Meet Our 2017 Speakers
Gain insights from global thought-leading speakers on how overcome today’s challenges involving scale-up, facility design, characterization, tech transfer, regulatory approval, investment, reimbursement and more.
Three Focused Tracks
Cell & Gene Therapy Bioprocessing & Commercialization is streamlined to address the needs of developing cell and gene therapy products. This year's event focuses on tackling core bioprocessing and commercialization challenges, concentrating on the bottlenecks, pain points, and remaining hurdles during the production of cell-based products.
Reducing labor, time and cost in bioprocess analysis and characterization
Relieving bottlenecks in gene therapy bioprocessing
Advancing transduction for gene therapy bioprocessing
Advances in CAR-T Cell manufacturing
Developing and validating potency assays
- Commercialization strategy case studies
- Logistics and supply chain management
- Establishing and managing an allogeneic therapy supply chain
- Biopreservation, cryopreservation and storage for cell and gene therapies
North American regulatory, policy and healthcare landscape change
International Commercialization / Regulatory strategies
NEW! Clinical Developments
Designing late stage clinical trials for success
Regulatory update on expectations surrounding potency assays
Process Validation Strategies in the Clinic
Supply Chain Challenges when Anticipating Transfer from the Clinic to Commercial Scale
Raw material supply and quality agreements
Control strategy and the clinical trials experience
Present a Scientific Poster
Highlight your company's latest research findings by presenting a scientific poster, which will be displayed in the exhibit & poster hall during the event. The deadline to submit your poster is August 25, 2017.
Progress Toward Commercial Scale and Efficiency in Cell Therapy Bioprocessing
Cell and gene therapy is an extremely promising and growing medical technology sector with 631 ongoing clinical trials at the end of 2015. It is applicable to oncology, cardiovascular disease, infectious diseases and other diseases. The merit of cell and gene therapy has been demonstrated by FDA approvals, however commercialisation can prove a high hurdle that can trip up even approved therapeutics such as Dendreon’s Provenge autologous cell therapy. There are however steps that can be taken to reduce the risk associated with commercialisation that companies with a cell and gene therapy portfolio should consider. This whitepaper discusses practical measures to improve the chances of commercial success:
- Characterization and Comparability Risk reduction through Quality by Design (QbD)
- Improving efficiency and reducing costs in development and production
- Novel analytical technologies and methodologies
- Ensuring successful process scale up and transfer
- Progress towards the industrialization of cell and gene therapies through modularisation
The go-to conference for everything related to Cell Therapy Bioprocessing and Commercialization.Great technology, a comprehensive program, and a wonderful exhibit hall. This conference is a great place to do business.
The only one of its kind.
This is a great event to keep abreast of the manufacturing advancements for the rapidly evolving cell and gene therapy industry.
PCT, A Caladrius Company