Cambridge Healthtech Institute ’s 5th Annual
Cell Therapy Manufacturing
Commercializing Cell-Based Therapies
August 15-16, 2018
The recent approvals of CAR T therapies Yescarta and Kymiriah represent a major breakthrough for the cell therapy industry. 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 meeting 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 CAR-Ts, NK cells, TCRs and manufacturing CRISPR-based CAR Ts at scale.
Final Agenda
Wednesday, August 15
7:00 am Registration Open and Morning Coffee (Grand Ballroom Foyer)
8:05 Chairperson’s Remarks
Anthony Davies PhD, Founder & CEO, Dark Horse Consulting
8:15 KEYNOTE PRESENTATION: Manufacturing for Cell Therapies: Modeling the Decision on Make vs. Buy
Knut Niss, PhD, CTO, Mustang Bio
Autologous cell therapies require intensive manufacturing resources and while establishing a new manufacturing facility can be costly, it is critical to compare these costs to the ones required to manufacture at a CMO. In this respect, establishing
a comprehensive model that looks at all aspects can serve as a critical tool to make this decision. This presentation will go through the modeling process with a look at several different cell therapy platforms.
9:00 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.
9:30 NEW: Will the Cost of Commercial Manufacturing Kill Cell & Gene Therapy?
Anthony Davies PhD, Founder & CEO, Dark Horse Consulting
10:00 Coffee Break in the Exhibit Hall with Poster Viewing (Grand Ballroom)
10:45 Scalability Challenges with Molecular Switch Technologies for CAR T
Alan Smith, PhD, Executive Vice President, Technical Operations, Bellicum
Successful manufacture of a patient-specific CAR-T cell product is multifaceted and complex. Areas which need to be successfully managed and solved include logistics from the starting cell collection through product delivery, vendor qualification
and management and consistent sourcing of appropriate materials and equipment. Process reliability and product consistency are also challenges due to differences in patient age, genetics and disease treatments which vary substantially across the
patient population.
11:15 Development of the Manufacturing Process of CAR T Cell Therapies
Przemyslaw Kruczek, PhD, Senior Scientist, Autolus
11:45 Cell
Counting Method Development Process for CAR T Cell Manufacturing
Leo Chan, Manager, Technology Research & Development, Nexcelom Bioscience, LLC
Cell counting is highly important for all stages of cellular therapy development. The need for an accurate and consistent cell counting method is crucial for manufacturing under GMP/GLP conditions. Utilizing both bright field and fluorescence imaging,
Cellometer automated cell counters can provide rapid and accurate measurement of cell concentration and viability at any stage: from CAR T product development to manufacturing.
Keith R. Olson, PhD, Global Director, Business Operations, Life Sciences, Corning Incorporated
Optimal cell culture conditions are critical to manufacture the highest quality cell therapy products. As a leader in cell culture, Corning offers complete and customizable cell culture environments suited for anchorage-dependent or suspension cells
that are easily optimized to generate the highest quality cellular products. In this presentation, we will discuss the importance of building an optimal culture environment using various Corning platforms to suit your stage of cell therapy research.
We will present Corning’s customizable vessels and media for cell therapy applications, as well as advanced cell culture surfaces, including synthetic and biological surfaces and extracellular matrices. In addition, we will feature Corning’s
Dissolvable Microcarrier technology for scalable expansion of anchorage-dependent cells and discuss how it can simplify your cell harvest and separation processes.
1:00 Session Break
1:45 Chairperson’s Remarks
Knut Niss, PhD, CTO, Mustang Bio
1:50 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.
2:20 Next-Generation CAR T Manufacturing, Bedside Automated Manufacturing, No Longer a Dream
Ohad Karnieli, PhD, MBA, CEO and Co-Founder, Atvio Biotech Ltd.; Chair, Process and Product Development Subcommittee,
International Society of Cellular Therapies
Several approaches have been taken in recent years to automate the system, from automating unit operations to innovative end-to-end solutions. The talk will cover the available new technologies and future trends and will present a case study of
a CAR T therapy end-to-end automated process called ADVA.
2:50 Low Cost Closed Systems for the Research and Preclinical Stage
Shashi Murthy, PhD, Professor, Chemical Engineering, Northeastern University
My major focus is building low cost automation platforms that can be easily adopted in preclinical and research settings. A major advantage of embedding automation early on is that transition to automation for clinical trials is considerably simplified
and furthermore automation improves robustness of the early stage work. My presentation will discuss the above issues, plus topics like pros and cons of closed system, sensors, within the context of manufacturing dendritic cell-based therapies.
3:20 Application of Biosensors Technologies for Real Time Process Control
Damian Marshall, PhD, Head, Analytical Development, Non-Clinical Operations, Cell & Gene Therapy
Catapult UK
Developing reliable, cost-effective processes for cell and gene therapy manufacture is a significant challenge. For autologous products, this challenge can be even greater due to the variability of the patient specific starting material and
the lack of real-time process data. In this presentation we will show how optical biosensors can be applied for process monitoring to track cell behavior and gain higher level process control.
