Conference Information

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Scientific Committee

Kristi Griffiths
co-Chair ; Eli Lilly & Company
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Julia O'Neill
co-Chair ; Moderna
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Stan Altan
Janssen
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Timo Bailer
Boehringer-Ingelheim
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Rick Burdick
Burdick Consulting
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Catherine Cheng
Novartis Gene Therapies
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JoAnn Coleman
Spark Therapeutics
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Katherine Giacoletti
Synolostats, LLC
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Theodoro Koulis
Genentech
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Ruojia Li
Bristol-Myers Squibb
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Tsai-Lien Lin
FDA
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Jia Liu
Pfizer
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Areti Manola
Janssen
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Chuck Miller
Merck
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Guillermo Miro-Quesada
AstraZeneca
Laura Pack
Rezolute
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Jose Ramirez
Amgen
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Tara Scherder
Synolostats, LLC
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Tim Schofield
CMC Sciences
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Meiyu Shen
FDA
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Scientific Agenda

Confirmed Speakers

Confirmed Speakers - Session / Breakout co-Chairs – Facilitators

Stan Altan
Janssen Pharmaceutical R&D LLC
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Timo Bailer
Boehringer Ingelheim
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Diane Blumenthal
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Bruno Boulanger
PharmaLex
See the Biosketch See the Abstract
Andreas Brandt
BfArM
See the Biosketch See the Abstract
Cristiana Campa
GSK & Vaccines Europe
See the Biosketch See the Abstract
Fang Chen
SAS Institute Inc.
See the Biosketch See the Abstract
Aili Cheng
Pfizer
See the Biosketch See the Abstract
JoAnn Coleman
Spark Therapeutics
See the Biosketch
Reza Eivaskhani
Janssen
See the Biosketch See the Abstract
Paul Faya
Eli Lilly and Company
See the Biosketch See the Abstract
Jinxin (Jerry) Gao
Eli Lilly and Company
See the Biosketch See the Abstract
Katherine Giacoletti
Merck & Co., Inc.
See the Biosketch
Kristi Griffiths
Eli Lilly & Company
See the Biosketch
Theodoro Koulis
Genentech
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Qianqiu (Jenny) Li
Janssen Research & Development
See the Abstract
Ruojia Li
Bristol-Myers Squibb
See the Biosketch
Tsai-Lien Lin
FDA/CBER
See the Biosketch
Jia Liu
Pfizer
See the Biosketch
Olav Lyngberg
Janssen
See the Biosketch See the Abstract
Areti Manola
Janssen
See the Biosketch
Chuck Miller
Merck & Co., Inc.
See the Biosketch
Guillermo Miro-Quesada
AstraZeneca
Julia O’Neill
Moderna
See the Biosketch See the Abstract
Laura Pack
Rezolute
See the Biosketch
John Peterson
PDQ Research & Consulting
See the Biosketch See the Abstract
José Ramirez
Amgen Inc
See the Biosketch See the Abstract
Barbara Rellahan
Amgen Inc.
See the Biosketch See the Abstract
Tara Scherder
Synolostats
See the Biosketch
Tim Schofield
CMC Sciences
See the Biosketch
Arzu Selen
FDA/CDER/OPQ/OTR
See the Biosketch See the Abstract
Meiyu Shen
FDA/CDER
See the Biosketch
Li Zhang
Amgen
See the Biosketch See the Abstract

Parallel Breakout Sessions

Session I - Prior Knowledge as a Means to Further QbD Implementation

Breakout Session 1 - Prior Knowledge as a Means to Further QbD Implementation

Link to Abstract

Facilitated by Ruojia Li, Bristol-Myers Squibb

Breakout Session 2 – Opportunities for Working with Big Data in Biologicals

Link to Abstract

Facilitated by JoAnn Coleman, Spark Therapeutics

Session II – CMC Statistics Advancement in a Regulated Industry

Breakout Session 1 – CMC Statistics Advancement in a Regulated Industry

Link to Abstract

Facilitated by Laura Pack, Rezolute

Breakout Session 2 – Patient-Centric Specifications

Link to Abstract

Facilitated by Tim Schofield, IABS; CMC Science LLC

Session III – Current Trends and Issues in Continuous Manufacture Driving Drug Development

Breakout Session 1- Current Trends and Issues in Continuous Manufacture Driving Drug Development

Link to Abstract

Facilitated by Areti Manola, Janssen

Breakout Session 2 – Updating Limits Using Bayesian Methods

Link to Abstract

Facilitated by Tara Scherder, Synolostats, LLC

Session IV – Case Studies of Acceleration with a Lifecycle Approach

Breakout Session 1- Case Studies of Acceleration with a Lifecycle Approach

Link to Abstract

Facilitated by Katherine Giacoletti, Merck & Co., Inc.

Breakout Session 2 – Bayesian Success Stories in CMC

Link to Abstract

Facilitated by Chuck Miller, Merck & Co., Inc.

Meeting Slides

Access to meeting’s slides is given to meeting’s participants for a period of 4 weeks after the meeting.
A unique Login and password are sent by email to participants right after the meeting.
Afterwards the slides are only accessible to IABS member, using their Member Login and Password.


Click here to download the Meeting Slides

Organizer

The International Alliance for Biological Standardization (IABS) is an independent, non-profit scientific Alliance, governed by Articles 60-79 of the Swiss Civil code and by its Constitution. Its office is located in Geneva (Switzerland). IABS has members in over 50 countries.

Officers

Mission

IABS is devoted to the scientific and medical advancement of biologicals, by facilitating communication among those who develop, produce and regulate biological products for human and animal health.

Publications

Reports and proceedings of IABS conferences and workshops appear in its journal Biologicals, published by Elsevier and /or in the series Developments in Biologicals published by Karger.

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