Past Events

WP_Query Object
(
    [query] => Array
        (
            [post_type] => event
            [posts_per_page] => 6
            [type] => 
            [area] => 
            [before] => 2021-02-25
            [after] => 
            [tags] => 
            [showtitle] => false
            [meta_query] => Array
                (
                    [relation] => AND
                    [0] => Array
                        (
                            [key] => _ilsi_date
                            [value] => 2021-02-25
                            [compare] => <=
                        )

                    [1] => Array
                        (
                            [key] => _ilsi_end_date
                            [value] => 2021-02-25
                            [compare] => <=
                        )

                )

            [paged] => 2
            [meta_key] => _ilsi_date
            [orderby] => meta_value
            [order] => DESC
        )

    [query_vars] => Array
        (
            [post_type] => event
            [posts_per_page] => 6
            [type] => 
            [area] => 
            [before] => 2021-02-25
            [after] => 
            [tags] => 
            [showtitle] => false
            [meta_query] => Array
                (
                    [relation] => AND
                    [0] => Array
                        (
                            [key] => _ilsi_date
                            [value] => 2021-02-25
                            [compare] => <=
                        )

                    [1] => Array
                        (
                            [key] => _ilsi_end_date
                            [value] => 2021-02-25
                            [compare] => <=
                        )

                )

            [paged] => 2
            [meta_key] => _ilsi_date
            [orderby] => meta_value
            [order] => DESC
            [error] => 
            [m] => 
            [p] => 0
            [post_parent] => 
            [subpost] => 
            [subpost_id] => 
            [attachment] => 
            [attachment_id] => 0
            [name] => 
            [pagename] => 
            [page_id] => 0
            [second] => 
            [minute] => 
            [hour] => 
            [day] => 0
            [monthnum] => 0
            [year] => 0
            [w] => 0
            [category_name] => 
            [tag] => 
            [cat] => 
            [tag_id] => 
            [author] => 
            [author_name] => 
            [feed] => 
            [tb] => 
            [meta_value] => 
            [preview] => 
            [s] => 
            [sentence] => 
            [title] => 
            [fields] => 
            [menu_order] => 
            [embed] => 
            [category__in] => Array
                (
                )

            [category__not_in] => Array
                (
                )

            [category__and] => Array
                (
                )

            [post__in] => Array
                (
                )

            [post__not_in] => Array
                (
                )

            [post_name__in] => Array
                (
                )

            [tag__in] => Array
                (
                )

            [tag__not_in] => Array
                (
                )

            [tag__and] => Array
                (
                )

            [tag_slug__in] => Array
                (
                )

            [tag_slug__and] => Array
                (
                )

            [post_parent__in] => Array
                (
                )

            [post_parent__not_in] => Array
                (
                )

            [author__in] => Array
                (
                )

            [author__not_in] => Array
                (
                )

            [suppress_filters] => 
            [ignore_sticky_posts] => 
            [cache_results] => 1
            [update_post_term_cache] => 1
            [lazy_load_term_meta] => 1
            [update_post_meta_cache] => 1
            [nopaging] => 
            [comments_per_page] => 50
            [no_found_rows] => 
        )

    [tax_query] => WP_Tax_Query Object
        (
            [queries] => Array
                (
                )

            [relation] => AND
            [table_aliases:protected] => Array
                (
                )

            [queried_terms] => Array
                (
                )

            [primary_table] => wp_posts
            [primary_id_column] => ID
        )

    [meta_query] => WP_Meta_Query Object
        (
            [queries] => Array
                (
                    [0] => Array
                        (
                            [key] => _ilsi_date
                        )

                    [1] => Array
                        (
                            [0] => Array
                                (
                                    [key] => _ilsi_date
                                    [value] => 2021-02-25
                                    [compare] => <=
                                )

                            [1] => Array
                                (
                                    [key] => _ilsi_end_date
                                    [value] => 2021-02-25
                                    [compare] => <=
                                )

                            [relation] => AND
                        )

                    [relation] => AND
                )

            [relation] => AND
            [meta_table] => wp_postmeta
            [meta_id_column] => post_id
            [primary_table] => wp_posts
            [primary_id_column] => ID
            [table_aliases:protected] => Array
                (
                    [0] => wp_postmeta
                    [1] => mt1
                    [2] => mt2
                )

            [clauses:protected] => Array
                (
                    [wp_postmeta] => Array
                        (
                            [key] => _ilsi_date
                            [compare] => =
                            [compare_key] => =
                            [alias] => wp_postmeta
                            [cast] => CHAR
                        )

