by preparation of SIT solutions adjusted to the epitopes of the individual patient. Precision medicine on this level also brings along a new challenge in designing adequate trials for licensing these drugs. With the construction of the GA2LEN Mobile Pollen Exposure Chamber, GA2LEN has created a novel tool for this. Research in precision medicine also required to better understand the heterogeneity or homogeneity of different subtypes in diseases like atopic dermatitis or urticaria. Ideally, biomarkers are also found to discriminate them. For this purpose a large network is ideal as it allows a quick selection of also rare subgroups of patients when needed in trials. However, in precision
Implementing Precision Medicine in Best Practices of Chronic Airway Diseases. DOI: https://doi.org/10.1016/B978-0-12-813471-9.00031-1
203
© 2019 Elsevier Inc. All rights reserved.
204
28. GLOBAL MULTIDISCIPLINARY NETWORKS
medicine, research is only part of the necessity we face. As important as the research is rolling out the knowledge to health care professionals in the field and ensuring this knowledge is used for the better care of our patients. In this aspect, GA2LEN has worked in a groundbreaking strategy. Together with the European Academy, EAACI, many inter-disciplinary guidelines have been created. Strategies to ensure that the guidelines can be implemented into clinical care were developed in addition. The best current example is the urticaria guideline. The guidelines under the auspices of GA2LEN are updated every four years and have now, based on an originally European initiative with the EAACI, become a truly global endeavor. In the last guideline meeting in 2016, more than 40 international societies have been joining including all the major societies of the international regions and the world allergy organization. However, creating the guideline is only part of the work. Specialized centers of reference can help to build up local networks, ensuring that novel precision medicine and treatments really reach our patients. Apart from certified GA2LEN allergy centers covering all areas of allergies, a specific initiative has been started, creating centers of excellence and reference in fields of allergy. This group of initiatives is the so called UCARE centers [1]. Meanwhile, UCARE centers have been established globally (see Fig. 28.1). The centers are certified and regularly checked, but it is also assured that they are joining initiatives for registries and supporting each other to increase our knowledge in this field of allergy. GA2LEN created its CORE (Centres of Research and Excellence) project which includes the development, interaction and accreditation of centers of reference and excellence in special areas of allergy embedded in its overall quality management of allergy centers of excellence. The CORE project was successfully applied to 27 centers, showcasing their excellence in—among other things—quality management concentrating on patient needs, staff training and compliance to guidelines. The CORE Quality Management criteria consists of 23 basic requirements and is split into three levels: QM Level 1, 2 and an advanced level 1 and 2 combined. These requirements are reflected in the first specified area for CORE. Under the GA2LEN CORE framework, urticaria was the first area chosen to be investigated further. Centers of Reference and Excellence in Urticaria (UCAREs) can help to improve the management of hard to treat conditions such as urticaria. GA2LEN UCARE describes the aims, the requirements and deliverables, the application process, and the audit and accreditation protocol for its centers. The main aims of GA2LEN UCAREs, under the GA2LEN CORE umbrella framework, are to provide excellence in urticaria management, to increase the knowledge of urticaria by research and education and to promote the awareness of urticaria by advocacy activities. Urticaria centers that want to become a certified GA2LEN UCARE center have to apply and fulfill 32 requirements, defined by specific deliverables that are assessed during an audit visit. The GA2LEN UCARE program
FIGURE 28.1 World map of certified UCARE centers (copyright: GA2LEN/Google Maps).
VI. BRINGING PRECISION MEDICINE TO THE CLINIC
REFERENCE
205
has and still is resulting in a strong network of urticaria specialists, promotion urticaria research and harmonization and improvement urticaria management on a global scale. A GA2LEN UCARE audit visit and meeting makes sure that an urticaria center complies with the rules and fulfills the requirements to become a GA2LEN UCARE center. The audit visit is also intended to strengthen the interaction between UCAREs and to promote the discussion of urticaria management, the organization of urticaria centers and joint urticaria projects between GA2LEN UCARE centers in the future. GA2LEN CORE is now focusing its attention on Atopic Dermatitis (ADCARE) and is the newest project currently in planning, following on from the success of UCARE. ADCARE will be equipped with the 23 requirements from CORE and will address areas, among other topics, such as guidelines, impact, treatment and control for patients.
Reference [1] Maurer, et al. Definition, aims, and implementation of GA(2) LEN urticaria centers of reference and excellence. Allergy 2016;71 (8):1210 18.
VI. BRINGING PRECISION MEDICINE TO THE CLINIC