Cell Therapy - TRAcking, Circulation, & Safety (CT-TRACS) Committee

Mission Statement

To establish a platform where an international network of experts from multiple sectors (public and private sector research scientists, regulators, clinicians, health foundations, and technology developers) can collaborate sharing knowledge, experience, and resources in the rapidly evolving field of cell therapy.

Call for Participants (March 2021): International Collaborative Study for the Identification of Off-Target Mutations Associated with Genome Editing

The CT-TRACS Committee is seeking additional partners (academic/research institutions, government agencies, non-profit institutions, private sector companies, or CROs) for an international collaborative project focused on advancing the application of sequencing technologies for identification and evaluation of off-target mutations that may be associated with genome editing via CRISPR Cas9. This initiative aims to advance the implementation of novel cell and gene therapies by improving the science underlying their safety evaluation. For full details on study objectives, rationale, roles for project partners, and instructions on how to express interest, please read the call for participants description document here.

Working Groups

  • Point of Administration-Biodistribution (PoA/BD) Working Group (Cell Tracking)

    This working group aims to identify current approaches, gaps, and needs in monitoring/evaluating the fate and activity of cells after their administration in vivo, to assess the safety of cell-based therapies.

  • Tumorigenicity Working Group

    This working group aims to address concerns regarding the potential for tumorigenicity of PSC-derived products by assessing and/or developing methodologies and approaches that could support tumorigenicity evaluation.

HESI Staff

Leadership Team

  • Tineke van den Hoorn, PhD

    Medicines Evaluation Board, The Netherlands

  • Bill Shingleton, PhD

    Cytiva

Committee Events

CT-TRACS Committee and NIH/NHLBI PACT Program Joint Webinar

Webinar, hosted by the National Heart, Lung, and Blood Institute (NHLBI) PACT Program

The HESI Cell Therapy - TRAcking, Circulation, & Safety (CT-TRACS) Committee is pleased to present a webinar on "Methods for Cellular Tracking Cells In Vivo and Following Biodistribtion" in collaboration with the National Heart, Lung, and Blood Institute (NHLBI) PACT Program. Cell therapies show great ...

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CT-TRACS Session at ISCT 2020 Virtual Meeting

Paris, France

The HESI Cell Therapy - TRAcking, Circulation, & Safety (CT-TRACS) Committee is pleased to present a session on "Imaging Cellular Therapeutics" as part of the newly designed International Society for Cell & Gene Therapy (ISCT) Virtual Meeting program. Please note that due to health and safety concerns related to the ...

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Pluripotent Stem Cell Manufacturing Expert Panels 2019

Los Angeles, California, USA

After the success of the 2018 CIRM/IABS “4th Cell Therapy Conference: Manufacturing and Testing of Pluripotent Stem Cells” and the associated HESI CT-TRACS Tumorigenicity Workshop (Abbot et al., 2018), five organizations have come together to continue the discussion and address bottlenecks associated with the ...

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	Methods for Cellular Therapies: Tracking Cells In Vivo and Assessing Biodistribution in Patients
What are your cells doing? Where do they go?

The HESI Cell Therapy - TRAcking, Circulation, & Safety (CT-TRACS) Committee is pleased to present a webinar on "Methods for Cellular Therapies: Tracking Cells In Vivo and Assessing Biodistribution in Patients" in collaboration with the National Heart, Lung, and Blood Institute (NHLBI) PACT Program.

 

Details:

  • Date: Thursday, 3 September 2020
  • Time: 12:00 PM - 1:00 PM EST
  • Registration: Click here to register.
CT-TRACS Web Seminar Image v2

 

Speakers:

  • Bill Shingleton, PhD, Alliances Manager at Cytiva
  • Brooke Helfer, PhD, Director of Research and Development at Celsense, Inc.
  • David Morrow, PhD, MBA, ATMP and Vaccine Scientific Program Manager at EATRIS

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.

In this web seminar, the CT-TRACS Committee speakers will provide an overview of technologies currently available for use in patients, how these are relevant to evaluate safety and efficacy aspects of cellular therapies, and the importance of collaboration to address challenges and needs facing the translation of cell therapies into the clinic​.

The CT-TRACS 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 improve confidence in the safety and efficacy of these therapies.

