Accelerating Your Product Timeline to Market by Keeping Up with Process Development Advancements
Thursday, May 30, 2024 03:45 PM - 04:45 PM
Room 212-214
Concurrent Session
Chair:
How the process development stage of a CGT product goes is critical to both the speed and success of getting your product to market and into patients.
Process development approaches and considerations are constantly changing based on the state of technology and regulation.
In this session we describe recent success stories in process development and outline how successful companies have approached this stage of product development.
We will also tackle the future of process development from both a regulatory perspective and considerations for applying machine based learning and AI to your process development.
Attedees will come out of this session with insights on what to think about in their next stages of process development for their CGT product.
- Lise Munsie, PhD, CCRM, Canada
- Kimberly Schultz, MD, FDA, United States, "Regulatory Considerations for Cellular and Gene Therapy Product Development"
- Nooshafarin Sanaie, PhD, Vice President of Process Development, Poseida Therapeutics, Inc., United States, "Strategic Approaches on Process Optimization
and Manufacturing of Allogenic Cell Therapy Products" - Janet Rothberg, PhD, Director of Process and Analytical Development, CCRM, Canada, "Challenges with moving iPSC derived cell therapies through Process Development"
How the process development stage of a CGT product goes is critical to both the speed and success of getting your product to market and into patients.
Process development approaches and considerations are constantly changing based on the state of technology and regulation.
In this session we describe recent success stories in process development and outline how successful companies have approached this stage of product development.
We will also tackle the future of process development from both a regulatory perspective and considerations for applying machine based learning and AI to your process development.
Attedees will come out of this session with insights on what to think about in their next stages of process development for their CGT product.
Nooshafarin(Nooshie) Sanaie
Vice President of Analytical and Process Development
Poseida Therapeutics
Speaker
Vice President of Analytical and Process Development
Poseida Therapeutics
Speaker