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PBSS Workshop——Translational PK/PD and Human Dose Projection for Antibodies/ADCs and Novel Therapeutic Modalities

2024-08-27
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The landscape of disease-treatment modalities has undergone a dramatic transformation in recent years. New therapeutic modalities, with innovative mechanisms of action, are revolutionizing patient care. Some of these advancements extend beyond traditional small molecules and antibodies to encompass exciting areas like bispecific antibodies, ADCs and gene therapies. Even within the small molecule realm, covalent binders, biased agonists and pan-inhibitors are pushing the boundaries of our understanding of pharmacokinetic (PK)/pharmacodynamic (PD) relationships. In addition to this, therapeutics that are intended for ocular and neuro delivery put forth challenges associated with delivering desired drug concentrations at the site of action. Translational PK/PD aspects for these emerging modalities present unique challenges and opportunities. The recommendation of an optimal First-In-Human (FIH) dose as well as the determination of "efficacious dose" – both cornerstones of drug development – is being re-evaluated. This workshop brings together a distinguished panel of experts working at the forefront of these modalities. They will share their insights and experiences in navigating translational PK/PD considerations and projecting human doses for these groundbreaking therapies. Medicilon team will be present throughout the event. 

Agenda

Time   PSTTopicSpeaker
8:45-9:00 amPBSS   Welcome Shichang   Miao, PhD, President, PBSS
9:00-9:10 amWorkshop   Introduction Smita   Salian-Mehta, PhD, DABT, ERT, Senior Project Toxicologist, Nonclinical Safety   and Pathobiology, Gilead Sciences
9:10-9:50 amSetting   the Stage: an Overview of BiotherapeuticsChristina   de Zafra, PhD, DABT, Director, Drug Safety Research & Development, Pfizer
9:50-10:30 amCD3   bispecific: An Important Modality in Cancer Immunotherapies – Considerations   for Nonclinical DevelopmentKaushik   Datta (KD), PhD, DABT, Senior Scientific Director, Bristol Myers Squibb
10:30-11:10 amNonclinical   Safety Assessment Strategies for Peptide-MHC Targeting TherapeuticsXiaoting   Wang, PhD, DABT, Director Translational Safety and Bioanalytical Sciences,   Amgen
11:10-11:20 amMajor   Sponsor PresentationSponsor
11:20-11:40 amBreak   and Vendor Show Break   and Vendor Show 
11:40am-12:40 pmLunchLunch   (BioIVT)
12:40-1:15 pmUsing   a Platform Approach to Assess Nonclinical Safety of ADCsHaley   Neff-LaFord, PhD, DABT, Executive Director, Drug Safety Research &   Development, Pfizer
1:15-1:50 pmEvolution   of Peptide Therapeutics - Nonclinical Considerations for Drug DevelopmentMayur   Mitra, PhD, DABT, Distinguished Scientist, Toxicologist, Genentech
1:50-2:30 pmA   Sticky Situation: Current Safety Considerations for Developing Molecular   Glues and Other Targeted Protein DegradersJessica   Sims, PhD, DABT, Principal Scientist, Toxicologist, Genentech
2:30-2:40 pmMajor   Sponsor PresentationSponsor
2:40:3:00 pmBreak   and Vendor Show Break   and Vendor Show 
3:00-3:25 pmManaging   Immunogenicity of Biologics During Nonclinical Safety Assessment StudiesMajlinda   Thomas, Senior Research Scientist II, DMPK, Gilead Sciences 
3:25-3:50 pmOverview   of in-vitro Cytokine Releases Assays in the Context of Preclinical Safety   AssessmentsCarolyne   Dumont, DABT, Scientific Director, Immunology, Charles River Laboratories
3:50-4:30 pmRegulatory   perspectivesIjeoma   Uzoma, PhD, Pharmacology/Toxicology Team Lead, FDA
4:30-5:00 pmAll   SpeakersPanel   Discussion
5:00-6:00 pmHappy   HourHappy   Hour Sponsor (Sponsor) 


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Subject丨PBSS Workshop September 10

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