Tuesday, February 19
BREAKOUT DISCUSSION GROUPS
4:10 Find Your Table and Meet Your Moderator
4:15 Interactive Breakout Discussion Groups
Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the key issues presented earlier in the day’s sessions. Delegates will join a table of interest and become an active part of the discussion at hand. Bring your pharma, biotech, CRO, site, hospital or patient perspective to each of the discussions below. To get the most out of this interactive session and format please come prepared to share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and, most importantly, participate in active idea sharing.
5:00 Welcome Reception in the Exhibit Hall
6:30 Close of Day
We are continually building the breakout discussion groups for SCOPE 2019 and the topics and co-moderators are listed below. We will be updating this list regularly…
Patient Engagement and Recruitment
TABLE: What Is Holding Back the Adoption of eConsent?
Thorsten Ruppert, MD, Senior Manager, Research, Development and Innovation, Association of Research-Based Pharmaceutical Companies (vfa)
Alexa Richie, DHSc, Research Operations Manager, Research Administration, Mayo Clinic
Jill Collins, Executive Director, Global Operations Management, Syneos Health
- Is eConsent for every trial? Discuss when eConsent is or isn’t appropriate
- Understand IRB and regulatory feedback on the eConsent process
- Discuss how eConsent technology integrates with other systems
- Review a typical implementation timeline and how it impacts all stakeholders
TABLE: Strategies for Aligning and Accelerating Recruitment in Complex Clinical Trials in a Resource Constrained Environment
Kelly McKee , Head, Patient Recruitment, Vertex
Lynne Becker, Senior Data Analyst, Enterprise Intelligence & Data Solutions (EIDS), Program Management Office (PMO), Deputy Asst Director Information Operations, Defense Health Agency (DHA)
Kevin Hudziak, Consultant, Innovation Lead, Patient Experience and Design Innovation, Eli Lilly & Co.
- Dealing with the Acute Patient where timing is critical
- Do traditional/past tactics still work in current environment? What tactics (new and old) work best today?
- Ensuring success for procedure driven protocols (Non-conventional administration, device and/or diagnostic intense)
- Utilization of supportive field resources to accelerate recruitment (Medical Science Liaisons & Clinical Trial Educators)
TABLE: Strategies for Patient-Centric Trial Design and Digital Patient Engagement
Carolyn Brehm, Associate Director, BMS Study Connect Business Lead, Bristol-Myers Squibb
Antonieta Sosa, Director, Clinical Innovation, Janssen
David Fuehrer, CEO, GRYT Health
Jason LaRoche, Clinical Innovation Leader, Janssen Research & Development
- What are current digital patient projects gaining traction, engagement pilots, new technologies, the role of patient communities?
- What is a complete digital patient experience? What is required to make this a reality for all trials?
- What are we getting right and what are we getting wrong as we re-align our processes and our research organizations around the patient-centric model?
TABLE: Understanding and Implementing the New Reality of Diversity in Clinical Trials
- What are the regulatory changes from FDA and updated requirements for ethnicity/race inclusion in trial populations?
- How do you formalize into a clinical development plan at a company level to make it part of corporate culture by educating and training teams so that they can embrace the ethnicity value?
- How do you then implement at project team level and operationalize the activities to support diversity in clinical trials?
Protocol Optimization and Trial Design
TABLE: Embracing Best Practices in Protocol Design to Reduce Protocol Amendments and Improve Trials
Kimberly Cristall, Senior Director, Feasibility Group Lead, Study Optimization, Clinical Development & Operations, Pfizer
Chuck Bradley, Vice President, Clinical Development, FibroGen, Inc.
Michelle Everill, Senior Director, Head of Global Feasibility, Janssen
Michael Fites, Senior Feasibility Strategist, Global Clinical Trial Services, Bayer
- What are the updated metrics on the prevalence and causes of protocol amendments and what does this mean for us?
- How can we as an industry improve our process of protocol development?
- What are some community initiatives and individual company approaches to finding success?
TABLE: How to Start from Scratch to Get Patient Input into Clinical Trial Design
Beth Zaharoff, Director, Patient Focused Clinical Trial Engagement, TESARO
Julie Dietrich, Director, Center for Design & Analysis, Amgen
Stephen Yates, Clinical Program Director, UCB
Michele Teufel, Patient Engagement Lead, Clinical Operations, AstraZeneca
- Speaking to objections from senior leadership
- Discuss how to partner with advocacy organizations in order to obtain patient input
- How to work within timelines to get input from patients
Feasibility and Site Selection
TABLE: Optimizing Country and Site Selection: Strategies for Positioning Trials for Success Using a Global Footprint
Divya Chadha Manek, PhD, Head, Business Development, National Institute for Health Research (NIHR) Clinical Research Network
Christine Crandall, Head of Strategic Clinical Planning, Study Start Up, R&D Projects Clinical Platforms & Sciences, GSK
Sandra Smyth, Director, Central Feasibility and Recruitment Group, AstraZeneca
Tara Warren, Strategic Feasibility Manager, UCB Biosciences, Inc.
