Wednesday 11th March - Main Conference Day Two - PT (Pacific Time, GMT-08:00)
- Elizabeth H. Scheideman PhD. - Staff Scientist, Vaccine Production Program, VRC, NIAID,, NIH
- Thomas Jostock, PhD - Associate Director, Novartis
- Hiren Panchal - Principal Investigator, Incyte
- Engineering strategies for allogeneic CAR-T cell therapies for improved safety and efficacy
- Increasing scale of allogeneic cell therapies without compromising quality
- Improving access to CAR-T therapy with off-the-shelf products
- Shu Wang - Principal Investigator, Incyte
- Whitney Liu - Senior Scientist, Bristol Myers Squibb
- Discuss the challenges of external tech transfers when outsourcing CDMOs for clinical manufacturing.
- How to condense timelines and reduce costs through in-house utilization of AD/PD teams to perform parallel development with external partners.
- Strategies to identify and mitigate risks for allogeneic therapies.
- Isaura (Alex) Villalba - Senior Research Associate, Tr1X Bio
- Stefano Menegatti - Professor, Chemical and Biomolecular Engineering, NC State University, North Carolina State University
- John Matthews - Director, Amgen
- Mukesh Mayani - Senior Director, Ultragenyx
- Tony Chikere - Director, Sangamo
- Saurabh Sen - Associate Director, Cell Line Development, Genomic Medicine Unit CMC, Sanofi
- Vilas Shukla, Ph.D. - Director, Large Molecule Global Engineering Projects, Johnson & Johnson Innovative Medicine
- Paul Hanson - Head of Lifecycle Management, Innovation, and Strategy, Interim Head of, Business Excellence, Global Manufacturing Sciences, Takeda Pharmaceuticals
- Jim Fries - CEO, RX-360
Case studies on digital platforms, logistics coordination, and AI scheduling algorithms improving vein-to-vein times and reliability.
- Arathi Krishnakumar - Scientific Associate Director, Bristol Myers Squibb
Presentations on alternative host systems for complex biologics. Talks will highlight modeling and AI-enabled prediction of yield, quality, and downstream compatibility.
Best practices for maintaining genetic stability and ensuring consistent quality. Panelists will discuss digital monitoring and AI-enabled risk prediction across development to commercial stages.
- Zvi Kelman - Director, Biomolecular Labeling Laboratory, NIST
- Yi Liu - Scientist III and Team Lead, Cell Line Development Vaccine Production Program, VRC/NIAID/NIH
- Ken Hamilton - Director of Process Engineering, Genentech
Integrated CMC strategies aligning formulation, device development, and manufacturing planning. Case studies will highlight how modeling and analytics enable cross-functional collaboration, accelerating delivery of combination products.
A panel exploring how facility design and process strategies maximize sustainability, flexibility, and multiproduct capabilities. Discussions will include modeling and digital tools to enable agile facility operations.
- Srivatsan Ramesh - Scientist, BridgeBio Gene Therapy
Forward-looking discussion on how continuous processing, single-use technologies, and AI-driven purification systems will transform downstream operations by 2030.
Presentations on innovative formulations, cryopreservation, and vector stabilization. Talks will highlight predictive modeling and data analytics for stability and manufacturability.
Panelists will discuss scaling CGT processes for launch, including validation, comparability, COGS, and supply chain readiness. Focus on digital readiness for regulatory filings and scale-up.