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Walter E. Washington Convention Center

Jun 15, 2025 7:15 AM - Jun 15, 2025 5:45 PM

801 Allen Y. Lew Place, NW, Washington, DC 20001-3614, USA

Global Regulatory Harmonization and Improving Access to Advanced Therapies Summit

Registration Ends In

DAYS

HOURS

MINUTES

SECONDS

Agenda

Day 1 Jun 15, 2025

7:15 AM — 8:00 AM

Registration and Continental Breakfast

8:00 AM — 8:10 AM

Opening Remarks

8:10 AM — 8:40 AM

Overview of the Cell and Gene Therapy Field

8:40 AM — 9:10 AM

The Bench to Bedside Journey for Cell and Gene Therapies

9:10 AM — 10:20 AM

Panel Discussion of Current Regulatory Guidance Documents Around the World and Overcoming the Challenges

10:20 AM — 10:40 AM

Refreshment Break

10:40 AM — 12:45 PM

Challenges and Opportunities Case Studies

12:45 PM — 1:45 PM

Networking Luncheon

1:45 PM — 2:30 PM

Panel Discussion

2:30 PM — 2:50 PM

Update from the AMP BESPOKE Gene Therapy Consortium (BGTC)

2:50 PM — 3:10 PM

Genome Editing as a Platform Technology

3:10 PM — 4:50 PM

Introducing the Format for the Roundtable Discussions

4:50 PM — 5:35 PM

Report-Outs on Recommendations

5:35 PM — 5:45 PM

Closing Remarks

5:45 PM — 5:45 PM

Summit Adjourns

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Global Regulatory Harmonization and Improving Access to Advanced Therapies Summit

Agenda

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