• Overview of the Tech Transfer landscape, specifically in regard to CGTs: a complex and new field.
• Key challenges when approaching tech transfer (in house or outsourced).
• Considerations for IP and regulation.

• Identifying and assessing commercial potential of novel technologies for use in CGT production.
• Due diligence processes during technology evaluation.
• Balancing innovation with market needs.
• Working collaboratively with multiple stakeholders.
• Considering your therapeutic development needs and how to align with cutting-edge technologies.

• Navigating the tech transfer process from a developers perspective
• Key milestones and challenges along the journey:
  • Finding a suitiable CDMO
  • Scaling up
  • IP hurdles
  • Building a winning team, what expertise and partnerships were crucial for successful tech transfer

• Importance of IP protection in tech transfer for CGTs.
• Strategies for patenting and protecting CGT inventions.
• Managing IP ownership and collaborations with universities/research institutions, as well as vendors.

Stages in Process Development:

• Examining design, qualification and validation - Discover what to do and when
• Pre-requisites to start production for clinical studies
• Product and Process development & characterization
• How to define preliminary critical quality attributes (pCQAs)
• Linkage studies of preliminary critical quality attributes (pCQAs) and preliminary critical process parameters (pCPPs)

Process Characterization:

• Small-scale process model definition and utilization
• Learn how to use small process models
• Statistical models
• Proven Acceptable Range studies & Design Space development

• Process overview
• Objectives of main processing steps
• Cell lines (generation & characterization) - regulatory requirements
• Materials and risks
• Where processing under GMP needs to start?

Join us for a rare opportunity to explore St James's Hospital's Wellcome HRB Clinical Research Facility. Nestled within Ireland's largest teaching hospital, this cutting-edge facility stands at the forefront of medical innovation, leading the charge in groundbreaking early-phase clinical trials and studies. Witness first-hand the specialized infrastructure that has paved the way for revolutionary advancements, including Ireland's first gene therapy and CAR-T clinical trials.

During this tour, you will:

• Access restricted areas: Delve into clinical consultation rooms, a dedicated ward, inpatient rooms, a sample processing laboratory, and a specialized research pharmacy equipped to store Investigational Medicinal Products (IMPs).
• An inside look: Experience the GMP-grade clean room, a sterile environment meticulously designed for the aseptic preparation of life-altering gene and cell therapies.
• Learn about ongoing projects: Gain insights into the diverse range of clinical trials currently underway, including CAR-T cell therapy for Multiple Myeloma, gene therapies for Haemophilia, and pioneering gene therapies for Neurological conditions.

Important Notes:

• Photography restrictions: Please respect patient privacy; photography is not permitted in patient areas.
• Guided experience: For your safety and to ensure a smooth experience, you will be accompanied by knowledgeable CRF staff throughout the tour.

Don't miss this unique chance to explore this cutting-edge facility. Spaces are limited, RSVP required!