                    [mt1] => Array
                        (
                            [key] => _ilsi_date
                            [value] => 2021-02-25
                            [compare] => <=
                            [compare_key] => =
                            [alias] => mt1
                            [cast] => CHAR
                        )

                    [mt2] => Array
                        (
                            [key] => _ilsi_end_date
                            [value] => 2021-02-25
                            [compare] => <=
                            [compare_key] => =
                            [alias] => mt2
                            [cast] => CHAR
                        )

                )

            [has_or_relation:protected] => 
        )

    [date_query] => 
    [request] => SELECT SQL_CALC_FOUND_ROWS  wp_posts.ID FROM wp_posts  INNER JOIN wp_postmeta ON ( wp_posts.ID = wp_postmeta.post_id )  INNER JOIN wp_postmeta AS mt1 ON ( wp_posts.ID = mt1.post_id )  INNER JOIN wp_postmeta AS mt2 ON ( wp_posts.ID = mt2.post_id ) WHERE 1=1  AND ( 
  wp_postmeta.meta_key = '_ilsi_date' 
  AND 
  ( 
    ( mt1.meta_key = '_ilsi_date' AND mt1.meta_value <= '2021-02-25' ) 
    AND 
    ( mt2.meta_key = '_ilsi_end_date' AND mt2.meta_value <= '2021-02-25' )
  )
) AND wp_posts.post_type = 'event' AND (wp_posts.post_status = 'publish' OR wp_posts.post_status = 'acf-disabled') GROUP BY wp_posts.ID ORDER BY wp_postmeta.meta_value DESC LIMIT 6, 6
    [posts] => Array
        (
            [0] => WP_Post Object
                (
                    [ID] => 22879
                    [post_author] => 13
                    [post_date] => 2020-08-03 13:40:52
                    [post_date_gmt] => 2020-08-03 18:40:52
                    [post_content] => 
	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.

				
	
 
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.

                    [post_title] => CT-TRACS Committee and NIH/NHLBI PACT Program Joint Webinar
                    [post_excerpt] => 
                    [post_status] => publish
                    [comment_status] => closed
                    [ping_status] => closed
                    [post_password] => 
                    [post_name] => cttracs-committee-pact-program-webinar
                    [to_ping] => 
                    [pinged] => 
                    [post_modified] => 2020-10-29 13:38:55
                    [post_modified_gmt] => 2020-10-29 13:38:55
                    [post_content_filtered] => 
                    [post_parent] => 0
                    [guid] => https://hesiglobal.org/?post_type=event&p=22879
                    [menu_order] => 0
                    [post_type] => event
                    [post_mime_type] => 
                    [comment_count] => 0
                    [filter] => raw
                )

            [1] => WP_Post Object
                (
                    [ID] => 22133
                    [post_author] => 14
                    [post_date] => 2020-01-16 13:25:44
                    [post_date_gmt] => 2020-01-16 18:25:44
                    [post_content] => 
				
				
	
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, 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]
				
		
			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, 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]

                    [post_title] => CT-TRACS Session at ISCT 2020 Virtual Meeting
                    [post_excerpt] => 
                    [post_status] => publish
                    [comment_status] => closed
                    [ping_status] => closed
                    [post_password] => 
                    [post_name] => ct-tracs-session-at-isct-2020-annual-meeting
                    [to_ping] => 
                    [pinged] => 
                    [post_modified] => 2020-08-28 15:05:02
                    [post_modified_gmt] => 2020-08-28 15:05:02
                    [post_content_filtered] => 
                    [post_parent] => 0
                    [guid] => https://hesiglobal.org/?post_type=event&p=22133
                    [menu_order] => 0
                    [post_type] => event
                    [post_mime_type] => 
                    [comment_count] => 0
                    [filter] => raw
                )

            [2] => WP_Post Object
                (
                    [ID] => 21939
                    [post_author] => 14
                    [post_date] => 2019-11-07 11:34:35
                    [post_date_gmt] => 2019-11-07 16:34:35
                    [post_content] => 
				
	
THIS EVENT HAS BEEN POSTPONED IN RESPONSE TO COVID-19. PLEASE STAY TUNED FOR UPDATED DATE, TIME, AND OTHER MEETING DETAILS.
 
Background
The field of immuno-safety is a dynamic one in which changing public health concerns, novel biomedical research advances, and innovative technological developments constantly change the landscape and the way in which work is carried out and utilized. As this field requires combined expertise in both immunology and toxicology, the need for continued training and interdisciplinary interactions are critical for those who work within this field. This is essential both for those with an immunology background who seek to apply this expertise to drug development and safety, as well as those who wish to enhance their current drug safety expertise with a deeper understanding of immunology.
 
