08:20 Chair s opening remarks Agenda Highlight!

Transcription

1 Program Day One 7 th September :30 Registration and refreshments 08:20 Chair s opening remarks Agenda Highlight! 08:30 KEYNOTE PRESENTATION Identifying the real meaning of a strategic partnership between sponsor and service provider to consider the future of outsourcing Differentiating the preferred provider model to the strategic partnership model Creating a partnership with clear lines of responsibility in order to avoid the blame game Outlining the positives and negatives of giving your service provider more responsibility Analyzing collaborative partnering for clinical trial design to use all areas of expertise Anticipating the types of relationships for the future considering the cyclic nature of outsourcing Christopher Rull, Vice President, Global Head, Service Provider Management, EMD Serono 09:00 Session reserved for PRA Health Sciences 09:30 Designing an effective oversight management plan to maintain GCP throughout your trial Highlighting the importance for sponsors to maintain oversight to ensure compliance Defining responsibilities between sponsor and service provider from the start avoiding the blame game Creating a clear and concise protocol Setting up an effective monitoring plan in order to keep track of progress Engaging in regular meetings / conference calls to maintain high levels of communication

2 Steven Kates, Vice President, Research, Ischemix 10:00 Session reserved for SynteractHCR 10:30 Morning refreshment break and networking STREAM A Strategic toolkit for outsourcing STREAM B Effectively managing trial sites and patients 11:00 Creating an appropriate strategy for your product - deciding if, when and how to outsource Content to be confirmed Tina Karunaratne, Director of Clinical and Late Stage Program Management, Ocata Therapeutics Identifying an effective strategy to set up trial sites in order to avoid delays Ensuring sites have the inclusion exclusion check list from the beginning Creating a strategy to work closely with your sites in order to set up clear lines of communication Analyzing the effect new technologies can have on site activation Evaluating the use of academic sites for your trial Kathryn Hoffman, Director, Clinical Projects, GE Healthcare 11:30 Session reserved for Acurian Session reserved for IMS Health New for 2016! 12:00 Revealing an accurate and efficient method for negotiating CRO/sponsor contracts in order to avoid unnecessary delays Panel discussion: Overcoming challenges of finding trial sites in high demand Developing a strategy to engage investigators and sites from first

3 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 language from the beginning Outlining any incentives or penalties for delays in order to create transparency Minimising costs with lawyers through creating a template that works for both CRO and sponsor Revealing a strategy for calculating realistic timelines Carol Lewis-Cullinan, Head of Clinical Operations, Seres Health contact Creating long lasting relationships with Principal Investigators to ensure you stay on their radar Considering the manner in which patients are communicated with Outlining the challenges for academic sites to get up and running Working collaboratively with your service provider to use both strengths Linda Tedder, Director, Clinical Trial Management, DePuy Synthes Robert D. Arbeit, SVP, Clinical Development, X4 Pharmaceuticals Inc. 12:30 Lunch break and Networking 1:45 Investigating unique Challenges in rare disease clinical trials Highlighting the need for patient or family-centric approach The importance of CRO and vendor selection Setting expectations around timelines and budget Managing stakeholder expectations Maria Mancini, Senior Director, Clinical Research, Catabasis Pharmaceuticals Investigating the reliability of Patient Reported Outcomes to ensure your data is clinically meaningful Highlighting the difference in process for patient reported outcomes Creating a flawless strategy with a specialised CRO in order to ensure accuracy of trial results Outlining the potential downfalls in patient reported outcomes Considering the impacts this could have on trial costs in order to create a cost-benefit analysis Ensuring reports are legitimate throughout your trial Tia DeFeo-Fraulini, Senior Director, Clinical Operations, Voyager Therapeutics

4 2.15 Working with advocacy groups: making it a win-win collaboration Investigating how pharma/biotech and advocacy groups can work collaboratively to support clinical research. Insight will be drawn from advocacy leaders leveraging a 1:1 approach Discovering what the dos and don ts are - get real world examples of missteps and successes Outlining what you need to have in place to make this partnership work for your next study/product in pipeline Shazia Ahmad, Patient & Physician Services, UBC: an Express Scripts company Agenda Highlight 2:45 Panel discussion: Deliberating the Procurement vs. Outsourcing debate Session reserved for Celerion Content to be confirmed Staci McDonald, Executive Director, Scientific Clinical Operations, Celerion Utilizing technology to optimize clinical development and patient recruitment New for 2016! Defining the key differences between procurement and outsourcing Presenting the importance of certain clinical practices to procurement departments Analyzing the opportunity or hindrance of outsourcing becoming part of procurement Presenting effectively with different departments of your organisation in order to communicate the necessary requirements Content to be confirmed Rahul Chaturvedi, VP Clinical Development, Kaleido Biosciencees

5 Jennifer Goodfellow, Senior Director, Global Clinical Procurement, Sanofi Kenneth G Olovich, Financial and Sourcing Director, Eli Lilly and Company Tara O Meara, Vice President, Clinical Development Operations and Program Lead, Bluebird Bio 3.15 Results from Veeva 2016 Paperless TMF Survey: Annual CRO Report Session reserved for INC Research Hear results from the industry-wide Veeva 2016 Paperless TMF Survey. This annual survey analyzes the observations of TMF owners at both sponsors and CROs to identify the barriers, business drivers, and benefits of moving to fully paperless TMFs. Join this session to: Understand how CROs and sponsors each approach TMF management See how desired benefits of an etmf align with benefits experienced Learn the importance of performance metrics when evaluating etmf systems Mike Burton, Director, CRO Alliances, Veeva Systems 3:45 Afternoon refreshment break and networking 4:15 Interview session: the trials and tribulations of a start up An opportunity to ask in depth questions to a CEO of a start up:

