International Alliance for Biological Standardization

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BIOTHERAPEUTICS

Introduction

The Biotherapeutics Committee works together to increase global access to critical protein-based therapies by encouraging science-based solutions and supporting access to venues where scientists can meet and discuss challenges and potential opportunities for global alignment.

Goals & Objectives

Identify and provide opportunities for researchers, industry, and regulators to address long standing and emerging issues which affect global access to biotherapeutics.

Provide organizational support for meetings where leaders can openly discuss challenges and share information, leading to potential solutions or sparking
innovation.

Engage leaders working in the biopharmaceutical field and health care such that the paths to achieve common goals are well articulated and can be realized.

Encourage innovation and forward-thinking solutions.

Members

Shawn NOVICK
Chair, consultant

Tim SCHOFIELD
CMS Sciences

Barbara RELLAHAN
Amgen

Annie STRUGESS
BMS

Robert MATALIANO
Genzyme

Elaine GRAY
NIBSC

Madhu SILUVERA
Merck

Melody GOSSAGE
Lilly

T. LUBINIECKI
IABS

Michael TARLOV
NIST

Ned MOZIER
Pfizer

Kris BARNTHOUSE
JnJ

Brendan HUGHES
BMS

Frank LI
Catalent

Priorities & Initiatives

Conferences and Workshop planning

In 2019, 2nd Specifications Workshop and the 5th annual statistics workshop (merged) : “Setting specifications for biological products: A pathway to harmonization”
2020 : 6th Annual Statistics Workshop

In 2021, the Biotherapeutics committee is currently in the planning stages for 2 conferences and a webinar.

  • 7th annual statistics conference : Quality by design and leveraging platform knowledge, November 8-11
  • The 3rd workshop on Global Harmonization of Specifications, Date Q4, 2021 TBD
  • A webinar on FMT (Fecal microbial transplantation), May 21 2021