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

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

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

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

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