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Session Details

ROUNDTABLE APAC 3 - Regulating biological ancillary materials, who's doing it right?
Saturday, June 3, 2023 11:45 AM - 12:45 PM  
Room 251
APAC
Roundtable
Compare approaches in APAC, the US, and the EU on risk assessment of ancillary materials

Moderator
Bryan Choi, PhD, Professor, Inha University, Korea 

Panelists
David Smith, MBA, President/CCO, Akron Biotech, USA
Sudipto Bari, PhD, Head & Assistant Director, Strategic Development & Communications, Advanced Cell Therapy & Research Institute, Singapore
Pawan Kumar Gupta, MD, MBBS, PhD, DNB, MNAMS, President – Medical & Regulatory Affairs, Stempeutics Research, India
Donald Fink, PhD, Master Practice Expert, Regulatory, Dark Horse Consulting Group, USA 



Learning Objectives
  1. To understand the differences in the current regulations in Asian countries and the United States (US) and European Union (EU) with regard to biological ancillary materials (AMs) used for manufacturing cell and gene therapy products.
  2. To understand the current guidelines and practices of each country regarding specific AMs like the bovine serum, trypsin, and recombinant proteins.
  3. To understand the regulations of each country regarding the eligibility requirements of mesenchymal stem cells (MSCs) as starting cells for cell therapy products, and the comparability data before and after changes in their manufacturing process.

 
Bryan Choi PhD
Professor
 Inha University
 Moderator
Sudipto Bari PhD|MBA
Head, Strategic Development & Communications; and Translational Services & Regulatory Management
 Advanced Cell Therapy and Research Institute Singapore
 Panelist
Donald Fink
Dark Horse Consulting
 Panelist
Pawan Kumar Gupta MBBS, MD, DNB, PhD, MNAMS
President – Medical & Regulatory Affairs
 Stempeutics Research
 Panelist
David Smith RPh, MBA
President/CCO
 Akron Biotech
 Panelist