- Optimizing the site feasibility process: Improving global site feasibility assessment to identify sites that will recruit on time and within budget
- Objective country feasibility and selection: Where are the patients?
- Data-driven site selection: Understand the number of sites, their probability of success, and the impact of site non-performance
Study Start Up and Operations
TABLE: Barriers and Opportunities in Site Adoption of Clinical Trial Technology
Jim Kremidas, Executive Director, Association of Clinical Research Professionals (ACRP)
Laura Galuchie, Director, Global Clinical Trial Operations, Merck & Co., Inc. & TransCelerate Program Lead
Scott Askin, Digital Solutions Director, Digital Development, Novartis
- What site facing technology is critical to improving clinical trials?
- What is holding sites back from adopting this technology?
- What can be done to minimize the burden of technology for sites?
- What opportunities exist to streamline and integrate technology in clinical trials?
TABLE: Identifying and Alleviating Burdens Inherent in Clinical Trials (for Patients, Sites, Caregivers, Investigators and Trial Managers)
John Makowski, Head, Clinical Operations, Audentes Therapeutics
Rashieda Gluck, Senior Vice President, Global Clinical Operations, Aurinia Pharmaceuticals
Alyssa Lanzi, MS, University of South Florida, Ambassador & Researcher, Patient-Centered Outcomes Research Institute (PCORI)
- Identifying study requirements that may be burdensome
- Transportation to and from study visits – how can sponsors help
- Helping research sites to alleviate their internal burdens
TABLE: Partnering with Qualified Investigators and Study Teams for Improved Site Performance, Efficiency, and Execution of Clinical Trials
Kathy Goldstein, PharmD, Senior Director, Head, Quality Management Lead, Regeneron Pharmaceuticals
Joseph Kim, MBA, Senior Advisor, Patient Experience and Design Innovation, Eli Lilly
Jennifer Byrne, Founder and President, Greater Gift, former CEO, PMG Site Network
- Idendentify inefficiencies in current approaches to investigator training and lean how these impact the conduct and timelines of clinical trials
- Discuss strategies for developing a culture of collaboration between sponsors/CROs and site teams in preparing investigators and their delegates for the quality conduct of clinical trials
- Describe approaches to combining “qualification” and “preparation” activities for site teams.
TABLE: Improving Both Time and Quality in Site Activation and Study Start-Up
Kelly Loughner, Senior Associate Director, Site Enablement, Boehringer Ingelheim
Lorena Gomez, Director, Global Study Start Up & Essential Documents, Global Site Management Operations, Allergan
Mano Das, IT Business Partner, Clinical Patient and Site Operations, Bristol-Myers Squibb
Julie VanOrsdel Daves, MSHS, Director, Clinical Contracts & Outsourcing, miRagen Therapeutics, Inc.
- Identifying and consolidating site start up activities that are redundant, inefficient and needlessly complex
- What are key learnings and opportunities for different approaches, including a centralized approach of study activation and site performance?
- How can sponsors, CROs and site streamline site activation and study start-up?
Data and Technology
TABLE: Wearable Devices in Clinical Trials
Christian Gossens, PhD, Global Head Early Dev Workflows, Roche Pharmaceutical Research & Early Development
Bhaskar Dutta, Principal Scientist, Advanced Analytics Center, AstraZeneca
Pravin Jadhav, PhD, Senior Director, Innovation and Business Transformation, Corporate Projects, Otsuka Pharmaceutical Dev & Commercialization Inc.
Emmanuel Fombu, MD, Director, Digital Health Solutions, Novartis
- What is the value, beyond scientific interest?
- Where do we want to be in 5 years (and why we are not there already!)?
- Key challenges for industry uptake?
- Opportunities for industry-wide collaborations
TABLE: Digital Data Transfer and Virtual Trials
Mary Hall Gregg, PhD, Vice President, Business Technology, Research & Development, Pfizer
Rob DiCicco, Principal Consultant, TransCelerate Biopharma Inc
- The Digital Health eco-system and its impact on clinical trials
- EHR2EDC: how to implement and advance
- Mastering collaborations between pharma companies and academic medical centers
TABLE: Artificial Intelligence and Machine Learning: Extreme Case of Data Analytics?
