Past Events

Past Events

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

Read more

Cancer Immunotherapies: Biology, Therapeutic Approaches, and Immune Related Safety Assessments

Tres Cantos, Spain

THIS EVENT HAS BEEN POSTPONED IN RESPONSE TO COVID-19. PLEASE STAY TUNED FOR UPDATED DATE, TIME, AND OTHER MEETING DETAILS. 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.

Read more

FDA/CDER – HESI Immunomodulators and Pregnancy Risk Assessment Workshop

Silver Spring, MD, USA

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 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.

Read more

Pluripotent Stem Cell Manufacturing Expert Panels 2019

Los Angeles, CA, 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 (conference report: Abbot et al. 2018. Biologicals, 56: 67-83), five organizations have come together to continue the discussion and address bottlenecks associated with the manufacture 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.

Read more

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				HESI-Logo_text_regA_Cropped
				ISCT 2020 Paris Virtual Logo
	

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 Dr. Sosabowski's Bio WSIC0791_Bettina Weigelin_Picture_209x209

Bettina Weigelin, PhD
Group Leader, Werner Siemens Imaging Center, Eberhard Karls
Universität Tübingen
Dr. Weigelin's Bio Vidya Gopalakrishnan_Picture_209x209

Vidya Gopalakrishnan, PhD
Associate Professor, Division of Pediatrics, MD Anderson Cancer Center, University of Texas Dr. Gopalakrishnan's Bio [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] => 2020-05-26 10:54:01 [post_modified_gmt] => 2020-05-26 15:54:01 [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 ) [1] => WP_Post Object ( [ID] => 21939 => 105 => 2019-11-07 11:34:35 [post_date_gmt] => 2019-11-07 16:34:35 [post_content] => ITC Workshop Image_April 2020

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] => 2020-02-28 15:11:03 [post_modified_gmt] => 2020-02-28 20:11:03 [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 ) [2] => WP_Post Object ( [ID] => 22078 => 105 => 2020-01-02 13:06:03 [post_date_gmt] => 2020-01-02 18:06:03 [post_content] => FDA CDER Immunomodulators and Pregnancy Workshop

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:

  1. The current state of reproductive immunology
  2. How adequate are the current set of tools/methodologies to address pregnancy risk under immunomodulatory therapies
  3. What additional tools/methods are currently being developed that could address gaps
  4. 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] => 2020-01-13 13:24:48 [post_modified_gmt] => 2020-01-13 18:24:48 [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 ) [3] => WP_Post Object ( [ID] => 21355 => 105 => 2019-06-20 12:21:14 [post_date_gmt] => 2019-06-20 17:21:14 [post_content] => ITC Workshop Image_September 2019

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] => 2019-09-19 11:37:05 [post_modified_gmt] => 2019-09-19 16:37:05 [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 ) [4] => WP_Post Object ( [ID] => 21367 => 105 => 2019-06-24 13:14:22 [post_date_gmt] => 2019-06-24 18:14:22 [post_content] => PSCM2019_Comm Image 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] => 2019-06-25 12:12:04 [post_modified_gmt] => 2019-06-25 17:12:04 [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] => 5 [current_post] => -1 [in_the_loop] => [post] => WP_Post Object ( [ID] => 22133 => 105 => 2020-01-16 13:25:44 [post_date_gmt] => 2020-01-16 18:25:44 [post_content] => HESI-Logo_text_regA_Cropped ISCT 2020 Paris Virtual Logo

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 Dr. Sosabowski's Bio WSIC0791_Bettina Weigelin_Picture_209x209

Bettina Weigelin, PhD
Group Leader, Werner Siemens Imaging Center, Eberhard Karls
Universität Tübingen
Dr. Weigelin's Bio Vidya Gopalakrishnan_Picture_209x209

Vidya Gopalakrishnan, PhD
Associate Professor, Division of Pediatrics, MD Anderson Cancer Center, University of Texas Dr. Gopalakrishnan's Bio [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] => 2020-05-26 10:54:01 [post_modified_gmt] => 2020-05-26 15:54:01 [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 ) [comment_count] => 0 [current_comment] => -1 [found_posts] => 155 [max_num_pages] => 31 [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] => [is_admin] => [is_attachment] => [is_singular] => [is_robots] => [is_favicon] => [is_posts_page] => [is_post_type_archive] => [query_vars_hash:WP_Query:private] => 273dd02d4a661a0ce824cb1b69e9bfea [query_vars_changed:WP_Query:private] => [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 ) )