Cell Therapy – TRAcking, Circulation, & Safety (CT-TRACS) Committee Regulatory Perspectives Webinar

  • Start Date/Time :
  • End Date/Time :
  • Location : Zoom webinar, co-organized by EATRIS and the HESI CT-TRACS Committee

The HESI Cell Therapy – TRAcking, Circulation, & Safety (CT-TRACS) Committee will present a webinar on Tuesday, 28 September 2021 featuring three speakers, included in the program details below, who will share regulatory perspectives from both sides of the Atlantic. This activity is part of the CT-TRACS Committee’s efforts to continue filling the knowledge gap about methods that can assess the fate of therapeutic cells and/or can help the timely identification of eventual unexpected effects while highlighting the regulatory component of these endeavors.

This webinar is co-organized by EATRIS and the HESI CT-TRACS Committee and will be open to the public. Participants in the audience will have the opportunity to ask questions through the webinar platform.

Details

  • Date: Tuesday, 28 September 2021
  • Time: 10:00 AM – 12:00 PM EST
  • Register: Registration is free and open to the public – register here.

CT-TRACS Committee Regulatory Perspectives Webinar Speakers

  • Tineke van den Hoorn, PhD

    Medicines Evaluation Board, The Netherlands

    Read Bio
  • Kate Dabirsiaghi, VMD, MS, MA

    US Food and Drug Administration (FDA), CBER/OTAT, USA

    Read Bio
  • Marta Rayo Lunar, BSc Pharm

    Asphalion, Spain

    Read Bio
  • Bill Shingleton, PhD

    Cytiva, UK

    Read Bio

CT-TRACS Committee Regulatory Perspectives Webinar Program

Tuesday, 28 September 2021

Introduction: Background (HESI & CT-TRACS) and Setting the Stage (Bill Shingleton, Cytiva, CT-TRACS Committee Co-Chair)

Talk 1: Regulatory Considerations for Preclinical Development of Cell-Based Therapies – Learnings for the Future (Tineke van den Hoorn, Medicines Evaluation Board, The Netherlands)

Read Abstract

Regulatory Considerations for Preclinical Development of Cell-Based Therapies – Learnings for the Future

Regulatory guidelines on preclinical development of cell-based products should not be used as a tick-box but mostly provide lines for thought for design of the development program. Cell-based products are a diverse group of products, therefore a one-size-fits-all guideline is not possible. Comparison of the development programs of cell-based products (from scientific advise procedures) that are categorized based on their cell origin (autologous versus allogeneic) and on the genetic manipulation status reveals quite some variability. A comparison of the development programs of similar type of cell-based products (from registration procedures) seems to provide a more specific framework of relevant studies.

Talk 2: Preclinical Considerations for Cellular Therapies – A CBER/FDA Approach (Kate Dabirsiaghi, US Food and Drug Administration, CBER/OTAT, USA)

Read Abstract

Preclinical Considerations for Cellular Therapies – A CBER/FDA Approach

In this talk, Dr. Dabirsiaghi will describe the organizational structure of the Office of Tissues and Advanced Therapies in the Center for Biologics Evaluation and Research at FDA (FDA/CBER/OTAT) and the products they regulate. She will discuss preclinical considerations for assessing the safety and distribution of cell-based products as well as principles for selecting appropriate animal models for these studies. Last, Dr. Dabirsiaghi will describe opportunities for early interaction with CBER/OTAT.

Talk 3: Case Study, nTRACK Project – Utilizing Nanoparticles for Cell Tracking; Lessons Learned From the Regulatory Process in the EU (Marta Rayo Lunar, Asphalion, Spain)

Read Abstract

Case Study, nTRACK Project – Utilizing Nanoparticles for Cell Tracking; Lessons Learned From the Regulatory Process in the EU

n-TRACK is a H2020 EU funded project developing nanoparticles for tracking of stem cell therapy on muscle regeneration. As it is not straightforward to define the regulatory pathway to develop a product such as n-TRACK, in this talk Marta Rayo Lunar will present this case-study focusing on the knowledge gained on regulatory aspects and preclinical development after several regulatory actions carried out in the EU.

Presentations will be followed by a Q&A/panel discussion with all speakers (~20-30 minutes), moderated by Bill Shingleton, Cytiva, CT-TRACS Committee Co-Chair.

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