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Symposium

[Free Online] Highlights of 2022 FDA Approvals


Speakers: Elizabeth Kelley (Genentech), Karen Samy (Genentech)
Organizers: Cyrus Khojasteh, Genentech; Shichang Miao PhD, Amgen
Date: 2023-06-20
Time: 11:30-13:40 Pacific Time
Registration fee: 0
Location: Online via Zoom
Major Sponsor:
Vendor show vendors registered to date:
Registration: http://www.PBSS.org
Registration deadline:2023-06-19  (it will close sooner if the seating cap is reached)

About the Topic

[Note: this event is part of the "Success Stories and Lessons Learned from Recent FDA Approvals", a joint series by PBSS and California Life Sciences (CLS). The Zoom link will be provided to the registrants 1+ days before the event]

Seminar Overview: 

In this presentation, the speakers will summarize the 2022 cohort of new drugs approved by the FDA.  Statistics on the overall cohort will be discussed, followed by a short summary of key features of approved drugs. the speakers will highlight case studies with interesting discovery or development stories from the cohort as well as some examples of drugs that have failed to get approvals in 2022 and discuss various reasons and their overall journey. 


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2024-08-22, [Free Online] Diabetes and Obesity Treatments: Current and Emerging Landscapes of GLP-1, GIP, and Beyond
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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