Key Sessions
Cynthia Lam
Utilizing a regulated targeted integration expression system as both a diagnostic tool for difficult to express molecules and as a method to improve specific productivity without affecting cell growth in CHO cell lines
Genentech
Jesse Richter
Successful Global Launch with a Risk-based Approach to Tech Transfer
AstraZeneca
Wenqin Ni
Comparability Studies to Support Manufacturing Process Change, Enhancing Product Quality and Accelerating Timeline to Commercial Launch
Pfizer
Lakshman Prakash Balajepalli
Selecting CDMO’s for Successful Translation from Lab to Clinic
Cedars Sinai Biomanufacturing Center, USA
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Wednesday 19th March - Main Conference Day One - PT (Pacific Time, GMT-08:00)
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Wednesday 19th March - Main Conference Day One - PT (Pacific Time, GMT-08:00)
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Cell and Gene Therapy Manufacturing
11:15am - 11:20am
Chairperson's Remarks: Cell and Gene Therapy Manufacturing
11:20am - 11:50am
Complexities of CGT Manufacturing & Standardizing the Path to Successful Commercialization
- Spotlight on the complexities of CGT manufacturing;
- How do we address these complexities by standardizing the path to commercialization;
- What innovation and platforms exist to make CGTs more accessible now and in the future?
- Adam Haskett - Senior Director, External Manufacturing, Cargo Therapeutics, USA
11:50am - 12:20pm
Scaling Up Manufacturing Processes for Commercial-Level Production
- How do manufacturers achieve scalability without compromising product quality?
- Increasing batch sizes and maintaining consistency to reduce costs;
- How early is too early to consider strategy for scaling up?
- Strategies to ensure reproducibility, robustness and cell product quality to uphold therapeutic efficacy;
- Harnessing rapid/integrated platforms and process improvements to broaden cell therapy impact;
- Accelerating delivery to patients and catering to increased demand at a clinical and commercial scale.
- Kate Rochlin - Chief Operating Officer, IN8bio
12:20pm - 12:50pm
Spotlight Presentation – Calling all Technology Thought Leaders!
Whether you're increasing your company profile, launching a new product or focusing on new business development opportunities, collaborate with us to identify custom solutions to help you reach your goals.
Contact us today to learn more: Partners@informaconnectls.com
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Cell and Gene Therapy Manufacturing
1:55pm - 2:00pm
Chairperson's Remarks: Cell and Gene Therapy Manufacturing
2:00pm - 2:30pm
How the Joint Audit Model Helps in Cell and Gene Therapy
Over the past 3 years the joining of cell and gene therapy material quality with the joint auditing model has proven to not only increase safety but also decrease money spent. The joint audit model can partner confidentially C&G organizations together to audit material suppliers, which in turn provides a much more robust audit, and return. This presentation will dive into the joint auditing model and provide case examples on best practices as well as guidance.
- Kendall Feshuk - Senior Manager, Member Development, Rx-360, USA
2:30pm - 3:00pm
Selecting CDMO’s for Successful Translation from Lab to Clinic
- Pointers for evaluating academic/early stage programs before technology transfer to a commercial CDMO;
- Choosing and interacting with an optimal CDMO for streamlining manufacturing protocol development;
- Practical tips to avoid time and cost in early manufacturing planning.
- Lakshman Prakash Balajepalli - Manage QA, Cedars Sinai Biomanufacturing Center, USA
3:00pm - 3:30pm
Scientific Presentation by Single Use Support
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Cell and Gene Therapy Manufacturing
4:30pm - 5:30pm
PANEL DISCUSSION: Preparing for the Future of ATMP Commercialization & Attracting Investment to Avoid Roadblocks
- Ensuring the commercial sustainability of cell & gene therapies;
- Tackling barriers and identifying opportunities for commercialization;
- Innovative payment models in the US and globally;
- Strategies for attracting investment to ensure smooth transition from bench to bedside.
- Adam Haskett - Senior Director, External Manufacturing, Cargo Therapeutics, USA
- Kate Rochlin - Chief Operating Officer, IN8bio
- Dan Oliver - CEO and Founder, Rejuvenate Bio, USA
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