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Programme

We will soon begin our research for the 8th Annual Outsourcing in Clinical Trials East Coast event. If you would like to help us develop our research, or are interested in speaking at the next event, please get in touch with the Production Manager

Nadia Kim
nadia.kim@arena-international.com
+44 (0) 207 936 6626

Overview

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

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

        • 09:00 - 09:30
          • Speaker

            James Krupa – Director, Clinical Supplies Team Lead, SHIRE

          Opening keynote: Highlighting Shire’s strategy for expiry date allocation of IMP

          •Highlighting the difficulties and successes with managing documented expiry date for IMP

          •Identifying differences between US and EU regulations for Expiry Date allocation of IMP

          •Lessons Learned ensuring that patients receive IMP on time without sacrificing SISQP

          •Developing approaches to maintain temperature at storage to minimize deviations

        • 09:30 - 10:00
          • Speaker

            Kunal Jaiswal – Vice President, Strategic Development Solutions, CATALENT

          Flexible clinical supply strategies for small and mid-size biopharma sponsors

          •Advancing promising pipeline candidates from the preclinical to clinical phase by developing supply strategies by phase

          •Explaining how later phase studies become more complex to prepare for new challenges from Phase 1 studies

          •Taking a multitude of clinical supply considerations to pay attention to both the obvious and not-so-obvious factors

          •Developing fit-for-purpose clinical supply strategy that will suit your pipeline, internal resources and business goals

        • 10:00 - 10:30
          • Morning refreshments and networking

          • 10:30 - 11:00
          • Determining personalized cellular therapy logistics strategies to prevent temperature excursions

            •Providing an overview of the unique substance of therapeutic drugs to explain the need with specialized shipping boxes

            •Explaining challenges when managing extreme temperature during distribution to demonstrate the danger of mishandling materials

            •Understanding import and export regulations well to ensure a smooth distribution process under the time constraint environment

            •Highlighting the significance of preparing paperwork correctly to avoid delays at custom and temperature deviation

          • 11:00 - 11:30
            • Speaker

              Brian F. Horan – Executive Director of Sales and Business Development, RXSOLUTIONS

            Easing the burden of un-blinded supply needs of any phase study through pharmacy dispensing

            • Invest in Clinical Supply Simplification

            • Learn to Eliminate Sourcing Hassles For Unblinded Study Supplies

            • Achieve Forecasting Assistance Supported Using Prescription Data

            • Understanding How to Eliminate Inventory Management Issues

            • Discover How to Jump Start the Entire Supply Process Completed In 30 Days or Less

          • 11:30 - 12:00
            • Speaker

              Pratik Sheth – Associate Director, CMC/Formulations, RADIUS HEALTH

            Establishing and managing storage condition and shelf life/re-test date in early stages of development: US and EU perspective

            •Exploring what kind of stability studies are needed to support establishment of re-test date in US and EU

            • Discovering regulatory requirements, risk tolerance, and industry practice to maintain high quality

            • Setting stability expectations at early IND stage vs at NDA stage

            • Exploring stability studies to support temperature excursions during shipping

          • 12:00 - 12:20
            • CTS survey feedback and result

            • 12:20 - 13:50
              • Lunch and networking

              • 13:50 - 14:10
                • Speaker

                  Debbie Robertson – Associate Director, Drug Supply Management, Clinical Supply Operations, BRISTOL-MYERS SQUIBB
                • Speaker

                  Carla Reis – Senior Randomization/IRT Manager, CSO Drug Supply Manager, BRISTOL-MYERS SQUIBB

                Keynote: Minimizing cost on clinical trials by implementing pooling to maximize drug use across multiple protocols

                •Identifying areas such as oncology and biologics where clinical drug production is extremely difficult to highlight the need for cost efficiency

                •Using IRT to plan pooling by analyzing patient demographics

                •Sharing a strategy to effectively manage pooling by developing program wide labels to allow flexibility

                •Working across departments to create pooling program while meeting regulations and avoid countries where flexibility is limited

              • 14:10 - 14:30
                • Implementing forecasting tools and enhancing cross department cooperation to improve planning accuracy with IRT system

                  •Reviewing the difficulties in advanced planning for clinical supplies with presumptive data to allow for more accurate estimations

                  •Highlighting the need to improve forecasting capability without patient enrolment data to help plan as early as possible and ensure a smooth supply chain

                  •Implementing an innovative forecasting tool to increase accuracy

                  •Encouraging working closely with clinical development team to develop more insight into data

                  Session reserved for sponsor

                • 14:30 - 14:50
                  • Speaker

                    Kerri Yuszkus – Principle IXRS Business Analyst, VERTEX PHARMACEUTICALS

                  Enhancing your IXRS system by setting KPIs in vendor selection to meet your expectations and requirements

                  •Sharing strategies to audit vendor’s capability to meet expectations and requirements

                  •Setting specifications when discussing needs for your trial to customize features accordingly

                  •Identifying what defines a good IXRS vendor to address pharma’s interest and find better ways to work together as partners

                • 14:50 - 15:20
                  • Open discussion with audiences

                  • 15:20 - 15:50
                    • Afternoon refreshments and networking

                    • 15:50 - 17:20
                      • Roundtable Discussion

                        Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Hosted by industry experts and each focused on a single issue, roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others.

                        • Roundtable 1 Al Prescott – Speaker

                          Implementing clinical supply chain system to meet requirements for a clinical trial start-ups

                        • Roundtable 2 Maryam Ahmadi – Speaker

                          Exploring strategies to guarantee a successful API import into US

                        • Roundtable 3 Hope Foudoulakis – Speaker

                          Analyzing pros and cons of mode of shipments to meet the needs of your trials

                        • Roundtable 4 James L. Sherley – Speaker

                          Supplying private stem cell treatment clinics with sourced preparations of potentially therapeutic tissue stem cells

                        • Roundtable 5 James Krupa – Speaker

                          Exploring strategies to manage expire dates better

                      • 17:20 - 17:30
                        • Chairman’s Closing Remarks and End of Day one

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