Cambridge Healthtech Institute’s 6th Annual
Cell Therapy Manufacturing
Commercializing Cell-Based Therapies
August 14-15, 2019
Cell therapy is one of the most exciting areas of biotech today. But how will we manufacture these products at scale? And what platforms, technologies and cell processes can we expect to see in the future? Do the answers lie in traditional biomanufacturing
methods or custom-made processes?
CHI’s Cell Therapy Manufacturing conference takes an in-depth look at the practical challenges of manufacturing autologous and allogenic cell therapies at scale, with dedicated sessions on cell processing, scalability, bioreactors, next-generation
production technologies, automation, closed systems, supply chain and facility design. The meeting will feature extensive sessions on autologous and allogeneic production platforms, CAR Ts, NK cells, TCRs and manufacturing CRISPR-based CAR Ts at scale.
Final Agenda
Wednesday, August 14
6:00 - 6:45 am Seaport Fun Run/Walk (Seaport Hotel Plaza Lobby)
7:00 Registration Open and Morning Coffee
8:05 Chairperson’s Remarks
Ohad Karnieli, PhD, MBA, CEO and Co-Founder, Atvio Biotech Ltd
8:15 KEYNOTE PRESENTATION: Developing Allogeneic NK Cell Therapies with iPSC Technology
Wen Bo Wang, PhD,
Senior Vice President, Technical Operations, Fate Therapeutics
Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of next-generation cellular immunotherapies for cancer and immune disorders. We are pioneering a revolutionary approach to cell therapy – we use renewable
master induced pluripotent stem cell (iPSC) lines generated from our proprietary iPSC platform to derive cell therapy product candidates that can be delivered off-the-shelf for the treatment of a large number of patients.
9:00 Allogeneic Manufacturing: Exploiting NKG2D Receptor for Non-Gene Edited Allogeneic CAR T Cells
Jean-Pierre Latere, COO, Celyad
NKG2D Receptor is a clinically validated target for autologous NKG2D CAR T cells. Celyad is now exploring two non-gene edited approaches to allogeneic CAR T cells. We will share our experience in manufacturing of these allogeneic products as well
as a brief discussion related to incorporation of other clinically validated targets such as CD19 and BCMA.
9:30 The Impact of Facility Design on the Cost of Goods in Autologous Cell Therapy
Knut Niss, PhD, CTO, Mustang
Bio
By considering the actual process operations for an autologous cell therapy the design of a manufacturing facility can help improve the cost of goods (COGS) for the product. This can be achieved mainly by increasing the capacity of the facility while
maintain a small footprint. This presentation will discuss the possibilities and requirements for the design of a cost effective facility.
10:00 Coffee Break in the Exhibit Hall with Poster Viewing
10:45 NCI Manufacturing for Multi-Center CAR T Cell Clinical Trials
Anthony R. Welch,
PhD, Program Director/Project Officer, National Cancer Institute, Biological Resources Branch, DTP/DCTD/NCI
Recently the NCI has invested in establishing centralized manufacturing for cell therapy products to support multi-center clinical trials. This presentation will highlight the challenges of developing manufacturing and CMC support for autologous cell
therapy products including: tech transfer, use of closed manufacturing systems, aseptic validations, process qualification, QC/QA rapid release, cryopreservation, and chain of custody logistics.
11:15 Manufacturing Lentiviral Vectors for Immunotherapy
David Hsu, PhD, Senior Director,
Center for Biomedicine and Genetics, City of Hope
City of Hope has manufactured over 70 clinical lots of Lentiviral vector for CART clinical studies. The ability of the lentiviral vectors to transduce primary T cells with high efficiency has been repeatedly demonstrated. At this talk the experience
of lentiviral vector manufacturing will be presented. In addition, the process development efforts to establish a new manufacturing platform using suspension cell culture will also be discussed.
11:45 Manufacturing, Supply Chain, and Automation Strategies for Engineered T Cell Therapies
Bruce Levine, PhD, Barbara and Edward, Netter Professor, Cancer Gene Therapy, University of Pennsylvania Perelman School of Medicine
12:15 pm Luncheon Presentation: Closed Systems for Dendritic Cell Generation
Shashi Murthy,
PhD, Professor of Chemical Engineering, Northeastern University
Due to the rise of personalized therapies, the demand for Dendritic cells has increased. However, the process for generating Dendritic cells has remained laborious, error-prone, and time intensive. Dr. Murthy will present a new system and process
that is efficient, affordable, and 10x more productive than current methods and devices.
1:00 Dessert Break in the Exhibit Hall with Poster Viewing
1:45 Chairperson’s Remarks
Ohad Karnieli, PhD, MBA, CEO and Co-Founder, Atvio Biotech Ltd
1:50 Current Strategies to Optimize Tumor Specific T Cells
Juan Vera, PhD, Chief Development
Officer, Marker Therapeutics, and Associate Professor, Department of Medicine, Center for Cell and Gene Therapy, Baylor College of Medicine
Marker Therapeutics is a clinical-stage immuno-oncology company focused on developing novel T cell-based immunotherapies. Marker’s technology relies on using non-transduced T cell receptors to provide a polyclonal T cell product capable of recognizing
multiple tumor associated antigens. Marker’s strategy differs significantly from other therapies by providing a T cell product with a greater safety profile and versatility, allowing the extension of this platform to multiple clinical indications
including solid tumors.