3:50 Refreshment Break in the Exhibit Hall with Poster Viewing (Grand Ballroom)
4:45 Plenary Keynote Session (Constitution Ballroom)
4:45 pm Chairperson’s Remarks
John Sterling, Editor in Chief, Genetic Engineering & Biotechnology News (GEN)
4:50 Digital Transformation to Advance Next-Generation Biomanufacturing through
Data Integration and Analytics
Jerry Murry, PhD, Senior Vice President, Process Development, Amgen
Hundreds of millions of data points are currently generated through the development and execution of biopharmaceutical processes. It is expected that the volume and complexity of biomanufacturing data is set to grow exponentially as developers
and manufacturers integrate novel sensors, smart materials, process analytical technologies and process automation into laboratories and manufacturing plants. This presentation will describe the value associated with a comprehensive digital
strategy incorporating a structured data integration and analytics platform inclusive of AI, predictive modeling and visualization, and how digital transformation can advance next-generation biomanufacturing.
5:20 Driving Change in Biomanufacturing through Innovation in Processes, Technologies and Operations
Eliana Clark, PhD, Vice President, International Manufacturing Operations, Biogen
A critical step in meeting the demand of biologic production worldwide involves implementing disruptive manufacturing technologies, processes and capabilities. This talk will use Biogen’s new manufacturing site in Switzerland, due
to go online in 2019, as an example to demonstrate the new processes, operational models and technologies being adopted to drive value through innovation and deliver new medicines in areas such as Alzheimer’s.
5:50 End-to-End Solutions Considering New Trends in Biomanufacturing
Guillaume Plane, MSc, MBA, Manager, Global Development, Biodevelopment Solutions, MilliporeSigma
The presentation will get into the current state of biomanufacturing, from DNA to market approval, considering the way a key supplier can support drug makers to the fullest, thanks to a deep understanding of the trends that could affect
our industry in the midterm, including growth of the pipelines, strengthening of regulations, and acceleration of timelines, for development as well as for the set-up of capabilities. Some thoughts and ideas will be proposed to consider
commercial manufacturing with single-use equipment.
6:25 Close of Plenary Keynote Session
6:25 10th Anniversary Champagne Celebration in the Exhibit Hall with Poster Viewing (Grand Ballroom)
7:30 End of Day
Thursday, August 16
8:00 am Registration Open and Morning Coffee (Grand Ballroom Foyer)
8:25 Chairperson’s Remarks
Ohad Karnieli, PhD, MBA, CEO and Co-Founder, Atvio Biotech Ltd.; Chair, Process and Product Development Subcommittee, International Society of Cellular Therapies
8:30 Overcoming Challenges in Advancing Allogeneic Cell Therapy beyond Phase II
Tehila Sonnenfeld, PhD, Director, Manufacturing & Technology Transfer, Immunovative
Therapies
Allogeneic cell therapy products have the potential for achieving economies of scale. As biological products, these therapies are licensed together with the manufacturing processes and facilities. Therefore, careful planning is required
in order to assure manufacturing development occurs in parallel with the clinical development. This presentation will discuss our experiences in developing a scalable, economical manufacturing process for an allogeneic immune cell
therapy for cancer.
9:00 Process Development: Lessons Learned from Virus-Specific T cells
Adrian Gee, PhD, Professor, Pediatrics-Hem-Onc Cell & Gene, Baylor College of Medicine
9:30 Poster Presentation: Novel Application of AMBR 250 for CAR-T Cell Therapy Bioprocess Automation and Future Commercialization
Vienna Lo, PhD., Principal Scientist, CGTDM, Novartis Pharmaceuticals Corporation
10:00 Coffee Break in the Exhibit Hall with 2nd Session Poster Winner Announced (Grand Ballroom)
10:45 Scaling Up Cell Therapy Products in an Academic Cell Therapy Facility
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
This presentation will focus on our experience translating cellular therapies from a basic science discovery at the bench into a Phase I clinical trial. Included in this presentation will be how to engage all members of the team, from
clinicians to the manufacturing team, and design a system to best meet the needs of the process. These items include reagent qualification, cell selection, staffing, and product testing.
11:15 Leveraging Academic and Commercial Cell Therapy Manufacturing Organizations to Facilitate Accelerated FDA Approval
Linda L. Kelley, PhD, Senior Member, Director, Cell Therapy Facility, Moffitt Cancer Center
We have embraced an academic and industry partnership to facilitate multicenter clinical trials using Tumor Infiltrating Lymphocytes (TIL) for solid tumors. Through a combination of process improvements intended to shorten product
manufacturing time, as well as innovative implementation of GMP practices, we have maximized the contribution of academic and contract manufacturing organizations to support multiple ongoing trials intended to receive Fast Track
FDA approval for a new cellular therapy.
11:45 Manufacturing Strategy for Chemotherapy-Resistant γδ T Cells for Treatment of Glioblastoma
Lawrence Lamb, PhD, Clinical Laboratory Immunologist, Professor of Medicine, The University
of Alabama at Birmingham; Co-Founder, Incysus
TMZ-resistant γδ T cells, injected in the post-resection tumor bed simultaneously with intravenous TMZ therapy, provide an active response to GBM when the tumor is in its most vulnerable state. We will discuss manufacturing
operations for γδ T cell manufacturing and MGMT gene modification for our Phase I clinical trial that will begin accrual Summer 2018.
12:15 pm Enjoy Lunch on Your Own
1:15 10th Anniversary Cake Break in the Exhibit Hall with Last Chance for Poster Viewing (Grand Ballroom)
1:55 End of Conference