20 TH ANNUAL CLINICAL TRIAL SUPPLY EUROPE

Transcription

1 20 TH ANNUAL CLINICAL TRIAL SUPPLY EUROPE 13 th -14 th MARCH MILAN, ITALY Developing best practices and incorporating novel technologies to meet the demands of a more complex, international clinical trial supply chain VALUE FROM ATTENDING Clinical Trial Supply Europe is a strategic event targeted at those who have clinical, technological and regulatory responsibility for the supply of clinical trials. The key outcome of this meeting will be to balance supply chain delivery to overcome current operational challenges in clinical trials. Throughout the last 20 years Clinical Trial Supply Europe has established itself as the must attend event within the clinical trial supply space. Year on year this conference brings together the leading European thought leaders from both big and small pharma to debate discuss and learn best practice from one another. Building on this success our 20 th edition promises to deliver great content and networking opportunities for all of those involved allowing sponsors and suppliers the opportunity to learn and build relationships. We are also co-located with Temperature Controlled Logistics in Biopharmaceuticals to offer insight across the commercial supply chain 2019 SPEAKING FACULTY Tania Snioch, Director Healthcare, GS1 Peter Orosz, Head of Clinical Supply Chain Management & Oncology, Boehringer Ingelheim Thomas Thoma, Head Clinical Trial Supply Europe, Teva Niklas Mattsson, Lead Comparator Sourcing and Planning, MSD Peter Christensen, Director Clinical Supplies Project Planning, Novo Nordisk Guido Koch, Chief Operating Officer, Topadur Luca Russo, VP Head Clinical Trial Supply, Janssen Francesco Spoto, IRT Manager, Novartis Kovid Jolly, Lead Business Integration Manager, Novartis Henk Dieteren, Senior Clinical Supply Manager, Grunenthal Alex Robertson, Senior Director, Supply Chain Management, AstraZeneca David Dronneau, Process and Excellence Operation Head, Sanofi Dario Cogo, Global Head of Supply Chain, Clinical Supply, Novartis Pharma Ana-Zeralda Canals DPhil, Preclinical and Supply Chain Manager, Laboratorios Sanifit Elizabeth Cooper, Senior Manager Supply Chain Operations, Clovis Oncology Elnouaman Samadi, Operational Excellent Manager, Hikma Pharmaceuticals John Murray, Supply Chain Transformation Leader, AstraZeneca Gareth Crowder, Head of Indirect Purchasing, Norgine Massimo Eli, Clinical Supply Regional Lead, Merck

2 Mimi Choon-Quinones, Executive Senior Director, Clinical Operations and Patient Engagement, Arena Pharmaceuticals Gary Cunnington, Global Head of Business Consultancy (CTSU), Boehringer and Ingelheim David Collin, Director of Clinical Operations, MiNA Therapeutics Alena Bolazeva, Manager, R&D Logistics, Bristol-Myers Squibb Julia Mauger, Clinical Supply Manager, Nestle Clinical Development Unit Uwe Gessner, Clinical Research Sourcing Strategist, Pfizer Ina Lewinsky, Program Manager, Novo Nordisk Steven Benson, Head of Core Technologies, Target to Patient Supply Chain, GlaxoSmithKline FURTHER INFORMATION For sponsorship opportunities please contact: Paul Adams, Health Care Director Tel For program enquires please contact: Charlie Abrines, Senior Conference Producer Tel

3 Clinical Trial Supply Europe 2019 Day One 13 th March :45 Registration Sponsor Lanyard Sponsor 08:10 Chairs opening remarks 08:15 Personalised medicine; could this be the future? Considering how personalisation will affect the supply chain and what changes will be needed to accommodate this transformation Weighing up the costs of adopting a personalised medicine model as a company Reviewing how large companies can partner with tech-disruptors to improve delivery for patients Luca Russo, VP Head Clinical Trial Supply, Janssen 08:45 Session reserved for Marken 09:15 Discovering the practical benefits of e-labelling; how this technological innovation can expedite packaging and labelling timelines Exploring reasons driving the development of e-label technology to best understand its value for industry as a whole Framing e-labels as a patient friendly solution instead of a cost cutting mechanism to guarantee regulatory buy-in Comparing the value of e-labels versus traditional forms of labeling to emphasize their value for your supply chain planning Investigating US and EU regulators ambivalence towards approving e-labels and understanding what can change this Outlining cost saving opportunities associated with e-labels David Dronneau, Process and Excellence Operation Head, Sanofi 09:45 Session reserved for Parexel 10:15 Morning refreshments and networking Clinical Supply Operations Clinical Supply Technology 10:45 Panel Discussion How to select the best vendor, keep them engaged to successfully run your trial Reviewing current partnership models; which one works Moving beyond the theory; harnessing the power of technology to design a functioning Direct to Patient (DtP) supply chain Recognizing the complexities of making a DtP supply chain a reality

