08:20 Chair s opening remarks Agenda Highlight!

Transcription

1 Program Day One September 7 th, :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 Creating a partnership for success: accessing difficult patient populations This presentation will explore how ideal partners align themselves in order to optimize enrollment potential for clinical trials. Choosing the Right Fit Partner(s) Collaboration Strategies Capitalizing on your Partner s Strengths Stacey Flattery, General Partner, Vice President of Operations, PRA Health Sciences 09:30 Designing an effective oversight management plan to maintain GCP throughout your trial

2 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 Steven Kates, Vice President, Research, ISCHEMIX 10:00 Investigating the new EU clinical trials regulation: The impact it will have for US sponsors running global trial? Outlining the rationale behind the changes in the previous clinical trials directive Discovering the revised timeline for the new EU CT Regulation to go into effect Developing an understanding of the core components and country-specific aspects of the regulation Highlighting differences between the EMA s and FDA s expectations Unraveling the advantages of the New EU CT Regulation and the impact that this will have on sponsors Dr. Ludwig Baumann, Director Regulatory Affairs, SYNTERACTHCR 10:30 Morning refreshment break and networking STREAM A Strategic toolkit for outsourcing 11:00 Panel discussion: Deliberating the procurement vs. outsourcing debate Agenda Highlight STREAM B Effectively managing trial sites and patients Identifying an effective strategy to set up trial sites in order to avoid delays Defining the key differences between procurement and outsourcing Presenting the importance of certain clinical practices to procurement departments 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

3 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 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 Earl Sands, Chief Medical Officer, Selecta Biosciences Kenneth G Olovich, Financial and Sourcing Director, ELI LILLY AND COMPANY Tara O Meara, Vice President, Clinical Development Operations and Program Lead, BLUEBIRD BIO 11:30 Considering Commercial Model Innovations in Patient Enrollment Highlighting the need for the drug development industry to seek innovative but proven ideas to think beyond the legacy site construct Discussing patient enrollment innovation Exploring a site and patient model that could change how sponsors conduct clinical trials in certain indications Determining a framework for pursuing success in each of these areas Discussing tips for an effective global recruitment process that enhances site productivity Amanda Paley, Associate Director, Enrolment Solutions, ACURIAN Investigating best practices in forecasting outsourcing costs Discussing key success criteria in developing a reliable budget from early planning to RFP execution Highlighting the complexity of creating budgets to ensure they are completed correctly Outlining the challenges throughout the process in order to prepare Revealing lessons learnt throughout the process Nancy Sullivan, Senior Forecasting Manager, VERTEX PHARMACEUTICALS Ying Jiang, Director, Customer Success, Clinical Trial Optimization Solutions, IMS HEALTH New for 2016!

4 12:00 Investigating unique challenges in rare disease clinical trials Panel discussion: Overcoming challenges of finding trial sites in high demand 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 Developing a strategy to engage investigators and sites from first 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, Senior Vice President, Clinical Development, X4 PHARMACEUTICALS Lisa Garrett, Director of Project Delivery, PRA HEALTH SCIENCES 12:30 Lunch break and Networking 1:45 Discovering patient perspectives on clinical research: Highlighting key areas to consider when designing your trial New for 2016! Investigating the reliability of patient reported outcomes to ensure your data is clinically meaningful Reveling actual and preferred sources of clinical trial information Spotlighting the need for patients to be confident in finding appropriate research study Outlining the most important information for patients prior to deciding to participate 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

5 Identifying the top factors likely to influence participation decision Considering who would discuss clinical trial experience Julia Farides-Mitchell, Project Manager, Patient Communications and Engagement Programs, CISCRP 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 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 and Physician Services, UBC: AN EXPRESS SCRIPTS COMPANY Isabelle Lousada, President & CEO, AMYLOIDOSIS RESEARCH CONSORTIUM 2:45 Deciphering an effective strategy for fully outsourced trials to minimize timelines Investigating Early Clinical Proof of Concept and NDA enabling clinical pharmacology package studies Understanding how to streamline the study setup process and eliminate protocol amendments Utilizing the CRO experience and discovering how to benefit from it Discovering the benefits of real-time access to clinical data Staci McDonald, Executive Director, Scientific Clinical Operations, CELERION New for 2016! Applying technology from silicon valley to drug development Identifying the difficulties of fully outsourced trials for gene therapies highlighting areas that require more attention Discovering the advantages of choosing an affordable service provider with the relevant Investigating a powerful new platform for finding great contract and consulting talent Outlining machine learning data science applied to clinical trial recruitment (a case study) Identifying how to successfully

6 experience Creating realistic timelines for yourself and your service provider to eliminate the possibility of overruns Considering the challenges experienced when outsourcing manufacturing in gene therapies creating a foolproof plan implement communication and project management tools used by computer scientists in biopharma Considering the future of technology and clinical trials Rahul Chaturvedi, Vice President Clinical Development, KALEIDO BIOSCIENCEES David Sherris, CEO, GENADAM THERAPEUTICS 3:15 Results from Veeva 2016 Paperless TMF Survey: Annual CRO Report 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 Starting at the beginning and incorporating patient awareness and engagement in your trial process to create effective clinical trial awareness Revealing the role of a CRO in Patient and Awareness and Engagement Discovering why Patient Awareness is important to reveal the benefits experienced throughout your trial Creating new solutions for Clinical Trial Awareness to ensure effective patient involvement in your trial Clare Grace, VP of Site and Patient Access, INC RESEARCH 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

