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

7:00 am Registration Open and Morning Coffee

COMMERCIALIZING CAR Ts - ALLOGENEIC AND AUTOLOGOUS

8:05 Chairperson’s Remarks

Ohad Karnieli, PhD, MBA, Chair, Process and Product Development Subcommittee, International Society of Cellular Therapies, 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 (Sponsorship Opportunity Available)

CAR T MANUFACTURING FOR CLINICAL SUPPLY

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 Sponsored Presentation (Opportunity Available)

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 Session Break

NEXT-GEN PRODUCTS AND PROCESSES - CART 2.0, TILS

1:45 Chairperson’s Remarks

Wen Bo Wang, PhD, Senior Vice President, Technical Operations, Fate Therapeutics

1:50 Optimizing Cell-Based Therapy Manufacturing

Fabio Fachin, PhD, Head, Cell Engineering and Automation, Takeda

Preparing for upscaling of cell and gene therapy products should be considered early during the product development to ensure success in the clinic and this includes streamlining manufacturing processes, sourcing raw materials, and QC for cell and gene therapy products. This presentation will discuss the design, optimization and automation of processes for T cell manufacturing.

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 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.

3:50 Refreshment Break in the Exhibit Hall with Poster Viewing (Sponsorship Opportunity Available)


4:45 Plenary Keynote Session View details

6:00 A Taste of New England Reception in the Exhibit Hall with Poster Viewing (Sponsorship Opportunity Available)

7:00 End of Day

Thursday, August 15

8:00 am Registration Open and Morning Coffee

OPTIMIZING SCALE-UP AND MANUFACTURING

8:25 Chairperson’s Remarks

Dominic Clarke, PhD, ISCT Process & Product Committee Member 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 Sponsored Presentation (Opportunity Available)

10:00 Coffee Break in the Exhibit Hall with Poster Viewing (Sponsorship Opportunity Available)

NEXT-GENERATION MANUFACTURING - LOGISTICS AND SUPPLY CHAIN

10:45 Next-Generation Cell Therapy Manufacturing

Lan Cao, PhD, Senior Director, Head Product Development and Manufacturing, Cell Therapy, Takeda

11:15 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.

11:45 Analyzing the Role of Real-Time Information for Improved Logistics and Supply Chain

Chelsea White, PhD, Schneider National Chair, Transportation and Logistics, Professor, H. Milton Stewart School of Industrial and Systems Engineering, 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.

12:15 pm Enjoy Lunch on Your Own

1:15 Refreshment Break in the Exhibit Hall with Last Chance for Poster Viewing (Sponsorship Opportunity Available)

1:55 End of Conference


August 15-16 Recommended Training Seminar

TS9C: DOE for Cell and Gene Therapies

* The program is subject to change without notice, due to unforeseen reason.