Conference Day Two: Thursday, June 13, 2024

8:00 am Check-In & Coffee

8:50 am Chair’s Opening Remarks

  • Divya Varun Senior Principal Scientist, Senior Manager II, 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 staff 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

10:30 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

11:00 am The Sustainability Scare – What Your Waste is Really Costing You!


  • Defining sustainability in the era of multi-million dollar dose costs 
  • Where is your waste coming from and what is it costing you? 
  • Moving from waste to haste, developing therapies at speed 
  • Keeping the end in mind – the patient, how sustainability directly impacts treatment, affordability and accessibility 
  • Steps YOU can take today to become sustainable, reach your inflection point sooner
  • Make moving from bench to bedside something more than just a tagline

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

  • Raymond Luke Director - Manufacturing, Science & Technologies & Head of Chemistry, Manufacturing, and Controls, 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

  • Dave 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 Panel Discussion: Accelerating Process Scale-Up for Allogeneic Cell Therapies

  • Yinpeng Zhan Senior Scientist - Research & Process Development, ImmuneBridge
  • Mark Lalli Associate Director - Process Development, Be Biopharma
  • Matthew Breton Director - Process Development & Manufacturing, Tr1X
  • Divya Varun Senior Principal Scientist, Senior Manager II, Bristol Myers Squibb
  • Ignacio Nunez COO, Cell Ready


  • 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? 

2:15 pm Afternoon Break & Networking

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

2:45 pm CRISPR/Cas9-Based Engineering of a Large & Modular Cassette into a Safe Harbor Site to Improve CAR-T Cell Therapy Efficacy & Safety


  • 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

3:15 pm Developing a Robust CRISPR-Cas9 Editing Process for a TIL Product

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


  • Developing a robust gene editing process to retain cell health and function
  • Optimization of editing process to precisely deliver CRISPER 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

3:45 pm Chair’s Closing Remarks

  • Divya Varun Senior Principal Scientist, Senior Manager II, Bristol Myers Squibb

4:00 pm End of Conference Day Two