Programme

Overview

Stream A: ...

Stream A: Looking at varying contract formats and learning from different industry approaches to outsourcing

Looking at common strategic challenges that disrupt the trial to learn from different industry approaches.

    • 08:15 - 08:45
      • Conference registration

      • 08:45 - 09:00
        • Chair

          Pierre Corin – Senior Director Development Operations, Cerexa
        • Cerexa, Inc

        Chairman's opening remarks

      • 09:00 - 09:30
        • Keynote Speaker

          William Schmidt – VP Clinical Development, Crystal Genomics Inc

        Keynote Presentation: Providing insight into what it takes to conduct a sound, successful study in Korea

        • Gaining a comprehensive understanding into what it means to run a clinical trial in Asia to dramatically accelerate your knowledge of this global market

        • Closely examining lessons learned to ensure compliance with foreign regulatory bodies and global teams to master and contextualize the trial process

        • Dissecting Korea’s regulatory processes and reforms to better educate your internal and contractual teams and manage positional risks

        • Highlighting changes in the regulatory outline and showcasing its effects on the trial process

        • Analyzing Korea’s cultural panorama to develop a more informed business strategy

      • 09:30 - 10:00
        • Speaker

          Nick Richards – VP, Product Management, Perceptive Informatics
        • Perceptive Informatics

        Keynote Presentation: Understanding Cloud-based eClinical Suite solutions and the future impact on the contracting process

        • Overview and presentation of major cloud-based eClinical solution capabilities that are currently on the horizon

        • Chronicling the evolution of eClinical suite solution providers and the potential impact on pricing for customers

        • Analyzing the Integration of the contracting process into eClinical solutions to provide more efficient workflows

        • Evolving partner/contracting models that work well for both large and small pharmaceutical and biotechnology companies

      • 10:00 - 10:30
      • Leveraging established vs. emerging markets to facilitate CRO and site selection

        Conference

        • How to avoid and counter delaying timelines and an expanding budget to optimize the vendor contracting procedure

        • Setting up authentic and meticulous ground rules to drive the patient recruitment process to a successful finish

        • Constructing an airtight contract that anticipates and prevents vendor discrepancies

        • Including well-scoped qualitative and quantitative performance indicators in the contractual agreement to establish a result-driven and successful collaboration and trial outcome

        • Building on a pre-existing Intelligence base to attain a more refined method of regulatory adherence

      • 10:30 - 11:00
      • Morning refreshments and networking

      • 11:00 - 11:30
        • Speaker

          Dale Posner – Clinical Outsourcing Manager, Genentech
        • Speaker

          Chris Chan – Senior Director, Clinical Finance, Fibrogen

        Devising flexible contract formats to ensure smooth and efficient trial procedures

        • Assessing how subcontracting improves the research capabilities of small to mid-size CROs and aids the drug development process

        • Assessing the current working relationship between sponsors and vendors and showing how this affects contract formats and negotiation

        • Clarifying the hierarchical structure in a sub-contractual agreement to ensure more control for the sponsor

        • Evaluating what method of vendor management a sub-contractual alliance demands to strengthen your support team

        • Analyzing performance management techniques you can use to ensure your CRO is delivering results

      • 11:30 - 12:00
      • Conversion from a temporary staffing model to a full service provider outsourcing model: considerations and helpful hints

        • Determining the model which best fits your project needs

        • Identifying the appropriate time to convert from a staffing to an outsourcing model

        • Implementing processes to ensure a seamless staffing-to-outsourcing model transition

      • 12:00 - 12:30
      • Case Study: Insight into methods used by a small company who use outsourcing to create a matrix of providers to support globally run trials

        • Outlining the reasons for using a matrix of providers instead of a single provider for all resources

        • Establishing methods to select appropriate CROs with focussed strengths for oversees trials

        • Introducing the idea of flexible outsourcing for small biotech companies

        • Determining how to identify and assemble the most cost effective and efficient resources for these types of studies

