Agenda
Registration has closed
Friday, September 5, 2025
* indicates virtual speaker
| 9:00 - 9:10 | Opening Remarks (Kate Beers, MML Director) |
| 9:10 - 10:30 | Session 1 – Gene Delivery Systems |
| 9:10 - 9:30 | Regulatory Perspectives on Reference Materials for Measuring Potency of Gene Therapy Products (Anurag Sharma, FDA) |
| 9:30 - 9:40 | Overview of Gene Delivery Terminology (Ed Kwee, NIST) |
| 9:40 - 10:05 | Analytical Considerations and Challenges for Gene Therapy CDMOs (Will Fountain*, Andelyn Biosciences) |
| 10:05 - 10:30 | Quantifying CAR-T Cell Development and Functional Dynamics (Allison Cross, Agilent) |
| 10:30 - 11:00 | AM Coffee Break |
| 11:00 - 12:00 | Session 2 – Measurement Opportunities and Reference Material Needs |
| 11:00 - 11:20 | Use of Next Generation Sequencing for Adventitious Virus Detection in Biologically derived products (Brad Hasson, MilliporeSigma) |
| 11:20 - 11:40 | Lentiviral Vector Copy Number Interlaboratory Study (Hua-Jun He, NIST) |
| 11:40 - 12:00 | Panel Discussion |
| 12:00 - 1:00 | Lunch & Networking |
| 1:00 - 2:30 | Session 3 – Counting and Functional Measurements |
| 1:00 - 1:10 | NIST-led Gene Delivery Interlaboratory Study (Jamie Almeida, NIST) |
| 1:10 - 1:30 | Counting with Flow Cytometry Methods (John Nolan*, Cellarcus) |
| 1:30 - 1:50 | Full/empty AAV Capsid Measurements with CryoEM (Tom Cleveland, NIST) |
| 1:50 - 2:10 | Impact of bioconjugation on structure and function of antibodies for use in immunoassay by HDX-MS (Luise Luckau, LGC) |
| 2:10 - 2:30 | Panel Discussion |
| 2:30 - 3:00 | PM Coffee Break |
| 3:00 - 4:00 | Session 4 – Protein Therapeutics |
| 3:00 - 3:30 | Life Cycle Management of NISTmAb (Katharina Yandrofski , NIST) |
| 3:30 - 4:00 | NIST Reference Materials for Biomanufacturing (Megan Cleveland, NIST) |
| 4:00 - 4:30 | Closing Remarks |