Building a foundation to advance clinical trial processes through UK focused innovation admits dynamic regulatory and political environment

Transcription

1 Building a foundation to advance clinical trial processes through UK focused innovation admits dynamic regulatory and political environment The 5 th Annual Outsourcing in Clinical Trials UK & Ireland 2018 conference is back after a successful 2017 to help build business strategy through the changing regulatory and political climate. This event is part of a global series aimed at tackling the vital concerns presently taxing the UK and Ireland Pharmaceuticals sector in this varied and evolving commercial area. Confirmed 2018 Speakers Tim Cave, VP - Head Strategic Planning and Digital Practices, Global Medical Affairs, GSK Lucy Clossick Thomson, Director Clinical Operations Strategy, Early Clinical Development, AstraZeneca John Shillingford, CEO, Orsus Medical Chris Holland, Director, Clinical Documentation Operations, GSK Andrew Thompson, Director of Therapy Research and Analysis, Medical Devices, GlobalData Health Tianbo Xu, Co- author & Research Associate, UCL Institute of Neurology George Morris, COO, ValiRx Diane Driver, Head Outsourcing Contracts & Strategic Partnerships, UCB Tone Bjaaland, Director- Head of Clinical Operations, PrEP Biopharm Tanja Ouimet, Head of Clinical Operations, Pharma Leads Trishna Bharadia, Patient Advocate Dr Yuri Martina, VP- Clinical Operations, Grünenthal GmbH Ian Hodgson, Head of Clinical Operations, Mereo BioPharma Tina Harris, Director, Data Management, Amgen Dr Panos Georgiou, Senior Clinical Scientist, Indivior Pharma Belle Roels, Head of Clinical Operations UK and Ireland, GSK Alan Palmer, Non- Executive Director, One Nucleus 2018 Event Sponsors

2 Outsourcing in Clinical Trials, UK & Ireland Programme Day One Tuesday 12 th June, :45 Registration and refreshments 08:20 Chair s opening remarks 08:30 Keynote It s A Digital World! Making Technology The Foundation Of Clinical Trial Advancement The future of clinical trials requires a more streamlined, connected and more engaged with the patient. For pharmaceuticals to embrace these requirements, the adoption of new digital tools will be vital. Clinical trials are becoming increasingly complex with growing amounts of data being collected, thus better approaches are needed, applying the current systems and technology better to meet these new age challenges. Analysing the new GSK business model to evaluate the various ways to leverage digital platforms to create seamless trial operations Practicing targeted and influential engagement with HCPs & patients to boost sales and marketing by optimising new technologies and trends Highlighting various digital technology in clinical trials to promote integration & innovation of digital strategy for long-term success Communicating clinical trial evidence through digital tools avenues for transparency Tim Cave, VP - Head Strategic Planning and Digital Practices, Global Medical Affairs, GSK 09:00 Session reserved for UBC 09:30 Case Study Reviewing Your Request For Information (RFI) & Request For Proposal (RFP) To Ensure Long Term Business Objectives Are Met Case study analysis into the pertinent questions surrounding the composition RFI and RFP documents to ensure clarity between the supplier and sponsor Clarifying who is responsible when creating the RFI to ensure transparency Incorporating a scoring framework to evaluate the RFI & RFP so that business aims can be reviewed Creating the right RFI to identify lower cost alternatives and reductions Assessing the tools needed to make the final decision on your service provider Lucy Clossick Thomson, Director Clinical Operations Strategy, Early Clinical Development, AstraZeneca 10:00 Session available to sponsor

