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 PST | Topic | Speaker |
8:45-9:00 am | PBSS Welcome | Shichang Miao, PhD, President, PBSS |
9:00-9:10 am | Workshop Introduction | Smita Salian-Mehta, PhD, DABT, ERT, Senior Project Toxicologist, Nonclinical Safety and Pathobiology, Gilead Sciences |
9:10-9:50 am | Setting the Stage: an Overview of Biotherapeutics | Christina de Zafra, PhD, DABT, Director, Drug Safety Research & Development, Pfizer |
9:50-10:30 am | CD3 bispecific: An Important Modality in Cancer Immunotherapies – Considerations for Nonclinical Development | Kaushik Datta (KD), PhD, DABT, Senior Scientific Director, Bristol Myers Squibb |
10:30-11:10 am | Nonclinical Safety Assessment Strategies for Peptide-MHC Targeting Therapeutics | Xiaoting Wang, PhD, DABT, Director Translational Safety and Bioanalytical Sciences, Amgen |
11:10-11:20 am | Major Sponsor Presentation | Sponsor |
11:20-11:40 am | Break and Vendor Show | Break and Vendor Show |
11:40am-12:40 pm | Lunch | Lunch (BioIVT) |
12:40-1:15 pm | Using a Platform Approach to Assess Nonclinical Safety of ADCs | Haley Neff-LaFord, PhD, DABT, Executive Director, Drug Safety Research & Development, Pfizer |
1:15-1:50 pm | Evolution of Peptide Therapeutics - Nonclinical Considerations for Drug Development | Mayur Mitra, PhD, DABT, Distinguished Scientist, Toxicologist, Genentech |
1:50-2:30 pm | A Sticky Situation: Current Safety Considerations for Developing Molecular Glues and Other Targeted Protein Degraders | Jessica Sims, PhD, DABT, Principal Scientist, Toxicologist, Genentech |
2:30-2:40 pm | Major Sponsor Presentation | Sponsor |
2:40:3:00 pm | Break and Vendor Show | Break and Vendor Show |
3:00-3:25 pm | Managing Immunogenicity of Biologics During Nonclinical Safety Assessment Studies | Majlinda Thomas, Senior Research Scientist II, DMPK, Gilead Sciences |
3:25-3:50 pm | Overview of in-vitro Cytokine Releases Assays in the Context of Preclinical Safety Assessments | Carolyne Dumont, DABT, Scientific Director, Immunology, Charles River Laboratories |
3:50-4:30 pm | Regulatory perspectives | Ijeoma Uzoma, PhD, Pharmacology/Toxicology Team Lead, FDA |
4:30-5:00 pm | All Speakers | Panel Discussion |
5:00-6:00 pm | Happy Hour | Happy Hour Sponsor (Sponsor) |