Clinical Trial Supply Europe 2016 Barcelona, 2 nd & 3 rd March 2016 2016 SPEAKERS INCLUDE Jan-Pieter Kappelle, Senior Director, Global Clinical Trial Supplies, UCB Didier Basseras, Vice President, Clinical Supplies, Sanofi Henk Mollee, Senior Director, CTM Manufacturing, Astellas Ross MacRae, Senior Director, Clinical Supply Manufacturing, Pfizer Maria Kuthning, Head of Global Clinical Trial Supplies, Boehringer Ingelheim Johan Verboven, Manager, Clinical Trial Supply Management, GSK Alena Bolazeva, Senior Logistics Specialist, Bristol-Myers Squibb Henk Dieteren, Clinical Supply Logistics Expert, Grunenthal Nigel Hughes, Director, Integrative Healthcare Informatics, Janssen Romain Bourgin, Director, Clinical Supply Chain, Sanofi Pasteur Tom Cochrane, Head of Security Operations, MundiPharma Niklas Mattsson, Associate Director, Comparator Lead, Merck Carmen Salazar, Senior Project Manager, Clinical Supplies, GSK Andreas Schwinn, Head PQIE, Qualified Person IMPs, Roche Uwe Gessner, Comparator Strategy Lead, Pfizer Meinrad Kopp, Head, External Networks Management, Merck Sharp & Dohme Ayelet Weissbach, Clinical Logistics Leader, OPKO Biologics Cas Hilhorst, Global Supply Chain Manager, Johnson & Johnson Matan Koren, CSC Study Lead, Teva Pharmaceuticals Barbara Czech, Global Clinical Supply Coordinator, Roche Sanjin Mirkovic, IVR/IWR Manager, Janssen Subrata Bose, Senior Improvement Initiative Lead, Bayer Jeroen Gerritsen, Clinical Supply Expert, Nabriva Therapeutics SPONSORS INCLUDE For sponsorship opportunities please contact: Jaz Kent Email: JazKent@arena-international.com +44(0) 207 936 6948 Paul Adams Email: PaulAdams@arena-international.com +44(0) 207 936 6695 1
Clinical Trial Supply Europe 2016 Day One 2 nd March 2016 Programme Day One 08:30 Registration and refreshments 08:50 Chairman s opening remarks Chairman: Jan-Pieter Kappelle, Senior Director, Global Clinical Trial Supplies, UCB 09:00 Incorporating a global, multinational focus within your clinical trial supply strategies to promote success on an international level Highlighting the need for an international approach to clinical supply to accommodate the supply needs of the growing trend of global trials Emphasising the need for input from all teams in the planning stage to ensure geographic-specific requirements can be investigated as early as possible Exploring potential strategies to align processes for international trials to meet both EU and FDA standards Communicating effectively with regulatory teams to ensure any updates to requirements are identified in due time for country access Capitalising on vendor knowledge to navigate potentially complex regulatory landscapes Speaker: Cas Hilhorst, Global Supply Chain Manager, Johnson & Johnson 09:30 Session Reserved for World Courier 10:00 Developing effective Just in Time Manufacturing (JIM) strategies for Phase I studies to meet requirements when combining different protocols Involving the CMO in the planning stage of clinical supply to ensure their perspectives and needs are appreciated and accounted for Evaluating the need to spend more in the short term to appreciate the benefits in the longer term trial budgets Highlighting the need for strong relationships with sites, CROs, supplier and CMOs to promote the idea of Just in Time Manufacturing Recognizing the need to take this approach to ensure more complex trials can be accommodated for and clinical study teams can continue with new doses without waiting Speaker: Henk Mollee, Senior Director, CTM Manufacturing, Astellas 10.30 Session Reserved for PCI 11:00 Morning refreshments and networking 2
11:30 12:00 Clinical Supply Operations One size does not fit all; Overcoming issues with constantly changing and updating regulations within trial supply Underlining the reality that global harmonization does not currently exist to highlight the need for flexibility within your organisation Implementing strategies to ensure you are kept updated of incoming changes to clinical supply regulations Defining specific requirements for import alongside new regulatory environments through understanding customs practices Identifying requirements as early as possible to ensure necessary documentation can be compiled in a timely manner Working closely with your CMOs to ensure specific regional GMP regulations are being adhered to Speaker: Senior Representative, Novo Nordisk Session reserved for IMP Logistics Clinical Supply Technology Exploring how IRT can be implemented effectively to add the most value to your supply chain Pinpointing the specifics of your trial that need to be considered when setting up IRTs Investigating the true flexibility that utilizing an effective IRT system will add for adaptive trials Evaluating IRT as a tool for drug accountability throughout your trial to overcome issued with current outdated accountability processes Considering the capabilities IRT can offer within big data analytics to identify how we can capitalize in this