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The HESI Emerging Issues Subcommittee on cell therapies safety, CT-TRACS (Cell Therapy - TRAcking, Circulation, & Safety) is pleased to present a session selected based on scientific merit, at the International Society of Cellular Therapy (ISCT) annual meeting in London on May 6th, 15:00-16:30. View the meeting website and access the full program here: http://isct2017.com
Session Chair: Dr. William Shingleton (GE Healthcare, CT-TRACS co-chair)
Introduction: HESI CT-TRACS structure, mission, goals and collaborations.
Current developments: (presenters from CT-TRACS and two guest speakers, 10 minutes each)
I. Tracking cells after administration/biodistribution:
- Imaging Modalities and Probes. Dr. Brooke Helfer, Celsense, CT-TRACS sub-group co-leader.
- Imaging Cell Delivery Near The Bed: Are We There Yet? (case-studies). Prof. Jeff Bulte, Director of Cellular Imaging, The Johns Hopkins Institute for Cell Engineering.
- Pre-Clinical and Clinical Biodistribution Study in Cell-Based Therapeutic Product Development. Dr. Nobuhiro Umeda, Astellas Pharma Inc.
II. Tumorigenicity assessment:
- Tumorigenicity Assessment of Human Cell-Based Therapeutic Products. Dr. Yoji Sato, Head of the Division of Cell Based Therapeutic Products, NIHS Japan.
- Tumorigenicity Evaluations of AST-OPC1: Oligodendrocyte Progenitor Cells for the Treatment of Spinal Cord Injury (case-study). Dr. Jane Lebkowski, President of R&D and Chief Scientific Officer, Asterias Biotherapeutics Inc.
Panel Discussion: The session chair and all speakers will join the stage for an interactive discussion with the audience, focusing on gaps and needs in the translation of cellular therapies to the clinic. Seeking feedback from therapy developers and regulators (30 minutes).
Cell therapies show great therapeutic promise in the fields of regenerative medicine and immunotherapy. To realize their full clinical potential there is a need for greater understanding of their mode of action, how they migrate after administration to deliver their therapeutic benefits, their persistence at sites of action, and whether their properties, localization or distribution may cause safety issues. Currently, there are several existing and many emerging tools available to develop pharmacokinetic data on these cell-derived therapies to improve our understanding of the mechanism of action and demonstrate on target delivery, but adoption by clinical investigators has been limited.
The Health and Environmental Sciences Institute (HESI) Emerging Issues Committee launched a new multi-sector collaborative sub-committee to identify key needs for assessing the safety of cell therapies and identify opportunities to meet these needs. This program, the Cell Therapy - TRAcking, Circulation, & Safety (CT-TRACS) sub-committee, provides a neutral platform for cell therapy developers, researchers, regulators, imaging specialists and other stakeholders to interact, discuss current challenges and identify best practices to ensure that these therapies are safe and effective for use.
In this session, CT-TRACS members and invited guest speakers will discuss these objectives and provide two case examples of applications. The ultimate goal is to promote the dialogue with the international community and initiate an interactive discussion about opportunities to address the challenges facing the translation of cell therapies into the clinic.
- To bring awareness on how the application of existing cell tracking technologies, methods, and best practices can benefit the clinical translation of cell therapies.
- To promote the dialogue with the international community and discuss opportunities to address the challenges facing the translation of cell therapies into the clinic.
CT-TRACS is an international and multi-disciplinary team of experts with interest in sharing their knowledge, common challenges and seek consensus on finding harmonized solutions.
Speakers biographies and learning objectives for each presentation are available here.
For additional information, please contact Dr. Lucilia Mouriès, HESI Scientific Program Manager, email@example.com.