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Workshop
[In-Person] DMPK/Clinical Pharmacology Studies for IND/NDA Filings
Speakers:
Natalie Hosea, Amgen; Jan Wahlstrom, Amgen; Simon Wong, Aditum Bio; Sekhar Surapaneni, Nimbus Therapeutics; 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 (Mirati)), 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:
Vendor show vendors registered to date:
(9)abzena; Aliri Bioanalysis; Alturas Analytics; BioIVT; Curia; Discovery Life Sciences; Ellegaard BioResearch; Frontage Laboratories; 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)
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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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Barbara Saechao, BMS (Mirati)
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9:00 - 9:30 am
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Overview of Sections 2.6.4, 2.6.5, 2.7.1, 2.7.2, and Modules 4/5
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Simon Wong, PhD, Vice President, Aditum Bio;
Jan Wahlstrom, PhD, Executive Director, Amgen
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9:30 - 10:10 am
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DMPK Best Practices
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Jennifer Yang, PhD, independent consultant
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10:10 - 10:20 am
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Major Sponsor Presentation
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Fortrea
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10:20 - 10:40 am
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Break and Vendor Show
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-
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10:40 - 11:20 am
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Drug-Drug Interactions: Precipitant and Object
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Jan Wahlstrom, PhD, Executive Director, Amgen
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11:20 - 12:00 pm
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Transporter-Mediated Drug-Drug Interactions
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Shinji Yamazaki, PhD, Senior Director, Certara UK
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12:00 - 1:00 PM
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Lunch
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Sponsor (TBD)
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1:00 pm -1:40 pm
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In Vitro Metabolism, Clinical MetID and MIST
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Sekhar Surapaneni, PhD, Executive Director, DMPK, Nimbus Therapeutics
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1:40 - 2:25 pm
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Overview of IND/NDA Experiences
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Natalie Hosea, PhD, Vice President, Amgen
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2:25 - 3:10 pm
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FDA Experience and Expectations on IND/NDA ADME Studies
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Xinning Yang, PhD, Policy Lead of Clinical Pharmacology, FDA
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3:10 - 3:20 pm
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Major Sponsor Presentation
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BioAgilityx
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3:20 - 3:40 pm
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Break and Vendor Show
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-
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3:40 - 4:20 pm
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Clinical Pharmacology Studies to Support NDA Submission and Inform Drug Label
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Naveed Shaik, PhD, Senior Director, Pfizer
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4:20 - 5:00 pm
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ADME Package of KRAZATI® (adagrasib) and DMPK/Clin Pharm Challenges
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Cornelius Cilliers, PhD, Director, BMS
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5:00 - 5:30 pm
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Panel Discussion
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All Speakers
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5:30 - 6:30 pm
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Happy Hour
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Sponsor (TBD)
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2024-10-17, [Free Online] Patient Centric Blood Sampling for Facilitating De-centralized Clinical Trials: Implications for ClinOps, PK/ClinPharm, Bioanalytical and Biomarkers
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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
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