space Sourcing the right IRT provider to find out which of the different systems available would best fit your trial From dispensation to destruction Best practices on how to handle drug reconciliation using an IRT application Efficient requirements gathering and IRT design. Point of view of an IRT provider Best practices on IRT drug management challenges: from drug pack level to subcontent level Examples of adapting to local requirements and regulations and real-world use cases: best practices to reduce cost, effort and study risks Speaker: Senior Representative, Oracle 12.30 Investigating challenges faced within the Vaccine clinical trial supply chain Developing an IRT strategy that can be used in line with temperature maintenance systems Exploring country infrastructure to identify how your geographic market impacts your transportation strategies Balancing timelines, quality and cost to Identifying the key challenges of integrating temperature monitoring and interactive response technologies to highlight the key pain points 3
discover which approach will be most effective for your product Highlighting the specific requirements of vaccine products to highlight the needs for a logistics provider to have experience in this field Considering temperature maintenance strategies within air shipping and evaluating the costs of this method Speaker: Carmen Salazar, Senior Project Manager, Clinical Supplies, GSK Ensuring that sites are well trained to use and understand the IRT systems to ensure excursions are identified and managed in a timely manner Utilizing IRT systems to ensure temperature monitors are being used in the right way Pushing the need to invest in technology early on in the trial to avoid astronomical costs midway through Speaker: Henk Dieteren, Clinical Supply Logistics Expert, Grunenthal 13:00 Lunch and Networking 14:30 Capitalising on drug pooling as a method to optimise your supply chain whilst adhering to trial budgets Developing effective alignment with IXRS to ensure an optimized supply chain Considering how best to meet infrastructure and investment requirements for smooth implementation of drug pooling Weighing up the differences between global and regional suppliers to elucidate the benefits of each approach Evaluating the impact of international pooling to predict issues that may arise working is some specific regions Speaker: Sanjin Mirkovic, IVR/IWR Manager, Janssen Ensuring your IRT systems are proactive to ensure an optimized clinical trial supply chain is in place Utilizing IRT for automatic approvals of temperature deviations in shipments Investigating the use of IRT for automatic approvals of temperature deviations at sites Improving IRT triggers by adding more parameters to promote success Ensuring a flexible by implement IVRS and IWRS to allow interaction with study databases and making multi-site study deployment more efficient Speaker: Matan Koren, CSC Study Lead, Teva Pharmaceuticals 15:00 Session reserved for Marken Session reserved for Cenduit 15:30 Afternoon refreshments and networking 16:00 Capitalising on smart stock as a method to optimise your supply chain whilst adhering to trial budgets Identifying the variables involved to pinpoint what to consider when putting together your pooling strategy Evaluating the impact of international pooling to predict issues that may arise Exploring the role of big and real world data in randomized clinical trial supply Investigating how real world and/or big data can help Identifying the need for more sophisticated tools to meet the demands of more complex trials Maximizing on the ability to evaluate the 4
16:30 working is some specific regions Incorporating Just In Time labelling in your supply chain to enable flexibility in multicentre trials Optimizing JIT labelling whilst drug pooling to minimize any possible delays Speaker: Jeroen Gerritsen, Clinical Supply Expert, Nabriva Therapeutics Session reserved for Mene Research feasibility of a study protocol, inclusive of inclusion/exclusion criteria to allow for more efficient and less expensive studies Considering the implications of changes in management of patient consent and data storage on clinical research Speaker: Nigel Hughes, Director, Integrative Healthcare Informatics, Janssen How the Internet of Things is shaping the clinical trial supply chain Discusses challenges in the clinical trial supply chain such as temperature control, traceability and patient compliance Examines how mobile and cloud technologies can be applied to provide realtime insights to aid proactive supply chain management Explores how historical trend data can be used to facilitate predictive analytics for more accurate planning and forecasting Looks into the future to see how technologies will be extended to the patient Speaker: Andrea Zobel, Global Senior Portfolio Director, Clinical Trial Supplies & Logistics, PAREXEL 17:00 Highlighting the key differences and similarities between a clinical and