October 7, 2024   Regulated Bioanalysis Workshop
October 8, 2024   Discovery Bioanalysis and New Technologies Workshop
October 9, 2024   Mechanistic ADME Workshop

Title

Speaker

Company

Time

Registration, Breakfast, Exhibits

 

7:30 - 8:30

Workshop Introduction.

8:30 - 8:40 

Session I: Regulatory Audits and Industry Perspectives on Audits

Session Introduction: Nevena Mollova, Gilead; Jay, ?? & Joseph Tweed, Bicycle Therapeutics

 

 

8:40 - 8:45

Recent Data Integrity Findings in Bioresearch Monitoring

Yi-Ying Chen

FDA

8:45 - 9:10

Title TBA

TBA

TBA

9:10 - 9:35

Title TBA

Faye Vazvaei

Merck

9:35 - 10:00

Plenary Talk - Title TBA

TBA

TBA

10:00 - 10:35

AM Break & Exhibits

10:35 - 10:55

Session II: Advances in Sampling Strategies and Drug Delivery Innovations

     

Session Introduction: Lori Payne, Alturas Analytics & Jeongsup Shim, Genentech

 

 

10:55 - 11:00

Implementation of Low Volume Sampling Technologies for PK and Biomarker Analysis: Technical and Logistical Challenges and Solutions

Xiaoyun Yang

Genentech

11:00 - 11:25

"Space - The Final Microsampling Frontier"/ Mitra Device /Part II

Lori Payne

Alturas

11:25 - 11:45

Accelerator Mass Spectrometry (AMS) Applications for Supporting Clinical Development

Xiaomin Wang

BMS

11:45 - 12:10

Sponsor Presentation:TBD

TBD

12:10 - 12:25

Lunch, Exhibits, and Poster Viewing

 

12:25 - 1:40

Title TBA

TBD

Pharmaron

1:40 - 2:05

Session III: Advances in Drug Modalities and Emerging Technologies for Characterization

Session Introduction: Ang Liu, Daiichi Sankyo; Fumin Li, Unitides Bioanalytical Lab & Yongjun Xue, BMS

 

2:05 - 2:10

Plenary Talk - Application of AI in Drug Development

Joe Rajaro

Accenture

2:10 - 2:50

A Novel Hybridization LC-MS/MS Methodology for Bioanalysis of siRNA

Long Yuan

Biogen

2:50 - 3:15

Sponsor Showcase

3:15 - 3:35

Title TBA

Jason DelCarpini

Moderna

3:35 - 4:00

PM Break & Exhibits

4:00 - 4:20

Development of Nonclinical Total Anti-Drug Antibody (ADA) Assays to Support Zinpentraxin Alfa Reproductive Toxicology Studies

Audrey Arjomandi

Genentech

4:20 - 4:45

RT-qPCR Method Development and Validation for mRNA Analysis

Nazneen Bano

Merck

4:45 - 5:10

Session IV: Rapid Fire Poster Presentations

Session Introduction: Joeseph Tweed, Bicycle Therapeutics

 

5:10 - 5:15

Poster Presenters:

5:15 - 5:35

Reception, Exhibits, and Poster Viewing

 

5:35 - 6:35

Title

Speaker

Company

Time

Registration, Breakfast, Exhibits

 

7:30 - 8:30

Workshop Introduction

Hiroshi Sugimoto

Takeda

8:30 - 8:40

Session I: Emerging Analytical & Bioanalytical Platform Technology

     

Session Introduction: Hiroshi Sugimoto, Takeda & Zack Parsons, BMS

 

 

8:40 - 8:45

Plenary Talk - Understanding the tumor microenvironment using multi-omics and spatial omics - Title TBA

William Hwang

Harvard

8:40 - 9:20

Subcellular PK/PD Analysis Using Spatial Transcriptomics Technology

Quishi Liu

Takeda

9:20 - 9:50

Bio-Digital Transformation of Proteomic Analysis

Yohei Kosugi

Takeda

9:50 - 10:20

AM Break & Exhibits

 

10:20 - 10:50

Basics of Machine Learning and Its Applications in Drug Discovery

Reilly Eason

Merck

10:50 - 11:20

Session II: Novel Strategy to Advance Biotherapeutic Development

     

Session Introduction: Yu Tian, AbbVie & Ju Liu, Eli Lilly

 

 

11:20 - 11:25

Measuring Endogenous and Transgene-Expressed Protein Levels in Gene Therapy Bioanalytical and Biomarker Studies - tentative title

Li Chin Wong

Eli Lilly

11:25 - 11:55

Domain Specificity in the Tiered Approach: Never Too Late for Immunogenicity Characterization of Multi-Domain Therapeutics

Richard Hughes

Resolian

11:55 - 12:25

Title TBD

TBD

TBD

12:25 - 12:55

Lunch, Exhibits, and Poster Viewing

 

