Sunday, September 15, 2024
Program subject to change.
9:00 am - 12:00 pm | Concurrent Short Courses 1 and 2
Short Course 1: Physiologically Based Pharmacokinetic Modeling to Predict Induction Mediated Drug-drug Interactions
Co-Chairs: Kunal Taskar, GSK, Stevenage, United Kingdom and Koji Chiba, Yokohama University of Pharmacy, Yokohama, Japan
Background: This short course is designed to provide a comprehensive overview of PBPK modeling and outline challenges and opportunities for the prediction of CYP induction mediated DDIs, initially using CYP3A as the primary induced enzyme and building in complexities observed in real world examples.
Why and When Do I Use PBPK Modeling
Kunal Taskar, GSK, Stevenage, United Kingdom
How Do I Build an ‘Ideal’ PBPK Model if My Drug is Either a Substrate or Inducer
Ryuta Asaumi, Astellas Pharma, Chuou-ku, Japan
How Do I Use PBPK Modeling to Discern Complex Drug-drug Interactions?
Jayaprakasam Bolleddula, EMD Serono, Boston, Massachusetts, USA
How will CYP Induction Related PBPK Applications be Evaluated during the NDA Reviews?
Ying-Hong Wang, FDA, Silver Spring, Maryland, USA
Short Course 2: Minimizing Off-Target Toxicities of Reactive Metabolites
Co-Chairs: Valerie Kramlinger, Amgen, Nashville, Tennessee, USA and Miki Nakajima, Kanazawa University, Kanazawa, Japan
Background: This short course explores strategies for minimizing off-target toxicities caused by reactive metabolites in drug development. Featuring speakers from industry and academia, the course covers industrial perspectives, mitigation strategies for drug-induced liver injury, novel mechanisms of drug-metabolizing hydrolases, and in vivo models for assessing toxicity. Attendees will gain valuable insights into identifying, evaluating, and mitigating risks associated with reactive metabolites in pharmaceutical research and development.
Industrial Perspective of Reactive Metabolites: When to be Afraid and When to be Very Afraid
Jonathan Bauman, Pfizer, Groton, Connecticut, USA
Mitigating Strategy for Drug Induced Liver Injury Led by Reactive Metabolites
Sean Zhu, Takeda, Cambridge, Massachusetts, USA
Novel Mechanisms of Drug-metabolizing Hydrolases Regulating the Toxicity Caused by Reactive Metabolites
Tatsuki Fukami, Kanazawa University, Kanazawa, Japan
In Vivo Models for Assessing the Toxicity of Reactive Metabolites
Xinxin Ding, University of Arizona, Tucson, Arizona, USA
12:00 pm - 1:00 pm | Short Course Attendee Lunch
1:00 pm - 4:00 pm | Concurrent Short Courses 3 and 4
Short Course 3: Cutting-Edge Technologies for Predicting Drug Absorption and Disposition in Oral Drug Development
Co-Chairs: Yoshiyuki Shirasaka, Kanazawa University, Kanazawa, Japan and Bhagwat Prasad, Washington State University, Spokane, Washington, USA
Background: This short course provides an easy-to-understand explanation of gastrointestinal absorption of drugs from multiple perspectives including formulation, pharmacokinetics, and physiology, and also shares cutting-edge technologies and the latest research findings to realize a high-precision prediction for oral drug absorption.
Quantitative Analysis of Gastrointestinal Drug Absorption and Disposition Using State-of-the-art Technology
Yoshiyuki Shirasaka, Kanazawa University, Kanazawa, Japan
Gastrointestinal Imaging with MRI: Insights into the Behavior of Dosage Forms and the Conditions at the Site of Drug Release
Werner Weitschies, University of Greifswald, Greifswald, Germany
Human Enteroid Monolayers – A Fit-for Purpose Model to Elucidate Intestinal Natural Product-drug Interactions
Kenneth E. Thummel, University of Washington, Seattle, Washington, USA
Towards A Pharma[e]cological View of Precision Medicine
Peter Turnbaugh, University of California, San Francisco, San Francisco, California, USA
Integrating Intestinal Physiology and Drug Metabolism, Disposition, and Interactions through PBPK Modeling
Bhagwat Prasad, Washington State University, Spokane, Washington, USA
Short Course 4: Addressing ADME/PK Challenges of Novel Biologic Modalities with Advanced Analytical Tools
Co-Chairs: Yoshiro Saito, NIHS, Kawasaki, Japan and Matt Albertolle, San Diego, California, USA
Background: This short course will address the growth of biologic modalities beyond small molecules (peptides, oligonucleotides, multi-specific therapeutic proteins, protein degraders, antibody drug conjugates, etc.) that demand the need for innovative techniques to answer ADME-related questions.
Downstream Effects of Protein Degraders
Katherine Donovan, Dana-Farber Cancer Institute, Boston, Massachusetts, USA
Bioanlaysis, Biotransformation and Pharmacokinetics of Antibody-drug Conjugate
Yuki Kishino, Daiichi Sanyko, Tokyo, Japan
Tips for Bioanalytical Method Development of Peptides, and their DDI Risk Evaluation
Kosuke Saito, National Institute of Health Sciences, Kawasaki, Japan
Oligonucleotide Target Engagement
Michael McCoy, Takeda, Cambridge, Massachusetts, USA
4:00 pm - 5:45 pm | Concurrent Focus Group Meetings
4:00 pm - 4:45 pm | Concurrent Focus Group Meetings Session 1
Biotransformation, Mechanisms, and Pathways Focus Group Meeting
Transporters Focus Group Meeting
5:00 pm - 5:45 pm | Concurrent Focus Group Meetings Session 2
Bioanalysis in ADME Science Focus Group Meeting
Modeling and Simulation Focus Group Meeting
6:00 pm - 6:15 pm | Opening Welcome Remarks
Welcome Remarks
Meeting Co-Chairs, Natalie Hosea, San Diego, California, USA and Kiyomi Ito, Musashino University, Tokyo, Japan
Aleksandra Galetin, ISSX President, University of Manchester, Manchester, United Kingdom
Yukio Kato, JSSX President, Kanazawa University, Kanazawa, Japan
6:15 pm - 7:15 pm | Keynote Lecture 1
AI Platform to Accelerate Drug Discovery
Yasushi Okuno, Kyoto University, Kyoto, Japan
7:15 pm - 9:15 pm | Opening Welcome Reception
Attendee and Exhibitor Reception and Networking
All participants are invited to meet with fellow attendees, speakers, and our sponsoring and exhibiting partners who will be on-hand to share information about their latest products and services.
