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

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Zoom 1280 x 200_NR

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:

Catalent 400x200

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.


REGISTER FOR WORKSHOP

  • $50 (trainee members);
  • $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

 

Marinna Madrid picture

[Program Committee + Moderator]
Marinna Madrid, PhD

Cellino, USA

Shekhar_Jha square

[Speaker and Panelist]

Shekhar Jha, PhD
National Institutes of Health, USA

Rasko square

[Speaker and Panelist]

John Rasko, MBBS, PhD
University of Sydney, Australia

Heidrun_Holland_square

[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 Monville, 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.

 

 

Headshot - Pagliuca -IMG_0858 square

[Speaker and Panelist]

Felicia Pagliuca, PhD
Vertex Pharmaceuticals, USA

 

 

Stephan_Fricke square

[Speaker and Panelist]

PD Dr. med. habil. Stephan Fricke
Fraunhofer Institute for Cell Therapy and Immunology IZI, Germany

Derel Hei square

[Speaker and Panelist]

Derek Hei, PhD
BlueRock Therapeutics, USA

 

 

Ina Meiser

[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

Kapil Bharti

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

 

2021 Jordan Lancaster square

[Speaker and Panelist]

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

Headshot - Pagliuca -IMG_0858 square

[Panelist]

Felicia Pagliuca, PhD
Vertex Pharmaceuticals, USA

 

 

Nabiha Saklayen sqare

[Speaker and Panelist]

Nabiha Saklayen, PhD
Cellino, USA

Ronny_Schulz square

[Speaker and Panelist]

Ronny Schulz PhD, MSc, Dipl.-Eng.
University of Leipzig, Faculty of Medicine, Germany

Masayo Takahashi square

[Speaker and Panelist]

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

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



Christelle Monville picture

[Program Committee + Moderator]
Christelle Monville, PhD

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

Abigail Shearin square

[Speaker and Panelist]

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

Sol Ruiz square

[Speaker and Panelist]

Sol Ruiz PhD
Spanish Medicines Agency, Spain

 

Joy Cavagnaro square

[Panelist]

Joy Cavagnaro, PhD
Access BIO, USA

Ronny_Schulz square

[Panelist]

Ronny Schulz PhD, MSc, Dipl.-Eng.
University of Leipzig, Faculty of Medicine, Germany

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

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.

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