Tuesday, September 12, 2023

Program subject to change.

7:15 am - 8:15 am | Concurrent Industry-Sponsored Symposia

Eurofins Discovery: Evaluating P-gp and BCRP Drug-Drug Interaction Assessment -New Approaches with CRISPRTM Knock-Out/ Knock-In Cell Lines for Applications in Drug Discovery | Marina Ballroom
Shantanu Roychowdhury, ADME-Tox Business Leader, Eurofins Discovery

Frontage Laboratories: Metabolites in Safety Testing (MIST): What, Why, and How | Grand AB
Philip Tiller, Distinguished Scientist, DMPK, Frontage Laboratories

8:30 am - 9:30 am | Plenary Lecture 2 | Grand AB

Recent Studies on Metabolism, DNA Adducts, and Biomarkers of Tobacco Carcinogens
Stephen Hecht, University of Minnesota, Minneapolis, Minnesota, USA

9:30 am - 10:00 am | Refreshment Break with Posters and Exhibitors | Galleria Hall

9:45 -10:00 am | Exhibitor Showcase by Javelin

A Novel Milli-fluidic Liver Tissue Chip with Continuous Recirculation for Predictive Pharmacokinetics and Toxicology Applications
Murat Cirit, PhD, co-founder & CEO of Javelin Biotech

10:00 am - 12:00 pm | Concurrent Symposia 5 and 6

Symposium 5: N-Nitrosamine Impurities: Formation, Potential Toxicity, and Regulatory Environment | Grand AB
Chairs: Sharon Ripp, Pfizer, Gales Ferry, Connecticut, USA and Rheem Totah, University of Washington, Seattle, Washington

N-Nitrosamine Safety Assessments - Current Challenges
Krista Dobo, Pfizer, Groton, Connecticut, USA

Strategies for De-risking N-nitrosamine Impurities in APIs
Joel Bercu, Gilead, Foster City, California, USA

Latest Developments in Nitrosamine Structure-activity Relationships for Carcinogenicity
David Ponting, Lhasa Limited, Leeds, United Kingdom

Alternatives to Rifampin: A Perspective on Conducting Clinical Drug Interaction Studies
Jayaprakasam Bolleddula, EMD Serono, Billerica, Massachusetts, USA

Symposium 6: PK of ADCs | Marina Ballroom
Chairs: Robert Lyon, Seattle Genetics, Seattle, Washington, USA and Brandon Bordeau, State University of Buffalo, Buffalo, New York, USA

Effect of Linker-Payload Design on the PK of ADCs 
Robert Lyon, Seattle Genetics, Seattle, Washington, USA

Use of Mathematical Modeling to Guide Out-of-the-box Thinking for ADC Development
Greg Thurber, University of Michigan, Ann Arbor, Michigan, USA

Increasing the Therapeutic Index of ADCs with Payload Binding Selectivity Enhancers
Brandon Bordeau , State University of Buffalo, Buffalo, New York, USA

Anti-TNF GRM ADCs: PK/PD Considerations to Inform Clinical Development
Ronilda D’Cunha, Abbvie, North Chicago, Illinois, USA

12:00 pm - 2:30 pm | Exhibits and Posters | Galleria Hall

Exhibit Hall Open

12:15 -12:45 pm | Exhibitor Showcase by Pharmaron

In silico Approaches to DMPK – A Journey Through the Ages 

Barry Jones 

2:00 -2:15 pm | Exhibitor Showcase by Admescope

In vitro – in vivo Correlation of Antisense Oligonucleotide Metabolism

Dr. Ari Tolonen, CSO & Head of in vitro Metabolism and Biotransformations

12:30 - 2:30 | Poster Presentations P1-P91

2:30 pm - 4:00 pm | ISSX Poster Award Finalist Competition Podium Presentations | Grand AB

4:00 pm - 4:15 pm | ISSX Poster Awards Presentations | Grand AB

4:30 pm - 7:00 pm | Plenary Session | Grand AB

Discovery Tales
Chairs: Deepak Dalvie, Crinetics, San Diego, California, USA and Axel Pähler, Roche, Basel, Swizterland

Liver Targeted Therapy: What MIST and DDI Data Mean for Efficacy
Axel Pähler, Roche, Basel, Switzerland

Translational PK/PD of the Targeted Radioligand Therapy Pluvicto
Larissa Lachi Silva, Novartis Pharmaceuticals, East Hanover, New Jersey, USA and Fariba Khanshan, Novartis Pharmaceuticals, San Francisco, California, USA

Potential ADME-related Issues for PROTACs
Matthew Hoffman, Insmed Incorporated, Bridgewater, New Jersey, USA

Successful Optimization of Pharmacokinetics and Pharmacodynamics of Oral Cyclic Peptide PCSK9 Inhibitors
Tjerk JH Bueters, Merck, West Point, Pennsylvania, USA

7:00 pm - 9:00 pm | Networking Event | Westin Pavilion (next to Grand AB)


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