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Washington Marriott Hotel

Apr 15, 2013 8:30 AM - Apr 17, 2013 12:00 PM

1221 22nd Street NW, , Washington, DC 20037-1294 , USA

CMC Workshop: From Drug Development to Global Supply to Patients

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Session 9C: Advanced-Therapy Medicinal Products (ATMP)

Session Chair(s)

Deborah Hursh, PhD

Senior Investigator, CBER

FDA, United States

Interest in ATMP’s continues to grow, with the recent authorization of Glybera in the EU and there are a substantial number of products under development. The Committee for Advanced Therapies at the EMA has received a large number of scientific advice requests and FDA has seen increasing numbers of Investigational New Drug Applications and more advanced Phase trials. This experience shows that common issues arise for CMC related to characterization, consistency and comparability, particularly for potency assays. The current regulatory climate will be explored and examples discussed to highlight these aspects.

Speaker(s)

CMC Regulatory Considerations for Advanced Therapies

Deborah Hursh, PhD

FDA, United States

Senior Investigator, CBER

Development Experience Gained From The EU Authorization Glybera

Harald Petry, PhD

uniQure B.V, Netherlands, Netherlands

VP, Director Research and Development

Speaker

Robert A Preti, PhD

PTC Cell Therapy Services, United States

President & CSO

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