Jobs
View more job listings or post a job
InnoAlliance Scientist/Sr Scientist of Bioanalysis & Biomarkers
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
Post a job

Workshop

[In-Person] DMPK/Clinical Pharmacology for IND/NDA Filings


Speakers: Natalie Hosea, Amgen; Jan Wahlstrom, Amgen; Simon Wong, Aditum Bio; Sekhar Surapaneni, Neurocrine Biosciences; Shinji Yamazaki, Certara; Jennifer Yang, consultant; Naveed Shaik, Pfizer; Cornelius Cilliers, Bristol Myers Squibb; Xinning Yan, FDA
Organizers: Jan Wahlstrom, PhD (Amgen), Jennifer Yang, PhD (consultant), Barbara Saechao (BMS), Simon Wong (Aditum Bio)
Date: 2024-10-01
Time: 8:45-17:00 Pacific Time
Registration fee: Regular attendees: $295; Academic/Students/Postdocs/Out-of-pocket: $45; Major Sponsorship: $3000; Vendor Show: $695; Lunch Sponsorship: $1,250; Happy Hour Sponsorship: $975; On-site Registration:$500
Location: Hilton Del Mar, 15575 Jimmy Durante Blvd, Del Mar, CA 92014
Major Sponsor: (2)BioAgilytix; Fortrea
Vendor show vendors registered to date: (4)Aliri Bioanalysis; Alturas Analytics; Discovery Life Sciences; Resolian
Registration: http://www.PBSS.org
Registration deadline:2024-09-30  (it will close sooner if the seating cap is reached)

About the Topic

Characterization of ADME (absorption, distribution, metabolism, and excretion) and the clinical pharmacology profiles remains a critical component for the successful development of new medicines. With complex regulatory requirements for both IND and NDA, the task can seem daunting, and unfortunately - inconsistent. Disparity across small and large pharma creates a diverse landscape of ADME data supporting first in human and registrational studies, and increased reliance on contract research organizations has shifted DMPK/ClinPharm expertise to a “one size fits all” approach. Assembling a seasoned panel of dedicated and recognized DMPK/ClinPharm scientists, this workshop explores the key components of IND and NDA filings for small molecules, leveraging decades of experience to provide perspective on data that drives decisions and works in concert with clinical pharmacology to advance molecules towards successful approval.


About the Speakers

Time (PT) 

Topic 

Presenter 

8:45 - 9:00 am 

PBSS Welcome and Introduction 

Barbara Saechao, PBSS

9:00 - 9:30 am 

Overview of Sections 2.6.4, 2.6.5, 2.7.1, 2.7.2, and Modules 4/5 

Simon Wong, PhD, Vice President, Aditum Bio;

Jan Wahlstrom, PhD, Executive Director, Amgen

9:30 - 10:10 am

DMPK Best Practices

Jennifer Yang, PhD, independent consultant

10:10 - 10:20 am 

Major Sponsor Presentation 

 Fortrea

10:20 - 10:40 am 

Break and Vendor Show 

 -

10:40 - 11:20 am 

Drug-Drug Interactions: Perpetrator and Victim

Jan Wahlstrom, PhD, Executive Director, Amgen

11:20 - 12:00 pm

Transporter-Mediated Drug-Drug Interactions

Shinji Yamazaki, PhD, Senior Director, Certara UK

12:00 - 1:00 PM

Lunch 

Sponsor (TBD)

1:00 pm -1:40 pm

In Vitro Metabolism, Clinical MetID and MIST

Sekhar Surapaneni, PhD, DMPK Leader, NeurocrineBiosciences

1:40 - 2:25 pm 

Overview of IND/NDA Experiences

Natalie Hosea, PhD, Vice President, Amgen

2:25 - 3:10 pm 

FDA Experience and Expectations on IND/NDA ADME Studies

Xinning Yang, PhD, Policy Lead of Clinical Pharmacology, FDA

3:10 - 3:20 pm 

Major Sponsor Presentation 

 TBD

3:20 - 3:40 pm 

Break and Vendor Show 

-

3:40 - 4:20 pm

Clinical Pharmacology Studies to Support NDA Submission and Inform Drug Label

Naveed Shaik, PhD, Senior Director, Pfizer

4:20 - 5:00 pm

ADME Package of KRAZATI® (adagrasib) and DMPK/Clin Pharm Challenges

Cornelius Cilliers, PhD, Director, BMS

5:00 - 5:30 pm 

Panel Discussion 

All Speakers 

5:30 - 6:30 pm 

Happy Hour 

 Sponsor (TBD)


2024-10-17, [Free Online] Patient Centric Blood Sampling for Facilitating De-centralized Clinical Trials: Implications for ClinOps, PK/ClinPharm, Bioanalytical and Biomarkers
2024-10-17, [Free Online by PBSS-San Diego] Patient Centric Blood Sampling for Facilitating De-centralized Clinical Trials: Implications for ClinOps, PK/ClinPharm, Bioanalytical and Biomarkers
©Pharmaceutical & BioScience Society, International; Last Modified: 7/25/2024; Admin Logon
Ads (in random order)
Submit a Text Ad
($250 for 2 months)

Simulations Plus GastroPlus X: Science, models & refined algorithms—now with intuitive interface, faster processing & streamlined workflows for faster PBPK modeling.
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.
Submit a Text Ad