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Symposium

Tox 21 and New Approach Methodology (NAMs): Using Emerging Technologies to Improve Translational Research and Safety Assessment Predictions (jointly by SOT-NorCal & PBSS)


Speakers: Kathryn Page (Clorox); Shichang Miao (ChemoCentryx); Thomas Hartung (The Bloomberg School of Public Health); Emily Reinke (U.S. Army Public Health Center); Suzanne Fitzpatrick (FDA); Pamela Lein (UC Davis); Ellen Berg (Eurofins); Will Proctor (Genentech)
Organizers:
Date: 2019-04-25
Time: 8:30-17:00 Pacific Time
Registration fee: (USD): Regular (with lunch): $60; Students & Postdocs (with lunch): $0
Location: South San Francisco Conference Center
Major Sponsor:
Vendor show vendors registered to date:
Registration: http://www.PBSS.org
Registration deadline:2019-04-23  (it will close sooner if the seating cap is reached)

About the Topic

Preliminary Agenda

Morning Session

7:30 am – 8:30 am          Registration & Breakfast

8:30 am – 8:45 am          Opening message from The NorCal & PBSS Presidents - Kathryn Page, PhD, DABT, Clorox; Shichang Miao, PhD, ChemoCentryx

8:45 am – 9:30 am          Plenary Speaker:  Alternative Methods for the 21st Century - Thomas Hartung, PhD, Johns Hopkins Bloomberg School of Public Health

9:30 am – 10:15 am        From Experimental Concept to Regulatory Acceptance:  The Success of Alternative Methods in Skin Sensitization Testing - Emily Reinke, PhD, DABT, U.S. Army Public Health Center

10:15 am – 10:30 am     Coffee Break

10:30 am – 11:15 am     Consumer Product Safety Assessment: An Alternative Approach - Kathryn Page, PhD, DABT, Clorox

11:15 am – 12:00 pm     Predictive Toxicology for Regulatory Decisions:  Implementing New Approaches at FDA - Suzanne Fitzpatrick, PhD, FDA

12:00 pm – 1:30 pm       Lunch Break: Lunch with Experts, Posters

Afternoon Session

1:30 pm – 1:45 pm         Chapter announcements and acknowledgements

1:45 am – 2:05 am          NorCal Student Award presentation: TBD

2:05 pm – 2:45 pm         In Vitro and Alternative Models of Neurotoxicity:  Opportunities and Challenges for Neurotoxicity Testing - Pamela Lein, PhD, DABT, UC Davis

2:45 pm – 3:00 pm         Coffee Break

3:00 pm – 3:45 pm         Applying Human-based Phenotypic Profiling in Early Drug Discovery - Ellen Berg, PhD, Eurofins

3:45 pm – 4:30 pm         Industry Perspective on Evaluating, Qualifying, and Implementing Complex In Vitro Models to Support Drug Discovery - Will Proctor, PhD, DABT, Genentech

4:30 pm – 6:00 pm         Reception & Networking


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2024-09-10, [In-Person] Translational PK/PD and Human Dose Projection for Antibodies/ADCs and Novel Therapeutic Modalities
2024-09-20, [In-Person] Nonclinical Safety Assessments of Biologics and Other Novel Modalities for IND/NDA/BLA Filings
2024-09-25, [Free Online] Development of Protein Degraders: Computational Modeling, Medicinal Chemistry and Early Development
2024-10-10, [In-Person] Regulatory Global Submission: Strategies and Best Practices for FDA, EMA and PMDA
2024-10-25, [Free Online Workshop] Unleashing the Power of Real-World Evidence / Data (RWE/RWD) to Facilitate Drug Discovery, Development, and Beyond
2024-11-01, [In-Person] Clinical Pharmacology Studies on Hepatic and Renal Impairments for NDA Filing: Strategies, Design, Conduct, Analysis and Regulatory Aspects
2024-11-13, [Free Online Workshop] Career Transition for Research Scientists: Business Development & BioPartnering
2024-11-15, [In-Person] Bioanalysis for Biologics and Cell/Gene Therapy Products: Refining Established Approaches for New Complex Therapeutics
2025-01-22, [In-Person] Small-Molecule Formulation for Discovery & Early Development (jointly by PBSS / AAPS-BADG / Syner-G)
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