Management team
The management team consists of the initiators of DARE-NL and is responsible for the overall execution of the DARE-NL project. Their main tasks include monitoring the status of each work package against deliverable and milestone planning, risk assessment and contingency planning.
Trudy Straetemans
Associate Professor Translational Tumor Immunology and ATMP Development at the University Medical Center Utrecht
Inge Jedema
Head of Translational Cellular Immune Therapy at the Netherlands Cancer Institute / Antoni van Leeuwenhoek
Harry Dolstra
Professor Translational Immunohematology, Head Cell Therapy Facility at the Radboud University Medical Center
Edwin Bremer
Tenure track professor Immunohematology and head of the Cellular Therapy Processing Facility at the Department of Hematology, University Medical Center Groningen
Project team
The project team is composed of the work package leaders and supported by the project manager. The work package leaders coordinate the daily activities in their work packages (see: Activities – DARE-NL). Responsibilities include the monitoring of technical, infrastructural and financial progression, and ensuring the realization of milestones. Specific responsibilities include the successful recruitment of personnel across participating institutions, work progress, decisions on mitigating measures and ensuring that the complimentary strength of the DARE-NL partners is optimally exploited.
Trudy Straetemans
Associate Professor Translational Tumor Immunology and ATMP Development at the University Medical Center Utrecht
Inge Jedema
Head of Translational Cellular Immune Therapy at the Netherlands Cancer Institute / Antoni van Leeuwenhoek
Harry Dolstra
Professor Translational Immunohematology, Head Cell Therapy Facility at the Radboud University Medical Center
Edwin Bremer
Tenure track professor Immunohematology and head of the Cellular Therapy Processing Facility at the Department of Hematology, University Medical Center Groningen
Emma de Pater
Director Cell Therapy Facility at the Erasmus Medical Center
Pauline Meij
Head of Center for Cell and Gene Therapy / Qualified Person ATMP at the Leiden University Medical Centre
Steering Committee
The steering committee oversees the strategic and technological development of DARE-NL. Each institute involved in DARE-NL is represented by one delegate in the steering committee. The steering committee facilitates communication between partners, monitors work package task progress, ensures full exploitation of consortium synergies and suggests adjustments as the landscape evolves both within and outside the infrastructure. The steering committee is the ultimate decision making body of DARE-NL.
Trudy Straetemans
Associate Professor Translational Tumor Immunology and ATMP Development at the University Medical Center Utrecht
Inge Jedema
Head of Translational Cellular Immune Therapy at the Netherlands Cancer Institute / Antoni van Leeuwenhoek
Harry Dolstra
Professor Translational Immunohematology, Head Cell Therapy Facility at the Radboud University Medical Center
Edwin Bremer
Tenure track professor Immunohematology and head of the Cellular Therapy Processing Facility at the Department of Hematology, University Medical Center Groningen
Emma de Pater
Director Cell Therapy Facility at the Erasmus Medical Center
Emma de Pater
Director Cell Therapy Facility at the Erasmus Medical Center
Pauline Meij
Head of Center for Cell and Gene Therapy / Qualified Person ATMP at the Leiden University Medical Centre
Laurens Bloem
Assistant Professor Clinical Therapeutics at the Utrecht Institute for Pharmaceutical Sciences, Utrecht University
Monique Grommé
Responsible person organ bank stem cells at the Maastricht University Medical Centre
Friso Calkoen
Pediatric Oncologist at the Princess Máxime Centre for Pediatric Oncology
Carlijn Voermans
Head of Department Cell Therapy at Sanquin Bloedvoorziening
Patient Advisory Board
Patient advocates have been involved in DARE-NL from the early discussions and setup into the organization and implementation of plans. A patient advisory board (PAB) with representatives from four patient organisations and a patient relations liaison has been established to represent the patient interests and meets at least three times a year. The project leader will also involve the PAB on an ad hoc basis to obtain advise on specific technical issues as well as strategic questions that arise during the project.