4 best for you company s size and budget Discussing ways alliances can be best managed to ensure you get the best service for what you pay for Evaluating ways you can keep your partner engaged throughout a trial Determining whether contract incentives work to keep partners committed to your success Presenting practical actions that have delivered positive results Reviewing current regulatory limitations with impending DtP into your clinical trial strategy Considering patients storage capabilities and limitations this can have on your trial design Maximising current technologies to improve patient adherence and prevent drop-offs Guido Koch, Chief Operating Officer, Topadur Pharma Alex Robertson, Senior Director, Supply Chain Management, AstraZeneca Mimi Choon-Quinones, Executive Senior Director, Clinical Operations and Patient Engagement, Arena Pharmaceuticals 11:15 Improving the site-sponsor relationships; developing a true site-centric clinical supply Session reserved for PCI Considering the demands placed on sites when running multi-trials for various sponsors Showcasing how a site centric supply strategy can improve your patient enrolment and retention rates Moving away from a one-size-fits-all approach; working with sites to ensure their needs are considered Suggesting ways integrating multiple IT systems can streamline supply management and minimise human error Session reserved for Oracle 11:45 Content TBC Showcasing what IRT can do for you; harnessing this tool to simplify your clinical supply, reduce operational costs and maximise your budget Considering the value of building internal IRT systems vs purchasing off-the-shelf for your business model Appreciating IRT s ability to simplify your supply chain process through automation versus traditional data management systems Outlining how specialized IRT vendors can offer technical expertise which can save time and money Evaluating and selecting the right IRT

5 provider for your specific needs to ensure success Highlighting ways through which custommade systems can ensure regulatory compliance and prevent problems throughout the studies development Gareth Crowder, Head of Indirect Purchasing, Norgine Henk Dieteren, Senior Clinical Supply Manager, Grunenthal 12:15 Session reserved for PRA Session reserved for Faubel 12:45 Lunch and Networking 14:00 How will the IMP GMP environment change when EU Regulation 536/2014 enters into force? Presenting innovative IT solutions for planning your clinical trial supply chain Regulatory Update The future regulatory landscape From Regulations to Detailed Commission Guidelines on GMP for IMPs Recommendations on AxMPs Annex VI the new IMP label text bible Utilising digital systems during your manufacturing process to minimise human mistakes Exploiting digital tools to forecast inventories for numerous studies in one go Designing lean end-to-end planning systems to reduce wasted drug supply New temperature control systems and how to ensure fast handling of deviations Peter Orosz, Head of Clinical Supply Chain Management & Oncology, Boehringer Ingelheim Peter Christensen, Director Clinical Supplies Project Planning, Novo Nordisk 14:30 Session reserved for GNH India Session reserved for 4G Clinical 15:00 Case Study Nestlé experience: particularities of clinical supply in Nutrition What is the role of GMP, GDP when dealing with a nutritional clinical trial Identification of global standards for labelling and package within nutrition trials Key technologies used to engage labelling and packaging for nutritional trials Lessons learned Q&A Julia Mauger, Clinical Supply Manager, Nestle Clinical Development Unit Case Study An intelligent, customer-centric, fast, riskmanaged and lean clinical supply chain Content TBC John Murray, Supply Chain Transformation Leader, AstraZeneca

6 15:30 Session reserved for Durbin Session reserved for N-Side 16:00 Afternoon refreshments and networking 16:30 Session reserved for Almac Session reserved for Cenduit Brand new 2019! Think Tank sessions offer delegates the possibility of delving into a topic and unpacking this in a thoughtful and constructive manner. Each speaker is a subject matter expert in their field and comes prepared with questions which will allow delegates the chance to debate and discuss in detail. Each session lasts 45 minutes and delegates will be able to attend 1 session 17:00 Think Tank 1 Improving the sponsor-site relationship to prevent overburdening your sites and delaying your trial results Elizabeth Cooper, Senior Manager Supply Chain Operations, Clovis Oncology Think Tank 2 Practical applications of e-labelling in clinical trials and ways to role this out across your supply chain Gary Cunnington, Global Head of Business Consultancy (CTSU), Boehringer and Ingelheim Think Tank 3 Session available for sponsor Think Tank 4 Session available for sponsor Think Tank 5 Which area of you clinical trial supply should receive the priority for funding? Think Tank 6 Debating ways to digitalising your clinical supply chain Alena Bolazeva, Manager, R&D Logistics, Bristol- Myers Squibb 17:45 Chairs summation and close of day one