3 10:30 From Print To Speech; Improving clinical trials with machine learning Revitalising the way you view clinical trials to make sure the best environment is created to conduct your trials. Appreciating the complexities of human beings and reflecting this accurately in trials through the use of machine learning instead of archaic statistical techniques to achieve the most accurate study results Highlighting the positive cost implications in using machine learning to conduct your clinical trials to formalise complex decisions and to detect drug side- effects that are typically missed Outlining how the UK public health infrastructure is complimentary for the large amounts of data needed when applying machine learning Recognising the need to upgrade legacy technology systems with new machine learning tools to get the best data Driving your workforce to engage with new technology to push trial innovation Tianbo Xu, Co- author & Research Associate, UCL Institute of Neurology 11:00 Morning Break and Refreshments 11:30 Likes & Pokes As The Tool To An Effective Patient Recruitment Strategy This panel session will explore the use of digital platforms, debunking the myth that digital platforms have demographic, cost and compliance restrictions to strengthen the bridge between the patients and clinical trials. Unlocking social media platforms such as Facebook and Instagram as a pre-screening tool to save time during patient recruitment Tackling the potential compliance and confidentiality issues surrounding the use of social media to recruit patients whilst adhering to best practice Saving money on lengthy recruitment processes through cost effective digital advertising strategies Engaging the extensive network of patient advocacy groups based online by using their social media platforms to advertise your trial Tanja Ouimet, Head of Clinical Operations, Pharma Leads 12:00 Retain Retain Retain Effectively Engaging Patients To Ensure Trial Completion An ineffective enrolment strategy can have huge ramifications on a study, with delays costing sponsors on average over 32K in operational costs and up to 7M in lost opportunity costs. How can your study remain attractive for patients? Planning patient led trials, ensuring maximum retention rates throughout your study to ensure timelines are met Securing the retention of your participants from a distance by designing the right remote monitoring framework

4 Recognising the positive impact of creating strong links with patient advocacy groups on your trial to help generate a more suitable pool of patient candidates Ian Hodgson, Head of Clinical Operations, Mereo BioPharma 12:30 Workshop Patients Taking The Lead, Designing The Right Study Patient recruitment is still one of the most difficult challenges when conducting trials. This patient-led interactive workshop endeavours to provide you with the much needed patient lens to ensure you are constructing patient-focused studies. Mini case study and presentation on a patients journey through a clinical trial Discussing challenges and benefits for patient incorporation when designing your study Gather in small teams to create the right study for your patient using the tools from the presentation Present your study and highlight the key study components that make it attractive to patients Trishna Bharadia, Patient Advocate 13:15 Lunch and Networking 14:15 Site Roulette- Selecting The Best Facilities For Trial Harmonisation 60% of clinical trials do not enlist participants within the initially forecasted timelines, and typically between 20-30% of selected sites fail to recruit patients. As an integral part of the whole clinical trial experience it is necessary that there are verified and reliable frameworks used to select trial sites. Designing a suitable feasibility study for your trial so that you select a site that can deal with the capacity of your trial Recognising the complexity of feasibility studies as a multi- dialogue feedback platform in potentially adapting the overall structure of the trial to create a holistic study Establishing the capability of a site through strong partnership between the sponsor and vendor to ensure trial goals are met Incorporating feedback and information from all study stakeholders alongside additional data to reach optimal site selection Dr Panos Georgiou, Senior Clinical Scientist, Indivior Pharma 14:45 Session available to sponsor 15:15 Small And Mighty; Managing Vendors With Little Resources To Guarantee Your Objectives Are Achieved

5 The industry is under increased pressure to innovate to reflect the changing environment in which it operates. Thus more products are being developed and companies are working with more stakeholders particularly vendors to cope with the increasing products developed. This is opportunity to discuss ways to manage vendors with restricted resources. Sharing case studies of managing vendors during large studies with a limited budget and resources Maximising your company assets to make your business attractive to vendor partnerships Maintaining your budget and timeline goals by improving trial forecasting capabilities with your vendors Analysing the best framework to oversee vendors with limited time and staff to achieve all clinical trial objectives Tone Bjaaland, Director- Head of Clinical Operations, PrEP Biopharm 15:45 Case Study Putting The Theory To Action; The Little Guys Managing The Big Guys With the UK & Irish market being saturated with small pharmaceuticals and biotech s it is helpfully to strategise together to ensure you are managing your CRO for competitive advantage. Discussing specific case studies to illustrate best practice when managing multiple vendors as a smaller company Ensuring a detailed and explicit contract between stakeholders to ascertain areas for renegotiations of objectives to create potential cost savings Demonstration of creating transparency throughout vendor negotiations to make sure objectives are scalable and achievable Creating cost savings without compromising the integrity and timescale of your trial John Shillingford, CEO, Orsus Medical 16:15 Afternoon Refreshments and Networking 16:45 Regulatory Update Keeping Everything Private- Obeying The Data Privacy Laws For Regulatory Transparency As the General Data Protection Regulation (GDPR) is enforced, there will be increased accountability for all parties involved in handling and producing data, which is central to the way clinical trials are conducted. Stay ahead of the regulatory curve. Discussing your data handling methods to ensure compliance with the EU General Data Protection Regulation (GDPR) Addressing the best data storage framework to preserve your clinical data Designing your study to reflect the data privacy changes to avoid regulatory discrepancies Preserving the balance between the big data boom and patient confidentiality Selecting the right data protection officer to manage the extra regulatory responsibility