        • Managing complex trials in transfusion medicine; specific requirements for a complex biological

      • 12:30 - 14:00
        • Lunch and networking

        • 14:00 - 14:30
        • Investigating the top five myths in clinical trial enrollment and retention; separating fact from fiction and turning obstacles into opportunities

          • Clarifying the significance of efficiency in the patient enrolment stage in terms of timely trial completion

          • Determining the feasibility of sites meeting enrolment expectation through internal databases, and the options available beyond this

          • Exploring the trends between trial complexity, patient availability and enrolment outcomes to determine realistic timelines

          • Learning how to turn enrolment challenges into opportunities; looking into five myths given by industry sponsors and the associated facts to help develop successful enrolment and retention strategies:

          1. We can enroll all the patients we need using social media

          2. Centrally recruited patients are not as good as patients sourced by our sites

          3. We’ve selected the best sites and they will be able to enroll this study

          4. Adding more sites is a cost effective patient enrollment solution

          5. People in the US are just not interested in clinical trials

        • 14:30 - 15:15
          • Speaker

            Tristen Moors – Associate Clinical Director, Hyperion Therapeautics
          • Speaker

            Diana Chung – Associate Director, Clinical Operations, Gilead Sciences
          • Speaker

            Monica Gangal – Director, Clinical Operations, Anthera Pharmaceuticals

          Panel discussion: Evaluating characteristics, benefits and risks of various outsourcing models to help you refine your outsourcing policy

          • Explaining the rationale and design behind different outsourcing methods to qualify which best suits your personal trial needs

          • Evaluating what separates a quality personalized initial model versus a one-size-fits-all model to ascertain which the best fit is

          • Picking the type of vendor that best suits your study to guarantee that your drug candidate produces the required pharmacological effect

          • Clearly highlighting what operational and strategic deficiencies necessitate an outsourcing procedure

        • 15:15 - 15:45
          • Afternoon refreshments and networking

          • 15:45 - 16:15
          • CRO/Sponsor collaboration; how working together effectively on a clinical trial is like doing a successful skydive

            • Establishing goals; ensuring clinical trial agreements between CRO and sponsor are clear and inclusive of all tasks

            • Knowing your team; beginning with the kick off meeting, ensuring each primary contact is an integral part of study start up discussion

            • Preparing for success; setting up expectations that are mutually agreed upon by both parties

            • Assigning responsibilities; knowing who will be responsible for what or “the effective use of a Gantt Chart”

            • Being accountable; following up before a task is due, not when it is due

            • Expecting the unexpected; responding to the out of scope requests

            • Knowing the end result; maintaining transparency between both parties throughout the course of the project to promote clear communication

          • 16:15 - 16:45
            • Speaker

              Spencer Guthrie – Senior Director, Clinical Operations and Program leader, Ultragenyx Pharmaceuticals

            Executing the benefits of Influence management to provide effective staff support and motivate the whole team

            • Clearly defining project management outlines to improve adherence of timelines and make sure you are audit ready

            • Reviewing the best methodology to facilitate multi vendor integration and streamline the trial process

            • Reviewing the best way to mitigate risks for a comprehensive risk management strategy

            • Overthrowing a hierarchical management structure to boost motivation and instill a real feeling of ownership in your in-house and outsourcing teams

          • 16:45 - 17:00
            • Chair

              Darren Hart – Vice President, Clinical Operations and Biometrics, Elan Pharmaceuticals

            Chairman's summation and close of day one

          • 17:00 - 18:00
          • Drinks Reception

        Stream B: ...

