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.

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Past Webinars:
The webinars below can be accessed in the Members Only Webinar Library: Access Library
  • The US Food & Drug Administration's Perspective on Immunogenicity
  • Quantitative Clinical Pharmacology Approaches Towards Understanding Exposure and Response of CAR-T Cell Therapies
  • Product to Patient Translation of Cell Therapies: Opportunities & Challenges for MIDD
  • Development of Talimogene Laherparepvec, First FDA Approved Genetically Modified Oncolytic Virus: Perspectives of Clinical Pharmacology
  • Considerations in the Design and Development of T-cell Dependent Bispecific Antibodies for Cancer Immunotherapy
  • Mechanistic Models of the Immune System for Quantitative Prediction and Simulation of Biotherapeutic Immunogenicity
  • Role of PK/PD Assessments at the Site of Action in Decision Making during the Development of Monoclonal Antibodies: Examples and Case Studies
Junyi Li

Junyi Li, PhD

Community Chair
Sihem Bihorel

Sihem Bihorel, PhD

Community Vice Chair
J Chen

Joseph Chen, PharmD

Community Co-Past Chair
A Singh

Aman Singh, PhD

Community Co-Past Chair

Steering Committee Members

Yow-Ming Wang, PhD
Ryan Funk, PharmD, PhD
Joseph Chen, PharmD
Ye Xiong, PhD
Nael Mostafa, PhD
John Davis, PhD
Chandra Udata, PhD
Lora Hamuro, PhD
Bojan Lalovic, PhD
Songmao (Ben) Zheng, PhD
Hazem Hassan, PhD
Junyi Li, PhD
Aman Singh, PhD
Sharad Sharma, PhD
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