SHORT COURSE - Monday, October 19 - Tuesday, October 20, 2020
For 2020 Short Course Sponsorship Information Please Call 781.861.0134 or Email: This email address is being protected from spambots. You need JavaScript enabled to view it.
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
Confirmed Speakers:
| 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.
|
TalkTitle TBA |
1:00PM-1:40PM |
| Q&A | 1:40PM-1:55PM | ||
| Break | 1:55PM-2:00PM | ||
 |
Mark Milton, PhD, Novartis Institutes for BioMedical Research | Talk Title TBA | 2:00PM-2:30PM |
| Q&A | 2:30PM-2:45PM | ||
 |
Vibha Jawa, PhD, Director, Risk Assesment and Clinical Immunogenicity, Merck | Talk Title TBA | 2:45PM-3:15PM |
| Q&A | 3:15PM-3:30PM | ||
| Thusday, Oct. 20, 2020 | Speaker Name | Talk Title | Time |
 |
Plenary Speaker: Christopher Saeui, PhD Cell & Gene Therapy Reviewer at FDA
|
"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. | Title TBA | 2:00PM-2:30PM |
| Q&A | 2:30PM-2:45PM | ||
 |
Timothy Mack, PhD, Senior Principal Scientist, Bristol Myers Squibb | Title TBA | 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.