IBC Life Sciences

New Online Partnering System Information

All attendees of this conference will receive access to our new online partnering system before, during and after the event.

Log in information will be sent to you via email shortly after you have completed the registration process. After receiving your username, you may log in here

Keynote Presentations

The Critical Elements of a Successful Regulatory Filing for Outsourcing Biopharmaceutical Manufacturing
Terry Milby, M.S., Director, Regulatory CMC, Genentech, Inc.

Global Regulatory Strategies for Validation and Transfer of Biotech Processes and Products
Robert L. Garnick, Ph.D., President & CEO, Lone Mountain Biotechnology and Medical Devices, Inc.

Lessons Learned and Where are We Going? A CMO's Perspective
John McGrath, Business Unit Head, Lonza Biologics

"It's Not About the Molecule!": Capability, Competency, and Suitability in Biopharmaceutical Manufacturing
Jeffrey Baker, Ph.D., Senior Director, Manufacturing Sciences, MedImmune

Featured Presentations

Humira History - The Impact of Global Technology Transfers and Validation - Challenges and Lessons Learned
George Avgerinos, Ph.D., Senior Director, Humira Technical Operations, Abbott Laboratories

Upstream and Downstream Process Development Using a QbD Approach - Results from the CMC Biotech Working Group
Victor A. Vinci, Ph.D., Director, Bioprocess OperationsBioproduct R&D, Eli Lilly and Company

Amit Banerjee, Ph.D., Research Fellow, Global Biologics, Pfizer Inc.

Priority Updates

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With the rapid growth of the outsourcing industry, the options and strengths of possible partners has become quite complex, placing increased importance on due diligence to ensure the long-term success of the partnership with and performance of the CMO.

IBC's Outsourcing Manufacturing of Biopharmaceuticals is designed to help companies navigate the complex landscape of contract manufacturing by highlighting the latest developments in the industry and providing practical tools and approaches to make the best manufacturing outsourcing decisions to fit their company's specific needs.

By attending this event, you will benefit from exclusive case studies emphasizing lessons learned that will help you establish partnerships and maximize the client-to-CMO relationship. In addition, the latest QbD case studies will be delivered as well as the required content of a successful regulatory filing and regulatory strategies for outsourcing biopharmaceutical manufacturing.

• Ensure due diligence to identify and establish successful contract partnerships
• Learn to design and implement a risk management process into contract manufacturing
• Examine successful contracts and quality agreements to avoid the pitfalls of contract manufacturing
• Evaluate successful strategies to align expectations with the CMO early in the process
• Hear lessons learned from the unique challenges of outsourcing antibody drug conjugates

Hear what attendees had to say:

"Great insight into emerging global challenges."
- S. Suggett, Genentech Inc, Senior Product Manager, Global Supply Chain

"Very interesting and important contract manufacturing concepts were discussed ."
- E. Zarther, Merck Research Fellow, Bioprocess Analytical & Formulation Science