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Biologics Community

The Biologics Community focuses on the application of clinical pharmacology and translational medicine principles in the development and clinical usage of biological drug therapies.

Community Goals 

Scientific Expertise
The Biologics Community is a resource for best practices in Clinical Pharmacology for Biologic Therapies, via Annual Meeting programming and Community educational efforts.   
Catalyst for Innovation
Identifies ‘disruptive’ approaches and new modalities of biologic drugs (vaccines, sRNAi, gene therapy, etc.) that challenge standard thinking within the Clinical Pharmacology discipline and showcase new ideas with the Community and ASCPT.
Influence and Impact
Develops and maintains strong relationships with other Communities within ASCPT and other complementary organizations to shape the conversation and be a recognized thought leader on the most current issues impacting the utilization of biologic therapies.
Education and Communication
The Biologics Community is developing educational materials that describe the unique characteristics of biologic drug therapies and clinical considerations for their safe and effective use.
Organizational Effectiveness
The Biologics Community Steering Committee has been established along with general roles & expectations necessary to align the Steering Committee contributions with other Community goals. The Community also has steady communication outreach to Community members to announce key dates and news updates as well as recognition of our Community volunteers and members for their time and effort in organizing various Community activities.

Join the LinkedIn Group.

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:

Yow-Ming Wang, PhD

Community Chair

 

Ganesh M. Mugundu, MPharm, PhD

Community Vice Chair

 

Ryan S. Funk, PharmD, PhD

Community Past Chair

Steering Committee Members
Bojan Lalovic, PhD
Ganesh Mugundu, MPharm, PhD
Chaitali Passey, PhD
Ye Xiong, PhD
Yi Ting (Kayla) Lien
Nael Mostafa, PhD


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