        Stream B: Analyzing different operational issues that occur mid-trial to provide a broader insight into how best to handle problems while on site

        Analyzing different operational issues that occur mid-trial to provide a broader insight into how best to handle problems while on site

          • 08:15 - 08:45
            • Conference registration

            • 08:45 - 09:00
              • Chair

                Pierre Corin – Senior Director Development Operations, Cerexa
              • Cerexa, Inc

              Chairman's opening remarks

            • 09:00 - 09:30
              • Keynote Speaker

                William Schmidt – VP Clinical Development, Crystal Genomics Inc

              Keynote Presentation: Providing insight into what it takes to conduct a sound, successful study in Korea

              • Gaining a comprehensive understanding into what it means to run a clinical trial in Asia to dramatically accelerate your knowledge of this global market

              • Closely examining lessons learned to ensure compliance with foreign regulatory bodies and global teams to master and contextualize the trial process

              • Dissecting Korea’s regulatory processes and reforms to better educate your internal and contractual teams and manage positional risks

              • Highlighting changes in the regulatory outline and showcasing its effects on the trial process

              • Analyzing Korea’s cultural panorama to develop a more informed business strategy

            • 09:30 - 10:00
              • Speaker

                Nick Richards – VP, Product Management, Perceptive Informatics
              • Perceptive Informatics

              Keynote Presentation: Understanding Cloud-based eClinical Suite solutions and the future impact on the contracting process

              • Overview and presentation of major cloud-based eClinical solution capabilities that are currently on the horizon

              • Chronicling the evolution of eClinical suite solution providers and the potential impact on pricing for customers

              • Analyzing the Integration of the contracting process into eClinical solutions to provide more efficient workflows

              • Evolving partner/contracting models that work well for both large and small pharmaceutical and biotechnology companies

            • 10:00 - 10:30
            • Leveraging established vs. emerging markets to facilitate CRO and site selection

              Conference

              • How to avoid and counter delaying timelines and an expanding budget to optimize the vendor contracting procedure

              • Setting up authentic and meticulous ground rules to drive the patient recruitment process to a successful finish

              • Constructing an airtight contract that anticipates and prevents vendor discrepancies

              • Including well-scoped qualitative and quantitative performance indicators in the contractual agreement to establish a result-driven and successful collaboration and trial outcome

              • Building on a pre-existing Intelligence base to attain a more refined method of regulatory adherence

            • 10:30 - 11:00
            • Morning refreshments and networking

            • 11:00 - 11:30
              • Speaker

                Darren Hart – Vice President, Clinical Operations and Biometrics, Elan Pharmaceuticals

              Establishing robust, scalable processes and governance structured RFPs to efficiently rate the quality of vendor bids

              • Conducting audits to qualify CROs, to avoid a decline in productivity later in the trial

              • Outlining the severe implications of varying CRO price bids to simplify vendor selection with standardized bid formats

              • Establishing a flawless oversight plan, a concrete study plan and regular checkpoints to conduct a successful study

              • Learning how to negotiate for the best CRAs and regulate their work demands to prevent your study team from getting burnt out

            • 11:30 - 12:00
            • Including Russia in your global clinical study planning from the outset, and at a minimum, in your risk management and contingency planning

              • Reviewing risk management as one of the fundamentals of good project management and lagging enrolment as one of the key risks for any clinical trial

              • Addressing how contingency plans often inadequately address enrolment risks because they seek minor changes to existing strategies, such as adding more sites in the same country or extending the enrolment timeline, rather than identifying flaws in the initial strategy and implementing new approaches

              • Evaluating the value and practical considerations of including Russia in your global clinical study plans at the outset or for risk management and contingency planning

              • Examining how to leverage Russia in rescue study planning and the critical elements required for a successful study transition plan, e.g., regulatory tasks, drug storage, clinical management and investigator payments

            • 12:00 - 12:30
              • Chair

                Anisha Wharton – Manager of Regulatory Affairs, Nektar Therapeautics
              • Chair

                Davin Dillon – Senior Director, Program management, Nektar Therapeautics

              Case study: Utilizing the Voluntary Harmonization Procedure to accelerate regulatory approval for a clinical trial involving countries in the EU