 

Webinar Objectives:

  • To learn about available and emerging noninvasive cell tracking modalities and their value in assessing cell fate and safety in vivo
  • 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 emphasize the need for dialogue with the international community and discuss opportunities to address the challenges facing the translation of cell therapies into the clinic
  • To understand the importance of therapy developers communicating practical challenges and needs to aid the development of enabling technologies and tools addressing those needs

 

Additional details can be found via the webinar e-flyer here. For more information, please contact the CT-TRACS Committee's Senior Scientific Program Manager, Dr. Lucilia Mouriès at lmouries@hesiglobal.org.

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ISCT 2020 Program Schedule

ISCT 2020 Registration Portal

NEW - Students register for free!

Please note that due to health and safety concerns related to the COVID-19 pandemic, the ISCT 2020 Annual Meeting has been changed to a virtual meeting only. We have updated the information below accordingly and thank ISCT organizers for maintaining the HESI CT-TRACS session in the revised virtual program.

 

The HESI Cell Therapy - TRAcking, Circulation, & Safety (CT-TRACS) Committee is pleased to present a session on "Imaging Cellular Therapeutics" as part of the newly designed International Society for Cell & Gene Therapy (ISCT) Virtual Meeting program. The session will be pre-recorded and accessible to registered participants online starting May 28, 2020 at 7:00 AM CEST. During the two days of the virtual meeting, delegates will have the opportunity to post questions to speakers and the session chair via an open chat forum within the session virtual room. After the conclusion of the conference, the session recording will remain available to all delegates for streaming on-demand until 2021!

We look forward to interacting with you in this CT-TRACS Virtual Session and throughout the duration of the event, on May 28-29, 2020, featuring 30+ unique sessions, 45+ hours of live and on-demand streaming, and a fully interactive Poster Hall, Exhibit Hall, and Virtual Partnering Forum.

 

Session Details:

  • Title: "Imaging Cellular Therapeutics"
  • Chair: Dr. Brooke Helfer (Celsense, Inc.), CT-TRACS “Point of Administration / Biodistribution” Working Group Co-Chair
  • Duration: 90 minutes
  • Description: Guest speakers will present their experience with imaging cellular therapeutics to bring awareness to how non-invasive in vivo cell tracking technologies and methods can provide unique opportunities to optimize efficacy of cell-based therapies and aid in the assessment and management of eventual toxicities, and ultimately, benefit their clinical translation.

 

Learning Objectives: 

  • To learn about the different imaging modalities for monitoring cellular therapies
  • To learn about developing and available, clinically applicable cell tracking technologies
  • To learn how imaging can aid in the translation of cellular therapeutics

 

Program:

  • Introduction by Session Chair (Dr. Brooke Helfer, CT-TRACS PoA / BD Working Group Co-Chair)
  • Developments in Imaging Cell-Based Therapy: Applications in Cancer Immunotherapies (Dr. Jane Sosabowski, Barts Cancer Institute, Queen Mary University of London, UK)
  • Seeing is Believing: In Vivo Microscopy for Optimizing Cellular Immunotherapies (Dr. Bettina Weigelin, Werner Siemens Imaging Center, Eberhard Karls Universität Tübingen, Germany)
  • Monitoring of Intracerebellar Delivery of Natural Killer Cells (Dr. Vidya Gopalakrishnan, MD Anderson Cancer Center, University of Texas, USA)
  • Panel discussion (~15-20 minutes)

 

For more information, please contact Dr. Lucilia Mouriès at lmouries@hesiglobal.org.

CT-TRACS Session Speaker Bios

Jane Sosabowski_IMG_6385_Picture_209x209

Jane Sosabowski, PhD
Reader in Molecular Imaging, Barts Cancer Institute, Queen Mary University of London

[simple_tooltip bubblewidth='1024' content='Jane Sosabowski, PhD

Dr. Jane Sosabowski holds the position of Reader in Molecular Imaging in the Centre for Cancer Biomarkers and Biotherapeutics, Barts Cancer Institute, Queen Mary University of London. She carried out her PhD in Radiochemistry in the Joint Department of Physics at the Institute for Cancer Research, Royal Marsden Hospital in London before joining the Nuclear Medicine Research Laboratory at Barts and the London School of Medicine and Dentistry. She now leads the Cancer Imaging Laboratory at Barts Cancer Institute. Her research interests are in radiopharmaceutical development, in vivo imaging of biotherapeutics, as well as in vivo cell tracking and development of machine learning tools for image analysis. She is part of the CRUK Major Centre in Biotherapeutics and has an active role in moving new radiolabelled biomolecules or biotherapeutics into the clinic at Barts Health, including a cross-London effort to develop GMP methods for imaging cell therapies in clinical trials. Together with Dr Sophie Papa who leads the ImmunoEngineering Group at Kings College London, she is developing techniques for absolute quantitation of cell therapies in vivo using nuclear imaging (PET and SPECT). ']Dr. Sosabowski's Bio[/simple_tooltip]

