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

Confirmed Speakers - Session / Breakout co-Chairs – Facilitators

Stan Altan
Janssen Pharmaceutical R&D LLC
See the Biosketch
Timo Bailer
Boehringer Ingelheim
See the Biosketch
Diane Blumenthal
See the Biosketch
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
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
See the Biosketch
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

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.

The Meeting Slides will be available soon!

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.

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