REGISTRATION

December 15, 2022, 11am-1pm ET, Virtual

There have been tremendous advancements and breakthroughs in cell therapy treatments.  Autologous treatments are extremely effective personalized therapies, but have significant medical, cost and commercialization limitations.  Allogeneic treatments provide us with an opportunity to expand and extend access to personalized therapies to patients in need, but face efficacy, safety, and process hurdles.  

While related, the differences are stark, forcing your company to make unique and critical process and business decisions to ensure your company implements the best technologies to execute the most effective autologous and/or allogeneic cell therapy manufacturing strategy. 

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Meeting Agenda (subject to change)    

Moderator:                  Ben Locwin, Executive, Black Diamond Networks    

11:00 am – 11:30 am    Meet and Greet Networking + Welcome 

11:30 am – 11:50 am    Case Study 1: Implementing an Efficient Autologous Manufacturing Strategy 

                                      (Jonathan Tsang, Senior Director, Manufacturing Sciences and Technology, Kite 

                                      Pharma)

* Addressing starting materials variability and deviations 

* Why qualification of clinics is critical 

* Implementing clinical requirements and oversight

* Establishing and executing proper chain of custody

* Ensuring reliability of IT systems 

11:50 am – 12:10 pm    Case Study 2: Implementing an Efficient Allogeneic Manufacturing Strategy 

                                      (Marty Giedlin, Vice President, Head of Technology Operations, Senti Bio)

* Understanding and managing manufacturing expectations

* Letting the science drive your strategy 

* CMC must be driven by the data 

* Characterizing starting materials – be confident or don’t do it

* Why a “one size fits all” process is not realistic 

12:10 pm – 12:30 pm   Case Study 3: Multi-Modal Facility Design Considerations for Cell Therapy 

                                      (Stephen Judd, Process SME – Biologics and Cell Therapy, DPS Group Global)

* Autologous vs Allogeneic design considerations

* Implementing proper equipment design and cleanroom grading

* Operational challenges impacting facility design

* Essential multi-modal facility layout considerations    

12:30 pm – Close        Deep Dive Networking

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