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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

 

Monday, Oct. 19, 2020

Speaker Name

Talk Title

Time

Guangping Gao

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.

 "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 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 Mark Milton, PhDNovartis Institutes for BioMedical Research  The Pharmacokinetics of AAV Gene Therapies – Biodistribution and Shedding 2:45PM-3:15PM
Q&A 3:15PM-3:30PM

Tuesday, Oct. 20, 2020

Speaker Name

Talk Title

Time

Christopher Saeui

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
PiotrPierog SC APA2020 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
Timothy Mack 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.

Workshops

Regulated Bioanalysis

Discovery

Mechanistic ADME

Registration

Click here to register for the APA 2020 conference online.

APA 2020 will take place on-line, October 11-16th, 2020

 

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The Boston Society (R) is an internationally-recognized NON-PROFIT organization dedicated to bringing the best scientific ideas to industrial practice through focused, timely workshops and conferences. 501(c)3

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