PATB Committee Protein Toxins Workshop
October 21, 2020 – October 22, 2020
Virtual workshop, hosted by the HESI PATB Committee
Past Events
Past Events
CT-TRACS Committee and NIH/NHLBI PACT Program Joint Webinar
September 3, 2020
Web seminar, 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 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.
CT-TRACS Session at ISCT 2020 Virtual Meeting
May 28, 2020 – May 29, 2020
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.
Cancer Immunotherapies: Biology, Therapeutic Approaches, and Immune Related Safety Assessments
April 22, 2020 – April 23, 2020
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.
FDA/CDER – HESI Immunomodulators and Pregnancy Risk Assessment Workshop
February 11, 2020
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.
- Date: Wednesday, 21 October 2020 - Thursday, 22 October 2020
- Time: 9:00 AM - 1:00 PM EST
- Registration: Register here
Workshop Program
Wednesday, 21 October 2020
Session Chairs: Dr. Emir Islamovic (BASF and HESI PATB Committee Co-Chair) and Dr. Ray Matulka (Burdock Group Consultants and SOT member)
Opening Session
9:00 AM - Welcome and Opening Remarks (Dr. Lucilia Mouriès, HESI, and Session Chairs)
9:15 AM - Context and Background Presentations: From Protein Toxins to Biotechnology Products (HESI PATB Committee members and SOT FSSS speakers)
- Regulatory Approvals for Biotechnology Products: Dr. Laura Privalle, BASF, HESI PATB Committee Protein Toxins Task Force
- Allergen and Toxin Databases: Dr. Andre Silvanovich, Bayer, HESI PATB Committee member
- Essential Components of a Regulatory Safety Assessment for a Protein Based, Novel Food Ingredient: Dr. Ray Matulka, Burdock Group Consultants, SOT member
10:45 AM - Break
Keynote Presentation (11:00 AM - 12:00 PM EST)
11:00 AM - Overview of Protein Toxins Biology and the Vibrio MARTX Toxins: Prof. Karla Fullner Satchell, Northwestern University, USA
12:00 PM - Session-wide Q&A and discussion
1:00 PM - Adjourn
Thursday, 22 October 2020
Session 2: Bioinformatics and Computational Biology in Protein Toxins Research
Session Chairs: Dr. Colton Kessenich (Bayer and HESI PATB Committee Protein Toxins Task Force) and Dr. Mansi Krishan (BD, Immediate Past President, and SOT Food Safety Specialty Section 2020-2021)
9:00 AM - Opening Remarks (Session Chairs)
9:10 AM - Protein Toxins: Overview of Databases and Other Resources: Dr. Florence Jungo, Swiss Institute of Bioinformatics / SwissProt, Switzerland
9:50 AM - Discovery of Novel Bacterial Toxins Through Bioinformatic Data Mining: Prof. Andrew Doxey, University of Waterloo, Canada
10:30 AM - Break
10:45 AM - Insights into the EFSA Protein Risk Assessment: In Silico Tools: Dr. Anna Lanzoni, European Food Safety Agency, Italy
11:15 AM - Protein Toxicity: An Integrated In Silico Pipeline: Dr. Luca Palazzolo, University of Milano, Italy
11:45 AM - Session-wide Q&A and discussion
12:30 PM - Summary of Day 1 and Day 2
1:00 PM - Adjourn
Please see the full, detailed workshop program here as well as suggested reading materials here. For more information, please contact the PATB Committee's Senior Scientific Program Manager, Dr. Lucilia Mouriès at lmouries@hesiglobal.org.
[post_title] => PATB Committee Protein Toxins Workshop [post_excerpt] => [post_status] => publish [comment_status] => closed [ping_status] => closed [post_password] => [post_name] => patb-committee-protein-toxins-workshop [to_ping] => [pinged] => [post_modified] => 2020-10-20 13:09:16 [post_modified_gmt] => 2020-10-20 18:09:16 [post_content_filtered] => [post_parent] => 0 [guid] => https://hesiglobal.org/?post_type=event&p=22887 [menu_order] => 0 [post_type] => event [post_mime_type] => [comment_count] => 0 [filter] => raw ) [1] => WP_Post Object ( [ID] => 22879 => 2 => 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 PatientsWhat 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.
