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Webcast
[Free Online Webcast From Boston-PBSS] PK-PD considerations and human dose projection for novel modalities
Speakers:
Zheng Yang, BMS; Vijay Upreti, Amgen; Guohua An, Univ of Iowa; Joanne Brodfuehrer, Pfizer; Jeff Kurz, Alnylam; Pablo Morentin Gutierrez, Astrazeneca
Organizers:
Punit Marathe (Agios) and Haojing Rong (Atlas Venture NewCo)
Date:
2022-10-06- 10/07/2022
Time:
13:00-16:30 Eastern Time
Registration fee:
Free
Location:
Webcast from Boston PBSS
Major Sponsor:
Vendor show vendors registered to date:
Registration: http://www.PBSS.org
Registration deadline:2022-10-05
(it will close sooner if the seating cap is reached)
About the Topic
The concept of “drugs” has been expanded significantly in the past decade. New modalities stemming from novel mechanisms of action are delivering their therapeutic promise to the patients. These novel modalities range from bispecific antibodies to siRNA to gene therapy in the large molecule area. While in the traditional small molecule area, new players such as targeted protein degraders and covalent binders challenge us to consider PK/PD relationships differently. When it comes to determining the most important parameter in drug development – “the efficacious dose”, learnings from both old and new approaches are being used. In this workshop, we have invited a panel of speakers that are working at the forefront of these new modalities to share their experience in investigating the PK/PD relationship and projecting human dose of these novel modalities.
Note: This is an online meeting, The Zoom link will be sent to the registrants 1+ days before the event.
Day 1 Agenda
Time (EST)
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Time (PDT)
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Topic
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Presenter
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1:00 - 1:05pm
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10:00 -10:05am
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PBSS Introduction
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1:05-1:10 pm
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10:05-10:10am
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Introduction
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Punit Marathe, VP, DMPK/Clin Pharm, Agios
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1:10-2:00 pm
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10:10-11:00am
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Pharmacokinetic and Pharmacodynamic Considerations in Achieving a Low Human Dose for Targeted Covalent Inhibitors
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Zheng Yang, Scientific Senior Director, BMS
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2:00-2:50 pm
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11:00-11:50am
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Model-Informed Drug Development – Case Examples of Small-Molecule Compounds Exhibiting Target-Mediated Drug Disposition
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Guohua An, Associate Professor, University of Iowa |
2:50-3:00 pm
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11:50-12:00pm
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Break
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-
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3:00-3:50 pm
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12:00-12:50pm
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Clinical Pharmacology, Modeling and Simulation Strategies for Optimal Development of Bispecific T-cell Engagers
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Vijay Upreti, Director and Clinical Pharmacology Oncology Therapeutic Area Leader, Clinical Pharmacology, Modeling & Simulation, Amgen Inc.
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3:50-4:30 pm
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12:50-1:30pm
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Panel discussion
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All Speakers
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Day 2 Agenda
Time (EST)
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Time (PDT)
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Topic
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Presenter
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1:00 - 1:05 pm
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10:00 -10:05 am
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PBSS Introduction
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1:05-1:10 pm
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10:05-10:10 am
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Introduction
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Haojing Rong, SVP, Translational Science, Atlas Venture NewCo
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1:10-2:00 pm
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10:10-11:00 am
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Clinical Pharmacology, Modeling & Simulation Strategies for Optimal Development of Bi-Specific T-cell Engagers
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Vijay Upreti, Director and Clinical Pharmacology Oncology Therapeutic Area Leader, Clinical Pharmacology, Modeling & Simulation, Amgen Inc.
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2:00-2:50 pm
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11:00-11:50 am
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Translation of Preclinical Gene Therapy in Vivo Studies Across Species
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Joanne Brodfuehrer, Research Fellow, Pfizer
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2:50-3:00 pm
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11:50-12:00 pm
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Break
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-
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3:00-3:50 pm
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12:00-12:50 pm
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Intrathecal Delivery of siRNA-Conjugates to the CNS: PK/PD Relationships in Nonclinical Species
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Jeff Kurz, Associate Director, Alnylam
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3:50-4:30 pm
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12:50-1:30 pm
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Panel discussion
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All Speakers
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2024-06-25, [In-Person] Preclinical development and IND filing for small molecules: Nuts, Bolts and Best Practices
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