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Workshop

[In-Person] Human PK and Dose Prediction for Small Molecules


Speakers: Li Di (Pfizer), Ryota Kikuchi (AbbVie), Kishore Pasikanti (Gr├╝nenthal 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: (2)Alturas Analytics; Veloxity Labs
Vendor show vendors registered to date: (12)Altasciences; Ardena; Celerion; Corden Pharma; Covance; Cyprotex US. LLC; Ellegaard BioResearch; KCAS Bioanalytical & Biomarker Services; Meadowhawk Biolabs; Medicilon; Quotient Sciences; Siegfried
Registration: http://www.PBSS.org
Registration deadline:2023-10-05  (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)

Topic

Presenter

8:45-9:00 am

PBSS Welcome and Introduction 

Cuiping Chen (Jazz Pharmaceuticals)

9:00-9:45 am

1. Human Clearance IVIVE and PK Prediction

Li Di, Pfizer

9:45-10:30 am

2. Allometry in Prediction of Human PK Parameters

Ryota Kikuchi, AbbVie

10:30-10:40 am

Major Sponsor’s Presentation

Patel Kwan Consultancy LLC/Veloxity Labs

10:40-11:00 am

Break and Vendor Show 

 -

11:00-11:45 am

3. Prediction of Human Volume of Distribution

Kishore Pasikanti, Grünenthal Group

11:45-12:30 pm

4. Prediction of Transporter-Mediated Hepatobiliary and Renal Clearance 

Yurong Lai, Gilead

12:30-1:30 pm

Lunch 

Sponsor TBD

1:30-2:15 pm

5. Prediction of Human Oral Absorption

Cory Kalvass, AbbVie

2:15-3:00 pm

6. PK/PD and Human Dose Prediction 

Tom De Bruyn, Genentech

3:00-3:10 pm

Major Sponsor’s Presentation

Alturas Analytics

3:10-3:30 pm

Break 

-

3:30-4:00 pm

7. Case Study: PAXLOVIDTM Human PK and Dose Prediction

Li Di, Pfizer

4:00-4:45 pm

8. Regulatory Perspective on Design of First-in-Human Studies and Selection of Dosing Regimen

Yuching Yang, FDA

4:45-5:15 pm

Panel Discussion 

All Speakers

5:15-6:15 pm

Happy Hour

Sponsor TBD


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