Conference Day 1

8:30 AM - 8:50 AM Registration and Coffee

8:50 AM - 8:55 AM PharmaIQ Welcome

8:55 AM - 9:00 AM Chairman's Opening Address

9:00 AM - 9:40 AM MHRA: Advanced Therapy Medicinal Products (ATMP) Manufacturing Approaches

  • Determine how different starting materials will affect the different GMP approaches
  • Hear how the Human Tissues Act addresses, amongst others, are involved in the use of autologous cells in production
  • Examine what different regulatory requirements are apparent with MHRA and how the Tissues and Cells Directive falls under two competent authorities

9:40 AM - 10:20 AM Identify the Opportunities and Challenges in Advanced Therapy Manufacturing Process (ATMP)

  • Determine what to consider when moving from research to commercial production
  • Understand what different set backs will become apparent when looking at cost efficiency of manufacturing
  • Hear the recommended actions that need to be considered when in the positions of discovery and development of advanced therapies

10:20 AM - 10:50 AM Coffee Break

10:50 AM - 11:30 AM The Development of Advanced Therapy Medicinal Products

  • Decipher further understanding of regulatory approaches for the development of ATMP
  • Clarify the different quality attributes and regulatory convergence for different countries with focus to GMP compliance.
  • Plan for the future with foreseeing further specific regulations and guidelines, leading the way for concise understanding of being GMP compliant

11:30 AM - 12:10 PM Ensuring Quality of Cell Therapy Products

  • How to include Quality as integral part of development of cell therapy products
  • Decipher what needs to be considered for QC testing and when are where they need to be addressed
  • Demonstrate stability in supply chain and logistics of product after production

12:10 PM - 1:10 PM Lunch

1:10 PM - 1:50 PM Case Study: Development of a Manufacturing Process to supply a Neural Stem Cell Therapy for the Treatment of Stroke

  • Hear about the development strategies that have been implemented to help enable scale up of stem cell therapies
  • Uncover the different manufacturing challenges that are specifically associated with stem cell therapies
  • Determine what analytical testing can be used for stem cell therapies

1:50 PM - 2:30 PM The Future Landscape of Gene Therapy Production

  • Discover how gene editing is being implemented in the gene therapy stage
  • Understand why the transition to gene editing is shifting the focus around gene therapy products
  • Engage on how to create a more stable gene therapy product with improved vector assembly

2:30 PM - 3:00 PM Coffee Break

3:00 PM - 3:40 PM Panel Discussion: Following GMP Compliance in Cell & Gene Therapy Manufacturing

  • Discuss how to choose the right GMP approach for your manufacturing process
  • Depict the different aspects involved in Quality Assurance of Advance Therapy Manufacturing
  • Examine ways to clarifying different products and harmonising the novel entities involved in GMP and QA
  • Understand the different between allogenic and autologous therapy and how this effects the manufacturing process at your facility
  • Speculate as to how political developments like Brexit will alter the GMP environment

3:40 PM - 4:20 PM Case Study: Risk Based Approach To Commercialising Gene Therapies

  • Decipher what the risk based approach is to maximising manufacturing opportunity in cell and gene therapy
  • Hear what different factors need to be considered in the move from early phase development to commercial production
  • Identify barriers that can become apparent in the evolution of cell and gene products

4:20 PM - 4:30 PM Chairman's Summary of Day One