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Hilton Washington DC/Rockville Hotel & Executive Meeting Ctr.

Apr 24, 2017 7:30 AM - Apr 26, 2017 12:00 PM

1750 Rockville Pike, , Rockville, MD 20852 , USA

CMC Workshop

Session 5A: Leveraging CDMOs to Optimize Biologics Product Development and Manufacturing Strategies

Session Chair(s)

Michael  Jenkins, PhD

Michael Jenkins, PhD

Senior Consultant

BioProcess Technology Consultants, Inc., United States

One of the strategic decisions that must be made during product development is how and where to develop and manufacture the product. Manufacturing in-house, partnering with a company with excess capacity, and working with a CMO are common options. This session focuses on advantages of working with CDMO that go beyond accessing capacity. A good CDMO has extensive expertise in areas such as cell line, process and method development QbD, continuous manufacturing, and accelerated development programs, and will apply this expertise as appropriate to optimize the long-term manufacturing strategy for their client. This session will discuss best practices in working with CDMOs.

Speaker(s)

Jose  Ochoa

Speaker

Jose Ochoa

IDT Biologika, United States

Chief Business Officer

Karen  Cui, MD, PhD

Selecting a CDMO: Perspective from a Small Biopharma Company

Karen Cui, MD, PhD

Precision Biologics, Inc., United States

Head, Drug Development

Manoj  Menon, PhD

Getting to Win-Win: Reflections from CMO and Client Perspectives

Manoj Menon, PhD

AstraZeneca, United States

Director, New Products, Biologics Global Technical Operations

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