              • Detailing the Voluntary Harmonization process and showing how it helps streamline the review of multinational trial applications across the EU

              • Explaining how to maximize speed of regulatory approvals under the VHP by working closely with your CRO

              • Highlighting potential issues with different member states and mitigation strategies to outline what the key risks are

              • Demonstrating how utilizing the VHP to streamline approval of protocol amendments can add value to the trial

              • Reviewing Case Study Outcomes: A retrospective look at regulatory approval timelines under VHP

            • 12:30 - 14:00
              • Lunch and networking

              • 14:00 - 14:30
                • Case Study: Orphan drug final development; anticipating operational challenges in complex studies – satisfying international regulators' trial design and data submission expectations

                  Session reserved for Cytel

                • 14:30 - 15:15
                • Panel Discussion: Examining what mistakes some vendors make when approaching new clients to build and strengthen outsourcing partnerships

                  • Understanding contrasting sponsor/vendor psychologies and defining how best to standardize on-site dialogue to improve pitching techniques

                  • Transforming the question and answer approach in the bid proposal stages: getting the linguistics and language right by asking the right questions

                  • Ensuring that a comprehensive provision of data and pre clinical data is made available to the clinical trial team to enhance their knowledge on trial details

                  • Demonstrating how vendors can effectively tailor their presentations to a sponsors needs in a bid to secure new or repeat business

                  • Highlighting sponsor concerns relating to a growing culture of overselling and overpromising of expertise to optimize the tendering process

                • 15:15 - 15:45
                  • Afternoon refreshments and networking

                  • 15:45 - 16:15
                  • Optimizing clinical operations; finding an efficient and cost-effective operating model

                    • Envisioning the optimal solution for trial outsourcing to a CRO from a trial sponsor perspective

                    • Outlining the requirements for optimal performance from the CROs perspective

                    • Drawing on experience in order to develop an appropriate governance model and ensure efficient planning

                    • Using feasibility as basis for risk assessments surrounding patient recruitment retention

                    • Developing appropriate methods to complete terformance evaluation

                  • 16:15 - 16:45
                  • Taking a close look at site initiation and defining what is required to make this process successful

                    • Assessing the most lean method to establish the adequacy of a site, making sure you have access to the right study population

                    • Quantifying the best method to measure progress to shorten the outsourcing process

                    • Setting up frequent site feasibility and site initiation visits to measure the site’s bandwidth

                    • Fully assessing competition for the patient pool to ascertain that the site in consideration has the qualifying clinical requirements

                  • 16:45 - 17:00
                    • Chair

                      Darren Hart – Vice President, Clinical Operations and Biometrics, Elan Pharmaceuticals

                    Chairman's summation and close of day one

                    Conference

                  • 17:00 - 18:00
                  • Drinks Reception

                Stream 1: ...

                Stream 1: Weighing up experience vs. cost in the selection of a tailor made sponsor/ vendor partnership

                  • 08:15 - 08:45
                    • Conference registration

                    • 08:45 - 09:00
                      • Chair

                        Pierre Corin – Senior Director Development Operations, Cerexa
                      • Cerexa, Inc

                      Chairman's opening remarks

                    • 09:00 - 09:30
                      • Keynote Speaker

                        William Schmidt – VP Clinical Development, Crystal Genomics Inc

                      Keynote Presentation: Providing insight into what it takes to conduct a sound, successful study in Korea

                      • Gaining a comprehensive understanding into what it means to run a clinical trial in Asia to dramatically accelerate your knowledge of this global market

                      • Closely examining lessons learned to ensure compliance with foreign regulatory bodies and global teams to master and contextualize the trial process

                      • Dissecting Korea’s regulatory processes and reforms to better educate your internal and contractual teams and manage positional risks

                      • Highlighting changes in the regulatory outline and showcasing its effects on the trial process

                      • Analyzing Korea’s cultural panorama to develop a more informed business strategy

