Regulatory Development and Approval Pathways for Immunotherapy Products

Regulatory strategy and agency engagement for immunotherapy products

• Preclinical stage
• Early stage interactions
• CMC considerations

Lessons learned from early stage development

Moderator: Livija Deban, Chief Scientific Officer, Prokarium

Panellists:

Callum Scott,  Senior VP, Development, Scancell

Margareth Jorvid, Senior Partner, LSM Group / Life Science Management

Date July 1, 3-3.50pm UK time

Advancing CGT – Commercial & Regulatory Considerations
Duration: 50 minutes

0–20 mins | Expert Interview

Commercialising CGT: lessons from development, manufacturing, supply chain and market readiness
A focused interview exploring how cell and gene therapies can move from development to commercial reality, including operational readiness, manufacturing strategy, supply chain complexity and market access considerations.

20–50 mins | Panel Discussion: Advancing CGT – Commercial & Regulatory Considerations

Confirmed Panelists:

• Amir Hefni, CEO, Resolution Therapeutics
• Ruben Rizzi, Senior Vice President, Global Regulatory Affairs, BioNTech
• Christopher Middendorf, Senior Director, Technical, Pharma & Biotech GxP Compliance, Hogan Lovells

Discussion points:

• Balancing innovation, regulation and speed to market
• Building scalable manufacturing, quality and compliance strategies
• Commercialising advanced therapies in a challenging funding and access environment