WSIC0791_Bettina Weigelin_Picture_209x209

Bettina Weigelin, PhD
Group Leader, Werner Siemens Imaging Center, Eberhard Karls
Universität Tübingen

[simple_tooltip bubblewidth='1024' content='Bettina Weigelin, PhD

Bettina Weigelin is a Group Leader at the Werner Siemens Imaging Center, Department for Preclinical Imaging and Radiopharmacy at the University of Tübingen, Germany. She obtained her PhD in Medical Sciences from the Radboud University of Nijmegen, The Netherlands, where she applied intravital multiphoton imaging to study cancer invasion and immune function in solid tumors. In 2016 she received a Rubicon Young Investigator Award (NWO) to support her stay at MD Anderson Cancer Center, Houston, USA, where she used intravital microscopy to understand immunosuppression mediated by the bone microenvironment to develop novel strategies for immunotargeting of bone metastasis. Her group ‘Multiscale Immunoimaging’ at the University of Tübingen combines advanced microscopic techniques with state-of-the art macroscopic imaging to gain mechanistic insight in adoptive T cell therapies at the cellular and whole-body scale, to identify strategies for improved cancer immunotherapies.']Dr. Weigelin's Bio[/simple_tooltip]

Vidya Gopalakrishnan_Picture_209x209

Vidya Gopalakrishnan, PhD
Associate Professor, Division of Pediatrics, MD Anderson Cancer Center, University of Texas

[simple_tooltip bubblewidth='1024' bubblecolor='#FFFFFF' content='Vidya Gopalakrishnan, PhD

Michelle received her PhD in toxicology in 2004 and BS in Biology and Environmental Science and Policy in 1998 from Duke University. She is currently the Associate Director of Environmental Science at the Health and Environmental Sciences Institute (HESI), where she provides leadership, technical direction, and guidance to varied, multi-stakeholder, collaborative committees on topics related to risk assessment and environmental protection worldwide.

Dr. Gopalakrishnan completed her BS and MS degrees in Microbiology and Biochemistry from the University of Bombay in India. She obtained her PhD degree in Microbiology and Genetics at the University of Pittsburgh-School of Medicine in 1995 for her work identifying proteins that regulated the replication of human papilloma virus DNA replication. Her thesis work was supported by the Ben Franklin graduate fellowship. She subsequently accepted a post-doctoral fellowship position in Dr. Thomas Kelly’s group at the Johns Hopkins University School of Medicine, where she applied genetic and biochemical tools to uncover molecular mechanisms that restricted initiation of DNA replication to a once per cell cycle event. During this time, she successfully competed for fellowships from the Leukemia and Lymphoma Society and the National Institutes of Health (NIH). This work laid the foundation for her foray into brain tumors, which she has studied for the last 15 years. She is currently an Associate Professor in the Division of Pediatrics at the University of MD Anderson, where her research aims to delineate the molecular underpinnings of pediatric brain tumors and to leverage druggable pathways for therapeutic purposes.

Work in her group is broadly divided into 3 areas: (A) Brain tumor epigenetics: with a major focus on the transcription factor REST and its role in driving initiation and progression of pediatric brain cancers, medulloblastoma (MB) and diffuse intrinsic pontine glioma (DIPG), (B) Brain tumor proteomics: with an emphasis on a component of the proteasomal machinery called USP37, and studying the consequences of its dysregulation in brain tumors and, of relevance to this talk (C). Development of immunotherapy for pediatric brain tumors: She leads the efforts of a multidisciplinary team of scientists and physicians at MD Anderson Cancer Center to develop immunotherapy for recurrent/refractory pediatric brain tumors. Her lab findings have been transitioned to the clinic through initiation of a Phase-I clinical trial to test the safety of intracranial administration of immune cells. To monitor the fate of infused cells, she is working with imaging experts to develop novel 19F MRI-based imaging approaches. Overall, her work spans the spectrum of basic, translational and clinical research. Her work has been consistently supported by grants from the NIH, American Cancer Society, Cancer Prevention Research Institute of Texas (CPRIT) and multiple pediatric cancer foundations. She currently is mentor to a group of 11 scientists, fellows and graduate students.

