Ana Garcia Canon, ICRO (Clinical Operations) Group Head, Novartis Pharma

Transcription

1 Arena International s 7th Annual Outsourcing in Clinical Trials Europe Conference, Barcelona, Spain Program Day One May 16 th :40 Registration and refreshments 8:10 Chair s opening remarks 8:15 KEYNOTE Case study: Investigating the preferred provider model to identify its PRESENTATION reliability Outlining the steps necessary to create a preferred provider model Discovering if possible and how to motivate your service provider to maintain best standards and not become complacent Creating a strong relationship with your service provider with clear lines or responsibility Revealing lessons learnt and considering what to do differently next time Ana Garcia Canon, ICRO (Clinical Operations) Group Head, Novartis Pharma 8:45 Session reserved for Medidata 9:15 Panel discussion: What is oversight management? Identifying the key responsibilities for sponsor and service provider to ensure clear lines of responsibility Outlining the relevant guidelines to identify how these can help you create an effective oversight management Creating an effective oversight monitoring plan enabling all aspects of the trial to be observed Stephanie Kamp, Head of Outsourcing and Vendor Management, Grunenthal Susan Tio, Senior Director Clinical Operations, ProQR Estrella Garcia Alvarez, Head of Global Clinical Operations, Almirall 9.45 Session reserved for UBC: An Express Scripts Company Morning refreshment break and networking

2 OPERATIONAL EXCELLENCE AND CRO MANAGEMENT WORKING EFFECTIVELY WITH PATIENTS AND SITES Chair: Susan Tio, Senior Director Clinical Operations, ProQR Analysing amendments to GCP and highlighting best practices to ensure your clinical trial is of highest quality NEW FOR 2017 Unraveling a proactive to amend your protocol to meet new guidelines Creating a with your service provider to ensure all parties are clear on amended practices Considering future amendments to GCP and ensuring your trial is inspection ready at all times Outlining the consequences of failing GCP to highlight the importance Considering patient recruitment for small populations Working with your service provider to build an effective and utilise their expertise Sharing the site s point of view Attracting interest into your trials to avoid screening failures Creatively thinking of ways you can reach a wider population Ruth Proebe, Associate Director, Clinical Affairs Europe, CR Bard César Molinero, CMO & Clinical Operation Director, Oryzon Genomics Deciphering a for finding the right partner for your clinical trial Content to be confirmed Session content to be confirmed Dr. Terence Myles Eagleton, Senior Medical Director, Medical Affairs, Medpace Session reserved for proinnovera Establishing an endto-end approach to AGENDA HIGHLIGHT business operations for clinical research to allow for more effective forecasting and budgeting Promoting the idea of business operations and outsourcing teams being under the same management to avoid any knowledge being lost Considering how best to build links Panel discussion: Revealing trial advantages experienced through creating a patient centric Incorporating patients at the start of your clinical trial to include patient preference Realising the benefits of keeping patients engaged before, during and after your trial for future recruitment Considering how language used can

3 between project management and business operations to improve forecasting and budgeting processes Ensuring specific plans and processes for each team when change order occurs to minimize their impact Developing plans for forecasting strategies as the trial grows to international levels or takes different avenues affect patients creating a comfortable environment Ensuring outcomes are in line with patient expectations Robert S. Greene, President, HungerNdThirst Foundation Gaetan de Schaetzen, Associate Head of Project Management and CTA Unit, EORTC Mitchell Silva, CEO, Esperity Charlotte French, Senior Director, Service Provider Management, EMD Serono Networking Lunch Writing the best request for proposal to ensure you attract the relevant service providers for your trial Identifying the key responsibilities for sponsor and service provider ensuring each bid has the relevant experience Outlining the relevant guidelines to identify how these can help you create an effective oversight management Incorporating work culture into your RFP in order to attract like-minded service providers Revealing lessons learnt through case studies Karim Bagate, Senior Clinical Pharmacology and Operational Excellence Manager, Skyepharma Creating NEW FOR relationships with 2017 sites in order to retain sites for future clinical trials Revealing best practices for writing contracts clearly defining responsibilities Incorporating sites early on to get buy in for your trial Creating relationships with investigators ensuring you are the preferred sponsor Revealing benefits that can be experienced with using repeat sites Sonja Weiser, Director, Clinical Operations Europe, Insmed Inc Presentation reserved for Celerion Presentation reserved for Worldwide Clinical Trials Discovering best for outsourcing from a small company s perspective Unravelling an effective to decide when to outsource CEO Interview TBC Eric Leire, CEO, DanDrit AGENDA HIGHLIGHT

