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Program

The program for the Clinical Operations in Oncology Trials West Coast Conference is underway. If you have a case study, or key message to deliver to this audience, please contact the Programme Director below with your proposal.

nadia.kim@arena-international.com
Telephone: +44 0207 936 6626

Overview

    • 08:30 - 08:50
      • Registration and refreshments

      • 08:50 - 09:00
        • Chairman’s opening speech

        • 09:00 - 09:30
          • Speaker

            Florence Tao – Director, Regulatory Program Management, GENENTECH

          Developing a global trial to approach native patient populations and analyse better insights into drug’s effectiveness

          •Working with regional vendors to capitalize local knowledge and develop localized patient recruitment approaches

          •Approaching regions/countries with prominent patient population for your study area as an alternative method to patient recruitment

          •Developing a global regulatory platform early to plan logistics accordingly to requirements and avoid delays

          •Seeking fit-for-purpose strategies to manage global trials in incorporating timeline with consistent data quality

        • 09:30 - 10:00
        • Precision medicine is “bending the curve” of drug development

          •Targeted therapies and personalized medicine require a “smart” match of the right drug with the right patient

          •Prospective identification and development of biomarkers will help inform clinical response to treatment and improve decision- making

          •Predicting operational challenges and addressing them up-front to improve speed

          •Fundamentally changing overall trial designs

        • 10:00 - 10:30
        • Working with patient advocacy groups to develop effective communication routes with potential patients

          •Establishing mutual goals for both sponsors and patients groups to understand each other’s needs and expectations

          •Engaging with patient groups at an early clinical development stage to reflect patient’s perspectives into the study

          •Developing working relationship with patient advocacy group to create win-win strategies that benefits both sponsors and patients

          •Facilitating approvals from FDA by including more all-encompassing data from patients

        • 10:30 - 11:00
          • Speaker

            Jack London – Research Professor, Cancer Biology, THOMAS JEFFERSON UNIVERSITY & Informatics Director, SIDNEY KIMMEL CANCER CENTER

          Case Study: Adopting a cloud-based research Platform to improve cohort analysis and site selection

          •Building clinical collaborations with other biopharmas and CROs to collectively develop a clinical trial

          •Getting connected with a federated model with an interoperable terminology mapping to identify eligible patient populations

          •Customizing the system to increase trial feasibility

          •Demonstrating how to build a protocol design by using the network to be efficiently in managing

        • 11:00 - 11:30
          • Morning refreshments and networking

          • 11:30 - 12:00
            • Speaker

              Sameena Sharif – Vice President, Business Operations, Portfolio and Project Management, ASTEX PHARMACEUTICALS

            Finding the right patients for your trial in the crowded oncology space to avoid timeline delays and speed up market launch

            •Pinpointing the patient recruitment challenges with competing against large pharmas in terms of resources and brand value

            •Working directly with sites to identify patients with longer survival level to maximize retention rate

            •The longer it takes, the more money it costs: highlighting the importance of avoiding patient recruitment delays to keep investigator’s interest and minimize cost

            •Identifying patient demographics to approach specific regions with higher population

          • 12:00 - 12:30
            • Speaker

              Rajneesh Patil – Sr. Director, Risk-based Monitoring & Analytics, QUINTILESIMS
            • Speaker

              Susanna Nolley – Associate Director, Clinical Project Management, QUINTILESIMS

            Session reserved for Quintiles

          • 12:30 - 13:00
          • The future of clinical trials: Implementing mobile technology to enhance patient convenience and optimize trial operations

            •Attracting patient’s interest in participating by promoting mobility to allow at-home trials with mobile technology

            •Developing a strategy to implement mobile technology on a global scale by managing different regulatory requirements by countries

            •Questioning its limits to approach elder generations to create an user-friendly system with easy accessibility

            •Promoting mobile technology as a comprehensive method to manage global trial by proving multilingual information

          • 13:00 - 13:30
            • Speaker

              Tina Bees – Project Director, Chiltern

            Maintaining a successful partnership with your CRO to manage the complexity of immuno-oncology studies

            •Examining the complexity of CAR-T studies including the general therapeutic process from patient identification to post-infusion

            •Listing what should be considered for a startup and introducing to biovigilance

            •Exploring logistics management in a successful CAR-T study including identifying key departments and staff for the study and other best practices

            •Reviewing the process for a successful partnership between CRO and investigative site

          • 13:30 - 14:30
            • Lunch and networking

            • 14:30 - 15:00
            • Understanding operational staff’s needs to improve their engagement in your trial

              •Highlighting the increasing complexity of oncology trials to identify strategies to keep operational staff fully engaged throughout trial

              •Providing training to operational members prior to trials to improve understanding of complicated study area

              •Achieving better patient education and interests by having site staff fully informed about the study

              •Establishing internal resources to provide continuous training and monitoring to optimize trial operation

            • 15:00 - 15:30
              • Speaker

                Souhil Zaim – Head of Global Medical and Science Affairs, BIOCLINICA

              When is a central review required for your oncology trial?

            • 15:30 - 16:00
              • Speaker

                Jamie Cross – Senior Director, Regulatory Affairs, FORTY SEVEN

              Overcoming regulatory challenges unique to the conduct of immuno-oncology trials

              •Outlining the difficulties in immuno-oncology without clear regulations to follow and meet compliance requirements

              •Encouraging operating with traditional model to minimize regulatory concerns and avoid rejections

              •Consulting health authority frequently to be on the right track with compliance expectations

              •Highlighting the importance of building site relationship to meet immuno-oncology’s different needs from other oncology trials

            • 16:00 - 16:30
              • Afternoon refreshments and networking

              • 16:30 - 17:00
                • Speaker

                  Jennifer Brandl – Associate Manager, Clinical Trials, IMMUNE DESIGN

                Highlighting the importance of quality sample management in the development of immunotherapies

                • Bridging the gap between research and clinical operations teams to design custom sample management processes

                • Emphasizing the significance of real-time sample tracking to deliver high quality data

                • Exploring new innovations and partnerships to enable efficient and improved sample management

                • Reducing development timelines to bring effective immunotherapy to patients

              • 17:00 - 17:30
                • Speaker

                  Nicole Graves – Director, Client Services, Client Services, BRACKET

                Simplifying oncology clinical trials with Bracket’s Central Pharmacy Support

                •Managing large organizations that maintain multiple site investigators, or sites without IP storage capabilities with a common site pharmacy organization such as U.S. Oncology

                •Managing inventory system by predicting what is needed down to the patient level for multiple sites, assigning the IP in real time for patient visits

                •Resupplying for expiry management, buffer supply, and quarantined IP are centralized

                •Reducing IP wastage and unnecessary expenditures by maintaining a small amount of added inventory at one central location

              • 17:30 - 17:40
                • Chairman’s Closing Remarks and End of Day one

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