Invitation to participate in a survey on the organization and techniques of ATMP facilities by DARE-NL, EBMT, T2EVOLVE, and NXTGEN-HIGHTECH – a GoCART Coalition initiative

Dear GoCART stakeholder,

We are reaching out to invite you to participate in a survey on the organization and techniques employed in Advanced Therapy Medicinal Product (ATMP) facilities across Europe and beyond. This survey targets academic, non-profit and commercial facilities actively involved in or considering to move into the handling, development, and/or production of (pre-)GMP-grade gene therapies and/or ATMPs. Specifically, we seek the insights of facility (operations) managers, production (operations) managers, quality assurance managers and quality control managers engaged in cell and gene therapy activities.

The survey aims to: 

1. Understand ATMP facility structure and capacity

  • We aim to gather comprehensive data on the structure and capacities of ATMP facilities in Europe and beyond. This information will help clarify how various ATMPs are handled across different facilities;
  • The findings will be summarized in a detailed report, providing action items and recommendations. This report will offer valuable insights into the steps needed to meet the requirements for different ATMP processes.

2. Map current needs in cell culture technology

  • Another key aim is to identify and understand the current needs in cell culture technology used in ATMP production processes;
  • The insights gained will support technological innovations aimed at improving ATMP production processes.

To participate, follow the link to the survey: https://www.surveymonkey.com/r/ATMPfacilities 

Please only fill one survey per center. You can change your answers to the survey at any time until final completion.

We estimate that completing the survey may take 30 – 60 minutes to complete. You can find the total list of questions attached, as a reference of the information requested. Please note that many questions only apply dependent on the answers selected. We understand that your time is valuable, and we greatly appreciate your willingness to contribute to this endeavor. Your participation will significantly contribute to advancing the field of ATMP production by:

  • Providing a clearer understanding of current practices and capacities in ATMP facilities;
  • Identifying gaps and opportunities for technological advancements in cell culture and ATMP production processes;
  • Contributing to a collective effort to enhance the efficiency and effectiveness of ATMP handling, development, and production.

The aggregated data from this survey will serve as a foundation for informed decision-making and strategic planning in the ATMP sector, ultimately benefiting the entire field through shared knowledge and targeted recommendations.

We will share the results of this survey through abstracts, posters at various meetings, and research papers. We hope this will raise awareness of bottlenecks and help all stakeholders address these issues to improve access to ATMPs in the near future.

We hope you will consider participating in this survey and lend your expertise to this crucial initiative. Your input is invaluable, and we are confident that the insights gained will make a meaningful impact on the future of ATMP production.

We would be very grateful if your center could complete the survey by 8th August 2024.

Thank you in advance for your time and contribution.

Sincerely,

Annalisa Ruggeri – CTIWP chair
Jürgen Kuball – CTIWP co-chair
Michael Hudecek – On behalf of T2Evolve
Trudy Straetemans – On behalf of DARE-NL
Andrea Egan and Yolanda Cabrerizo – On behalf of GoCART
Ruud Das – On behalf of NextGen Hightech

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