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Pharmacometrics & Pharmacokinetics (PMK) Community

Community Goals

Scientific Expertise:
  • The PMK Community is a unique resource to learn about newer applications of pharmacometrics and pharmacokinetics and best practices via programming, webinars and white papers enabled by participation of members with diverse interests (pharmacokineticists, statistical pharmacometricians, PBPK experts, transporter experts from industry, academia, and regulatory, and student/trainees).
Catalyst for Innovation:
  • Hosts educational forums to promote emerging areas of influence by thought-leaders. Also contributes to establishing point-counterpoint formats to discuss hot topics to enhance the attendee experience at Annual Meetings.
Influence and Impact:
  • Currently working to identify at least one focus area for which a concept outline will be developed for a Best Practice White Paper followed by 2-year goal to publish an article.
Education and Communication:
  • The PMK Community is exploring opportunities to set up a model library to capture pertinent technical information to supplement information in published articles from select journals. PMK is also active on social media will ensuring frequent communication with members.
Organizational Effectiveness:
  • PMK has established Steering Committee membership along with general roles & expectations necessary to align with contributions with other Community goals. The Community is also developing a communication outreach plan to Community members to announce key dates and news updates.

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Upcoming Webinar
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

Past Webinars

Sree Kasichayanula, PhD

Community Chair

 

Chunze Li, PhD

Community Vice Chair

 

Michael A. Tortorici, PharmD, PhD

Community Past Chair

 

Steering Committee

Neeraj Gupta, PhD
Chao Liu, PhD
Robert Bies, PharmD, PhD
Hechun Wang, MS
Xiaoying Chen, PhD
Chunze Li, PhD
Michael Tortorici, PharmD, PhD
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