Objectives
-Review the background science of the immune system in both normal and diseased state

-Enhance awareness of toxicities associated with modulation of the immune system

-Provide a training mechanism that incorporates the latest science into preexisting drug development methodologies
 
Output
Beyond the dialogue that will be generated on the latest science, this training course will provide the opportunity to apply it to a drug development setting through the following means:
-Engagement and discussion with experts in the field will enable participants to see how the science translates to applicability in drug development

-The use of specific case studies will engage and illustrate to participants how they can systematically progress on a sample task

                    [post_title] => Cancer Immunotherapies: Biology, Therapeutic Approaches, and Immune Related Safety Assessments
                    [post_excerpt] => 
                    [post_status] => publish
                    [comment_status] => closed
                    [ping_status] => closed
                    [post_password] => 
                    [post_name] => cancer-immunotherapies-biology-therapeutic-approaches-and-immune-related-safety-assessments-2
                    [to_ping] => 
                    [pinged] => 
                    [post_modified] => 2020-10-28 14:59:49
                    [post_modified_gmt] => 2020-10-28 14:59:49
                    [post_content_filtered] => 
                    [post_parent] => 0
                    [guid] => https://hesiglobal.org/?post_type=event&p=21939
                    [menu_order] => 0
                    [post_type] => event
                    [post_mime_type] => 
                    [comment_count] => 0
                    [filter] => raw
                )

            [3] => WP_Post Object
                (
                    [ID] => 22078
                    [post_author] => 14
                    [post_date] => 2020-01-02 13:06:03
                    [post_date_gmt] => 2020-01-02 18:06:03
                    [post_content] => 
				
	
ABOUT THE EVENT
The goal of this workshop is to convene key stakeholders to discuss both current and novel methodologies in preclinical and translational safety assessment of pregnancy risk associated with immunomodulatory therapy. Through the sharing of case examples, followed by a longer in-depth discussion within each session, the goal is to begin to address gaps in biology, current tools, and other aspects of pregnancy risk that need to be considered during drug development.
 
The  workshop is intended to provide an interdisciplinary forum for industry, academia and regulatory scientists to discuss:

The current state of reproductive immunology
How adequate are the current set of tools/methodologies to address pregnancy risk under immunomodulatory therapies
What additional tools/methods are currently being developed that could address gaps
Global regulatory considerations across various immunomodulatory modalities

 
Requirements: To gain building access, you must bring acceptable and valid government issued identification (ID).
 
Registration: Up-to-date information and registration can be found here. Registration will close on February 5, 2020. Due to the format and structure of this workshop, attendance is restricted to in-person attendees only.

                    [post_title] => FDA/CDER - HESI Immunomodulators and Pregnancy Risk Assessment Workshop
                    [post_excerpt] => 
                    [post_status] => publish
                    [comment_status] => closed
                    [ping_status] => closed
                    [post_password] => 
                    [post_name] => fda-cder-hesi-immunomodulators-and-pregnancy-risk-assessment-workshop
                    [to_ping] => 
                    [pinged] => 
                    [post_modified] => 2020-10-28 14:06:50
                    [post_modified_gmt] => 2020-10-28 14:06:50
                    [post_content_filtered] => 
                    [post_parent] => 0
                    [guid] => https://hesiglobal.org/?post_type=event&p=22078
                    [menu_order] => 0
                    [post_type] => event
                    [post_mime_type] => 
                    [comment_count] => 0
                    [filter] => raw
                )

            [4] => WP_Post Object
                (
                    [ID] => 21355
                    [post_author] => 14
                    [post_date] => 2019-06-20 12:21:14
                    [post_date_gmt] => 2019-06-20 17:21:14
                    [post_content] => 
				
	
The goal of this workshop is to discuss the preclinical and translational safety assessment of engineered T cell therapies. The workshop will focus on six topics, followed by an in-depth discussion:

Designing engineered T cells for optimal activity and safety
Target expression and associated liability assessment
In vivo models informing safety and activity
Safety of viral and non-viral gene delivery systems – utility, risk of genomic injury
Linking preclinical development with the clinical experience
Regulatory considerations

 
Agenda: Please find workshop agenda here.
Accommodations: Click here to find a list of nearby hotels. Please note that participants are responsible for their own transportation to and from the US FDA site.
Requirements: To gain building access, you must bring acceptable and valid government issued identification (ID).
Registration: Onsite registration is now closed. To attend the workshop virtually, please use the webinar link located below.
Webinar: Click here to join the webinar.

