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ASCPT Members-Only Webinar presented by the Biologics Community, Pharmacometrics & Pharmacokinetics Community (PMK), Systems Pharmacology Community (SP), and Biomarkers & Translational Tools (BTT) Communities
: Clinical Pharmacology Considerations in Development of siRNA Therapeutics: Case Study of Givosiran
Date and Time
: Tuesday, April 21, 2020, 1:00 pm ET
: Sagar Agarwal, PhD and Varun Goel, PhD
: Sagar Agarwal, PhD
Description: Small interfering RNAs (siRNAs) are a promising type of RNA-based therapeutic oligonucleotide drugs that can inactivate several target RNA molecules in a sequence-specific manner. Since the discovery of RNA interference (RNAi), a significant progress has been made in the development of therapeutic siRNAs including approval of the first ever siRNA therapy. Givosiran is a FDA approved siRNA therapeutic for the treatment of acute hepatic porphyria. Givosiran which is administered subcutaneously utilizes a GalNAc conjugate technology to enable targeted delivery to liver, the site of action. This presentation will give an overview of the clinical pharmacology program of givosiran, that included characterization of the PK and PD of givosiran, the impact of extrinsic and intrinsic factors, as well as special populations. Modeling and simulation analysis that enabled dose selection will be discussed.
Registration Link: hhttps://zoom.us/webinar/register/WN_idlcGg4PRsOVGKc0H3A1Rw
Quantitative Pharmacology Network Hot Topics Initiative
One of the primary goals of the Quantitative Pharmacology Network is to enhance the educational opportunities for members. Help further the “Hot Topic” communications and raise awareness of new tools and methods developing in quantitative pharmacology, news and views relevant to the discipline, emerging challenges and opportunities, topics of active scientific debate, etc. Suggest your topic via email to email@example.com
Current Quantitative Pharmacology Hot Topic Commentaries:
Quantitative Pharmacology Influence & Impact Initiative
Under the visionary leadership of Anne C. Heatherington, PhD, the Impact & Influence Initiative was launched to highlight the impact of Quantitative Pharmacology approaches in clinical pharmacology, translational medicine and therapeutics across the discovery, development, regulation and post-marketing applications.
The crowd-sourced compendium of impactful case-examples along with detailed speaker notes provided by the contributors to the Quantitative Pharmacology Network at the ASCPT 2017 Annual Meeting and their contact information are now available:
On behalf of the ASCPT Quantitative Pharmacology Network, we would like to again invite you to contribute to a new case study for the Influence and Impact Initiative that broadly highlights the impact of Quantitative Pharmacology in discovery and development strategy making, as well as in regulatory and post-marketing decision making. The aim of the initiative is to build upon the first version of the crowd-sourced compendium repository with new state-of-the-art quantitative pharmacology applications to increase awareness, advocacy for and education in applied Quantitative Pharmacology sciences. In addition, the initiative aims to detect advances and new trends in the field.
If you would like to contribute, please let us know your interest by April 17, 2019
, by sending an email with the title for your case study to Aline Barth, PhD
, or Akshanth Polepally, PhD
. Draft case studies and speaker notes would be due May 31, 2019.