2:20 Lifileucel Gen 2 Manufacturing Process is Reliable, Robust, and Commercializable for TIL Adoptive Cell Therapy
Arvind
Natarajan, PhD, Vice President, CMC, Iovance
Iovance is developing TIL, a one-time cell therapy treatment that leverages and enhances the body’s natural defenses against certain solid tumors. TIL is being investigated in several multi-center Phase 2 clinical trials and preliminary results
have demonstrated safety and efficacy in melanoma, head and neck and cervical cancer patients. This presentation shows lifileucel gen 2 manufacturing process is reliable, robust, and commercializable for TIL adoptive cell therapy.
2:50 Transforming Cell Therapy with Gene Editing: The Case of “Off-the-Shelf” Engineered CAR T
David Sourdive, PhD, Executive Vice President, Technical Operations, Cellectis
Gene-editing has enabled off-the-shelf allogeneic CAR T product candidates to reach the clinic. It is also endowing engineered cells with multiple new features, enhancing their capabilities and functions to better address cancer. Hindsight in industrializing
these immuno-oncology products and the human clinical experience with the first cases in ongoing trials signal practical avenues for their further deployment and shed light on the transformative role they will play in the anti-cancer arsenal.
3:20 Panel Discussion: Next-Generation Products and Processes
Moderator: Knut Niss, PhD, CTO, Mustang Bio
Panelists:
Wen Bo Wang, PhD, Senior Vice President, Technical Operations, Fate Therapeutics
Arvind Natarajan, PhD, Vice President, CMC, Iovance
David Sourdive, PhD, Executive Vice President, Technical Operations, Cellectis Juan Vera, PhD, Chief Development Officer, Marker Therapeutics, and Associate Professor, Department of Medicine, Center for Cell and Gene Therapy, Baylor College of
Medicine
Lan Cao, PhD, Senior Director, Head Product Development and Manufacturing, Cell Therapy, Takeda
3:50 Refreshment Break in the Exhibit Hall with Poster Viewing
4:45 Plenary Keynote Session View details
6:00 A Taste of New England Reception in the Exhibit Hall with Poster Viewing
7:00 End of Day
Thursday, August 15
6:00 - 6:45 am Namaste@#BPSMT (Seaport Hotel Plaza Lobby)
8:00 Registration Open and Morning Coffee
8:25 Chairperson’s Remarks
Dominic Clarke, PhD, ISCT Process & Product Committee Co-Chair and Global Head, Cell Therapy, HemaCare
8:30 Optimizing Antigen-Specific T Cell Manufacturing
Patrick
J. Hanley, PhD, Laboratory Facility Director, Cellular Therapy and Stem Cell Processing, Program for Cell Enhancement and Technologies for Immunotherapy, Division of Blood and Marrow Transplantation, Children’s National Health System
CAR T cells have been a major focus of investigators, but other targeting strategies have demonstrated similar promise for treating viral infections and tumors. Here we will discuss the ex vivo expansion of
antigen-specific T cells and how they contrast with CAR T cells. More specifically, we will evaluate starting materials, manufacturing time, product variability, and process development needs.
9:00 Scale-Up Strategies and Process Optimization for Cell Therapies
Ravi Bhatia,
PhD, Scientific Director, Janssen
9:30 Selected Poster Presentation I: Manufacturing and Characterization of Bispecific CD19/22 CAR T for B-Cell Malignancies
Shabnum Patel, Scientist, Stanford University
9:45 Selected Poster Presentation II: Bioprocess Optimization of Nucleus Pulposus Derived Spheroid Production in Stirred-Tank Reactors
Daniel Rodriguez-Granrose, MBB, Sr. Bioprocess Scientist, DiscGenics Inc. & PhD candidate, University of Miami, Dept. of Biochemistry and Molecular Biology
10:00 Coffee Break in the Exhibit Hall with Poster Viewing
10:45 Manufacturing Complex Therapies - In-House, Outside or a Mix?
Devyn Smith, PhD, Chief Strategy Officer, Strategy & Ops, Sigilon
Making a decision on where and how to manufacture a therapy is one of the most important decisions a company will make. The decision has impact on both scientific and clinical strategies, as well as fundraising/capital strategies. Criteria
for considering how to make the most informed decision will be reviewed with case studies.
11:15 NEW: Analyzing the Role of Real-Time Information for Improved Logistics and Supply Chain
Brian Yi Liu, Georgia Tech
Gene-editing has enabled off-the-shelf allogeneic CAR T product candidates to reach the clinic. It is also endowing engineered cells with multiple new features, enhancing their capabilities and functions to better address cancer. Hindsight
in industrializing these immuno-oncology products and the human clinical experience with the first cases in ongoing trials signal practical avenues for their further deployment and shed light on the transformative role they will play
in the anti-cancer arsenal.
11:45 Panel Discussion: Next-Generation Products and Processes
Dominic Clarke, PhD, ISCT Process & Product Committee Co-Chair and Global Head, Cell Therapy, HemaCare
Panelists:
Devyn Smith, PhD, Chief Strategy Officer, Strategy & Ops, Sigilon
Fabio Fachin, PhD., Head, Cell Therapy Engineering and Automation, Takeda
Brian Yi Liu, Georgia Tech
12:15 pm Enjoy Lunch on Your Own
1:15 Refreshment Break in the Exhibit Hall with Last Chance for Poster Viewing
1:55 End of Conference
August 15-16 Recommended Training Seminar
TS9C: DOE for Cell and Gene Therapies