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[In-Person] Oncology Clinical Dose Optimization in Light of FDA Project Optimus

Speakers: Stacy Shord, FDA; Harald A.Weber, Seagen/Pfizer; Patrick Williams, Genentech; Donghua Yin, Pfizer; Peter C Trask, Genentech; Shelly Wang; Divya Samineni, Genentech
Organizers: Chunze Li, Jesse Yu, Joseph Chen (Department of Clinical Pharmacology, Genentech)
Date: 2024-04-26
Time: 8:45-17:00 Pacific Time
Registration fee: Regular attendees: $295; Academic/Students/Postdocs: $45; Out-of-Pocket: $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)Allucent; Olink Proteomics
Vendor show vendors registered to date: (2)BioAgilytix; Meadowhawk Biolabs
Registration deadline:2024-04-24  (it will close sooner if the seating cap is reached)

About the Topic

Historically, dose selection in oncology was driven by the MTD paradigm. This traditional approach was partly driven by the few available therapies in oncology, and the need to bring effective drugs to the market as soon as possible. Now that the field of oncology drug development has matured and cancer patients are living longer than ever on chronic therapies, we as drug developers need to meet these new challenges by shifting our approach to oncology dose selection to a new paradigm. This one-day workshop will discuss the new regulatory expectations to oncology dose selection, various approaches to optimize oncology dose selection from a study design as well as statistical perspective, different clinical pharmacology considerations and related analysis to support dose selection, and evaluations using patient-reported outcomes. 

About the Speakers

Time (PST) 



8:45 - 9:00 am 

PBSS Welcome and Introduction 

Shichang Miao (PBSS)

9:00 - 9:30 am 

FDA Embracing Innovation for Dosage Optimization of Oncology Products

Stacy Shord, Deputy Division Director, FDA 

9:30 - 10:10 am 

Clinical consideration for Oncology dose optimization

Harald A.Weber, MD, Executive Medical Director, Seagen/Pfizer

10:10 - 10:20 am

Major Sponsor Presentation 


10:20 - 10:40 am 

Break and Vendor Show 


10:40 - 11:20 am

Oncology dose finding CDP for different molecule classes  

Patrick Williams, MD, Senior Medical Director, Genentech

11:20 - 11:50 am

Biostatistic consideration and adaptive designs for oncology dose finding

Hao Wang, PhD, Director, Clinical Data Science-Biostatistics, Gilead 

11:50am-12:30 pm

Clinical pharmacology considerations towards efficient oncology dose finding

Donghua Yin, PhD, VP, Pfizer

12:30 - 1:20 pm


 Sponsor (TBD)

1:20 - 2:00 pm

Patient reported outcome for oncology dose optimization

Peter C Trask, Ph.D., MPH Senior Director, Head of Oncology, Patient-Centered Outcomes Research, Genentech 

2:00 - 2:40 pm

Population PK, covariates characterization, and E-R for dose selection

Shelly Wang, Ph.D.

2:40 - 2:50 pm

Major Sponsor Presentation 

Olink Proteomics

2:50 - 3:15 pm

Break and Vendor Show 


3:15 - 3:50 pm

Oncology dose optimization - IQ consortium perspectives

Divya Samineni, PhD, Distinguished Scientist, Genentech

3:50 - 4:30 pm

Panel Discussion and Q&A

 All Speakers 

4:30 - 5:30 pm

Happy Hour

 Sponsor (TBD)

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