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Programme

The program for Clinical Trial Supply West Coast will soon be underway. If you have a case study, or key message to deliver to this audience, please contact the Conference Producer below with your proposal.

Abi Jeyakumar, Conference Producer
abi.jeyakumar@arena-international.com
+ (44) 207 936 6621

Overview

    • 08:00 - 08:30
      • Registration and refreshments

      • 08:35 - 08:45
        • Speaker

          Ramani Aiyer – Executive Vice-President - TheraBiol

        Chairman’s Opening remarks

      • 08:45 - 09:15
        • Speaker

          Steven Moses – Vice President of Technical Operations - NovaRx

        Understanding how best to work with your manufacturers to ensure the efficient production of clinical supplies

        • Sharing ways companies can ensure they get the best allocated resources and time from their selected service providers to ensure efficient working relationships

        • Learning about the impact effective project management can have on clinical supply manufacturing timelines

        • Determining how you can ensure you get a good project manager when selecting your manufacturing partner

        • Reflecting on the potential cost and time savings of an experienced project manager

        • Showcasing the positive impact a good working relationship between a sponsor and a CRO will have towards trial efficiency

      • 09:15 - 09:45
        • Past Speaker

          Katy Ostertag – Clinical Supply Manager, PCI
        • Past Speaker

          Greig Ross – Clinical Account Executive, PCI

        Bridging the Gap of Clinical Supplies Management

        • Analyzing the traditional model, the role of the sponsor and the contract packager

        • Intro to clinical supply management including managing the drug supply from cradle to grave, clinical trial management and interaction with IRT

        • Exploring the evolution of the role and relationship transition from one study to managing the compound from the clinical trial perspective and responsibility of the unblinded role

        • Reviewing case study examples: contingency planning for company attrition and the virtual company model

        • Looking ahead to future plans and opportunities and how to enhance partnership feedback model with the sponsor

      • 09:45 - 10:15
        • Speaker

          Umar Hayat – Senior Director, Product Development and Manufacturing - Anthera

        Reviewing how clinical stage sponsor companies can develop efficient processes within their supply chain with limited resources

        • Reviewing how smaller companies can standardize their clinical supply processes when working with vendors to ensure efficient supply chain processes

        • Appreciating the limited resources when it comes to defining these processes and areas of responsibility to help avoid overstretching personnel

        • Highlighting the priority of cost savings in supplies for smaller biotech companies developing their first product for the market

        • Recognising the need for advice from service providers for early stage biotech companies without existing processes

      • 10:15 - 10:30
      • Industry Survey Results: Assessing the Current and Future State of Clinical Trial Supplies

      • 10:30 - 11:15
        • Morning networking and refreshments

        • 11:15 - 11:45
          • Speaker

            Chrysta Mayhew – Director, Clinical Manufacturing - Bioprocess Research & Development - Sanofi Pasteur

          GMP Compliance in Multi-Use Facilities ; Defining strategies to maximise usage from pilot GMP facilities

          • Implementing strategies to put in place a procedure which allows for cross-usage of sites for multiple projects

          • Ensuring they are versatile for non-GMP development and scale-up activities, whilst maintaining control and ensuring patient safety and product quality

        • 11:45 - 12:15
        • Clinical Trial Supply Sourcing – Considerations in Developing Markets

          • It’s now obvious: the importance of BRIC markets

          • Reflections to be made when sourcing supplies locally

          • Planning process: why experience matters

          • Getting Ready for protocol FPFV

          • After all the considerations, was it really the right decision?

        • 12:15 - 12:45
          • Speaker

            Ibrahim Saad – Senior Manager, Supply Chain - Chrono

          How to Manage Clinical Trial Supply in a development stage Medical Device Startup

          • Supply Chain Planning during Product Development

          • Challenges with Planning and Clinical Studies due to Product Design changes

        • 12:45 - 14:15
          • Lunch and networking

            Prior to the Annex 16 Workshop, please remember to hand in your Question Cards to the Registration Desk by the end of lunch.

          • 14:15 - 15:15
            • Speaker

              Robert Bronstein – Director, Clinical Supplies Management - Dynavax Technologies
            • Speaker

              Tristram Evans – Clinical Quality Director - PCI Pharma Services
            • Speaker

              Caitriona Lenagh – QP Services Manager and Qualified Person - Almac Clinical Services
            • Speaker

              Catherine Pedersen – Senior Quality Director, Early Development and Commercial QA - Dynavax Technologies

            Annex 16 Workshop – Discussion of changes and key strategies to address the sterner QP requirements and their impact on releasing IMP in Europe

            Be sure to pick up your question card at Registration and submit it to us by lunchtime of Day 1 of the event to have your quesitons answered within this interactive workshop featuring 2 QPs. Points also to be covered include; • Too much or too little? Balancing how much sponsors will need to adapt to meet regulatory changes with the least cost

            • Defining ways in which Annex 16 will place more responsibility on Qualified Persons to ensure that the supplies are being thoroughly checked with the introduction of a QP declaration

            • Preparing your QP team for the regulatory changes to ensure they are prepared for impending MHRA audits

            • Defining how Annex 16 could have a knock-on effect on other elements of your supply operations, such as forecasting

          • 15:15 - 15:45
            • Speaker

              Mark Maurice – Senior Project Manager / Industrial Engineer - Sensitech

            How to Balance the Risk and Cost of Controlled Room Temperature (CRT) Clinical Trial Shipments

            • Why is developing stability data up front in the trial process a necessity?

            • What are the risks associated with clinical distribution without temperature protection?

            • Can temperature excursions confound your clinical trial?

            • How to cost effectively monitor your CRT trial shipments

          • 15:45 - 16:15
            • Speaker

              Ravi Kiron – Chief Development Officer – Pharmaceuticals - formerly of Clasado

            Microbiome- Hope or Hype?

            • Human body & its Microbiome - Symbiotic relationship

            • Advances: Genomic & Big Data Analytics - crucial for enhanced understanding of this phenomenon

            • Hope (Innovate novel therapies) or Hype (Translation to commercial products)

            • Challenges: Financial ROI, IP, Regulatory, Manufacturing, Supply, Clinical POC, Precision Medicine

            • Impact: Cancer, GI, Immunology, CNS and other Therapeutic Areas

          • 16:15 - 16:45
            • Afternoon break and networking

            • 16:45 - 17:15
            • Assessing strategies for sponsor companies to help keep their clinical sites well stocked during longer trials

              • Defining universal methods for companies to distribute forecasting responsibilities internally

              • Preparing for the unexpected: how can companies ensure they have procedure in place for unforeseen events

              • Understanding how companies can pinpoint the right time re-forecast or change your production schedule to avoid delayed trial timelines

            • 17:15 - 17:45
              • Speaker

                Chantay Bullins – Director, SCM & Project Management - Ardelyx, Inc.

              How can sponsor companies maintain operational efficiency through planning

              • Highlighting the importance of investing in your planning to help streamline operations and produce long term cost-savings

              • Recognising and setting aside the adequate human resources to actively plan for your study and avoid unforeseen challenges

              • Maintaining ways to avoid research and development delays ensure these factors will not disrupt your planning process

              • Determining how companies can allow some flexibility in processes to help manage unexpected events within the clinical supply chain

              • Reviewing how companies can manage their supplies being shipped out during busy periods to avoid potential timeline delays

              • Appreciating the need to envision global requirements within your planning to ensure your supplies do not fall short when being shipped abroad

            • 17:45 - 18:00
              • Chairman's summation and close of conference

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