4 Identifying the specific trial needs in your RFP Highlighting an effective to ensure you remain within your budget Ensuring in-house expertise is used when necessary without exhausting your own team Pieter- Jan de Kam, Head Clinical Development & Pharmacovigilance, HAL Allergy Group Afternoon refreshment break and networking 15:45 Building a shared standard operational model with your service partner to achieve the same goals Outlining current challenges in clinical trials: an academic research organization perspective Communicating standard expected in RFP to attract appropriate service partners Streamlining your processes with your service partners to create the best Creating consistency throughout all parties from the start Considering the effectiveness of preferred partners in order to use the same standard each time Considering the differences between academic trials versus company sponsored trials Revealing hurdles and lessons learned through case studies Uncovering models of collaboration to ensure you are implementing the best Gaetan de Schaetzen, Associate Head of Project Management and CTA Unit, EORTC Arndt Shmitz, Research Biobank & Senior Translational Assay Technology Expert, Bayer Pharma Presentation reserved for Cytel Presentation reserved SynteractHCR Revealing an accurate and efficient method for negotiating CRO/sponsor contracts in order to avoid unnecessary costs Working with your service provider to build an effective and utilise their expertise in Niche markets Defining the responsibilities of both parties in order to create clear lines of responsibility Establishing a format you can both use to ensure you are speaking the same Overcoming language barriers to enable clear communication between parties Adapting your team, business style and trial management to local cultures and

5 language from the beginning Outlining any incentives or penalisations for delays in order to create transparency Minimising costs with lawyers through creating a template that works for both CRO and sponsor practices Familiarizing yourself about specific regulatory requirements and approval processes that differ to your usual country of work Overcoming the obstacles of working in different time-zones Christophe Dubreuil, Clinical Operations Director, Cellectis Mimi Choo-Quinones, Vice Director, Medical Affairs, EEMEA Roche Chair s summation and close of day one Arena International s 7th Annual Outsourcing in Clinical Trials Europe Conference, Barcelona, Spain Program Day Two May 17 th :30 Registration and refreshments 8:40 Chair s opening remarks The future of clinical trials Chairperson: Yannick Pletan, Chief Medical Officer, IDD Biotech Clinical Trial management Chairperson: Lidia Cappellina, Head of R&D Outsourcing Management, Chiesi Pharmaceuticals 8:45 Investigating functional outsourcing your clinical data management to utilise available technology NEW FOR 2017 Working collaboratively with academic institutions to ensure a successful trial Content to be confirmed Deciphering an effective to decide which service provider and technology is right for your trial Deliberating the responsibility for clinical data once you have partnered in order to set clear lines of responsibility Outlining best practices to maintain data for long term periods of time Evaluating the role of the clinical data Sebastian Rath, Project Manager, AIO- Studien-gGmbH

6 manager in-house once you have outsourced Yiannis Karageorgos, Compliance Lead, Global Data Strategies & Solutions, Bristol-Myers Squibb 9.15 Mid-study changes: keeping your clinical trial on track with EDC Presentation reserved for Bracket Learn how technology has adapted to better facilitate the development of Mid Study Changes on EDC trials Learn how sharing servers to reduce costs shouldn't complicate the process of Mid Study Changes on EDC trial Learn how deployment of mid-study changes can be made in-situ with zero downtime on your current EDC trial Rich Davies, Executive Director of Business Solutions, OmniComm Systems 9:45 NEW FOR Considering how to 2017 integrate technology into your business model in clinical trials to ensure maximum return on investment: the SMO perspective Site Management Organization (SMO) as a platform business model for clinical trials: incorporating technology in building an effective Value Proposition for Sponsors and Sites Discovering the important of fit-topurpose technology making sure you have the relevant technology for specific SMO business and delivery model Investigating the in-house changes technology can bring enabling you to make an informed decision Taking technology costs into account with service provider in the bid defense meeting to ensure business model sustainability Analysing the knock-on effects BYOD Panel discussion: Unravelling best practices for outsourcing to different markets Incentivising personnel to remain in their position the whole way through your trial avoiding loss of intellect Considering cultural differences when managing different teams Discovering the potential challenges experienced with volatile markets Analysing the impact on your in-house team as you are Frank Verheggen, Director Clinical Program Management, Astellas Pharmaceuticals Marco Salami, Head of Clinical Outsourcing Management, Chiesi Farmacetuici