7 An opportunity to ask in depth questions to a Chief Executive Officer of a start up: 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 Chief Executive Officer, LIPIMETIX DEVELOPMENT 4:45 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 Communications and Engagement Programs, CISCRP 5:15 Chair s summation and close of day one Program Day Two September 8 th, :00 Registration and refreshments 08:20 Chair s opening remarks Stream A: Pharma and Biotech Stream B: Medical Device 08:30 Designing and running a clinical trial to what extent can you rely on your CRO? Registration and refreshments Selecting the right CRO(s) to ensure success of your clinical

8 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, Vice President Clinical Development, Translational Research, Medical Affairs, ARQULE 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 SYTEMS Case study: Investigating a hybrid model for managing a clinical research department Identifying when to utilize inhouse versus CRO experience Outlining the impact of medical device trial complexity on selection of trial staff Discovering hybrid models for staffing medical device trials Investigating cost implications in order to budget effectively Adrian Orr, Director of Clinical Affairs, ANIKA THERAPEUTICS

9 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 Early feasibility trials and proof of concept trials in order to accelerate into a pivotal trial Ensuring you have the right data whilst putting together your RFP Choosing the right data monitoring system for your specific trial Outlining the steps that need to be taken to prove your technology is fully functioning in order to get clearance Uncovering what types of tools are available for feasibility trials Jonathan Bissett, Director, Clinical Affairs and Scientific Communication, NEOSYNC 10:00 Managing multi-protocol programs and building efficiencies while being a good partner Next level planning for risk management and project/program oversight Successful project delivery through communication and early project preparation Key challenges and lessons learned from the real life program management Svetlana Kolchinsky, Director of Project Management, BIOTELEMETRY RESEARCH (CARDIOCORE & VIRTUALSCOPICS) To outsource or not to outsource that is the question Mapping out what a service provider can do for you Identifying the skill set in house in order to develop an understanding of where expertise is needed Effectively calculated a costbenefit analysis for your clinical trial Geographically locating clinical trials in order to asses where areas of expertise are required Linda Tedder, Director, Clinical Trial Management, DEPUY SYNTHES

10 10:30 Morning refreshment break and networking Agenda Highlight 11:00 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, Senior Vice President, Clinical Development, X4 PHARMACEUTICALS Sean Seyffert, Director, Clinical Programs, SHIRE PHARMACEUTICALS Mollie Baird, Senior Director and Head Clinical Operations and Development, SAGE THERAPEUTICS Outlining the challenges and opportunities of global clinical trials Uncovering the advantages of using local experts who understand the markets to ensure a successful trial Establishing effective communication pathways early on to enable easy contact in an emergency Building a strategy to work out realistic timelines and budgets to avoid setbacks Developing a database with your service provider to increase visibility throughout your trial Understanding your solution provider s commitments and priorities so you can be prepared for possible delays Kelsey Miller-Torchia, Senior Director,Clinical Affairs, INTRINSIC THERAPEUTICS New for 2016! 11:30 Considering safety risk management in early clinical trials a CRO perspective Considerations for combined firstin-human studies (SAD/MAD) Outlining key regulatory guidance s around risk management, risk mitigation in early phase studies Spotlight sessions: Investigating the challenges of running a trial for a complex medical device 3 x 10 minute presentations on the complexity of clinical trials for first time grade III technology followed by a group panel discussion

11 Starting dose considerations: facility capabilities and protocol design Shaping of the early phase regulatory landscape, lessons from the BioTrials and Tegenero studies Revealing an early phase safety risk assessment and risk mitigation process based on the 2007 EMA guidance Dr. John Lambert, Vice President Chief Medical Officer, PAREXEL 12:00 Going beyond your borders: Comparing and contrasting clinical trials inside and outside of the USA John A. Delucia, Vice President, Regulatory Affairs, Clinical Affairs and Quality Assurance, icad Kevin McGinnis, Senior Clinical Program Manager, ABIOMED Patricia Keating, Senior Clinical Project Manager, KALEIDO BIOSCIENCES Agenda Highlight 12:15 Workshop: Changes in the FDA considering patient preferences in your clinical trial 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 Investigating the possibilities of risks being minimized by introduction of new data Considering the extent to which patient preferences can have an impact on studies put forward Identifying what data needs to be put forward in order to move forward Discovering the future for regulations in medical devices Joshua Freeman, Director Clinical Affairs, SOLACE THERAPEUTICS Eyal Ron, Chief Technology Officer, GELESIS

12 12:30 Lunch break and networking New for 2016! 13:45 Identifying GCP and a way of ensuring your clinical trial is of the highest quality throughout each phase 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 2:15 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 2:45 Afternoon refreshment break and networking 3:15 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 45 minutes, allowing delegates to attend up to 2 roundtables

13 Roundtable 1 Working in clinical trials for gene therapies Nancy Goodman, Associate Director, Dimension Therapeutics Stephanie Haller, Vice President, Clinical Operations, DIMENSION THERAPEUTICS Roundtable 2 Considering the strategic partner vs. Preferred supplier debate Sekou Dilday, Associate Director Strategic Sourcing, SUNOVION PHARMACEUTICALS Roundtable 3 Considering the future of the regulatory environment for medical devices Joshua Freeman, Director Clinical Affairs, SOLACE THERAPEUTICS Roundtable 4 Creating an effective strategy for training in house and external staff Deirdre Kraimer, Vice President, Global Clinical Development, SMITH & NEPHEW 4:45 Close of conference