Past Events

Past Events

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.

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2019 HESI Annual Meeting

Alexandria, Virginia, USA

Register now to celebrate 30 years of HESI science! This year’s program will bridge our past achievements and future plans to generate science for improved decision-making, enhanced human health and safety, and protected environments.

Read more

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				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.

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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.

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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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The Health and Environmental Sciences Institute (HESI) Protein Allergens, Toxins, and Bioinformatics (PATB) committee will be hosting a webinar to discuss emerging opportunities and innovations in the biotechnology and food safety assessment arenas. See details below!

Details

  • Date: Wednesday, May 22, 2019
  • Time: 11 AM - 12:30 PM EST
  • Registration: Click here to register.
dna

 

Speakers:

  • Scott McClain, Regulatory Product Safety Scientist, Syngenta Crop Protection (USA), PATB Committee Co-Chair
  • Lars Poulsen, Head of Research, Allergy Clinic, Copenhagen University Hospital at Gentofte (Denmark), Member of the COMPARE Database Peer-Review Expert Panel

Advances in agricultural and food biotechnology bring the opportunity to improve the way we grow food and feed crops. As part of the requirements to ensure food safety, it is vital to mitigate potential risks of introducing new allergens or unintended components in the food chain that could induce adverse reactions in humans.

The Health and Environmental Sciences Institute (HESI) Protein Allergens, Toxins, and Bioinformatics (PATB) committee engages international collaborative teams of academics, clinicians, regulators, and industry scientists who conduct research, design and populate public database resources, and convene trainings on the use and evaluation of biotechnology products.  The PATB oversees the creation, maintenance, and distribution of the Comprehensive Protein Allergen Resource (COMPARE) Database whose use in conjunction bioinformatic tools, offers an effective means for assessing allergenic potential of novel food proteins. 

Webinar attendees will:

  • Learn directly from experts in the committee about the nuts and bolts of food safety assessment of biotechnology products, the committee contributions to the field and new emerging issues
  • Engage in an interactive discussion about emerging opportunities, challenges, and innovations in the biotechnology and food safety assessment arenas
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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.

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