12:55 - 2:10

Sponsor Presentation:  Title TBD

TBD

 

2:10 - 2:30

Session III: Latest Advances: Elisa/Cell-based Assays/Hepatocytes tissue

     

Session Introduction: Hongying Gao, Innovo Bioanalysis LLC & Christopher Kochansky, Exelixis

 

 

2:30 - 2:35

Title TBA

TBD

TBD

2:35 - 3:05

Session IV: Recent Case Study to Support New Modalities (oligonucleotides/C&GT)/bioanalytical

     

Session Introduction: John Wiliams, Vertex, Jonathan Josephs, Genentech & Jing Tu, Resolian

 

3:05 - 3:10

non-vial gene therapies - Title TBA

Nag Chemuturi

Eli Lilly

3:10 - 3:40

PM Break & Exhibits

 

3:40 - 4:00

The Challenges and Solutions in Developing Ultra-Sensitive LC-MS Bioanalytical Assay for Oligonucleotides

Aihua Liu

Resolian

4:00 - 4:30

Characterizing In Vivo Stability of Large Molecule Conjugates Using Complementary Bioanalytical Tools

Jeff Lin

Genentech

4:30 - 5:00

Reception and Poster Viewing

 

5:00 - 6:15

Title

Speaker

Company

Time

Registration, Breakfast, Exhibits

 

7:30 - 8:30

Workshop Introduction

Donglu Zhang

Genentech

8:30 - 8:40

Session I: Role of NonCYP Enzymes in DDI

Session Introduction: Raman Sharma, Pfizer & Nagendra Chemuturi, Eli Lilly

 

 

8:40 - 8:45

Uncertainties and Opportunities in Predicting Non-CYP Mediated Drug Metabolism

Sandhya Subash

WSU

8:45 - 9:10

Title TBA

TBA

TBA

9:10 - 9:35

recent developments in predicting CYP-independent metabolism - Title TBA

Jasleen Sodhiei

Septerna

9:35 - 10:00

AM Break & Exhibits


10:00 - 10:25

Sponsor Showcase and Rapid Fire Poster Presentations

10:25 - 10:45

Session II: PK/PD Challenges of New Modalities: ADCs, in vivo Gene Therapies, and PROTACs

Session Introduction: Sara Shum, Renegade & Hongbin Yu, Boehringer Ingelheim

 

10:45 - 10:50

PK/PD of ADC - title TBA

Minu Pilvankar

Boehringer Ingelheim

10:50 - 11:15

In vivo CRISPR therapeutics - title TBA

Adam Amaral

Intellia

11:15 - 11:40

disposition of prodegraders - title TBA

Stefanus Steyn

Pfizer

11:40 - 12:05

Lunch, Exhibits, and Poster Viewing

 

12:05 - 1:20

Plenary Speaker Introduction

 

 

1:20 - 1:25

Plenary Talk - Prospects for New Approach Methodologies and Complex In Vitro Models to Reduce, Refine and Replace Animals in Drug Safety Testing

Terry Van Vleet

AbbVie

1:25 - 2:05

Session III: The importance of tracking missing metabolites/new technologies (covalent drugs)

     

Session Introduction: Eric Ballard, Takeda & Donglu Zhang, Genetech

 

 

2:05 - 2:10

A "Missing” Trazpiroben Metabolite Observed as the Most Abundant Metabolite in Human Plasma and Urine

Sean Zhu

Takeda

2:10 - 2:35

Human ADME Characterization of Linerixibat Reveals Unusual Pharmacokinetic Properties: Implications for Clinical Development

Maciej Gliszczynski

GSK

2:35 - 3:00

PM Break & Exhibits

3:00 - 3:20

impacts of mitigating missing metabolites for lead optimization in drug discovery - Title TBA

Joyce Liu 

Genentech

3:20 - 3:45

Session IV: New Approaches to in Vitro ADME Assays for Improved Drug-Drug-Interaction and Clearance Predictions

     

Session Introduction: Benjamin Johnson, BMS

 

 

3:45 - 3:50

translation of metabolic clearance for aldehyde oxidase substrates - title TBA

Prakash Bolleddula

EMD Serono

3:50 - 4:15

prediction of drug-drug interactions involving time-dependent P450 inhibitors - title TBA

Elaine Tseng

Pfizer

4:15 - 4:40

Hepatocyte Uptake and Loss Assay (HUpLA): Proof-of-Concept of an All-in-One System for Same Day Measuring Hepatic Influx, Egress, and Metabolic Clearance Based on the Extended Clearance Concept

Julia Pauly

AbbVie

4:40 - 5:05

Conference Closing Remarks

 

5:05- 5:10

Workshops

Regulated Bioanalysis

Discovery

Mechanistic ADME

Registration

Click here to register for the APA 2024 conference.

APA 2023 will take place October 7-9, 2024

Bristol Myers-Squibb, Cambridge, MA

 

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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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