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THE GLOBAL STEM CELL EVENT
VIRTUAL
21-26 JUNE, 2021

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PRE-MEETING WORKSHOP ON CLINICAL TRANSLATION  

TRANSLATING iPS CELL-BASED THERAPIES TO THE CLINIC

Monday, 7 June 2021

This year's Workshop on Clinical Translation focuses on bringing iPS cell-based therapies to market. Experts highlight key steps in the process, from designing and planning pre-clinical and clinical trials, to cell manufacturing, commercialization considerations, and reimbursement strategies - all with an eye toward global regulatory requirements and strategies. The workshop gathers speakers from academia, industry, and regulatory bodies to discuss how to progress cellular therapies in four sessions:

  • Designing Pre-Clinical and Clinical Trials
  • Manufacturing: How do You Know You Have Made the Right Cells?
  • Commercialization Considerations
  • Regulatory Considerations from Pre-clinical Studies Through Commercialization

Co-Sponsor:

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The Workshop on Clinical Translation is a full-day, live program designed for scientists, physicians, physician-scientists, and those interested in strategies to bring cell-based therapies from academic-based discovery to commercial application.  

Date:    07 June, 2021
Time:    09:00 - 18:30 EDT
Where: Online

Registration

Attendees can register for the Workshop on Clinical Translation when registering for the ISSCR 2021 Virtual Annual Meeting. Attendees may also register for the Workshop on Clinical Translation separately using the button below. *Trainees who register for the ISSCR 2021 Virtual Annual Meeting by the early-bird deadline of 21 April can register the Workshop for no cost.*  


REGISTER FOR WORKSHOP

  • $0 (trainee members who register for the workshop and the ISSCR 2021 Virtual Annual Meeting by 21 April);
  • $50 (trainee members who register after 21 April or without the Annual Meeting);
  • $100 (full/affiliate members);
  • $200 (nonmembers).

All prices in USD

Tentative Speakers + Topics

WELCOME |  OPENING REMARKS

[ Welcome to the Workshop on Clinical Translation. ]

Kapil Bharti

[Program Committee]
Kapil Bharti, PhD
NIH, USA


SESSION 1 |  DESIGNING PRE-CLINICAL AND CLINICAL TRIALS 

[ Clinical Development of iPSC-derived cell therapies, from preclinical work and trial design to product safety and regulatory strategies. ] 

Kapil Bharti

[Program Committee + Moderator]
Kapil Bharti, PhD
NIH, USA

 

Willem Fibbe picture square

[Program Committee + Moderator]
Willem Fibbe, MD, PhD
Leiden University Medical Center, the Netherlands

 

Rasko square

[Speaker and Panelist]

John Rasko, MBBS, PhD
University of Sydney, Australia

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[Speaker and Panelist]

Heidrun Holland, PhD
Leipzig University, Germany

Joy Cavagnaro square

[Speaker and Panelist]

Joy Cavagnaro, PhD
Access BIO, USA

SESSION 2 | MANUFACTURING: HOW DO YOU KNOW YOU HAVE THE RIGHT CELLS?

[ Processes and regulatory requirements for CMC production and manufacturing of cell-based therapies.] 

Christelle Monville picture

[Program Committee + Moderator]
Christelle Monvale, PhD

Evry/Paris-Saclay University and I-Stem, France

Faltus, Timo square

[Program Committee + Moderator]
Timo Faltus, Dr. iur. Dipl.-Jur., Dipl.-Biol
Martin-Luther-University Halle-Wittenberg, Germany



Jeanne Loring

[Speaker and Panelist]

Jeanne Loring, PhD

Aspen Neuroscience; Scripps Research Institute, USA.

 

 

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[Speaker and Panelist]

Derek Hei, PhD
BlueRock Therapeutics, USA

 

 

Sol Ruiz square

[Speaker and Panelist]

Sol Ruiz, PhD
Spanish Medicines Agency, Spain

 

 

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[Speaker and Panelist]

Felicia Pagliuca, PhD
Vertex Pharmaceuticals, USA

 

 

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[Panelist]

Ina Meiser, PhD
Fraunhofer Institute for Biomedical Engineering, Germany

 

SESSION 3 | COMMERCIALIZATION CONSIDERATIONS

[ Bringing a cell-based therapy across the "valley of death." ]

Marinna Madrid picture

[Program Committee + Moderator]
Marinna Madrid, PhD

Cellino, USA

Masayo Takahashi square

[Speaker and Panelist]

Masayo Takahashi, MD, PhD
Vision Care Inc., Japan

Headshot - Pagliuca -IMG_0858 square

[Panelist]

Felicia Pagliuca, PhD
Vertex Pharmaceuticals, USA

 

 

Nabiha Saklayen sqare

[Speaker and Panelist]

Nabiha Saklayen, PhD
Cellino, USA

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[Speaker and Panelist]

Jordan Lancaster, PhD
Avery Therapeutics Inc.; University of Arizona College of Medicine – Tucson, USA

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[Speaker and Panelist]

Ronny Schulz PhD
Translational Centre for Regenerative Medicine Leipzig, University of Leipzig, Germany

SESSION 4 | REGULATORY CONSIDERATIONS FROM PRE-CLINICAL STUDIES THROUGH COMMERCIALIZATION

[ Practical advice for bringing cell-based therapies to market. ]

Faltus, Timo square

[Program Committee + Moderator]
Timo Faltus, Dr. iur. Dipl.-Jur., Dipl.-Biol
Martin-Luther-University Halle-Wittenberg, Germany



Abigail Shearin square

[Speaker and Panelist]

Abigail Shear, VMD, PhD
Center for Biologics Evaluation and Research, US Food and Drug Administration, USA

Sol Ruiz square

[Panelist]

Sol Ruiz PhD
Spanish Medicines Agency, Spain

 

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[Panelist]

Ronny Schulz PhD
Translational Centre for Regenerative Medicine Leipzig, University of Leipzig, Germany

Joy Cavagnaro square

[Panelist]

Joy Cavagnaro, PhD
Access BIO, USA

[ All sessions will conclude with a panel discussion between the speakers and the moderator. ]

WRAP UP | CLOSING REMARKS

Cancellations

Until 02 June, 2021 
Please email a cancellation notice to: isscr@isscr.org to request a refund of the Workshop on Clinical Translation (minus a $25 USD cancellation fee).

After 02 June, 2021
No refunds will be granted.

  • Registration & Abstracts
    • Registration
    • Abstracts
  • Program
    • Scientific Program
    • Plenary Sessions
    • Concurrent Sessions
    • Pre-Meeting Workshop
    • Women in Science Panel
  • Exhibits & Sponsorships
    • About
    • Current Sponsors & Exhibitors
  • About
    • About ISSCR 2021
    • Official Vendors
    • Media Credentials
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