Conference Day Two: Thursday, June 13, 2024

8:00 am Check-In & Coffee

8:50 am Chair’s Opening Remarks

  • Sudhanshu Shekhar Principal Scientist, Drug Product Process Development, Bristol Myers Squibb

Implementing Cutting-Edge Technology & Methods to Revolutionize Process Design

9:00 am Automation & Digital Manufacturing of Cell Therapy Products – Why Paper is the Enemy of Scale

  • Emily Wisniewski Senior Scientist, Process Development, Takeda Pharmaceutical Co. Ltd.


  • Implementing an automated and digital workflow to improve regulatory compliance and save costs
  • Understanding the importance of technology as it relates to automation and standardization within cell therapy manufacturing
  • Leveraging digital tools to expedite root cause analysis and process optimization 

9:30 am Select & Expand Your Desired Phenotype While Reducing Risk & Increasing Speed to Patient

  • Evan Zynda Senior Scientist, Thermo Fisher Scientific Inc.


  • Reducing time and improving biological precision during process automation
  • Maintaining early and central memory T cell markers for improved therapeutic efficacy
  • Improving process consistency and scalability with high cell viability and improved growth

10:00 am Morning Break & Networking

Collaborating Seamlessly with Different Internal & External Teams to Expedite Timelines

11:00 am Accelerating Early-Phase Development: A Collaborative Approach Between Research and Process Development

  • Mary Keever Associate Director, Process Development, Inceptor Bio


  • Ensuring synergy between research and process development teams by addressing common challenges
  • Co-developing early phase functional assays to enable impactful discovery
  • Utilizing emerging technologies to expedite early-phase development

11:30 am Developing an Effective & Streamlined Process with an External CDMO

  • Raymond Luke Director, Manufacturing, Science & Technology, Verismo Therapeutics


  • Exploring key considerations for CDMO selection – do they have both the vision and the experience to carry out the plan?
  • Assess potential process parameter changes during the transfer and evaluating the impact and risks of such changes
  • Ensuring both teams have a strong expertise in process development, both scientifically and operationally, to ensure a smooth tech transfer 

12:00 pm Lunch Break & Networking

Enhancing Process Scalability to Facilitate Manufacture at Clinical & Commercial Scale

1:00 pm Preparing for Pivotal Product Manufacturing: Scale-up Considerations for Large-Market Allogeneic Cell Therapies

  • David Frey Vice President, Process Sciences, Atara Biotherapeutics Inc.


  • Addressing significant unmet need in cancer and autoimmune disease indications with Atara’s robust pipeline of investigational allogeneic CAR-T immunotherapies
  • Preparing for pivotal product manufacturing from the perspective of a commercialized cell therapy company
  • Moving from static to suspension cell culture production to enable scalability of T-cell therapy manufacturing and favorable cost-of-goods  

1:30 pm Allogeneic Cell Therapy Scale-Up Strategies for Commercial Success

  • Amanda Conerty Executive Director Process, Analytical Development and Manufacturing, Artiva Biotherapeutics, Inc.


  • Scaling allogeneic process from clinical to commercial
  • Addressing challenges and presenting potential solutions to alleviate the anticipated bottlenecks of scale-up
  • Potential challenges of harvest, fill finish, other logistics

2:00 pm Panel Discussion: Accelerating Process Scale-Up for Allogeneic Cell Therapies

  • Sudhanshu Shekhar Principal Scientist, Drug Product Process Development, Bristol Myers Squibb
  • Yinpeng Zhan Senior Scientist, Process & Analytical Development, ImmuneBridge
  • Mark Lalli Associate Director, Process Development, Be Biopharma
  • Matthew Breton Director, Process Development & Manufacturing, Tr1X


  • What are the biggest challenges regarding process scale-up?
  • What are the potential solutions to alleviate the anticipated bottlenecks for commercial-scale manufacture of high-quality therapeutic cells?
  • How can service providers aid with process scale-up? 

2:30 pm Afternoon Break & Networking

Overcoming Key Process Challenges to Unlock the Full Potential of Gene Edited Products

3:00 pm CRISPR/Cas9-Based Engineering of a Large & Modular Cassette into a Safe Harbor Site to Improve CAR-T Cell Therapy Efficacy & Safety

  • Alice Chang Principal Scientist, Process Development, ArsenalBio


  • Discussing advantages of ArsenalBio’s targeted, non-viral engineering platform, CRISPR integration of transgene by electroporation (CITE)
  • Identifying and characterizing on- and potential off-target integration sites
  • Developing a robust and scalable electroporation-based manufacturing process for integrated circuit T (ICT) cells

3:30 pm Developing a Closed, Automated CRISPR-Cas9 Editing Process for a TIL Product

  • Mingli Li Associate Director, Process Development & Tech Operation, KSQ Therapeutics


  • Developing a system where the genetic modifications are carried out within a sealed environment
  • Incorporating a “flow electroporation Process Assembly (PA)” to precisely deliver CRISPR components to TILs, maintaining sterility throughout the editing process, and minimizing contamination rises
  • Enhancing reproducibility, ensuring the safety and efficacy of the editing TIL product

4:00 pm Chair’s Closing Remarks

  • Sudhanshu Shekhar Principal Scientist, Drug Product Process Development, Bristol Myers Squibb

4:15 pm End of Conference Day Two