Agenda
Time (PST) | Topic | Presenter |
8:45 - 9:00 am | PBSS Welcome and Introduction | Shichang Miao (PBSS) |
9:00 - 9:30 am | Overview of Sections 2.6.4, 2.6.5 and Module 4 | Simon Wong (Aditum Bio) & Jan Wahlstrom (Amgen) |
9:30 - 10:10 am | Preclinical Metabolism and Victim Drug-Drug Interactions: | Sean Xiaochun Zhu, PhD, Scientific Director, Takeda |
10:10 - 10:20 am | Major Sponsor Presentation | Q2 Solutions |
10:20 - 10:40 am | Break and Vendor Show | - |
10:40 - 11:20 am | In vitro Metabolism, Clinical MetID and MIST | Cyrus Khojasteh, PhD, Senior Director, Genentech |
11:20 - 11:50 am | Human ADME – Case Studies – Phenotyping | Jan Wahlstrom, PhD, Executive Director, Amgen |
11:50am-12:30 pm | Translation of DDI Perpetrator to IND/NDA | Simon Wong, PhD, VP Nonclinical Development and Clinical Pharmacology, Aditum Bio |
12:30 - 1:20 pm | Lunch | Sponsored by Veloxity Labs |
1:20 - 2:00 pm | FDA Experience on IND/NDA ADME Studies | Xinning Yang, PhD, Policy Lead of Clinical Pharmacology, FDA |
2:00 - 2:40 pm | IND Enabling Studies for Antibody-Drug Conjugates | Werner Rubas, PhD, Vice President, Preclinical Development, Sutro Biopharma, Inc. |
2:40 - 2:50 pm | Major Sponsor Presentation | Fortrea CRO |
2:50 - 3:15 pm | Break and Vendor Show | - |
3:15 - 3:50 pm | Case Study: Izencitinib Disposition, Metabolism, and Transporter/Metabolism DDI Risk Assessment in Humans | Ilaria Badagnani, PhD, Previously Senior Director and Head of DMPK, Theravance Biopharma Inc |
3:50 - 4:30 pm | ADME Package of Covalent Drug Sotorasib | Upendra Dahal, PhD, Associate Director, Amgen |
4:30 - 5:00 pm | Panel Discussion | All Speakers |
5:00 - 6:00pm | Happy Hour | Sponsored by Alturas Analytics |