View more job listings or post a job
Alturas Analytics Scientist 1
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
Exelixis Senior Principal Scientist - DMPK
Exelixis Principal Clinical DMPK Scientist
Post a job


[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 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)



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


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



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

2023-11-07, [Free Online] The Science and Stories of Promising Biotech Startups
2023-11-13, [In-Person] Clinical Pharmacology Across the Drug Development Continuum: Key Clinical Studies, Modeling & Simulation to Support Drug Approval and Labeling
2023-12-06, [Free Online] Artificial Intelligence and Machine Learning to Drive Therapeutic Drug Discovery & Development
2024-01-19, [In-Person] ADME/DMPK Studies for IND and NDA Filing for Small Molecules: Nuts, Bolts and Best Practices
┬ęPharmaceutical & BioScience Society, International; Last Modified: 10/1/2023; Admin Logon
Ads (in random order)
Submit a Text Ad
($250 for 2 months)

Jie Du Center at the University of the Pacific Interested in creating a business in Biotech? Learn how to transition from thinking like a scientist to thinking like an entrepreneur.
BioTether Sciences Bioanalytical CRO, focused on PK, Biomarkers, and Immunogenicity. Custom Assay development, validation and testing. Advanced cell engineering.
Viva Biotech Join Viva Reception if you have a need in MedChem, SBDD, FBDD, CryoEM, ASMS, SPR, HDX, CADD, Bioassay, CMC, Ab,
ICON Innovation Workshop in SF Bay Area: Bringing the trial to the patient: Are you driving true patient centricity? Oct 19, Crowne Plaza Foster
Alturas Analytics, Inc. Expert GLP & non-GLP LC-MS/MS, GC-MS/MS bioanalytical & PK/TK analysis services of small & large molecules in any matrix. Discovery through phase IV.
Submit a Text Ad