']Dr. Gopalakrishnan's Bio[/simple_tooltip]

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Time: 13.00 - 18.00 PST
Location: Broad CIRM Center for Regenerative Medicine and Stem Cell Research at USC
First Floor, Seminar Room #101
1425 San Pablo Street, Los Angeles, CA 90033

 

After the success of the 2018 CIRM/IABS “4th Cell Therapy Conference: Manufacturing and Testing of Pluripotent Stem Cells” and the associated HESI CT-TRACS tumorigenicity workshop (conference report: Abbot et al. 2018), five organizations have come together to continue the discussion and address bottlenecks associated with the manufacturing and testing of pluripotent stem cell-based therapies.

 

The Pluripotent Stem Cells Manufacturing Meeting 2019 (PSCM2019) will be held on 30 June 2019 at the Broad CIRM Center for Regenerative Medicine and Stem Cell Research at USC (Los Angeles, California), following the International Society for Stem Cell Research (ISSCR) 2019 Annual Meeting. For more information, please contact Lucilia Mouriès (lmouries@hesiglobal.org).

 

This event is co-hosted by the following organizations:

 

Live-streaming information for the event and related materials will be available via GAiT’s website: http://www.gait.global/expert-panels-2019/

Start date in different time zones worldwide

See location on Google Maps

Agenda for the Expert Panels

 

13.00-13.25 Opening Panel: Review of takeaways from the June 2018 CIRM/IABS PSC Manufacturing, Standards, & Controls meeting; objectives and context for this year’s discussion.

  • Chair: Dr. Stephen Lin (CIRM)
  • Panel:
    • Assoc. Prof. Ngaire Elwood (ISCT)
    • Dr. Stephen Lin (CIRM)
    • Dr. Lucilia Mouriès (HESI CT-TRACS)
    • Dr. Yoji Sato (NIHS; HESI CT-TRACS)
    • Prof. Glyn Stacey (ISCBI)
    • Dr. Stephen Sullivan (GAiT)

 

13.30-13.55 Panel 2: Pluripotent stem cells as manufacturing cell substrates – challenges encountered and forecast

  • Chair: Dr. Wen Bo Wang (Fate Tx)

 

14.00-14.25 Panel 3: International standardization of human pluripotent stem cell manufacturing – rationale and review of current status

  • Chair: Prof. Glyn Stacey (SSCBio Ltd./University of Norfolk/ISCBI)

 

14.30-14.55 Panel 4: Defining Quality Parameters of Human Pluripotent Stem Cells as manufacturing intermediates for therapeutic development

  • Co-Chair: Assoc. Prof. Ngaire Elwood ((Murdoch’s Children’s Research Institute/ISCT/FACT/ BMDI Cord Blood Bank)
  • Co-Chair: Dr. Amanda Mack (Fujifilm Cellular Dynamics International)

 

15.00-15.25 Panel 5: Outlining a road map to cell therapy comparability

  • Chair: Prof. Jo Mountford (SNBTS/University of Glasgow)

 

16.00-16.25 Panel 6: Towards standardized tumorigenicity testing – challenges and the way forward

  • Chair: Dr. Yoji Sato (NIHS; CT-TRACS Tumorigenicity WG)

 

16.30-16.55 Panel 7: Towards automated and closed human Pluripotent Stem Cell Manufacture

  • Co-Chair: Dr. Elizabeth Schwarzbach (NYSCF)
  • Co-Chair: Dr. Mathilde Girard (YposKesi)

 

17.00-17.15 Panel 8: Financial and Logistical Challenges to human Pluripotent Stem Cell Manufacture

  • Co-Chair: Dr. Bill Shingleton, Assymtote
  • Co-Chair: Dr. Rajesh Ambasudhan (Allele Biotech)

 

17.20-17.35 Panel 9: Avoiding immunorejection and engraftment failure – challenges and the way forward

  • Chair: Dr. Stephen Sullivan (GAiT)

 

17.40-18.00 Closing Panel: Organizers summarizing and highlighting upcoming events

  • Co-Chair: Dr. Stephen Lin (CIRM)
  • Co-Chair: Prof. Glyn Stacey (SSCBio Ltd./University of Norfolk/ISCBI)

 

See more on the format and recommendations for participation here.

