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Biologics Community


The Biologics Community focuses on the application of clinical pharmacology 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, via Annual Meeting programming and Community educational efforts.

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. These will be made available through appropriate communication channels. The Community will also be piloting the first ASCPT Webinar in 2015.

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.

Community Announcements
Please log in as a member to access more Community content.

ASCPT 2017 Annual Meeting Community Meeting
Biologics Community Meeting
Friday, March 17, 2017
3:00 pm - 4:00 pm Ballroom Foyer


  Recent Webinars 
Biologics Webinar
Title: Trends in Biologics and Biosimilar Development and Approval in the US 
Speaker: Hae-Young Ahn, PhD, RAC, Deputy Division Director, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration 
Moderator: Chaitali Passey, PhD
Description: Therapeutic biologics often represent cutting-edge research in which the latest scientific discoveries are translated into novel therapies that provide new treatment options for patients.  Biologic development and approval have been very active, and more than one third of new drugs approved by US FDA’s Center for Drug Evaluation and Research (CDER) are biologics in recent years.  As of December, 2016, 123 biologic products have been approved, and clinical pharmacology studies play significant roles in biologic development and approval because of biologics’ unique characteristics.  The Biologics Price Competition and Innovation Act (BPCI Act) created an abbreviated licensure pathway for biological products shown to be biosimilar to an FDA-licensed reference product.  To implement the BPCI Act the Agency has published several guidance documents and  the most recently finalized guidance is the Guidance for Industry – Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product.  Clinical pharmacology studies are critical to developing the data needed to support a demonstration of biosimilarity as part of a totality of evidence framework. 
Learning Objectives:
After attending the webinar participants will be able to:
  • Be familiar with the current status of new biologic development
  • Understand the differences between the goals of new biologic development and biosimilar development
  • Be familiar with development strategies of biosimilar products in the US
Login as a member to access the presentation slides.

Leadership


Chair
John D. Davis
Regeneron Pharmaceuticals

Dr. Davis is Head of Clinical Pharmacology at Regeneron Pharmaceuticals in Tarrytown, NY. Dr. Davis holds a PhD from the Victoria University of Manchester and a Bachelor of Pharmacy (Hons) from Nottingham University, both in the UK. Full bio
  Vice Chair
Coming soon

Steering Committee Members
Ryan S. Funk, PharmD, PhD
Bojan Lalovic, PhD
Ganesh Mugundu, MPharm, PhD
Chaitali Passey, PhD
Jonathan Tran, PharmD


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