2022 BioMAN Summit on Platform and Process Innovation for Cell and Gene ...
[Pages:5]2022 BioMAN Summit on
for CPellal tafnodrmGeannedTPhreorcaepsys IMnannouvafaticotunring As cell and gene therapy products make the transition to commercialization, significant innovations in
manufacturing technologies are needed. This Summit will explore how innovations in production platforms and processes are enabling improved manufacturing operations that can meet the projected demand for these critical medicines.
T Wednesday, December 7th, 2022
Samberg Conference Center & Virtually Building E52| 7th Floor | 50 Memorial Drive | Cambridge, MA 02139
10:00 ? 11:00 AM Continental Breakfast & Registration
F 11:00 ? 11:15 AM
Welcome and Introduction Stacy L. Springs Executive Director MIT Center for Biomedical Innovation
A 11:15 ? 11:30 AM
Framing of the Workshop Jacqueline Wolfrum Director, BioMAN; Co-Director, Biomanufacturing Initiatives MIT Center for Biomedical Innovation
11:30 AM ? 12:00 PM Keynote Presentation Session Chair: Stacy L. Springs, MIT Center for Biomedical Innovation
11:30 ? 12:00 PM
Peter Marks Director, Center for Biologics Evaluation and Research United States Food and Drug Administration
R 12:00 PM ? 3:00 PM SESSION 1: Future Paradigms for Gene Therapy Manufacturing Session Chair: Jacqueline Wolfrum, MIT Center for Biomedical Innovation
D12:00 ? 12:30 PM
Francesco Aulicino - Virtual Senior Process Development Research Associate University of Bristol
Overcoming CRISPR delivery challenges using high capacity baculovirus vectors in
human cells
Draft ? Subject to Change
12:30 ? 1:00 PM Michael Birnbaum
Class of 1956 Career Development Professor of Biological Engineering
Massachusetts Institute of Technology
Topic: Improving Gene Therapy Transduction and Delivery
1:00 PM ? 2:00 PM LUNCH
2:00 ? 2:30 PM
Curtis Dobrowolski Co-founder Nava Therapeutics
Nanoparticle single-cell multiomic readouts reveal that cell heterogeneity influences lipid nanoparticle-mediated messenger RNA delivery
2:30 ? 4:00 PM
SESSION 2: Novel Strategies for Cell Therapies Session Chair: James Leung, MIT Center for Biomedical Innovation
T 2:30 ? 3:00 PM
Jeremy Crawford Principal Scientist, Director of Immunoinformatics St. Jude Children's Research Hospital
Joint analysis of CAR T cell products before and after infusion reveals hidden biomarkers of effector potential
F 3:00 ? 3:30 PM
Yvgeny Brudno Assistant Professor Biomedical Engineering, UNC - Chapel Hill and NC State - Raleigh North Carolina State University
Biomaterial cell factories for point-of-care CAR T cell therapy
A 3:30 ? 4:00 PM
Heather Leu Process Development Engineer Fate Therapeutics
Expansion scale-up and automation of an iPSC derived NK cell therapy
4:00 ? 4:15 PM
Closing Remarks Jacqueline Wolfrum Director, BioMAN; Co-Director, Biomanufacturing Initiatives MIT Center for Biomedical Innovation
DR 4:30 ? 7:00 PM
Poster Session & Networking Reception
Salon West Samberg Conference Center
Draft ? Subject to Change
2022 BioMAN Summit on
for CPellal tafnodrmGeannedTPhreorcaepsys IMnannouvafaticotunring Thursday, December 8th, 2022
Samberg Conference Center & Virtually Building E52| 7th Floor | 50 Memorial Drive | Cambridge, MA 02139
T 8:00 ? 9:00 AM
Breakfast & Registration
8:55 ? 9:00 AM
Framing of the Workshop Stacy L. Springs Executive Director MIT Center for Biomedical Innovation
F 9:00 ? 9:30 AM
Invited Speaker
9:30 AM ? 2:00 PM SESSION 3: Manufacturing Technology Advances in Cell and Gene Therapy Session Chair: Jacqueline Wolfrum, MIT Center for Biomedical Innovation
A 9:30 ? 10:15 AM
Alison Hubel Professor, Mechanical Engineering EVIA Bio
The development of a novel technology platform for preservation of cells
10:15 ? 10:45 AM
Abbygail Foster Technical Development Principal Scientist, Pharmaceutical Development Genentech
In-use physicochemical stability studies: Strategies to support the clinical administration of cell therapies
R 10:45 ? 11:15 PM Refreshment Break
D11:15 ? 11:45 AM
Michael Birnbaum Class of 1956 Career Development Professor of Biological Engineering Massachusetts Institute of Technology
Topic: Microbioreactors for production of CAR-T cell Therapies
11:45 AM ? 12:15 PM Yongchang Ji
Thermo Fisher Scientific
Draft ? Subject to Change
Automation solutions in cell therapy development
12:15 ? 12:45 PM Yanhong Zhang
12:45 ? 1:15 PM
1:15? 2:15 PM
T 2:15? 5:00 PM
2:15 ? 2:35 PM
F 2:35 ? 2:55 PM
2:55? 3:15 PM
A 3:15? 3:45 PM
3:45 ? 4:05 PM
DR 4:05 ? 4:25 PM
Principal Scientist I, Drug Substance Technologies BioMarin Removal of empty AAV capsids to undetectable levels using orthogonal purification steps ? Product quality and process robustness considerations
Hetal Bahmbhaltt Senior Manager, Science and Technology Thermo Fisher Scientific Quick to ClinicTM: A serotype agnostic AAV vector platform
Lunch
SESSION 4: Lightning Talks: Manufacturing Technology Advances in in Cell and Gene Therapy Session Chair: James Leung, MIT Center for Biomedical Innovation
Andres Castillo Market Entry Strategy Manager Sartorius Panning for gold - Faster insights DoE and MVDA for cell therapy manufacturing
Maurizio Cattaneo Chief Executive Officer Artemis Biosciences Continuous harvesting of lytic viruses using a VHU perfusion system
Anand Alembath Development Engineer, Filtration Research & Development MilliporeSigma Viral vector processing: Scalable ultra/diafiltration for improved process efficiency and viral recovery
Refreshment Break
Mahsa Hadidi Senior Scientist Sanofi Development of high throughput purification platform to accelerate AAV process development and product understanding
Nicholas Marchand Research and Development Manager Pall
Lentivirus and AAV filtration and viral reduction
Draft ? Subject to Change
4:25 ? 4:45 PM
Yuefei Shen
Principal Scientist, Biologics Drug Product Development & Manufacturing
Sanofi
DRAFT 4:45 ? 5:00 PM
NVGT formulations an impact on tissue targeting
Closing Remarks Stacy L. Springs Executive Director MIT Center for Biomedical Innovation
Draft ? Subject to Change
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