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Workshop Agenda

[Download File]

Dr. Carla Herberts, Medicines Evaluation Board, Netherlands

Regulatory Perspective (I)

[Download Presentation]

Dr. James McBlane, MHRA, UK

Regulatory Perspective (II)

[Download Presentation]

Dr. Keiji Yamamoto, Takeda/FIRM, Japan

Scheme of MEASURE, a Japanese PPP experimental consortium for standardization of tumorigenicity testing methods

[Download Presentation]

Dr. Yoji Sato, NIHS, Japan

In vitro testing methods for detection of tumorigenic cellular impurities in pluripotent stem cell-derived products

[Download Presentation]

Dr. Takatoshi Koujitani, Sumitomo Dainippon Pharma, Japan

In vivo tumorigenicity testing for pluripotent stem cell-derived products

[Download Presentation]

Professor Peter Andrews, University of Sheffield, UK

iPSC genomic instability and impact on product safety

[Download Presentation]

Dr. Bill Shingleton, GE Healthcare, UK

Industry perspective

[Download Presentation]

Professor Phil Blower, King's College London, UK

Academic/Translational Perspective

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HESI’s Cell Therapy–TRAcking, Circulation, & Safety (CT-TRACS) Committee is honored to have presented the first workshop of the new Cell and Gene Therapy Catapult seminar series.

Topics and Learning Objectives:

1. Future needs in patient safety of cell-based therapies. Identify challenges and opportunities to enhance the accuracy and efficiency of safety assessment of cell therapy products. Perspectives from a broad range of stakeholders from design to implementation settings.

2. Evolving safety tools and applied safety techniques. Learn about in vivo cell tracking approaches and their role in supporting clinical translation, as well as methods for evaluating the potential tumorigenicity risk of cell-based therapeutic products.

3. Role of collaboration in cell therapy development and use. Explore international opportunities to bridge stakeholders and improve our ability to develop and implement effective standards.

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What are your cells doing? Where do they go?

The HESI Cell Therapy - TRAcking, Circulation, & Safety (CT-TRACS) Committee is pleased to present a webinar on "Methods for Cellular Therapies: Tracking Cells In Vivo and Assessing Biodistribution in Patients" in collaboration with the National Heart, Lung, and Blood Institute (NHLBI) PACT Program.

 

Details:

  • Date: Thursday, 3 September 2020
  • Time: 12:00 PM - 1:00 PM EST
  • Registration: Click here to register.
CT-TRACS Web Seminar Image v2

 

Speakers:

  • Bill Shingleton, PhD, Alliances Manager at Cytiva
  • Brooke Helfer, PhD, Director of Research and Development at Celsense, Inc.
  • David Morrow, PhD, MBA, ATMP and Vaccine Scientific Program Manager at EATRIS

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.

In this web seminar, the CT-TRACS Committee speakers will provide an overview of technologies currently available for use in patients, how these are relevant to evaluate safety and efficacy aspects of cellular therapies, and the importance of collaboration to address challenges and needs facing the translation of cell therapies into the clinic​.

The CT-TRACS 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 improve confidence in the safety and efficacy of these therapies.

 

Webinar Objectives:

  • To learn about available and emerging noninvasive cell tracking modalities and their value in assessing cell fate and safety in vivo
  • 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 emphasize the need for dialogue with the international community and discuss opportunities to address the challenges facing the translation of cell therapies into the clinic
  • To understand the importance of therapy developers communicating practical challenges and needs to aid the development of enabling technologies and tools addressing those needs

 

Additional details can be found via the webinar e-flyer here. For more information, please contact the CT-TRACS Committee's Senior Scientific Program Manager, Dr. Lucilia Mouriès at lmouries@hesiglobal.org.

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Committee Publications

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Tumorigenicity Assessment of Cell Therapy Products: The Need for Global Consensus and Points to Consider

Pluripotent stem cells offer the potential for an unlimited source for cell therapy products. However, there is concern regarding the tumorigenicity of these products in humans, mainly due to the possible unintended contamination of undifferentiated cells or transformed cells. Here, we critically review currently available ...

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