                    [post_title] => FDA/CBER-HESI Workshop on the Safety Assessment of Engineered T-Cell Therapies
                    [post_excerpt] => 
                    [post_status] => publish
                    [comment_status] => closed
                    [ping_status] => closed
                    [post_password] => 
                    [post_name] => fda-cber-hesi-workshop-on-the-safety-assessment-of-engineered-t-cell-therapies
                    [to_ping] => 
                    [pinged] => 
                    [post_modified] => 2020-10-28 15:00:39
                    [post_modified_gmt] => 2020-10-28 15:00:39
                    [post_content_filtered] => 
                    [post_parent] => 0
                    [guid] => https://hesiglobal.org/?post_type=event&p=21355
                    [menu_order] => 0
                    [post_type] => event
                    [post_mime_type] => 
                    [comment_count] => 0
                    [filter] => raw
                )

            [5] => WP_Post Object
                (
                    [ID] => 21367
                    [post_author] => 14
                    [post_date] => 2019-06-24 13:14:22
                    [post_date_gmt] => 2019-06-24 18:14:22
                    [post_content] => 
				
	Date: June 30, 2019

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.

                    [post_title] => Pluripotent Stem Cell Manufacturing Expert Panels 2019
                    [post_excerpt] => 
                    [post_status] => publish
                    [comment_status] => closed
                    [ping_status] => closed
                    [post_password] => 
                    [post_name] => pluripotent-stem-cell-manufacturing-expert-panels-2019
                    [to_ping] => 
                    [pinged] => 
                    [post_modified] => 2020-10-28 13:46:51
                    [post_modified_gmt] => 2020-10-28 13:46:51
                    [post_content_filtered] => 
                    [post_parent] => 0
                    [guid] => https://hesiglobal.org/?post_type=event&p=21367
                    [menu_order] => 0
                    [post_type] => event
                    [post_mime_type] => 
                    [comment_count] => 0
                    [filter] => raw
                )

        )

    [post_count] => 6
    [current_post] => -1
    [in_the_loop] => 
    [post] => WP_Post Object
        (
            [ID] => 22879
            [post_author] => 13
            [post_date] => 2020-08-03 13:40:52
            [post_date_gmt] => 2020-08-03 18:40:52
            [post_content] => 
	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.

				
	
 
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.

            [post_title] => CT-TRACS Committee and NIH/NHLBI PACT Program Joint Webinar
            [post_excerpt] => 
            [post_status] => publish
            [comment_status] => closed
            [ping_status] => closed
            [post_password] => 
            [post_name] => cttracs-committee-pact-program-webinar
            [to_ping] => 
            [pinged] => 
            [post_modified] => 2020-10-29 13:38:55
            [post_modified_gmt] => 2020-10-29 13:38:55
            [post_content_filtered] => 
            [post_parent] => 0
            [guid] => https://hesiglobal.org/?post_type=event&p=22879
            [menu_order] => 0
            [post_type] => event
            [post_mime_type] => 
            [comment_count] => 0
            [filter] => raw
        )

    [comment_count] => 0
    [current_comment] => -1
    [found_posts] => 162
    [max_num_pages] => 27
    [max_num_comment_pages] => 0
    [is_single] => 
    [is_preview] => 
    [is_page] => 
    [is_archive] => 
    [is_date] => 
    [is_year] => 
    [is_month] => 
    [is_day] => 
    [is_time] => 
    [is_author] => 
    [is_category] => 
    [is_tag] => 
    [is_tax] => 
    [is_search] => 
    [is_feed] => 
    [is_comment_feed] => 
    [is_trackback] => 
    [is_home] => 1
    [is_privacy_policy] => 
    [is_404] => 
    [is_embed] => 
    [is_paged] => 1
    [is_admin] => 
    [is_attachment] => 
    [is_singular] => 
    [is_robots] => 
    [is_favicon] => 
    [is_posts_page] => 
    [is_post_type_archive] => 
    [query_vars_hash:WP_Query:private] => 29c9a1ea824ad87a97c1509b4d131eeb
    [query_vars_changed:WP_Query:private] => 1
    [thumbnails_cached] => 
    [stopwords:WP_Query:private] => 
    [compat_fields:WP_Query:private] => Array
        (
            [0] => query_vars_hash
            [1] => query_vars_changed
        )

    [compat_methods:WP_Query:private] => Array
        (
            [0] => init_query_flags
            [1] => parse_tax_query
        )

)