Upcoming Webinar: Challenges and Solutions for GxPs in Cell/Gene Therapy Product Development, June 3rd 4-6PM

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 3^rd (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

Speakers:

• 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

Moderators:

• 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!