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Webinar Resources

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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
Title: Clinical Pharmacology Considerations in Development of siRNA Therapeutics: Case Study of Givosiran
Date and Time: Tuesday, April 21, 2020, 1:00 pm ET
Speakers: Sagar Agarwal, PhD and Varun Goel, PhD
Moderator: 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

ASCPT Members-Only Webinar presented by the Early Career (EC) Community
Title: Clinical Pharmacology Considerations in the Development of Immune-Oncology Drugs
Date and Time: Thursday, April 30, 2020, 1:00 pm ET
Speaker: Nidal Al-Huniti, PhD
Moderator: Malek Okour, PhD, and Nithya Srinivas, PhD
Description: Building on the success of PD-1 (or PD-L1) inhibitors, a wave of next generation immunotherapies with different mechanisms of action (e.g., LAG3, CD40, ICOS, TIM-3, IDO1, GITR, STING, OX40, TIGIT) are being developed across multiple oncology indications. A key characteristic of immune-oncology programs is the assessment of clinical pharmacology information in patients within safety and efficacy studies, rather than through the use of healthy volunteer studies. As a result of this condensed trajectory of development, unique opportunities exist for the use of modeling and simulation strategies to address several important questions in immune-oncology development - from translation of pre-clinical data into first-in-human studies, to the characterization of relationships between exposure and safety/efficacy in pivotal clinical trials. This webinar will focus on strategies to optimize and highlight immuno-oncology drug development and expand on pharmacometrics, clinical pharmacology and statistical strategies to optimize clinical trial design and development of immune-oncology drugs.
Registration Link: https://zoom.us/webinar/register/WN_ZziZ45ahSci1dMlOumy0bA 


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