2025 Conference Agenda (Updated 2/18/2025)
Day I - March 20, 2025
SESSION | TOPIC | SPEAKER | COMPANY | TIME |
Registration and Breakfast | 7:30-8:30 | |||
Conference Opening | Vibha Jawa | BMS | 8:30-8:40 | |
Opening Plenary Lecture | Nonclinical Safety Strategies for Chimeric Antigen T Cell Programs | Kyle Kolaja | BMS | 8:40-9:20 |
Session I: Current State of Cell Therapies
Moderator: Steven Louie, Medicilon
SESSION | TOPIC | SPEAKER | COMPANY | TIME |
Session Introduction | 9:20-9:25 | |||
Journey of India's First CAR-T Cell Therapy and Its Global Impact | Alka Dwivedi | NIH | 9:25-9:50 | |
Overcoming Host Rejection in Allogeneic Adoptive Cell Therapy: Engineering Strategies for Persistence and Efficacy | Johannes Stanta | Celerion | 9:50-10:15 | |
Cryo-Fluorescence Tomography: Transformative 3D Imaging to Monitor Gene and Cell Therapies | Matt Silva | ![]() |
10:15-10:40 | |
AM Break | 10:40-11:00 |
Session II: Emerging Cell Therapies
Moderator: Nagendra Chemuturi, Eli Lilly
SESSION | TOPIC | SPEAKER | COMPANY | TIME |
Session Introduction | 11:00-11:05 | |||
AI-Driven Approaches to Enhancing CAR Design | Simon Bornschein | Coding Bio | 11:05-11:30 | |
Translational Development of the GbGm Vector for Sickle Cell Disease: Assessing Safety and Efficacy from Preclinical Models to Human | Mohammad Shadid | Korro Bio | 11:30-11:55 | |
CMC Aspects of ASO Manufacturing | Qingcong Lin | ![]() |
11:55-12:10 | |
Lunch | 12:10-1:25 |
Session III: Bioanalytical Assays
Moderators: Nanda Balasubramanian, BMS & Vibha Jawa, BMS
SESSION | TOPIC | SPEAKER | COMPANY | TIME |
Session Introduction | 1:25-1:30 | |||
Advanced Bioanalytical Strategies to Determine PK and Biodistribution of Cell and Gene Therapy Products | Salvatore Iovino | Editas Medicine | 1:30-1:55 | |
Harmonizing NAb Sample Testing and Reporting: Key Insights from the White Paper | Jason DelCarpini | Moderna | 1:55-2:20 | |
Bioanalytical Strategies for Cell Therapies: Current Considerations | David Williams | BioAgilytix | 2:20-2:45 | |
Panel Discussion | 2:45-3:05 | |||
PM Break | 3:05-3:25 |
Session IV: Clinical/Quantitative Pharmacology of Cell Therapies
Moderator: Dale Miles, Genentech & Yizhe Chen, BMS
SESSION | TOPIC | SPEAKER | COMPANY | TIME |
Session Introduction | 3:25-3:30 | |||
Making Drugs from T cells: Mathematical Model-informed Design and Deployment of Next Generation T Cell Therapies | Daniel Kirouac | Metrum Research Group | 3:30-3:55 | |
Clinical Pharmacology Considerations in the Development of Allogeneic Cell Therapies - Opportunities & Challenges | Hardik Moody | Genentech | 3:55-4:20 |
Session V: CMC
Moderators: Nanda Balasubramanian, BMS, and Lei Ci, Moderna
SESSION | TOPIC | SPEAKER | COMPANY | TIME |
Session Introduction | 4:20-4:25 | |||
CMC Development for Cell and Gene Therapies for the Treatment of β-hemoglobinopathies | Tamara Monesmith | Editas Medicine | 4:25-4:50 | |
Panel Discussion - Andy Lin, Genentech and Tamara Monesmith, Editas | 4:50-5:10 | |||
Reception | 5:10-6:10 |
Day II - March 21, 2025
SESSION | TOPIC | SPEAKER | COMPANY | TIME |
Registration and Breakfast | 8:00-9:00 | |||
Speaker Introduction | Vibha Jawa | BMS | 9:00-9:05 | |
Closing Plenary Lecture | From Innovation to Translation to Patients: The Future of Genetically Engineered T-Cells for Human Therapeutics | Bruce Levine | University of Pennsylvania | 9:05-9:45 |
Session VI: Lessons Learned from Approved Cell Therapies
Moderators: Nagendra Chemuturi, Eli Lilly
SESSION | TOPIC | SPEAKER | COMPANY | TIME |
Session Introduction | 9:45-9:50 | |||
Role of Clinical Pharmacology in Efficient Development of CAR-T Cell Therapy: From FIH Starting Dose Selection to RP2D and Beyond | Indrajeet Singh | J&J | 9:50-10:15 | |
Comprehensive Bioanalytical Cellular Kinetics Strategy for Adoptive T Cell Therapies | Sebastian Guelman | Genentech | 10:15-10:40 | |
AM Break | 10:40-11:00 |
Session VII: Regulatory Perspectives
Moderators: Steven Louie, Medicilon
SESSION | TOPIC | SPEAKER | COMPANY | TIME |
Session Introduction | 11:00-11:05 | |||
Navigating the Regulatory Landscape of Cell Therapies: Nonclinical Considerations | Helen-Marie Dunmore | Certara | 11:05-11:30 | |
Regulatory Expectations and Safety Concerns with CART and Next Generation CART Programs | Gabriela Hernandez-Hoyos | BMS | 11:30-11:55 | |
Closing Remarks | 11:55-12:00 |