7 can have on your trial Luca Angerame, Head of SMO Unit, Fondazione Policlinico A. Gemelli Morning refreshment break and networking Assessing risk effectively is RBM the answer? Working proactively with your service providers to create a fool proof Evaluating the effectiveness of RBM in comparison to its cost Understanding RBM and it s critical components Revealing lessons learnt in order to prepare Jose Manuel Ordonez, Spain CCO Therapeutic Area Leader Onco- Haematology, Roche Farma SA Discovering how to effectively manage third party outsourcing from the sponsor s perspective NEW FOR 2017 Outlining the benefits stem from third party outsourcing from the sponsor s perspective. Discussing the risks referring to the subcontracting concept as well as specific risks per subcontracted service. Describing possible processes to avoid or mitigate some of the risks. Additional soft parameters to take into consideration during the process Nili Azulay, Associate Director, Research & Development, Teva Pharmaceuticals A Patient Centred Approach, the Direct-to- Patient Model Understand the practical implications affecting patient recruitment and retention Hear about the value of a one stop shop and how quality and compliance are improved and competitive advantage can be gained Understand how the practicalities of set up and implementation can make or break a study Uncover the impact a patient-centric approach can have on trials and patients Presentation reserved for ERT David Spillet, Key Account Director, World Courier

8 12.00 Science and Machine Learning as means to super-enrich phase 2 trials in responders, and improve trial success rates AGENDA HIGHLIGHT Outlining the recent US adoption of FDA guidance for acceptance of newer technologies Considering an idea that goes much beyond traditional statistics and imposes specifics in the logistics to get positive results Revealing innovations so far implementing the idea Revealing Sanofi s Outsourcing Governance Internal strategic governance for the different outsourced category Outsourcing governance in place with our preferred service providers Success and challenges Myriam Cohen, Alliance & Partners Lead. Clinical Sciences & Operations Supplier Management, Sanofi Yannick Pletan, Chief Medical Officer, IDD Biotech Networking Lunch LIVE DEBATE Considering the influence Brexit will have for European companies AGENDA HIGHLIGHT An opportunity to discuss the effect Brexit will have on European companies along with challenging and revealing different approaches Considering the impact this will have on Outlining financial challenges this could create Discussing the challenges of finding sites Outlining strategic ways of conducting a for rare and orphan disease clinical trials Identifying the key challenges of working with small and sometimes geographically sparse patient populations Proactively identifying documents needed for trials in order to decrease timelines Incorporating added costs and reimbursement initially in order to budget appropriately Outlining the benefits of running trials for rare/orphan diseases Werner Gladdines, Snr. Director, Clinical Operations, Biomarin 15:00 Afternoon refreshment break and networking

9 15.30 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. 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. Each roundtable session lasts for 30 minutes, and delegates may attend up to 2 roundtables Roundtable 1 Outlining best strategies for integrating technologies into your trial Roundtable 2 Considering best practices for patient recruitment Katrien Clinckx, Head of Clinical Operations, Galapagos Roundtable 3 Discussing GCP guidelines and how to meet them Michael Zoerer, Senior Group Leader Clinical Operations, AOP Orphan Pharmaceuticals Roundtable 4 Creating long lasting partnerships with your service provider Lidia Cappellina, Head of R&D Outsourcing Management, Chiesi Pharmaceuticals 16:30 Chair s summation and close of conference