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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
Title:  Development of Talimogene Laherparepvec, First FDA Approved Genetically Modified Oncolytic Virus: Perspectives of Clinical Pharmacology
Date and Time: Tuesday, October 29, 2019, 2:00 pm ET
Speakers and Panelists: Matt Hsu, PhD, Sumita Bhatta, MD, and Xiaofei Wang, PhD
Moderators: Yow-Ming Wang, PhD
Description: Talimogene laherparepvec is an oncolytic virus-based therapeutic product that is derived from herpes simplex virus type 1 (HSV-1). It has been genetically modified to efficiently replicate within tumors and to enhance systemic antitumor immune responses by producing the immune stimulatory protein granulocyte-macrophage colony-stimulating factor (GM-CSF). Clinical pharmacology program of talimogene laherparepvec was designed to characterize the kinetics of viral clearance through biodistribution in the blood and urine, shedding from injected tumors and exterior of the dressing, anti-HSV-1 seroconversion, and GM-CSF expression in tumor tissue and serum. This special presentation will provide an introduction of genetically modified products and regulatory advances in this field, as well as challenges and clinical pharmacology support of talimogene laherparepvec development pathway.
Registration Link: 
https://attendee.gotowebinar.com/register/2000518926673682691
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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