Conference Day Two

Wednesday | January 31, 2024

9:00 am Coffee & Networking

9:20 am Chair’s Opening Remarks

Leveraging Automation of the Manufacturing Process to Ensure Streamlined Manufacturing

9:30 am Ensuring Reliability and Accuracy in Analytical Assays to Standardize Processes Across Multiple Sites

  • Sumona Sarkar Staff Scientist, National Institute of Standards & Technology

Synopsis

  • Discussing challenges and solutions related to the scalability of analytical techniques considering variations in product output
  • Exploring the use of automated analytical techniques to streamline the manufacturing process
  • Understanding the importance of implementing quality control measures and standardization protocols in scalable analytical assays to maintain reliability and consistency

10:00 am Audience Discussion: The Role of Automated Technology in Driving The Efficiency and Scalability in a Decentralized Manufacturing Setting

  • Sumit Verma Senior Vice President Global Strategic Manufacturing, Iovance

Synopsis

Outlining the various aspects of manufacturing that can be automated including, cell culture, processing, analytical techniques, and quality control

  • Discussing strategies for upskilling the workforce to effectively operate and maintain automated systems
  • Exploring how automation technologies can be seamlessly integrated into existing manufacturing workflows to maximize efficiency
  • Exploring regulatory expectations and validation requirements for automated systems used in cell therapy manufacturing

10:45 am Morning Refreshments

Synopsis

As this community unites for the first time, this session will provide valuable networking time with your peers, enabling you to forge new and lasting connections.

Addressing the Fundamental Requirements for a Decentralized Model to Enable Manufacturing Success

11:30 am Understanding the Decentralized Manufacturing Landscape for Academic Providers

  • Steven Feldman Site Head/Scientific Director, Laboratory for Cell and Gene Medicine, Stanford Medicine

Synopsis

  • Exploring the growing interest in decentralized manufacturing and its potential benefit for academic providers in advancing research and therapeutic development
  • Discussing the challenges that academic providers may encounter during the transition to a decentralized model and proposing strategies to overcome them
  • Exploring the potential for collaboration between academic providers and industry partners to leverage resources knowledge and expertise

12:00 pm Roundtable: Product Licensing Strategies and Regulatory Considerations to Establish Manufacturing Responsibilities

Synopsis

  • Exploring different licensing models and how this is applicable to the decentralized manufacturing landscape
  • Highlighting the challenges and opportunities in product licensing and gaining regulatory approval to ensure industry providers have a clear understanding of manufacturing responsibilities
  • Addressing the initial cost investment required for setting up decentralized facilities and the potential long-term cost savings

1:00 pm Lunch Refreshments

Enhancing Commercial Availability Through Decentralized Manufacturing

2:00 pm Maintaining Effective Quality Control Strategies Whilst Scaling Out a Decentralized Model

  • Vaishali Shukla Vice President Quality Commercial Quality Manufacturing, Kite Pharma Inc

Synopsis

  • Discussing the unique quality control challenges posed by decentralized manufacturing
  • Exploring how we can create an effective scalable model whilst maintaining product quality and consistency

2:30 pm Mastermind Session: Increasing Patient Access to Cell Therapy with Novel Manufacturing Models

  • Teresa Igler Senior Manager, Manufacturing & Supply, Kyverna Therapeutics
  • Vladimir Slepushkin Chief Technology Officer & Global Head of Manufacturing, MedTherapy Biotech

Synopsis

  • How do pricing policies align with manufacturing goals and processes?
  • Can incremental manufacturing improvements outcomes influence pricing strategies over time

3:30 pm Chair’s Closing Remarks

3:45 pm Close of Summit