6 Tina Harris, Director, Data Management, Amgen 17:15 Managing Your Trial Master File To Uphold The Integrity Of Your Product Given the new guidelines put in place to assist sponsors and investigators with clinical trial master file (TMF) requirements, how can we improve the total oversight process to stay compliant with TMF requirements? Evaluating ways to streamline TMF management to create a strong repository for trial compliance Discussing the multiple outsourcing options within this area to ensure you have the right partnership to manage your documents Highlighting the advantages of using an electronic trial master file system when conducting global trials, such as ease of access and traceability Considering the Regulation [(EU) No 536/2014] and ICH-GCP E6 as foundation to developing a TMF that adequately facilitates trial management Chris Holland, Director, Clinical Documentation Operations, GSK 17:45 Chair s Summary & Closing Close of Day One Outsourcing in Clinical Trials, UK & Ireland Programme Day Two Wednesday 13 th June, :30 Registration and Refreshments 08: Chair s Opening Remarks Speaker Hosted Roundtables 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. Each roundtable session lasts for 45 minutes. Roundtable 1 Roundtable 2 Roundtable 3 Roundtable 4 Delegates may select the most relevant roundtable discussion to their area of interest. All roundtable findings will be collated by your host, and shared post-event. Retain Retain Retain Effectively Engaging Patients To Ensure Trial Completion Belle Roels, Head of Clinical Operations UK and Ireland, GSK Creating The Optimal Vendor Selecting And Oversight Process Exploring The Avenues For Innovation post- Brexit Assessing The Necessary Requirements To Create A Suitable Protocol

7 10:30 Morning Refreshments and Networking 11:00 Case Study Partnerships Made Of Iron... Building Long Lasting Relationships For Seamless Study Execution A case study session which touches on tangible indicators used to create strong sponsor-vendor relationships through exploring a variety of outsourcing models, their advantages and fundamental points to consider. Exploring the best ways to create a healthy and mutually beneficial relationship between vendors and sponsors for trial harmonisation Pairing your study with the appropriate outsourcing model to get the most out of the vendorsupplier partnership A focused look at full service and functional outsourcing models to establish the most cost effective framework Negotiating suitable key performance indicators to ensure your master service agreement will lead to a harmonised vision of the study for successful trial completion Diane Driver, Head Outsourcing Contracts & Strategic Partnerships, UCB 11:30 The Birds Eye View: Defining Strategy To Maintain Vendor Oversight This session aims to explore the various frameworks and actors that can be applied or considered when overseeing vendors, to ensure there are clear responsibilities when undertaking any clinical trial so all aspects of the trial are executed effectively. Devising an effective oversight plan to maintain GCP throughout your trial to promote role transparency and successful completion of clinical trials Adhering to the ICH GCP R2 guideline to maintain sponsor oversight that fits within the regulatory guidelines so studies remain compliant Giving the CRO the necessary autonomy while fulfilling your oversight requirements to ensure trial harmonisation and unified trial objectives Implementing the right oversight framework when managing global trials to maintain transparent communication for smooth completion of your study George Morris, COO, ValiRx 12:00 What Does The Future Hold? Developing The Best Framework For Central Nervous System (CNS) Trials Due to the complexity of CNS products companies tend to face many obstacles in improving trial methods and quality to optimise products life cycles particularly because CNS trials are more expensive timeconsuming than other trials, they re also less likely to be successful and gain approval. With therapies for CNS-related disorders representing 21% of the total pharmaceutical marketplace but only 8% of CNS drugs making it through clinical trials, it s clear that a well-executed CNS clinical trial can be extremely

