SHORT COURSE - Monday, October 19 - Tuesday, October 20, 2020
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Download Short Course Full Program Here
Short Course: Current Trends and Future Direction in the Development of Cell and Gene Therapies
Location: Virtual Event
Course Coordinators - Cindy Xia, Takeda, Nagendra Chemuturi, Takeda, and Johanna Mora, BMS
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Monday, Oct. 19, 2020 |
Speaker Name |
Talk Title |
Time |
 |
Plenary Speaker: Guangping Gao, PhD, Co-Director Director, Li Weibo Institute for Rare Diseases Research, Director, Horae Gene Therapy Center and Viral Vector Core, Professor of Microbiology and Physiological Systems, Penelope Booth Rockwell Professor in Biomedical Research, University of Massachusetts Medical School; Elected fellows, both the US National Academy of Inventors (NAI) and American Academy of Microbiology; President, American Society of Gene and Cell Therapy.
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"In Vivo Gene Therapy as a New Paradigm in Medicine - The Road to Today and Beyond" |
1:00PM-1:40PM |
| Q&A | 1:40PM-1:55PM | ||
| Break | 1:55PM-2:00PM | ||
 |
Vibha Jawa, PhD, Executive Director, Nonclinical Disposition and Bioanalysis, Bristol Myers Squibb | Development of an Risk-based Immunogenicity Strategy for Support of AVV-based Gene Therapies in Clinic | 2:00PM-2:30PM |
| Q&A | 2:30PM-2:45PM | ||
 |
Mark Milton, PhD, Novartis Institutes for BioMedical Research | The Pharmacokinetics of AAV Gene Therapies – Biodistribution and Shedding | 2:45PM-3:15PM |
| Q&A | 3:15PM-3:30PM | ||
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Tuesday, Oct. 20, 2020 |
Speaker Name |
Talk Title |
Time |
 |
Plenary Speaker: Christopher Saeui, PhD Cell & Gene Therapy Reviewer at FDA
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"Preclinical Assessment of Cell and Gene Therapy Products to Support an IND" |
1:00PM-1:40PM |
| Q&A | 1:40PM-1:55PM | ||
| Break | 1:55PM-2:00PM | ||
 |
Piotr L Pierog, PhD, Head of Cell Product Clinical Translation, Cell Therapy Unit, Takeda Pharmaceutical In. |
An Integrated Approach to Investigating CART Cell Immuno-biology, a Pharmacology Perspective |
2:00PM-2:30PM |
| Q&A | 2:30PM-2:45PM | ||
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Timothy Mack, PhD, Director, Bristol Myers Squibb |
Considerations for the Bioanalysis of CART's |
2:45PM-3:15PM |
| Q&A | 3:15PM-3:30PM | ||
Topics to be covered:
1) Preclinical aspects of CGTs
2) Clinical pharmacology of CGTs
3) Bioanalysis- techniques used, analytes measured, etc.
4) Immunogenicity
5) Shedding
6) Regulatory aspects of CGTs
7) Role for modeling and simulation and DDI
Guangping Gao, PhD, is the Co-Director, Li Weibo Institute for Rare Diseases Research, Director, Horae Gene Therapy Center and Viral Vector Core, Professor of Microbiology and Physiological Systems, Penelope Booth Rockwell Professor in Biomedical Research, University of Massachusetts Medical School; Elected fellows, both the US National Academy of Inventors (NAI) and American Academy of Microbiology; President, American Society of Gene and Cell Therapy.