Regulatory + Government Affairs
Here are session recommendations for the regulatory and government affairs side of the field.

Tuesday, May 7

8 a.m. - 12 p.m.

Workshops

AAV Manufacturing for CMC Success: Translating Preclinical Gene Therapy Products to Clinical Success

Creating an Analytical Roadmap for Gene & Cell Therapies

1:30 p.m. - 3:15 p.m.

Oral Abstract Session

AAV Vectors - Product Development, Manufacturing, and Approval Considerations Session 1

Wednesday, May 8

8 a.m. - 9:45 a.m.

Fireside Chat

Fireside Chat: Regulating Cell and Gene Therapies from IND to BLA

1:30 p.m. - 3:15 p.m.

Scientific Symposium

Bespoke Gene Therapy Consortium

3:45 p.m. - 5:30 p.m.

Oral Abstract Session

Strategies and Technologies for Advanced CMC

Thursday, May 9

8 a.m. - 9:45 a.m.

Fireside Chat

Fireside Chat: Global Regulatory Convergence

1:30 p.m. - 3:15 p.m.

Scientific Symposium

How to Develop Gene and Cell Therapies with a DEI-forward Approach

3:45 p.m. - 5:30 p.m.

Scientific Symposium

Enabling Analytics for Decentralized and Point-of-Care Manufacturing

Friday, May 10

8 a.m. - 9:45 a.m.

Oral Abstract Session

Pharmacology/Toxicology Studies and Analytics/Assay Development

1:30 p.m. - 3:15 p.m.

Scientific Symposium

The Role of Government in Ensuring Equity of Access to CGTs

3:45 p.m. - 5:30 p.m.

Oral Abstract Session

AAV Vectors - Product Development, Manufacturing, and Approval Considerations Session 4

Saturday, May 11

8 a.m. - 9:45 a.m.

Scientific Symposium

Companion Diagnostics for AAV-based Gene Therapies

10:15 a.m. - 12 p.m.

Scientific Symposium

Gene Therapy and Genome Editing in Europe

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