Title

Speaker

Company

Time

Registration and Breakfast

7:00 - 8:00

Workshop Introduction

Ang Liu

Daiichi Sankyo

8:00 - 8:10 

Session I: State of the FDA - Guidance, Approval, and Beyond

Session Introduction: Ang Liu, Daiichi Sankyo & Joe Tweed, Bicycle Therapeutics

8:10 - 8:15

State of the FDA - Overview of Recent Guidances

Brian Booth

FDA

8:15 - 8:45

Plenary Talk - Title TBA (ADC's clin pharm perspective)

Malaz Abutarif

Daiichi Sankyo

8:45 - 9:25

Plenary Talk - State of the FDA - Antibody Drug Conjugates

Salaheldin Hamed

FDA

9:25 - 10:05

Panel Discussion (ICH:M10) - 

10:05 - 10:30

Vendor Presentation: Title TBA

10:30 - 10:55

Break

10:55 - 11:15

Session II: Roadmap to the Approval of COVID 19 Treatments and Testing

Session Introduction: Fumin Li, PPD & James Schiller, Merck

11:15 - 11:20

Supply Chain Impact on Drug Development: A Pandemic-Driven Global Perspective

& Capacity and Supply Chain Capabilities

Heather Myler

Christine Callahan

PPD

ThermoFisher

11:20 - 12:05

Application of Micro-Sampling Device, Tasso M20 in Pfizer's COVID-19 Therapeutic Drug Paxlovid Development

Haihong Shi

Pfizer

12:05 - 12:30

Preclinical Bioanalytical Challenges in Supporting the COVID-19 Oral Antiviral, Molnupiravir during a Pandemic

Shelia Breidinger

Merck

12:30 - 12:55

Lunch

12:55 - 1:55

Session III: Immunogenicity and Bioanalytical Considerations

Session Introduction: Darshana Jani, Moderna & Jenifer Vija, CRL

1:55 - 2:00

Practical Considerations for Neutralizing Antibody Assay Development

Jason Delcarpini

Bio-Agylitix

2:00 - 2:25

Recommendations for Harmonization of Anti-Drug Antibody Sample Testing and Reporting

Michele Gunsior

Astria

2:25 - 2:50

Recommendations for Development and Validation of qPCR Assays for Regulated Bioanalysis

Amanda Hays

BioAgilityx

2:50 - 3:15

Break

3:15 - 3:35

Session IV: Emerging Technologies for New Modalities and Biomarkers

Session Introduction: Lori Payne, Alturas Analytics & Yongjun Xue, BMS

3:35 - 3:40

The Promise of Peptide-Oligonucleotide Conjugates for Neruomuscular Diseases

Pallavi Lonkar

PepGen

3:40 - 4:05

ADME Properties of Bifunctional Degradation Activating Compounds (BiDAC degraders)

Prasoon Chaturvedi

C4 Therapeutics

4:05 - 4:30

DMPK biomarker talk - title TBA

Yongjun Xue

BMS

4:30 - 4:55

Reception

4:55 - 5:55

Title

Speaker

Company

Time

Registration and Breakfast

7:30 - 8:30

Workshop Introduction

Violet Lee

Genentech

8:30 - 8:40

Session I: Advancements in AAV, mRNA, and Lipid Nanopartical Technology for Viral and Gene Therapies

Session Introduction: Christopher Kochansky, Merck & Katie Matys, PPD

8:40 - 8:45

Programing T Cell Therapies for Solid Tumors is Enabled by Precise Delivery of Large and Modular Gene Circuits with Multiple Therapeutic Functions

Aaron Cooper

Arsenal Bio

8:45 - 9:15

Bioanalytical Strategies and Challenges for CAR-T Support

Nanda Balasubramanian

BMS

9:15 - 9:45

Plenary Talk : Immunogenicity prediction - Title TBA

 Steve Swanson

Genentech

9:45 - 10:30

Break

10:30 - 10:55

Sponsor Showcase

10:55 - 11:15

Plenary Speaker Introduction

TBA

TBA

11:15 - 11:20

Plenary Talk - Title TBA (On the role of single-cell-omics in drug discovery & delveopment)

