Conference Day 2
8:30 am - 8:55 am Registration and Coffee
8:55 am - 9:00 am Pharma IQ Welcome Address
9:00 am - 9:10 am Chairman's Summary of Day 1
9:10 am - 9:45 am Panel Discussion: Writing The Rulebook – Industry Harmonisation, CMO Collaboration And Process Optimisation
- Recap of the current industry paradigm: Where are we now and where do we want to be in the next five years?
- Discuss the need for cross-boarder and crosscompany collaboration to drive therapy commercialisation
- Examine the reality of achieving CMO – sponsor harmonisation: How realistic is this given the industry fragmentation?
- Identify the critical success factors in building industry capability and collaboration and how this can be translated into process optimisation for efficient therapeutic development
9:45 am - 10:20 am Manufacturing Of TCR-Based T-Cell Therapies For Solid Cancers To Enable Late Stage Clinical Trials
- Hear how Immatics proprietary discovery platforms, XPRESIDENT® and XCEPTOR®, identifies the targets and TCRs that are used as the basis of the various Immatics adoptive cell therapy programs
- Examine the development of autologous and allogeneic T-cell products for solid cancers using Immatics targets and TCRs
- Discuss the products that have been developed and manufactured under cGMP conditions to meet the pre-set release criteria for patient infusion of the Immatics 4 active Phase I clinical trials
- Develop the next generation of manufacturing processes for implementation in late stage clinical trials and commercialisation
10:20 am - 10:55 am Scaling Up Or Scaling Out: How Oxford Biomedica Ensured Their Manufacturing Process Was Market Ready
- Examine how Oxford BioMedica performed a gap analysis to identify critical areas of development for their manufacturing strategy to meet market demand
- Hear how Oxford BioMedica assessed market requirements and current manufacturing capabilities to assist in identifying whether to scale up or scale out their manufacturing process.
- Discuss the ramifications of selecting a scale up or scale out approach: How Oxford BioMedica managed this transition to minimise process disruption and delay
10:55 am - 11:25 am Morning Coffee Break
11:25 am - 12:00 pm Ensuring Scalability Of T-Cell Therapy Manufacturing Processes: A Gammadelta Therapeutics Case Study
- Identify the key challenges and inherent process limitations when moving from academia to manufacturing
- Develop a scalable manufacturing process for efficient autologous production at scale
- Ensure successful bridging to GMP suitable materials when building large scale production processes
12:00 pm - 12:35 pm Delivering Curative Gene Therapies To Patients Through Integrated Manufacturing And Supply Chain Operations
- Examine the promise and challenges of ex-vivo autologous gene therapy
- Discuss strategies to translate academic excellence to industrialised medicine
- Build an integrated manufacturing and supply chain model to increase process efficiency
12:35 pm - 1:10 pm Ensuring Process Comparability And Effective Manufacturing Strategy Validation To Avoid Unexpected Surprises
- Discuss how Pluristem have incorporated process comparability requirements as part of their process development
- Debate the critical success factors to be considered in your manufacturing strategy validation to ensure that you are asking the right questions!
- Implement a flexible manufacturing strategy to ensure that your process can react to market demand and manufacturing pressures
1:10 pm - 2:10 pm Networking Lunch
2:10 pm - 2:45 pm Optimising Your Process Lifecycle Management To Support Efficient Transition Towards Commercialisation
- Map out the critical steps to building a compliant and flexible process lifecycle strategy
- Discuss how to translate your lifecycle management strategy into a compliant filing and reporting structure to enable the commercial approval process
- Examine lessons learned from the approval of Kymriah and where Novartis is looking to implement future process developments
2:45 pm - 3:20 pm Utilising Third Party Suppliers And CMOs As A Means Of Driving Manufacturing Efficiency
- Discuss the Cost of Goods (COGs) pressure on SME manufacturing processes, and where outsourcing fits into the cost-efficiency equation
- Examine the risks to outsourcing ATMP-based manufacturing processes, particularly pertaining to extractables and leachables, process compatibility and regulatory compliance
- Analyse the management of external partners and CMOs across the product development lifecycle to ensure alignment from early stage development through to commercialisation
3:20 pm - 3:50 pm Afternoon Coffee Break
3:50 pm - 4:25 pm TECHNOLOGY SPOTLIGHT: Scalability Strategy and Implementation Dragon's Lair
4:25 pm - 5:00 pm Panel Discussion: How Achievable Is Scalability Without A Roadmap Of Commercialisation?
- Understand the role of CMO collaboration in building a scalable manufacturing capability
- Analyse the implications of an unestablished route to market on company and industry development: How to plan for the uncertain future?
- Discuss the challenge of achieving industry standardisation or harmonisation on scalability given the individual treatment requirements
- Examine recent commercialisation cases to help identify lessons learned in scaling for commercial capacity