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31 October – 2 November , 2017

London, UK

 

 

Pre Conference Workshops
Tuesday, 31st October, 2017

09.00 - 12.00
Workshop A: Investigating the Unique Regulatory Landscape of the Gene Therapy Field
Workshop Leader: Ann Gorman, Director, Regulatory Science, Voisin Consulting

As the gene therapy space advances and clinical investigations continue to produce promising results, uncertainty about the route to successful regulatory approval and commercialization remains a significant challenge.

Attend this workshop to gain an in-depth understanding of key regulatory issues for gene therapies for both clinical development and marketing authorization at this pivotal time for the gene therapy field.

Attendees will learn about:

  • CMC issues related to the development of gene therapies
  • Impact of environmental risk assessments on  clinical trials applications for GMO-based medicinal products
  • Specific regulatory requirements for gene therapies for successful MAAs

Ann Gorman, Director, Regulatory Science, Voisin Consulting

Ann Gorman

13.00 - 16.00
Unlocking the CMO Selection Process: How to Select & Manage External Manufacturers Effectively

Identifying CMOs with sufficient capacity, expertise and facilities to handle outsourced projects in cell and gene therapy is a major challenge in Europe and globally.

As scale-up and commercialisation of gene therapy programs draws closer, this workshop session is your opportunity to get up to speed with the most successful outsourcing strategies in this field.

Attendees will learn about:

  • The criteria you should be using to adequately assess potential partners to outsource projects to in the gene therapy space
  • Which requirements in your service request may be the ones guiding your selection process
  • How to tailor and assess the specific process requirements of an external manufacturer
  • Which kind of tools to use for data-driven CMO selection
  • Key factors impacting the decision to develop in-house capabilities or outsource services to third parties

Workshop Leader: Reinout Hesselink, Consultant, Cell & Gene Therapy, Exmoor Pharma Consulting