commercial supply chain to facilitate a new model to emerge in R&D arena Designing operating model and Clinical Supply chain strategies Applying robust and proven demand & supply regulation frameworks Looking at organizational model and supply chain roles transposed to R&D Implementing optimized manufacturing strategies Enhancing information solution landscape Speaker: Romain Bourgin, Director, Clinical Supply Chain, Sanofi Pasteur Managing a crisis when IVRS fails: A case study from a smaller company perspective Importing live study data to enable adjustments to stock to be made in enough time to meet changing demand Working closely with vendor data and supply managers in order to closely define your requirements and expectations Reviewing study statistics to identify early when issues with IVRS need to be addressed Investigating processes when having to take a manual approach to IVRS Speaker: Ayelet Weissbach, Clinical Logistics Leader, OPKO Biologics 5
17:30 Chairman s summation and close of day one Clinical Trial Supply Europe 2016 Day Two 3 rd March 2016 Programme Day Two 08:30 Registration and refreshments 08:50 Chair s opening remarks Clinical Supply Operations Clinical Supply Technology 09:00 Exploring packaging & labelling processes to overcome issues within global clinical supply chains Ensuring flexibility in your processes to allow for various requirements from different countries Considering the impact of temperature sensitive products on packaging costs and timelines Identifying where specifically vendors and fourth party logistic partners can add value in these processes Working with regulators to minimize impact of expiry date regulations and avoid repackaging and labelling were possible Investigating resources required to pinpoint where, when and by whom packaging and labelling is going to take place Speaker: Barbara Czech, Global Clinical Supply Coordinator, Roche Considering how companies can best plan for clinical trials utilizing forecasting technologies to ensure deadlines are met Establishing the need for more accurate forecasting supply processes as sourcing trial supplies becomes more complex Exploring approaches of utilizing novel forecasting technologies to optimize the supply chain whilst controlling costs Considering what factors need to be considered to ensure effective forecasting and avoid drug product shortages Highlighting the need for close communication with the site so forecasting variables can be continuously updated to provide accurate results Utilizing IXRS feedback to provide realistic information from the trial site to provide effective forecasting results for the duration of the trial Speaker: Ross MacRae, Senior Director, Clinical Supply Manufacturing, Pfizer 09:30 Session reserved for Sponsor Session reserved for N-Side 10:00 Incorporating Just In Time labelling in your supply chain to enable flexibility in multicentre trials Implementing effective end to end clinical trial supply management with SAP technology to ensure a streamlined trial Exploring different approaches with ERP 6
Investigating the truth behind the myth that JIT is the key to flexibility within clinical supply Promoting JIT labelling for unlabelled batches used in several different studies for a more efficient labeling process Highlighting JIT ethics and regulatory compliance considerations to identify new areas of improvement in the supply chain process Emphasizing the need for JIT labelling to cope with the growing trend of adaptive trials Considering specific challenges for JiT distribution for temperature controlled products Speaker: Meinrad Kopp, Head, External Networks Management, Merck Sharp & Dohme and SAP software to elucidate which would work best for your supply chain Investigating how SAP technology can be used to optimize your clinical forecasting techniques Ensuring your supply chain is viewed as a whole process, rather than function by function, by implementing SAP processes Utilizing SAP as a method for performing what-if analyses to identify impact of increased demands Considering how best to implement SAP processes into an already complicated biologics supply chain Speaker: Johan Verboven, Manager, Clinical Trial Supply Management, GSK 10:30 Morning refreshments 11:00 Highlighting the need for effective vendor management throughout your supply chain Exploring internal capabilities and resources to uncover where and when outsourcing will be necessary Promoting the involvement of the clinical supply team in CRO selection to ensure potential partners have the supply technology and expertise required Carrying out thorough training of external teams to ensure they have the required knowledge of your product Ensuring large scale logistics providers and CMOs pay your smaller scale clinical trial the attention they require Relying on vendors to provide updates on regulatory and technological advances to ensure an optimal supply chain is in place Speaker: Alena Bolazeva, Senior