The goals of the patient advocate are:
- Optimal patient care
- Timely access to new treatments
- Influence on clinical trials and guidelines for treatment
- Information on scientific research and involvement in discussions about future developments
Based on these goals, the PAB contributes to DARE-NL in several key areas:
- Registries for Hospital Exemption and ATMP trials
Currently, a substantial number of ATMPs without market authorization are clinically used through a hospital exemption (HE). An HE is only possible for ATMP treatments on a non-routine basis, for an individual patient, and when no centrally authorized treatment or clinical trial is available. However, it is currently unclear which, and where, ATMPs are used by means of HE. Therefore, setting up an HE registry with all ongoing HE, would be a highly effective step for bringing innovative ATMPs closer to patients. Similarly, a registry specifically for (academical or commercial) oncological ATMPs that are currently undergoing clinical evaluation is not yet available. Such Dutch ATMP-trial registry, which should include a non-technical description, would be beneficial for patients that would be looking to join a trial that is recruiting (facilitating recruitment) and/or interested in state-of-the-art developments in cancer research. Both registries would be very useful tools for authorities and other stakeholders (such as KWF) as well, to evaluate the status of ATMP development in the Netherlands. The PAB will actively contribute to setting up these registries and they will design a dissemination strategy for informing their members. Whenever possible these registries will align with or use already existing registries or initiatives.
- Facilitate discussions with regulatory authorities
The PAB will be actively involved in the discussions with regulatory authorities with regard to market access (WP6.1), representing the interest of cancer patients and aiming to make promising ATMP drug candidates available for patients as soon as possible.
- Setup of HTA and clinical studies
While the setup of clinical studies is not part of the DARE-NL infrastructure, it is important to start with the design of such studies in an early stage, and involve all stakeholders as early as possible. The PAB will help ATMP researchers with the design of clinical studies, such as proper patient selection, in-and exclusion criteria, endpoints, and management of side effects. In parallel, the PAB will support with assessment and design of appropriate patient reported outcomes (PROs) for HTAs of ATMPs under development.
- Patient perspective on Dutch ATMP R&D strategy.
Finally, patient representatives will provide their perspective on the role of ATMPs in future anticancer therapy, outlining their vision on the research and development priorities for ATMPs for the coming 5 years. The goal of this vision is to ensure the generation of a range of new advanced therapeutics that are developed towards the needs of all cancer patients as much as possible.
Gijs Lunenborg
Patient Advocate Innovative Treatments at the Dutch Federation of Cancer Patient Organizations (NFK)
Marianna van Maarschalkerweerd
Patient Advocate, Regulatory Affairs Expert at Hematon
Willemijn Plieger
Research employee at the Dutch Childhood Cancer Organisation (VOKK)
Simone Punt
Project Manager Cell and Gene Therapy projects, DARE-NL patient liaison
Patient Participation Review Committee
TEKST NODIG
Frank Baas
Professor emeritus Molecular Genetic Diagnostics at Leiden University Medical Center, Board member Stichting Hematon
Atefeh Sadeghi
Pharmacist and patient advocate, Women Cancer Europe
Friso Calkoen
Pediatric Oncologist at the Princess Máxime Centre for Pediatric Oncology
Scientific Advisory Board
The Scientific Advisory Board (SAB) comprises four internationally recognized leads in oncological ATMP development and clinical implementation. The role of the SAB is to communicate external judgement on the efficiency and effectiveness of work undertaken to the management and project teams, to ensure that the consortium is exposed to a divergent alternative view and to ensure that the management processes are robust. The SAB provides feedback on the workplan, challenges and opportunities regarding freedom to operate, specific technical issues and strategic questions.
Christian Chabannon
Professor, Head of the Cell Therapy Center at Institut Paoli-Calmettes
Stanley Riddell
Professor, Program in Immunology at Fred Hutchinson Cancer Center
Manel Juan
Professor, Head Immunopathology Section at Hospital Clínic de Barcelona
Timothy Devos
Professor, Hematologist at UZ Leuven