Overview:
There has been a phenomenal increase in activity within the Cell and Gene Therapy development space during the last 5 years. We have seen a year on year increase in CGTs which is forecasted to continue both in terms of number of products as well as a further diversification of product technology and target indications. Whilst Cell and Gene Therapies offer huge benefit and hope to patients, particularly for those with target indications of unmet need and/or where all other treatment pathways have been exhausted, they continue to present significant challenges to the Industry both in terms of operational delivery and patient access. These therapies have put pressure on every aspect of the traditional clinical trial delivery model which presents opportunities for innovation and the introduction of new and different approaches in response to this. This presentation provides an overview of the operational considerations and best practices for delivering these types of therapies within clinical phase development.
Agenda:
Time: 4:00-5:00pm (KST time)
Subject name: An exploration of the key challenges & operational best practice in delivering cell and gene therapies
Objectives: Overview of the operational differences in CGT trials vs. traditional models
Targeting contents: Planning and operational considerations for CGT trials
Time: 5:00-6:00pm (KST time)
Subject name: CGT Product Journey & Logistics Orchestration
Objectives: Overview of autologous & allogeneic cell therapy logistics requirements
Targeting contents: Planning and operational considerations for CGT trials
Registration details
Cost: 10,000KRW
Speakers:
Emily Merrell
Emily Merrell has worked within the Healthcare sector for 24+ years with global development experience spanning several industries, including Biotech, Pharma, CROs, and public sector. In addition to roles in drug development, Emily has also worked as a consultant within The National Healthcare System (NHS) where she led the development and implementation of a virtual COVID hospital that resulted in improved outcomes for COVID-19 patients. Whilst at the Cell and Gene Therapy Catapult within the UK she coordinated The Advanced Therapies Treatment Centre (ATTC) Network. Her clinical development experience spans all therapeutic areas and all stages of the clinical development lifecycle, from First In Human trials to Long-Term Follow Up and Post Marketing surveillances. Her current role at ICON is in the operational leadership of the Centre for Cell & Gene Therapy as well as driving the strategic growth of the Centre’s capabilities which has so far supported the delivery of 150+ Cell and Gene Therapy Clinical Trials over the last 5 years. Emily has a passion for enabling new ways of working by challenging ‘traditional models’ and cultivating more integrative working within and across organisations as the driving force of transformational change.
Tamie Joeckel
- 9+ years in cell & gene therapy global logistics strategy, site readiness & system integration
- Certified in Production & Inventory Management (CPIM)
- 25+ years in specialty biologics distribution, patient hub services, REMS & registries
- Former roles as SVP of Client Services for Cryoport managing over 5,000 global shipments of cell therapies; VP Commercialization Services for AmerisourceBergen Specialty Group