2022 Agenda - in progress
September 19, 2022 | Regulated Bioanalysis Workshop | |
September 20, 2022 | Discovery Bioanalysis and New Technologies Workshop | |
September 21, 2022 | Mechanistic ADME Workshop |
Regulated Bioanalysis Workshop - Monday, September 19, 2022
Title |
Speaker |
Company |
Time |
Registration and Breakfast |
|
|
7:00 - 8:00 |
Workshop Introduction |
Ang Liu |
Daiichi Sankyo |
8:00 - 8:10 |
Session I: The State of the FDA |
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Session Introduction |
|
|
8:10 - 8:15 |
State of the FDA - Overview of Recent Guidances |
Brian Booth |
FDA |
8:15 - 8:45 |
Plenary Talk - Title TBA |
Malaz Abutarif |
Daiichi Sankyo |
8:45 - 9:25 |
Panel Discussion |
|
|
9:25 - 9:55 |
Vendor Talk |
TBA |
TBA |
9:55 - 10:20 |
AM Break |
|
|
10:20 - 10:40 |
Plenary Speaker Introduction |
TBA |
TBA |
10:40 - 10:45 |
Plenary Talk - Title TBA |
TBA |
TBA |
10:45 - 11:30 |
Session II: Roadmap to the Approval of COVID 19 Treatments and Testing |
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Session Introduction |
|
|
11:30 - 11:35 |
Supply Chain Impact on Drug Development: A Pandemic-Driven Global Perspective |
Heather Myler Christine Callahan |
PPD ThermoFisher |
11:35 - 12:20 |
Lunch Break |
|
|
12:20 - 1:20 |
COVID Small Molecule Bioanalysis |
Haihong Shi |
Pfizer |
1:20 - 1:50 |
Bioanalysis of Molnupiravir - Title TBA |
Shelia Breidinger |
Merck |
1:50 - 2:20 |
Vendor Talk |
TBA |
TBA |
2:20 - 2:35 |
Session III: Immunogenicity |
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Session Introduction |
|
|
2:35 - 2:40 |
TBA |
TBA |
TBA |
2:40 - 3:10 |
PM Break |
|
|
3:10 - 3:30 |
Harmonization of ADA Data Reporting |
Michele Gunsior |
Horizon |
3:20 - 4:00 |
TBA |
TBA |
TBA |
4:00 - 4:30 |
Session IV: Emerging Technologies for New Modalities and Biomarkers |
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Session Introduction |
|
|
4:30 - 4:35 |
The Promise of Peptide-Oligonucleotide Conjugates for Neruomuscular Diseases |
Pallavi Lonkar |
PepGen |
4:35 - 5:00 |
TBA |
TBA |
TBA |
5:00 - 5:25 |
Workshop Closing Remarks |
|
|
5:25 - 5:30 |
Discovery Bioanalysis and New Technologies Workshop - Tuesday, September 20, 2022
Mechanistic ADME Workshop - Wednesday, September 21, 2022