Full Conference Details Inside

Tap into China’s Fast-Growing Biopharmaceutical Market
IBC’s 4th Annual
Tuesday, October 9, 2012
1:30 pm – 3:15 pm
Smart Solutions for Early Development and Manufacturing
of Biopharmaceuticals: How CMO’s Can Help Product
Companies be Successful
Co-Sponsored by:
Optimizing drug substance and drug product development & manufacturing is a key success factor in preclinical
development of biopharmaceuticals with a high impact on product quality and value. Both processes go hand in
hand and most biotech companies rely on external partner. This panel discussion focuses on critical issues such
as when to start, how to reduce the risk, how to keep costs down before POC and many other crucial questions.
This panel shall provide models and solutions for early stage product development leveraging a CMO’s core
competence. Leaders of international CMO’s bring in their view and answer specific questions from the audience.
Panelists:
Larry Thomas, Vice President, Global Sales & Marketing, DSM Biologics
David P. Wellis, Ph.D., Senior Vice Presidnet, Business Development, BioAtla LLC
Axel Schleyer, Ph.D., Vice President, Business Development & Key Account Management Americas,
Boehringer Ingelheim
Klause B. Schoepe, Vice President, Client Relations, Rentschler Biotechnologie GmbH
Wednesday, October 10, 2012
10:30 am – 12:00 pm
Reducing the Risk of a Contamination Event Due to
Raw Materials
Sponsored by:
Friday, October 12, 2012 (continued)
There are a number of strategies for reducing raw materials risk, including sourcing of animal-free or chemicallydefined
components. But, as the old saying goes, ‘the devil is in the details.’
For example, there is no standard definition for ‘animal free’ or ‘chemically defined’ media or supplements. As
a result, suppliers can have different interpretations, which can have implications for risk mitigation and raw
materials consistency in biopharmaceutical production.
This panel will address topics such as:
• What are the current definitions for AF and CD materials?
• Is there a need for standard definitions of AF and CD across the industry?
• What are the key criteria for mitigating the risk of viral or other biological contaminants?
• What are the best practices for sourcing raw materials in order to mitigate the risk of a
contamination event?
• What does the future hold for raw materials sourcing?
Moderator:
Barbara Potts, Ph.D., Senior Consultant, Potts and Nelson Consulting, LLC
Panelists:
To be announced
Thought Leadership Forums
August 21-22, 2012
Grand Hyatt Hotel
Shanghai, China
Download the brochure today at: www.IBCLifeSciences.com/BPIChina
Thursday, October 11, 2012
10:30 am - 12:00 pm
Update on Global Advances in the Development and Regulation
of Biosimilars
The global regulatory framework for biosimilars continued to evolve over the past year with the development
and publication of a number of significant new regulatory guidance documents. Notable milestones include
the publication of the first three draft biosimilar guidance documents by the US FDA and additional
draft product-specific guidelines by the EMA. In addition, the EMA initiated the process to update the
overarching guidelines on similar biological medicinal products originally published in 2006. This Thought
Leadership Forum will explore recent developments in this area, including:
• The US FDA risk-based “totality-of-evidence” approach to demonstrating biosimilarity;
• Challenges associated with the US interchangeability concept;
• Originator perspectives on innovation and biosimilars;
• Strategies for conducting global biosimilar programs;
• Revision of the overarching EMA guidelines on similar biological medicinal products;
• Post-approval changes and comparability exercises with biosimilar products.
Co-Moderators:
Stephen C. Hosselet, Ph.D., Director, Global Analytical Sciences, Amgen Inc.
Thomas J. Vanden Boom, Ph.D., Vice President, Global Biologics R&D, Hospira, Inc.
Panelists:
Michael J. Grace, Ph.D., Executive Director, Analytical Development and Testing, Bristol-Myers Squibb
Cyrus Karkaria, Ph.D., President, Biotech Division, Lupin Ltd., India
Steven Kozlowski, M.D., Director, Office of Biotechnology Products, OPS, CDER, US FDA
Nadine M. Ritter, Ph.D., Senior CMC Consultant, Biologics Consulting Group
Thomas Stangler, Ph.D., Development Strategy and Technology Manager, Biopharmaceuticals, Sandoz, Austria
John Stubenrauch, MBA, Ph.D., Head of External Commercialization and Operations, Biologics, Merck & Co., Inc.
Friday, October 12, 2012
10:15 am – 11:45 am
Structuring Process Knowledge for the Opportunity to Achieve Robust
Processes, Simplified Technology Transfer and Regulatory Compliance
Co-Sponsored by:
Learn and contribute your insights about the regulatory expectations and the potential benefits to be gained from
managing process information in a structured way. The panel will explore with the audience how this would facilitate
communication, accessibility and usability of process information within development and the manufacturing supply
chain. A sampling of goals to be addressed includes:
• How to speed up the development of robust processes by linking process development to manufacturing and
providing a framework to share process information to all stakeholders
• Methods to greatly facilitate the transfer of processes to manufacturing assets
• Managing process knowledge in a way that facilitates process understanding and continuous improvement
Moderator:
Peter Latham, President, Latham BioPharm Group
Panelists:
Barak Barnoon, Associate Director, Process Engineering Biotech Technology and Engineering, Pfizer Inc.
Jerry Chapman, Senior Editor, International Pharmaceutical Quality Journal
David E. Fein, Ph.D., Senior Process Engineer, Viral Vaccine Technology and Engineering, Merck & Co., Inc.
Rebecca Sendak, PhD, Senior Scientific Director, Therapeutic Protein Development, Genzyme, a Sanofi company
Andrew Sinclair, Managing Director, BioPharm Services Ltd., United Kingdom
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Early Registration and Group Discounts are Available (see page 27) 22