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Day 1 - Gene Delivery Systems Public Workshop

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



Time (ET) Topics

8:30 – 8:45 am 

Welcome & Opening Remarks

  • Charles Romine, Associate Director for Laboratory Programs (NIST)
  • Heather Lombardi, Director, Office of Cellular Therapy and Human Tissue, Office of Therapeutic Products, CBER (FDA)

8:45 – 9:35 am

Workshop Overview

  • "NIST Role in Standards for Emerging Biotechnology and advanced therapy" – Sheng Lin-Gibson (NIST)
  • “Standards Recognition Program for Regenerative Medicine Therapies”Judy Arcidiacono (FDA)
  • “Regulatory perspective: CMC considerations for viral vectors” – Anurag Sharma (FDA)
  • "NIST efforts on Gene Delivery Systems and ISO standards" – Ed Kwee (NIST)

9:35 – 10:05 am


Complementary Programs

  • “Accelerating Medicines Partnership Program – Bespoke Gene Therapy Consortium” – Courtney Silverthorn (FNIH)
  • “NIIMBL Program in Viral Vector Manufacturing and Analytics” – Kelvin Lee (NIIMBL)

10:05 – 10:20 am


10:20 – 11:35 am


Common challenges and difference of gene delivery systems and ongoing efforts

  • “Enabling Affordable and Accessible Advanced Medicines” – Boro Dropulic (Caring Cross)
  • “Common Analytical Challenges with Adeno Associated Virus Mediated Gene Therapy” - Will Fountain (Andelyn Bioscience)
  • Analytical Challenges Associated with Lipid Nanoparticle mediated Gene Delivery and Gene Editing” – Carl Co (Arbor Bio)
  • “Extracellular Vesicles (EVs) as a Novel Drug Delivery Platform" – Haiying Zhang (Weill Cornell Medical)
  • Analytical challenges for adenovirus-based vectorsNancy Sajjadi (Sajjadi Consulting)

11:35 am – 12:00 pm             

Panel Discussion – commonalities and differences

12:00 – 1:00 pm

Lunch Break

1:00 – 2:10 pm

Breakout Sessions (in-person only)

  • Viral vector functional measurements
  • Viral vector physical measurements
  • Non-viral vector functional measurements
  • Non-viral vector physical measurements

2:10 – 2:30 pm


2:30 – 4:30 pm


New Technology Showcase (Measurements and Systems)

  • “NibaPlex® assay platform for AAV vector genome integrity quantification” David Dobnik (Niba Labs)
  • “Viral vector capsid characterization using mass photometry”Gabriella Kiss (Refeyn)
  • How super resolution can helps you gain better insights into your samples”  –Ricardo Nunes Bastos (Oni)
  • “Image cytometry technology and applications for viral infectivity/transduction analysis” - Bo Lin (Revvity)
  • “Label-free single cell PAT precision analytics for cell and gene therapies and vaccines” - Renee Hart (Lumacyte)
  • “Insights into LNP quantification and their therapeutic application”- Carsten Russ (Intellia)
  • “Focused ultrasound modulation of the blood-brain-barrier permeability for delivery of gene therapy to the brain” - Frederic Padilla (Focused Ultrasound Foundation)
  • “Therapeutic Applications of Novel Q5 Exosomes” - Javed Siddiqi (Exom BioPharma)

4:30 – 5:00 pm


  • Report of breakout sessions
  • Summary with polling
  • Next Steps for NIST Gene Delivery Systems Working Group and opportunities for participation.

Jamie Almeida (NIST)

5:00 pm


Created September 6, 2023, Updated October 31, 2023