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Workshop
[In-Person] ADME/DMPK Studies for IND and NDA Filing for Small Molecules: Nuts, Bolts and Best Practices
Speakers:
Simon Wong (Aditum Bio), Jan Wahlstrom (Amgen), Sean Zhu (Takeda), Cyrus Khojasteh (Genentech), Xinning Yang (FDA), Werner Rubas (Sutro), Ilaria Badagnani (Theravance), Upendra Dahal (Amgen)
Organizers:
Simon Wong (Aditum); Jan Wahlstrom (Amgen)
Date:
2024-01-19
Time:
8:45-17:30 Pacific Time
Registration fee:
Regular attendees: $295; Academic/Students/Postdocs: $95, Between Jobs: $45; Major Sponsorship: $3000; Vendor Show: $695, Happy Hour Sponsorship: $975; Lunch Sponsorship: $1250; On-site Registration: $500
Location:
Crowne Plaza, Foster City, CA (San Francisco Bay Area)
Major Sponsor:
Vendor show vendors registered to date:
(26)Altasciences; AnaBios; Attentive Science; AustinPx; BioAgilytix; BioDuro-Sundia; ChemPartner Shanghai; Corden Pharma; Crystal Pharmatech Inc; Curia; Cyprotex US. LLC; Discovery Life Sciences; Ellegaard BioResearch; ICON Clinical Research; KCAS Bio; Meadowhawk Biolabs; Medicilon; Novabiosis, Inc; Olink Proteomics; QPS LLC; Quotient Sciences; Raybow USA, Inc.; Resolian; Selvita Inc.; SOLVO/CRL; WuXi AppTec
Registration: http://www.PBSS.org
Registration deadline:2024-01-18
(it will close sooner if the seating cap is reached)
About the Topic
| 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 |
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