                    • 09:30 - 10:00
                      • Speaker

                        Nick Richards – VP, Product Management, Perceptive Informatics
                      • Perceptive Informatics

                      Keynote Presentation: Understanding Cloud-based eClinical Suite solutions and the future impact on the contracting process

                      • Overview and presentation of major cloud-based eClinical solution capabilities that are currently on the horizon

                      • Chronicling the evolution of eClinical suite solution providers and the potential impact on pricing for customers

                      • Analyzing the Integration of the contracting process into eClinical solutions to provide more efficient workflows

                      • Evolving partner/contracting models that work well for both large and small pharmaceutical and biotechnology companies

                    • 10:00 - 10:30
                    • Leveraging established vs. emerging markets to facilitate CRO and site selection

                      Conference

                      • How to avoid and counter delaying timelines and an expanding budget to optimize the vendor contracting procedure

                      • Setting up authentic and meticulous ground rules to drive the patient recruitment process to a successful finish

                      • Constructing an airtight contract that anticipates and prevents vendor discrepancies

                      • Including well-scoped qualitative and quantitative performance indicators in the contractual agreement to establish a result-driven and successful collaboration and trial outcome

                      • Building on a pre-existing Intelligence base to attain a more refined method of regulatory adherence

                    • 10:30 - 11:00
                    • Morning refreshments and networking

                    • 17:00 - 18:00
                    • Drinks Reception

                  Stream 2: ...

                  Stream 2: Analyzing challenges and issues faced by medical device companies to understand the role they play in the industry

                    • 08:15 - 08:45
                      • Conference registration

                      • 08:45 - 09:00
                        • Chair

                          Pierre Corin – Senior Director Development Operations, Cerexa
                        • Cerexa, Inc

                        Chairman's opening remarks

                      • 09:00 - 09:30
                        • Keynote Speaker

                          William Schmidt – VP Clinical Development, Crystal Genomics Inc

                        Keynote Presentation: Providing insight into what it takes to conduct a sound, successful study in Korea

                        • Gaining a comprehensive understanding into what it means to run a clinical trial in Asia to dramatically accelerate your knowledge of this global market

                        • Closely examining lessons learned to ensure compliance with foreign regulatory bodies and global teams to master and contextualize the trial process

                        • Dissecting Korea’s regulatory processes and reforms to better educate your internal and contractual teams and manage positional risks

                        • Highlighting changes in the regulatory outline and showcasing its effects on the trial process

                        • Analyzing Korea’s cultural panorama to develop a more informed business strategy

                      • 09:30 - 10:00
                        • Speaker

                          Nick Richards – VP, Product Management, Perceptive Informatics
                        • Perceptive Informatics

                        Keynote Presentation: Understanding Cloud-based eClinical Suite solutions and the future impact on the contracting process

                        • Overview and presentation of major cloud-based eClinical solution capabilities that are currently on the horizon

                        • Chronicling the evolution of eClinical suite solution providers and the potential impact on pricing for customers

                        • Analyzing the Integration of the contracting process into eClinical solutions to provide more efficient workflows

                        • Evolving partner/contracting models that work well for both large and small pharmaceutical and biotechnology companies

                      • 10:00 - 10:30
                      • Leveraging established vs. emerging markets to facilitate CRO and site selection

                        Conference

                        • How to avoid and counter delaying timelines and an expanding budget to optimize the vendor contracting procedure

                        • Setting up authentic and meticulous ground rules to drive the patient recruitment process to a successful finish

                        • Constructing an airtight contract that anticipates and prevents vendor discrepancies

                        • Including well-scoped qualitative and quantitative performance indicators in the contractual agreement to establish a result-driven and successful collaboration and trial outcome

                        • Building on a pre-existing Intelligence base to attain a more refined method of regulatory adherence

                      • 10:30 - 11:00
                      • Morning refreshments and networking

                      • 17:00 - 18:00
                      • Drinks Reception

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