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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