6 what goes into it, what opportunities can present for different people and at different levels, the challenges of starting clinical trials from scratch Dennis Golderg, President and CEO, LipimetiX Development 4:45 Session reserved for Flex Databases 5.15 Panel discussion: Patient recruitment An opportunity to hear from patients and their thoughts on patient recruitment, what works, what doesn t work, what is appropriate, where there is opportunity... Discussion led by: Julia Farides Mitchell, Project Manager, Patient Communication and Engagement Programs, The Center for Information and Study on Clinical Research Participation (CISCRP) 5:45 Chair s summation and close of day one Chair s summation and close of day one Program Day Two 8 th September :00 Registration and refreshments 08:20 Chair s opening remarks Operational strategies for pharma and biotech

7 08:30 Designing and running a clinical trial to what extent can you rely on your CRO? Selecting the right CRO(s) to ensure success of your clinical trial Vetting your CRO(s) for their ability and expertise Assessing if your CRO has selected right sites and Investigators Considering the medical and operational consequences if your clinical study is not well-managed by CRO and Sponsor Highlighting case studies of poorly managed clinical trials as a result of CRO and Sponsor mistakes that have lead to failed trials Giovanni Abbadessa, VP Clinical Development, Translational Research, Medical Affairs, ArQule Inc. 09:00 Investigating site monitoring in the brave new world of RBM Understanding RBM and it s critical components Investigating the appropriate role of SDV and SDR Understanding centralized and remote monitoring Defining the new Site Monitor Assessing the impact of RBM on site monitor resource levels Steve Young, Senior Director of Transformation Services, OmniComm 09:30 Case study: Risk and contingency management in clinical trials Investigating slow site selection Slow start up execution Slow patient enrollment Outlining the need for sponsors to be more site/patient centric in study execution Kevin Anderson, Associate Director, Global Clinical Operations, Alexion Pharmaceuticals Session reserved for Virtual Scopics

8 10:30 Morning refreshment break and networking Agenda Highlight Panel discussion: Strategic ways of conducting a strategy for rare and orphan disease clinical trials Identifying the key challenges of working with small patient populations Proactively identifying documents needed for trials at the regional and country level in order to decrease timelines Identifying the most appropriate KOL for your trial Highlighting the benefits of maintaining a relationship with your IP Incorporating added costs for reimbursement into the initial trial plan Robert D. Arbeit, SVP, Clinical Development, X4 Pharmaceuticals Inc. Sean Seyffert, Director, Clinical Programs, Shire Pharmaceuticals Mollie Baird, Director Clinical Operations and Development, Sage Therapeutics Session reserved for sponsor 12:15 Going beyond your borders: Comparing and contrasting clinical trials inside and outside of the USA Sourcing excellent local knowledge with which to navigate specific regulations, risks and liability issues that are different from USA Modifying your trial design to adapt to regional specifications with respect to business styles and language barriers Adapting your team, business style and trial management to local cultures and practices Positioning yourself appropriately in-country and/or remotely so you have adequate oversight Familiarizing yourself about regulatory requirements and approval processes that differ to your usual country of work Eyal Ron, Chief Technology Officer, Gelesis 12:45 Lunch break and networking

9 2:00 Identifying GCP and a way of ensuring your clinical trial is of the highest quality throughout each phase New for 2016! Creating proactive quality management systems Training your staff internally and externally to ensure inspection readiness Establishing a method to test if your vendors are compliant to GCP Maintaining this standard throughout the clinical trial Ross Pettit, Senior Vice President, Development Operations, Infinity Pharmaceuticals Agenda Highlight 2:30 KEYNOTE PRESENTATION Evaluating the Health and Alignment of Drug Development and CRO Landscapes Reviewing trends and conditions characterizing the drug development operating environment Discussing the health and strategic imperatives of niche, mid- and major CROs Examining recent transactions signaling landscape transformation Identifying opportunities and areas of misalignment Ken Getz, Director and Associate Professor, Tufts Center for the Study of Drug Development 3:15 Afternoon refreshment break and networking 3:45 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. All roundtable session run twice, for 30 minutes, allowing delegates to attend up to 2 roundtables

10 Roundtable 1 Working in clinical trials for gene therapies Nancy Goodman, Associate Director, Dimension Therapeutics Stephanie Haller, VP, Clinical Operations, Dimension Therapeutics Roundtable 2 Investigating integrating systems for your clinical trial Speaker to be confirmed Roundtable 3 Considering the future of the regulatory environment for medical devices Mary McNamara-Cullinane, Senior Director of Regulatory Affairs, Intrinsic Therapeutics Roundtable 4 Creating an effective strategy for training in house and external staff Deirdre Kraimer, VP, Global Clinical Development, Smith & Nephew 5:15 Chair s summation and close of conference