8 profitable for a company. Preparing for CNS clinical trials by highlighting new trends and technologies in CNS product development Selecting the right site and other key stakeholders to improve your chances of successful trial Designing the most appropriate trial design to alleviate the burden on sites and patients participating in trials to ensure trial success Analysing the use of computerized approaches to gain more targeted data for your trial Alan Palmer, Non- Executive Director, One Nucleus 12:30 Networking Lunch 13:30 Exploring Clinical Trials With Advanced Therapeutic Medicinal Products (ATMP) Novel areas of therapy research are spawning an increasing variety of cell based, tissue engineered or gene modifying approaches for the treatment/prevention of disease. Companies conducting clinical trials with these products may encounter a variety of issues during development; this presentation considers the issues likely to be encountered and discusses ways to proactively address these Discussing the potential for ATMP s in a post- Brexit environment where innovative therapy may become increasingly important in maturing an independent UK clinical market Highlighting vital regulatory considerations when considering ATMP s to remain compliant in a dynamic, complex and rapidly advancing area Addressing operational challenges when conducting ATMP trials to avoid unsuccessful trials and incomplete products Exploring the expansive nature of ATMP s to expand your company s product capabilities 14:00 Discussing The role Of Companion Diagnostic Testing In Saving Costs This session is an insightful beginning into the partnership between medical device and pharmaceuticals in creating drugs with a personalised application to optimise its effect and save costs. Highlighting the collaboration between medical device and drug development companies to spark continuous innovation in this space Exploring key characteristics for the various specialised vendors who provide the niche tests for companion diagnostic tests to ensure you have suitable partnership for your trial Appreciating the role of companion diagnostic testing in solidifying the cost of your products to buyers through its ability to identify patients likely to benefit from a therapeutic product Emphasising the importance of this testing to make certain the right patients are signed up for your trial to mitigate any post approval study issues Andrew Thompson, Director of Therapy Research and Analysis, Medical Devices, GlobalData Health

9 14:30 Afternoon Break and Networking 15:00 Regulatory Update Compliance Is Key- Unlocking The ICH GCFP R2 Regulation To Improve Trial Performance Good Clinical Practice is at the foundation of all aspects of the trial process. Most major and critical findings are observed at Clinical Investigator, Sponsor, and CRO sites. Furthermore, the sponsor and the CRO accounts for nearly 43% of the total findings it is important to stay up to date with the evolving regulatory requirements for clinical trials to discuss the likely impacts and challenges they pose for current and future trials. Addressing the difference between the R1 and R2 version of the ICH guideline to ensure full compliance across all trials Exploring the amended oversight responsibilities for the sponsor for any outsourced work to ensure the integrity of the study tasks performed and any data generated Explaining the relevance for sponsors to have original written procedures in place for all electronic systems used during trials to uphold the integrity of the data collected Dr Yuri Martina, VP- Clinical Operations, Grünenthal GmbH 15:30 Live Debate This House Believes that Brexit Will Stimulate Clinical Trial Innovation in the UK 16:15 Moderator Opening Remarks Knocking On 10 Downing Street Preparing A Future Ready Plan - How can the UK remain positive? Let s discuss innovation, business adaptation and focus on bringing the UK industry at the forefront of the clinical market! 16:20 Initial Audience Vote 16:25 Arguments For 16:30 Arguments Against 16:35 Interactive Debate/Q&A 16:55 Final Audience Vote Discussing the advantages of Brexit in pushing drug innovation within the UK clinical market Highlighting the strength of the UK clinical industry to appeal to investors, ensuring future global collaborations Evaluating the regulatory impact of Brexit on current business structure to plan for the future Ensuring continued trial compliance by applying the right post- Brexit strategy 16:15 Chair s Summary & Closing Close of Conference

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