ISSX 2021 North American Meeting: Thursday, September 16, 2021


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Plenary Lecture 2: The Projection of Drug Interactions Caused by Time-Dependent Inhibition of CYP3A

Drug interactions (DDI) caused by cytochrome P4503A time-dependent inhibition (TDI) are common. In vitro assays to study TDI for new drug candidate molecules are employed in an effort to predict the magnitude of DDI or, better still, to aid in the design of alternate molecules that lack this property. A challenge has been that in vitro TDI assays appear to be very sensitive and approaches used to scale these data frequently result in over-predictions of DDI. Research results will be shared that address this problem, including a comparison of TDI data generated in human liver microsomes and primary human hepatocyte suspensions. Alternate proposals of the most appropriate estimates for in vivo concentrations of TDIs for reliable projections DDI will be discussed.

Symposium 7: ADME Success Stories
Co-chairs: Marcel Hop, Genentech Inc., South San Francisco, California, USA and Dermot McGinnity, AstraZeneca, Cambridge, United Kingdom

Scientists from a range of companies will present both preclinical and clinical ADME data that have not been presented in detail before. They will describe the process of identification of a clinical candidate with optimal ADME properties and the struggles encountered and necessary compromises throughout the process. Human PK predictions and the corresponding clinical PK, metabolism and DDI data will be included as well.

Symposium 8: New Strategies for Overcoming ADME Hurdles for Nucleic Acid
Co-chairs: Jessica Hawes, Food and Drug Administration, Silver Spring, Maryland, USA and Donglu Zhang, Genentech Inc., South San Francisco, California, USA

This symposium will cover the most recent advances in the development of new nucleic acid therapeutics, including ASO, siRNA, mRNA, and miRNA drugs. Areas of discussion include the principles, promise, and challenges of developing nucleic acid-based therapeutics, with special focus on new strategies for improving ADME, pharmacokinetic and pharmacodynamic (PK/PD) properties of nucleic acid drugs. Four leading investigators in the fields will present the most recent findings and lead the discussion of new nucleic acid medications. Attendees are expected to learn the fundamental principles and new strategies in discovery and development of nucleic acid therapeutics.

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Plenary Lecture 2: The Projection of Drug Interactions Caused by Time-Dependent Inhibition of CYP3A | R. Scott Obach | Joseph Balthasar
Recorded 09/16/2021
Recorded 09/16/2021 Drug interactions (DDI) caused by cytochrome P4503A time-dependent inhibition (TDI) are common. In vitro assays to study TDI for new drug candidate molecules are employed in an effort to predict the magnitude of DDI or, better still, to aid in the design of alternate molecules that lack this property. A challenge has been that in vitro TDI assays appear to be very sensitive and approaches used to scale these data frequently result in over-predictions of DDI. Research results will be shared that address this problem, including a comparison of TDI data generated in human liver microsomes and primary human hepatocyte suspensions. Alternate proposals of the most appropriate estimates for in vivo concentrations of TDIs for reliable projections DDI will be discussed.
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ADME Success Stories | Marcel Hop | Darius Babusis | Upendra Dahal | Christopher MACLAUCHLIN | Dermot McGinnity | Agnes Poirier, PharmD, PhD
Recorded 09/16/2021
Recorded 09/16/2021 Scientists from a range of companies present both preclinical and clinical ADME data that have not been presented in detail before. They describe the process of identification of a clinical candidate with optimal ADME properties and the struggles encountered and necessary compromises throughout the process. Human PK predictions and the corresponding clinical PK, metabolism and DDI data are included as well.
You must register to access.
New Strategies for Overcoming ADME Hurdles for Nucleic Acid | Jessica Hawes | Herana Seneviratne | Aiming Yu | Donglu Zhang
Recorded 09/16/2021
Recorded 09/16/2021 This symposium will cover the most recent advances in the development of new nucleic acid therapeutics, including ASO, siRNA, mRNA, and miRNA drugs. Areas of discussion include the principles, promise, and challenges of developing nucleic acid-based therapeutics, with special focus on new strategies for improving ADME, pharmacokinetic and pharmacodynamic (PK/PD) properties of nucleic acid drugs. Four leading investigators in the fields will present the most recent findings and lead the discussion of new nucleic acid medications. Attendees are expected to learn the fundamental principles and new strategies in discovery and development of nucleic acid therapeutics.
You must register to access.
Postdoctoral Poster Award Finalist Presentations
Recorded 09/16/2021
Recorded 09/16/2021 Co-chairs: Valerie Kramlinger, Novartis, Cambridge, Massachusetts, USA and Bhagwat Prasad, Washington State University, Spokane, Washington, USA A6 - ABSTRACT WITHDRAWN A7 - GUT-LIVER ORGAN ON A CHIP COMBINED WITH IN SILICO MODELLING AS A PROMISING TOOL FOR INVESTIGATION OF MYCOPHENOLATE MOFETIL PHARMACOKINETICS Nicolò Milani, Hoffmann-La Roche, Basel, Switzerland A8 - PREDICTING REGIONAL RESPIRATORY TISSUE AND SYSTEMIC CONCENTRATIONS OF ORALLY INHALED DRUGS THROUGH A NOVEL PBPK MODEL Mayur K. Ladumor, University of Washington, Seattle, Washington, United States A9 - DEEPER INSIGHT INTO THE CHROMATOGRAPHIC AND MASS FRAGMENTATION BEHAVIORS OF ENDOGENOUS STEROIDS FOR DEVELOPMENT OF A SELECTIVE LC-MS/MS METHOD Vijay Mettu, Washington State University, Spokane, Washington, United States A10 - LIVER IMAGING-INFORMED PBPK MODELLING FOR PREDICTION OF TRANSPORTER-MEDIATED DRUG-DRUG INTERACTIONS Nicola Melillo, The University of Manchester, Manchester, United Kingdom
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