Parag Mallick

Nautilus Biotechnology

11:20 - 12:05

Lunch

12:05 - 1:05

Session II: Bioanalysis of Oligonucleotide Therapeutics

Session Introduction: Jing Tu, Alliance Pharma & Hiroshi Sugimoto, Takeda

1:05 - 1:10

Bioanalytical Approach for Diverse Oligonucleotide Therapeutics Using Multiple Bioanalytical Platforms

Hisao Shimizu

1:10 - 1:40

Strategies for Assessment of Oligonucleotide Biodistribution in Tissues Via Hybridization ELISA

Laixing Wang

Chongqing Denali Medpharma

1:40 - 2:10

TBA

 TBA

2:10 - 2:40

 Break

2:40 - 3:05

Session III: Beyond the Rule of Five: Considerations in Bioanalysis and Data Analysis

Session Introduction: Dieter Drexler, BMS & Jonathan Josephs, Genentech

3:05 - 3:10

Development of a Target Engagement (TE) Assay for the Oral Peptide PCSK9-LDLr Inhibitor Program

Weixun Wang

Merck

3:10 - 3:40

To Infinity and Beyond Rule of Five Compounds: Challenges and Considerations for Discovery Stage Bioanalytical Support

Yue-Ting Wang

3:40 - 4:10

Expanding the Protein Degradation Toolbox

Jacques Saarbach

Yale

4:10 - 4:40

Reception

4:40 - 5:40

Title

Speaker

Company

Time

Breakfast

8:00 - 9:00

Workshop Introduction

James Driscoll

BMS

9:00 - 9:10

Session I: Microphysiological Systems: Recent Advances in 3D Cell Culture Models & Beyond to Address Unmet Needs in ADMET

Session Introduction: David Stresser, AbbVie & Chandra Prakash, Agios Pharmaceuticals

9:10 - 9:15

MPS for ADME Applications: Moving from Aspiration to Exploration

Stephen Fowler

Roche

9:15 - 9:45

IQ Microphysiological Systems Affiliate: Accelerating the Development and Adoption of MPS Models in Industry

David Stresser

AbbBie

9:45 - 10:15

Renal Proximal Tubule-On-A-Chip: Performance, Utility, and Benefit for Toxicity Mitigation During Drug Development

 Tomomi Kiyota

10:15 - 10:45

Break

10:45 - 11:10

Sponsor Showcase

11:10 - 11:30

Plenary Talk - Artificial Intelligence and In Silico ADMET Prediction

Pat Walters

Relay Therapeutics

11:35 - 12:20

Lunch

12:20 - 1:20

Session II: On the Battlefield with Analytical Challenges

Session Introduction: Lisa Christopher, BMS, Greg Walker, Pfizer, Hongbin Yu, Boehringer Ingelheim

1:20 - 1:25

Title Modern Radiolabeled ADME Study

Douglas Spracklin

Pfizer

1:25 - 1:55

The Importance of Tracking "Missing" Metabolites - How and Why?

Donglu Zhang

Genentech

1:55 - 2:25

The Crucial Role of NMR in Understanding the Human Disposition of PAXLOVID

 Greg Walker

2:25 - 2:55

Break

2:55 - 3:20

Session III: Mechanistic ADME of Novel Modalities

Session Introduction: Cindy Xia, Renegade Therapeutics & Donglu Zhang, Genentech

3:20 - 3:25

Title TBA

TBA

J&J

3:25 - 3:55

Intrathecal Delivery of siRNA-Conjugates to the CNS: Challenges of ADME Characterization

Jeff Kurtz

3:55 - 4:25

Optimising Proteolysis Targeting Chimeras (PROTACs) for Oral Drug Delivery: A Drug Metabolism and Pharmacokinetics Perspective

Andy Pike

AstraZeneca

4:25 - 4:55

Conference Closing Remarks

4:55- 5:00