Upcoming Webinar: Challenges and Solutions for GxPs in Cell/Gene Therapy Product Development, June 3rd 4-6PM
- Posted by ISPE Boston
- On May 18, 2023
Framingham State University and MassBay Community College are presenting a panel discussion with leaders from the New England Regional Chapter Society of Quality Assurance to discuss the current challenges and solutions for various Good Practices (GxPs) in the Cell/Gene Therapy industry, on June 3rd (Saturday) from 4 to 6 pm EST. The event will be held onsite in Hemenway Annex 534 at Framingham State University. Participants also can choose to attend online via a Zoom invitation, after free registration.
During this panel discussion, you will learn about the current quality and compliance challenges or uniqueness facing the biopharmaceutical industry for R&D, bio-manufacturing, nonclinical sciences, and clinical studies in cell/gene therapy product development. Panelists will also discuss distinctiveness and potential solutions for some of the challenges. Examples are as follow:
- Challenges For GLP
- Is it GLP or not?
- Test Article Characterization
- Challenges for GMP
- 100% custom-on demand manufacturing in autologous cell/gene therapy
- Little control on starting donor materials
- Uniqueness of GCP
- Quality Risk Management
- Product Management
- Edward Armstrong, Vice President, Quality/Head of Quality for Mustang Bio
- Bernadette Brown, Associate Director, Mustang Bio
- Danielle DeOssie, Senior Manager, GLP Operation QA, Vertex Pharmaceuticals
- Robert Dionne, Associate Director, Quality Assurance, Mustang Bio
- Melissa Jensik, Director, Quality Assurance, Eidos Therapeutics
- Malena Maier, Associate Director, Vertex Pharmaceuticals
- Judyth Zahora, Senior Director, Agenus
- Maryse Constant, Director, Regulatory Affairs And Quality Assurance, AliMedMember
- Sunny Tam, PhD, Director, PSM in Biotechnology, Framingham State University; Affiliate, Clark University Chemistry Department; Clark University BS in Biotechnology Advisory Board Member
Comment below if you plan to attend this webinar, or share with a friend who would be interested in this topic!