Conference Day One

Tuesday | January 30, 2024

7:45 am Registration & Coffee

8:45 am Chair’s Opening Remarks

Optimizing Early Phase Development to Build Infrastructure for Commercial Manufacturing

9:00 am Industry Leader’s Fireside Chat: Emphasizing the Importance of Strategical Planning to Establish a Solid Foundation for Successful Commercial Manufacturing

  • Amish Patel Senior Vice President - Technical Operations, Calidi Biotherapeutics
  • Vaishali Shukla Vice President Quality Commercial Quality Manufacturing, Kite Pharma Inc
  • Sumit Verma Senior Vice President Global Strategic Manufacturing, Iovance


Discussing how decisions made during early phase development impact supply chain design and management

  • Addressing the need to design infrastructure that can transition from early phase to commercial manufacturing to accommodate increased production demands
  • Exploring the regulatory challenges that impact early phase development decisions
  • Understanding how regulatory agencies will distribute licenses for each manufacturing site
  • Outlining the criteria for selecting suitable sites for decentralized manufacturing considering infrastructure, expertise, and regulatory compliance history

10:00 am Adopting a Decentralized Manufacturing Model to Usher in a New Era of Cell Therapy


  • Defining decentralized manufacturing and highlighting the need for a decentralized model within cell therapy manufacturing
  • Exploring the differences between point of care manufacturing and decentralized manufacturing
  • Outlining the key differences between decentralized and centralized manufacturing and a deep diving into the benefits of the decentralized model

10:30 am Safety and Quality Assurance in Decentralized Manufacturing to Achieve Product Consistency

  • Michelle Andraza Senior Directory Global Quality Assurance & Chemistry, manufacturing and controls, Exuma Biotech


  • Addressing the critical aspects of safety and quality assurance during decentralized manufacturing
  • Exploring effective quality control strategies and validation methods that uphold product consistency in a decentralized setting
  • Discussing the implementation of robust quality management systems that comply with GMP to meet regulatory requirements

11:00 am Speed Networking & Morning Refreshments


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

Innovating Manufacturing Operations to Enable Large Scale Expansion & Meet Patient Demand

12:00 pm Meeting Increased Patient Demand with Partially Automated Systems

  • Richard McFarland Chief Regulatory Officer, Advanced Regenerative Manufacturing Institute


  • Implementing real-time adjustments using machine learning algorithms
  • Integrating and controlling real time measurements with AI and predictive modelling
  • Maximizing yield with a production process tailored to unique characteristics of each batch

12:30 pm Reducing Manufacturing Complexity to Optimize Scalability


Developing a rapid personalized manufacturing process to reduce time for expansion and cell culture

  • Balancing increased potency of rapidly manufactured cells with in-vivo tolerability and persistence
  • Exploring use of a manufacturing facility with modules rather than ballrooms to offer greater flexibility for multiple product streams

1:00 pm Lunch Refreshments

Digitalizing the Manufacturing Ecosystem to Improve Quality Control

2:00 pm Introduction into Digitalization for Decentralized Manufacturing

  • Nan Zhang Chief Cell Therapy Manufacturing, NIH Clinical Center


  • Understanding the role of digital technologies in transforming quality management systems for decentralized manufacturing of cell therapies
  • Addressing the need for an effective digital management system
  • Discussing how to develop an information system that will effectively capture data from multiple sites

2:30 pm Roundtable Discussion: Considering End Commercialization Attributes Early in Development to Prevent Downstream Disruption

  • Chris Baldwin Senior Director - Cell & Gene Therapy Supply Chain, GSK


  • How do we get cell therapies to become “mainstream” treatments?
  • Can we tackle the issues of infrastructure by setting up a decentralized network in the US?

3:00 pm Afternoon Refreshments & Poster Session

Managing Site-to-Site Comparability for Product Consistency

4:00 pm Establishing Site-to-Site Comparability Protocols


  • Understanding the significance of site comparability in ensuring consistent product quality
  • Discussing best practices and methodologies for designing and implementing comparability protocols
  • Exploring data analysis approaches to assess comparability results and draw meaningful conclusions about product consistency

4:30 pm Leveraging Automation to Ensure Site-To-Site Comparability

  • Arya Pawar Senior Manufacturing Associate Oncology Cell Therapy, ImmunityBio


  • Developing strong automation protocols to ensure manufacturing is reproducible across all sites
  • Exploring how automating the manufacturing process will aid with scalability of manufacturing sites

5:00 pm Chairman’s Closing Remarks

5:15 pm Close of Day One