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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, PhDReader in Molecular Imaging, Barts Cancer Institute, Queen Mary University of London Dr. Sosabowski's Bio
Bettina Weigelin, PhDGroup Leader, Werner Siemens Imaging Center, Eberhard Karls
Universität Tübingen Dr. Weigelin's Bio
Vidya Gopalakrishnan, PhDAssociate 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] => 2020-08-28 09:56:34 [post_modified_gmt] => 2020-08-28 14:56:34 [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 ) [3] => WP_Post Object ( [ID] => 21939 => 105 => 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] => 2020-08-28 10:10:38 [post_modified_gmt] => 2020-08-28 15:10:38 [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 ) [4] => WP_Post Object ( [ID] => 22078 => 105 => 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.
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The HESI Protein Allergens, Toxins, and Bioinformatics (PATB) Committee is co-hosting a virtual workshop in collaboration with the Society of Toxicology (SOT) Food Safety Specialty Section titled "From Protein Toxins to Applied Toxicological Testing" in the context of safety assessment of novel foods and feeds. The virtual workshop will take place on 21–22 October 2020 from 9:00 AM to 1:00 PM EST each day and is open to all interested participants. It will cover the state of the science in protein toxins biology (structure, activity, MOA, etc.), current bioinformatics approaches used to identify and characterize protein toxins, with the ultimate goal to leverage computational biology and in silico approaches for determining the potential of a protein to present toxic properties.
The Protein Toxins Workshop will serve the dual purpose of learning about the advances in protein toxin research presented by recognized international academic experts in the field and assessing the translation of knowledge to practical applications (e.g., into weight-of-evidence approaches for the safety assessment of biotechnology products; relevance, applicability, and limitations of existing protein toxin databases and tools for risk assessment). The desired outcome of this event is to help inform the development of contemporary and scientifically robust approaches for the identification and classification of potential toxicity risk in novel proteins.
Details
- Date: Wednesday, 21 October 2020 - Thursday, 22 October 2020
- Time: 9:00 AM - 1:00 PM EST
- Registration: Register here
Workshop Program
Wednesday, 21 October 2020
Session Chairs: Dr. Emir Islamovic (BASF and HESI PATB Committee Co-Chair) and Dr. Ray Matulka (Burdock Group Consultants and SOT member)
Opening Session
9:00 AM - Welcome and Opening Remarks (Dr. Lucilia Mouriès, HESI, and Session Chairs)
9:15 AM - Context and Background Presentations: From Protein Toxins to Biotechnology Products (HESI PATB Committee members and SOT FSSS speakers)
- Regulatory Approvals for Biotechnology Products: Dr. Laura Privalle, BASF, HESI PATB Committee Protein Toxins Task Force
- Allergen and Toxin Databases: Dr. Andre Silvanovich, Bayer, HESI PATB Committee member
- Essential Components of a Regulatory Safety Assessment for a Protein Based, Novel Food Ingredient: Dr. Ray Matulka, Burdock Group Consultants, SOT member
10:45 AM - Break
Keynote Presentation (11:00 AM - 12:00 PM EST)
11:00 AM - Overview of Protein Toxins Biology and the Vibrio MARTX Toxins: Prof. Karla Fullner Satchell, Northwestern University, USA
12:00 PM - Session-wide Q&A and discussion
1:00 PM - Adjourn
Thursday, 22 October 2020
Session 2: Bioinformatics and Computational Biology in Protein Toxins Research
Session Chairs: Dr. Colton Kessenich (Bayer and HESI PATB Committee Protein Toxins Task Force) and Dr. Mansi Krishan (BD, Immediate Past President, and SOT Food Safety Specialty Section 2020-2021)
9:00 AM - Opening Remarks (Session Chairs)
9:10 AM - Protein Toxins: Overview of Databases and Other Resources: Dr. Florence Jungo, Swiss Institute of Bioinformatics / SwissProt, Switzerland
9:50 AM - Discovery of Novel Bacterial Toxins Through Bioinformatic Data Mining: Prof. Andrew Doxey, University of Waterloo, Canada
10:30 AM - Break
10:45 AM - Insights into the EFSA Protein Risk Assessment: In Silico Tools: Dr. Anna Lanzoni, European Food Safety Agency, Italy
11:15 AM - Protein Toxicity: An Integrated In Silico Pipeline: Dr. Luca Palazzolo, University of Milano, Italy
11:45 AM - Session-wide Q&A and discussion
12:30 PM - Summary of Day 1 and Day 2
1:00 PM - Adjourn
Please see the full, detailed workshop program here as well as suggested reading materials here. For more information, please contact the PATB Committee's Senior Scientific Program Manager, Dr. Lucilia Mouriès at lmouries@hesiglobal.org.
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