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Workshop
[In-Person] Human PK and Dose Prediction for Small Molecules
Speakers:
Li Di (Pfizer), Ryota Kikuchi (AbbVie), Kishore Pasikanti (Grünenthal Group), Yurong Lai (Gilead), Cory Kalvass (AbbVie), Yuching Yang (FDA)
Organizers:
Li Di (Pfizer), Cuiping Chen (Jazz Pharmaceuticals), Shichang Miao (PBSS)
Date:
2023-10-06
Time:
8:45-17:15 Pacific Time
Registration fee:
Regular attendees: $295; Academic/Students/Postdocs/Between Jobs: $125; Major Sponsorship: $3000; Vendor Show: $695; Happy Hour Sponsorship: $995; 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:
(13)Altasciences; Ardena; Celerion; Corden Pharma; Covance; Cyprotex US. LLC; Ellegaard BioResearch; IDEXX BioAnalytics; KCAS Bio; Meadowhawk Biolabs; Medicilon; Quotient Sciences; Raybow USA, Inc.
Registration: http://www.PBSS.org
Registration deadline:2023-10-04
(it will close sooner if the seating cap is reached)
About the Topic
Accurate prediction of human PK is the first step towards human dose prediction in the clinic. Clearance is one of the most important PK parameters, as it impacts not only dose, but also dosing frequency. In vitro to in vivo extrapolation (IVIVE) using human liver microsomes and hepatocytes is commonly applied in drug discovery to predict hepatic clearance of drug candidates. Allometric scaling is an effective approach to estimate human oral absorption, volume of distribution, renal clearance, and other PK parameters. Species difference in drug disposition will need to be considered when applying allometric scaling. The critical roles of transporters in drug disposition are increasingly recognized and new strategies have been developed to predict transporter-mediated clearance and volume of distribution. PK/PD relationships are highly effective in our understanding of efficacious dose for a given disease target. The workshop features contemporary approaches on important topics related to human PK and dose prediction, as well as regulatory perspective on design of first-in-human studies and selection of dosing regimen.
- Clearance IVIVE using liver microsomes and hepatocytes
- Allometry scaling of PK parameters
- Prediction of oral absorption and bioavailability
- Transporter-mediated hepatobiliary and renal clearance
- Prediction of human volume of distribution
- The role of PK/PD in human dose prediction
- PAXLOVIDTM case study
- Regulatory perspective on design of FIH studies and selection of dosing regimen
About the Speakers
Time (PT)
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Topic
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Presenter
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8:45-9:00 am
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PBSS Welcome and Introduction
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Cuiping Chen (Jazz Pharmaceuticals)
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9:00-9:45 am
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1. Human Clearance IVIVE and PK Prediction
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Li Di, Pfizer
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9:45-10:30 am
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2. Allometry in Prediction of Human PK Parameters
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Ryota Kikuchi, AbbVie
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10:30-10:40 am
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Major Sponsor’s Presentation
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Patel Kwan Consultancy LLC/Veloxity Labs
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10:40-11:00 am
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Break and Vendor Show
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11:00-11:45 am
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3. Prediction of Human Volume of Distribution
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Kishore Pasikanti, Grünenthal Group
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11:45-12:30 pm
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4. Prediction of Transporter-Mediated Hepatobiliary and Renal Clearance
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Yurong Lai, Gilead
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12:30-1:30 pm
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Lunch
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Sponsor TBD
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1:30-2:15 pm
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5. Prediction of Human Oral Absorption
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Cory Kalvass, AbbVie
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2:15-3:00 pm
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6. PK/PD and Human Dose Prediction
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Tom De Bruyn, Genentech
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3:00-3:10 pm
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Major Sponsor’s Presentation
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Alturas Analytics
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3:10-3:30 pm
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Break
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-
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3:30-4:00 pm
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7. Case Study: PAXLOVIDTM Human PK and Dose Prediction
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Li Di, Pfizer
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4:00-4:45 pm
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8. Regulatory Perspective on Design of First-in-Human Studies and Selection of Dosing Regimen
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Yuching Yang, FDA
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4:45-5:15 pm
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Panel Discussion
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All Speakers
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5:15-6:15 pm
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Happy Hour
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Sponsor TBD
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2024-08-14, [Free Online] Advances in Cancer Therapeutics (Organized by PBSS and BioScience Forum)
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2024-08-22, [Free Online] Diabetes and Obesity Treatments: Current and Emerging Landscapes of GLP-1, GIP, and Beyond
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2024-09-10, [In-Person] Translational PK/PD and Human Dose Projection for Antibodies/ADCs and Novel Therapeutic Modalities
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2024-09-20, [In-Person] Nonclinical Safety Assessments of Biologics and Other Novel Modalities for IND/NDA/BLA Filings
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2024-09-25, [Free Online] Development of Protein Degraders: Computational Modeling, Medicinal Chemistry and Early Development
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2024-10-10, [In-Person] Regulatory Global Submission: Strategies and Best Practices for FDA, EMA and PMDA
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2024-10-25, [Free Online Workshop] Unleashing the Power of Real-World Evidence / Data (RWE/RWD) to Facilitate Drug Discovery, Development, and Beyond
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2024-11-01, [In-Person] Clinical Pharmacology Studies on Hepatic and Renal Impairments for NDA Filing: Strategies, Design, Conduct, Analysis and Regulatory Aspects
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2024-11-13, [Free Online Workshop] Career Transition for Research Scientists: Business Development & BioPartnering
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2024-11-15, [In-Person] Bioanalysis for Biologics and Cell/Gene Therapy Products: Refining Established Approaches for New Complex Therapeutics
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2025-01-22, [In-Person] Small-Molecule Formulation for Discovery & Early Development (jointly by PBSS / AAPS-BADG / Syner-G)
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