Target Audience:

Commercial companies and academic institutions involved in all stages of development and manufacture of emerging cellular therapies and products.

Topics will focus on technology licensing and transfer, process development, manufacturing and characterization of cell-based products, and novel regenerative therapies in the clinic today.

Educational Objectives:

1. Address key issues in the IP and Technology Transfer process including patent filing, invention licensing, and clinical agreements.
2. Address key manufacturing-related issues of early- to mid-stage clinical trials, including process development and scale-up, maintaining comparability and consistency, assay qualification & validation, and material sourcing
3. Review the clinical landscape of cell-based regenerative medicine therapies and current logistical practices for safe delivery of cell therapy products to the clinical site.
4. Provide a platform for industry and academic networking.

Session Titles Include:

• Navigating the I.P and Technology Transfer Process
• Technology Transfer Strategies
• Patents and Their Implications in Cellular Therapy
• Manufactuing for Phase II to Enable Commercialization
• CMC Challenges: Characterization
• CMC Challenges: Manufacturing
• Regenerative Medicine: Therapies in the Clinic Today
• Management of Treatment Logistics and Quality Assessments in Regenerative Medicine
• Regenerative Medicine in the Pharmaceutical Industry

CLICK HERE to view the Strategies for Commercialization Track Program.

Organizing Committee

Tara Clark
Miltenyi Biotec
Andover, MA
tclark@miltenyibiotec.com

Scott Burger
Advanced Cell & Gene Therapy
Chapel Hill, NC
celltherapy@ac-gt.com

Karen Edward
Advanced Cell & Gene Therapy
New York, NY
kedward@ac-gt.com

Jon A. Rowley
Lonza Walkersville
Walkersville, MD
jon.rowley@lonza.com