7 Clinical Trial Supply Europe 2019 Day Two 14 th March :30 Registration Sponsor Lanyard Sponsor 08:50 Chair s opening remarks Clinical Supply Operations Clinical Supply Technology 09:00 Global standards for identification and data capture in clinical trial supply processes Considering the benefits from application of globally standardised identifiers and barcodes for clinical trial products Understanding industry trends and best practices for use of global standards Showcasing how these standards ensure process advantages in a crowded marketplace Tania Snioch, Director Healthcare, GS1 Case Study Has blockchain s time come? Is blockchain a buzzword or an actionable tool for disrupting operations? Unpacking how blockchain can be implemented within your current supply chain strategy Reviewing which components of your clinical supply chain can benefits from blockchain Considering the benefits blockchain could bring; improving traceability, accountability and compliance Determining potential costs savings which the blockchain can offer sponsors Francesco Spoto, IRT Manager, Novartis Kovid Jolly, Lead Business Integration Manager, Novartis Brand new 2019! 09:30 Session reserved for Inceptua Session reserved for Bracket 10:00 Presenting different sourcing models to guarantee you have the correct comparators for your clinical trial Panel Discussion Forecasting; can industry ever get this right? Highlighting which sourcing models are currently available for industry Reviewing benefits and drawbacks from each and how these can be incorporated within your sourcing strategy Discussing how integrating these models can offer better results than adopting one over another Determining why a hybrid sourcing model makes sense from a business Unpacking key shortfalls in forecasting software and methodology Highlighting how supply teams can work together with forecasting technologies to improve results Improving internal communication systems between operations and supply teams to know what is needed, when and where Planning for the unforeseen; ensuring each scenario is accounted for to minimize

8 perspective Niklas Mattsson, Lead Comparator Sourcing and Planning, MSD supply chain disruptions John Murray, Supply Chain Transformation Leader, AstraZeneca Ana-Zeralda Canals DPhil, Preclinical and Supply Chain Manager, Laboratorios Sanifit 10:30 Session reserved for Catalent Session reserved for sponsor 11:00 Morning refreshment 11:30 Panel Discussion Presenting the case for long term cooperation; working together to achieve better industry wide results Case Study Digitising your supply chain; managing temperature deviations within seconds Highlighting how long-term cooperation between sellers and buyers is good for all involved in the supply chain Discussing ways that open discussion can be implemented between sponsors Demonstrating the positive impacts of open discussion for comparator sourcing and accurate forecasting Preventing wastage and reducing costs through information sharing Content TBC Thomas Thoma, Head Clinical Trial Supply Europe, Teva Dario Cogo, Global Head of Supply Chain, Clinical Supply, Novartis Pharma Ina Lewinsky, Program Manager, Novo Nordisk 12:00 Session reserved for World Courier Session reserved for sponsor 12:30 The case for orphan drugs and their development in your supply chain Content TBC Unpacking Expanded Access Programs within your supply chain Reviewing compassionate use / named patient Presenting Right to Try as an application for your trial drugs Ana-Zeralda Canals DPhil, Preclinical and Supply Chain Manager, Laboratorios Sanifit Steven Benson, Head of Core Technologies, Target to Patient Supply Chain, GlaxoSmithKline 13:00 Lunch and networking

9 14:00 Session reserved for Caligor-Coghlan 14:30 Panel Discussion Brexit is here, what s next? What does the UK s future regulatory status may mean for clinical supplies Presenting alternative supply routes to prevent costly delays Reviewing how your suppliers are preparing and what best practice can be adopted across industry Hard-Brexit, soft-brexit, no-brexit; planning for all possible scenarios Alex Robertson, Senior Director, Supply Chain Management, AstraZeneca Massimo Eli, Clinical Supply Regional Lead, Merck David Collin, Director of Clinical Operations, MiNA Therapeutics Steven Benson, Head of Core Technologies, Target to Patient Supply Chain, GlaxoSmithKline 15:00 Session reserved Clinical Services International 15:30 Afternoon refreshments 16:00 Speaker Hosted Key Takeaway Sessions Interactive takeaway sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry. Hosted by industry experts and each focused on a single issue, takeaway session is an exciting, interactive way to build your personal network and learn from the experience and expertise of others. Each session lasts for 30 minutes, and delegates may attend up to 2 roundtables Key Takeaway Session 1 Considering how GDPR will affect sponsors ability to access patient data and draw results from large multi-sets Uwe Gessner, Clinical Research Sourcing Strategist, Pfizer Key Takeaway Session 2 Continuing the Brexit conversation; what final steps can industry take to prevent supply disruption Alena Bolazeva, Manager, R&D Logistics, Bristol-Myers Squibb Key Takeaway Session 3 Key Takeaway Session 4 From cradle to grave; working with partners to ensure all your product is accounted for and adequately disposed off Pedro Pala, Clinical Supply Manager, Bial How to achieve operational excellence for the pharmaceutical industry Elnouaman Samadi, Operational Excellent Manager, Hikma Pharmaceuticals

10 17:00 Chair s summation and close of conference