Speakers: Dennis X Hu, Drug Hunter; Sandhya Mandlekar, Genentech; Thomas Pillow, Genentech; Paulina Jakubiak-Fort, Genentech; Di Zhou, Amgen; Chee Ng, NewGround Pharmaceutical Consulting; Kapil Gadkar, Genentech
Organizers: Amrita Kamath, Genentech; Sandhya Mandlekar, Genentech; Vittal Shivva, Genentech
Date: 2024-09-10
Time: 8:45-17:30 Pacific Time
Registration fee: Regular attendees: $295; Academic/Students/Postdocs/Out-of-Pocket: $45; Major Sponsorship: $3000; Vendor Show: $695, Happy Hour Sponsorship: $975; Lunch Sponsorship: $1250; On-site Registration: $500
Location: Crowne Plaza, Foster City, CA (San Francisco Bay Area)
Major Sponsor: (1)Certara;(Major Sponsorship - afternoon session still open)
Vendor show vendors registered to date: (1)Meadowhawk Biolabs
Registration: http://www.PBSS.org
Registration deadline:2024-09-09  (it will close sooner if the seating cap is reached)

About the Topic

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. These advancements extend beyond traditional small molecules and antibodies to encompass exciting areas like bispecific antibodies, ADCs, ASOs, siRNA, cell & gene therapies. Even within the small molecule realm, targeted protein degraders, molecular glues and covalent binders 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.