Jobs
View more job listings or post a job
Bioduro-Sundia Associate Director/Director in Laboratory Animal and Exploratory Toxicology
Variant Bio (Senior) Scientist - DMPK
Alturas Analytics Scientist 1
University of California, Davis TOXICOLOGY ANALYTICAL CHEMIST (STAFF RESEARCH ASSOCIATE 3)
University of California, Davis CALIFORNIA ANIMAL HEALTH AND FOOD SAFETY LABORATORY - TOXICOLOGY LAB RESEARCH SUPERVISOR/GROUP LEADER
Eli Lilly and Company R-39973 Scientific Director ADME - Novel Modalities (Open)
FibroGen Director DMPK
Applied BioMath Technical Marketing Specialist
Horizon Therapeutics Director, Bioanalytical Sciences
Exelixis Principal Scientist - DMPK
Post a job
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: (2)Fortrea CRO; Q2 Solutions
Vendor show vendors registered to date: (26)Altasciences; AnaBios; Attentive Science; AustinPx, Pharmaceutics and Manufacturing; 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

Other Events of PBSS-San Francisco Bay:

2024-05-06, [In-Person] Human Mass Balance and Metabolite Profiling Studies: Strategies, Technical Approaches, Regulatory Guidance, Applications and Case Studies
2024-05-13, [Free Online] Highlights of 2023 FDA Drug Approvals
2024-05-21, [In-Person] Nonclinical Safety Studies for IND and NDA Filing for Small Molecules: Nuts, Bolts and Best Practices
2024-05-30, [Free Online Workshop] Career Transition for Research Scientists: Career Overview, Project Management and Regulatory Affairs (jointly with BioPharmaPM and RAPS-SF)
2024-06-13, [In-Person] CMC Strategies and Activities for IND and NDA Filing for Small Molecules: Nuts, Bolts and Best Practices
2024-06-20, Alzheimer's Disease: untangling what we thought we knew and future Precision Medicine Diagnostics and Therapeutics
2024-07-24, [Free Online] The Science and Stories of Promising Biotech Startups: Symposium No.6
2024-09-10, [In-Person] Rethinking Translational PK/PD and Human Dose Projections for Novel Therapeutic Modalities: Covalent Inhibitors, PROTACs, Molecular Glues, ADCs, Ocular and Neuro delivery, Vaccines, Bispecifics, Cell and Gene Therapies
2024-09-20, [In-Person] Non-clinical safety assessments of biologics and novel modalities for IND/NDA Filing: Nuts, Bolts and Best Practices
2024-10-10, [In-Person] Regulatory Global Submission: Strategies and Best Practices for FDA, EMA and PMDA
©Pharmaceutical & BioScience Society, International; Last Modified: 4/26/2024; Admin Logon
 Ads (in random order)
Submit a Text Ad
($250 for 2 months)
Lena Biosciences Predictive toxicology. Intrinsic & idiosyncratic drug-induced liver injury. Mitochondrial toxicity in a drug metabolism-competent model.
Hypha Discovery Synthesis, purification & NMR characterization of phase I and II drug metabolites & API impurities at mg-g scale with COAs.
Alturas Analytics, Inc. Expert Regulated & Non-Regulated LC-MS, GC-MS bioanalytical & PK/TK analysis of small & large molecules in any matrix. Discovery through phase IV.
Lena Biosciences Predictive toxicology. Mitochondrial toxicity in a drug metabolism-competent model with active transporters. Intrinsic & idiosyncratic DILI.
Submit a Text Ad