Logistics Specialist, Bristol-Myers Squibb Exploring novel technologies within temperature maintenance to determine the role they play in your biologics supply chain Assessing novel temperature monitors available to identify the true value they can bring Developing technology for aggregate temperature recording for the length of the supply chain Ensuring sufficient training of internal, vendor and site staff to facilitate effective use of new technologies and equipment Exploring what approach to take to ensure temperature maintenance technology and IRT systems can we smoothly integrated Developing e-training protocols to ensure patients are fully aware of requirements and to remove any risk within the Last Mile Speaker: Didier Basseras, Vice President, Clinical Supplies, Sanofi 11:30 Session reserved for Biocair Session reserved for Sponsor 7
12:00 Considering the benefits of forming a true partnership rather than a client-service provider relationship to reduce risk of trial failure, financial loss and damage to reputation Highlighting the importance of taking due time and care to select the appropriate vendor for the trial to avoid costly delays at the start of the trial Developing strategies to create longterm partnerships to maximize RoI for the sponsor and improve team alignment of sponsor and service provider Incorporating multi-trial contracts with service providers to reduce costs and difficulties associated with the vendor selection process Reviewing how best to form a strong partnership when working with multiple vendors to ensure a successful functional outsourcing model Speaker: Subrata Bose, Senior Improvement Initiative Lead, Bayer Developing effective security procedures for the clinical supply chain to ensure product quality and patient safety Evaluating current security guidelines from regulators from the US and Europe as well as internal company policies to enable a secure clinical process Recognising the importance of security throughout your whole supply chain to ensure brand integrity, temperature maintenance and product quality Exploring methods used in the commercial supply chain to see if they can be adapted and utilized in clinical supply Considering technological developments that can enable remote notification of package damage or interference to enable quicker reaction to tamper evidence Exploring security issues for comparator drugs to ensure these drugs are genuine and your trial is accurate Speaker: Tom Cochrane, Head of Security Operations, MundiPharma 12:30 Lunch and networking 13:30 Emphasizing the need for comparator sourcing to be considered an essential part of your supply chain Identifying comparator sourcing timelines, depending on trial size and requirements, to ensure it fits in your overall supply chain deadlines Considering the challenge of working in new markets to evaluate the availability of locally sourced comparators Evaluating whether to centrally source your comparator products or to take a more piecemeal approach to discover which approach is more cost-effective Implementing effective biosimilar sourcing strategies to overcome issues with limited stability and availability Outlining timelines for working with comparator sourcing vendors to avoid delays to studies Investigating different strategies for blinded trials to uncover the requirements for comparators Speaker: Niklas Mattsson, Associate Director, Comparator Lead, Merck 14:00 Session reserved for Durbin 8
14:30 Panel Discussion: Highlighting the risks and benefits of running trials in Eastern Europe to identify how best to approach these regions Outlining benefits of running trials in Eastern Europe to demonstrate the need for sponsors to capitalize on this landscape Designing efficient and cost-effective processes to ensure success when exporting to new markets such as this Navigating the regulatory landscape on an international scale to promote a swift import/export process Discovering the political landscape within Eastern Europe to ensure safe conduct of your supply Considering effects of poor infrastructure on temperature sensitive products Examining lessons learnt from past experiences to identify and alleviate potential complications Panellists TBC 15:00 Afternoon refreshments 15:30 Speaker Hosted Roundtables Each roundtable session lasts for 45 minutes, and delegates may attend up to 2 roundtables Roundtable 1 Roundtable 2 Roundtable 3 Roundtable 4 Identifying best practices for comparator sourcing Facilitator: Uwe Gessner, Comparator Strategy Lead, Pfizer Reserved for Endpoint Ensuring regulatory compliance and quality assurance along the clinical supply chain Facilitator: Andreas Schwinn, Head PQIE, Qualified Person IMPs, Roche Exploring how best to ensure effective time, resources and finances are allocated to your trial needs by senior management Facilitator: Maria Kuthning, Head of Global Clinical Trial Supplies, Boehringer Ingelheim 17:00 Chair s summation and close of conference 9