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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:
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
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.
- $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. ]
[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. ]
[Program Committee + Moderator]
Kapil Bharti, PhD
NIH, USA
[Program Committee + Moderator]
Willem Fibbe, MD, PhD
Leiden University Medical Center, the Netherlands
[Speaker and Panelist]
John Rasko, MBBS, PhD
University of Sydney, Australia
[Speaker and Panelist]
Heidrun Holland, PhD
Leipzig University, Germany
[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.]
[Program Committee + Moderator]
Christelle Monvale, PhD
Evry/Paris-Saclay University and I-Stem, France
[Program Committee + Moderator]
Timo Faltus, Dr. iur. Dipl.-Jur., Dipl.-Biol
Martin-Luther-University Halle-Wittenberg, Germany
[Speaker and Panelist]
Jeanne Loring, PhDAspen Neuroscience; Scripps Research Institute, USA.
[Speaker and Panelist]
Felicia Pagliuca, PhDVertex Pharmaceuticals, USA
[Speaker and Panelist]
PD Dr. med. habil. Stephan Fricke
Fraunhofer Institute for Cell Therapy and Immunology IZI, Germany
[Speaker and Panelist]
Derek Hei, PhDBlueRock Therapeutics, USA
[Panelist]
Ina Meiser, PhD
Fraunhofer Institute for Biomedical Engineering, Germany
SESSION 3 | COMMERCIALIZATION CONSIDERATIONS
[ Bringing a cell-based therapy across the "valley of death." ]
[Program Committee + Moderator]
Marinna Madrid, PhD
Cellino, USA
[Speaker and Panelist]
Jordan Lancaster, PhD
Avery Therapeutics Inc.; University of Arizona College of Medicine – Tucson, USA
[Panelist]
Felicia Pagliuca, PhDVertex Pharmaceuticals, USA
[Speaker and Panelist]
Nabiha Saklayen, PhD
Cellino, USA
[Speaker and Panelist]
Ronny Schulz PhD, MSc, Dipl.-Eng.
University of Leipzig, Faculty of Medicine, Germany
[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. ]
[Program Committee + Moderator]
Timo Faltus, Dr. iur. Dipl.-Jur., Dipl.-Biol
Martin-Luther-University Halle-Wittenberg, Germany
[Speaker and Panelist]
Abigail Shearin, VMD, PhD
Center for Biologics Evaluation and Research, US Food and Drug Administration, USA
[Speaker and Panelist]
Sol Ruiz PhD
Spanish Medicines Agency, Spain
[Panelist]
Joy Cavagnaro, PhD
Access BIO, USA
[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. ]
WRAP UP | CLOSING REMARKS
[Program Committee + Moderator]
Willem Fibbe, MD, PhD
Leiden University Medical Center, the Netherlands
Cancellations
Until 02 June, 2021
Please email a cancellation notice
After 02 June
No refunds will be granted.