2022 Agenda - Updated 6/3/2022
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: State of the FDA - Guidance, Approval, and Beyond |
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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 |
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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 |
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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 |
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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 |
Discovery Bioanalysis and New Technologies Workshop - Tuesday, September 20, 2022
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 |
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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 |
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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 |
Takeda |
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 |
TBA |
2:10 - 2:40 |
Break |
|
|
2:40 - 3:05 |
Session III: Beyond the Rule of Five: Considerations in Bioanalysis and Data Analysis |
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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 |
AbbVie |
3:40 - 4:10 |
Expanding the Protein Degradation Toolbox |
Jacques Saarbach |
Yale |
4:10 - 4:40 |
Reception |
|
4:40 - 5:40 |
Mechanistic ADME Workshop - Wednesday, September 21, 2022
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 |
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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 |
Genentech |
10:15 - 10:45 |
Break |
|
|
10:45 - 11:10 |
Sponsor Showcase |
|
|
11:10 - 11:30 |
Plenary Speaker Introduction | 11:30 - 11:35 | ||
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 |
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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 |
Pfizer |
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 |
Alnylam |
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 |