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Day 1 - Gene Delivery Systems Public Workshop

Wednesday, November 1, 2023 – 8:30 am to 5:00 pm ET

Agenda
 

Time Topics

8:30 am – 9:00 am

Welcome & Opening Remarks

9:00 am – 10:00 am

Workshop Overview

  • NIST Role in Standards for Emerging Biotechnology and advanced therapy – NIST speaker
  • FDA Role in Standards for Regulations of Cell and Gene Therapy – FDA speaker
  • FDA Regulations on Gene Delivery Systems – FDA speaker
  • Overview of NIST efforts on Gene Delivery Systems & ISO Standards – NIST speaker

10:00 am – 10:20 am

Break

10:20 am – 11:10 am

Common challenges and difference of gene delivery systems and ongoing efforts

  • Lentiviral vectors (LVV)
  • Adeno-associated virus (AAV)
  • Lipid nanoparticles (LNP)
  • Extracellular vesicles (EV)
  • Adenovirus

11:10 am – 12:00 pm

Panel Discussion – commonalities and differences

12:00 pm – 1:30 pm

Lunch Break

1:30 pm – 3:00 pm

New Technology Showcase (participant to be announced)

3:00 pm – 3:20 pm

Break

3:20 pm – 4:20 pm

Breakout Sessions:

  • Titer: e.g., concentration
  • Purity: e.g., empty/full
  • Activity: e.g., infectious titer, functional assay

4:20 pm – 5:00 pm

Report of breakout session
Summary with polling
Opportunities and next steps for NIST Gene Delivery Systems Working Group

5:00 pm

Adjourn

Created September 6, 2023, Updated September 18, 2023