Balazs Flink, MD, Head, Clinical Trial Analytics, Bristol-Myers Squibb
Francis Kendall, Director, Biostatistics & Programming, Cytel, Inc.
Angela Radcliffe, GM, Clinical Trial Solutions, PulsePoint
- Will data science and machine learning disrupt the provision of clinical evidence or compliment it?
- With Machine Learning becoming needing Big data sets, how could the industry share more data in a precompetitive framework?
- As more Deep learning techniques are deployed - how can we gain confidence in “Black Box” approaches?
- In what ways, if any, will we have to change how we work with regulators?
TABLE: Technologies to Enable Patient-Centered Trials
Munther Baara, Ms, Head, New Clinical Paradigm, Pfizer
Aman Thukral, Assistant Director, DSS, AbbVie
Laurie Myers, Global Health Literacy Director, Merck (MSD)
- Innovative digital technologies
- Technologies to capture patient experience
- Framework for converging patient-facing technologies
- Health literacy considerations in digital transformation
TABLE: Clinical Analytics Strategy
Nareen Katta, Director, Operations Analytics, Data Sciences, Data and Statistical Sciences, AbbVie
Faye O’Brien, Director, Metrics and Performance, GMD, AstraZeneca
Vinay Dheer, Director, Global Development Systems, Regeneron Pharmaceuticals Inc.
- Implementing analytics on top of existing operating model
- Study Start Up Methodology to Adopt a Clinical Analytics Strategy
- Data analytics in outsourced trials
MONITORING AND QUALITY
TABLE: RBM in a Finance and Resource Limited Environment
Sarah Bednarski, Associate Director, Strategic Monitoring, Sunovion
Sheri Kuss, Director, Clinical Quality Management, Pfizer
Catherine Sinclair, Manager, Quality and Capability, Risk Based Monitoring and Data Digital Analytics, GlaxoSmithKline, Inc.
- How are you assessing risk and developing an appropriate quality and risk plan?
- In terms of technology, what are nice to haves vs. need to haves for implementing RBM?
- Who are the stakeholders involved in putting RBM in action at smaller companies?
TABLE: RBM and Critical Reasoning Skills
Nechama Katan, Central Monitoring Manager, Data Monitoring and Management, Clinical Sciences and Operations, Global Product Development, Pfizer
Mary Arnould, Director, Clinical Science Operations and RBM Lead, Astellas
- How are central monitoring activities different than traditional monitoring?
- How do you train people to do critical problem solving around data?
- How do you uncover root causes of data issues instead of just fixing data afterwards?
TABLE: Vendor Performance Metrics and KPIs
Rosalie Filling, Vice President, Clinical Operations, Endo Pharmaceuticals
Ann Hegarty, Executive Director, GSMO, Head PLs, CRO Oversight & Ph I Site Management, Allergan
Linda Sullivan, Co-Founder & President, Metrics Champion Consortium LLC
David Nickerson, Head, Clinical Quality Management, Global Clinical Operations, EMD Serono
- How effective are your KPIs for measuring vendor performance and quality?
- What is your strategy for establishing KPIs and metrics? Who are the stakeholders developing performance metrics?
- What are the key areas that should be evaluated for vendor performance and quality?
TABLE: Building a Clinical Quality Management System (CQMS) from the Ground Up
Jonathan Rowe, PhD, Executive Director, Head of Clinical Development, Quality Performance and Risk Management, Pfizer
Brian Nugent, Senior Director, Clinical Compliance, GRAIL, Inc.
Angie Maurer, MBA, Clinical Quality & Risk Management Consultant, GRAIL, Inc.
Amy Neubauer, Associate Director, Data Management, Alkermes, Inc.
- What are the minimum requirements for a CQMS?
- What do you need to build a CQMS?
- How to build a CQMS with limited resources and budget
- Learn from each other’s current experiences with building a CQMS
Budgeting, Contracting and Resource Management
TABLE: Coordinating Contracting and Payments to Enhance Efficiencies
David Posselt, Director, Global Contract Management - Drug Development Operations, Allergan
Ly Kawaguchi, Senior Director, DBO-Outsourcing, Site Budgets, and Business Analytics, MyoKardia, Inc.
Richard O’Hara, Associate Director, Clinical Outsourcing, Endo Pharmaceuticals
- Understand how contracting and Investigator payments are connected
- Review standard terms to use on both ends of the contracting process
- Discuss how to improve and implement a plan to streamline operations
TABLE: Budgeting and Contracting for Remote and Digital Trials
Jamie Cash, Section Manager, Clinical Planning & Resource Management, Abbott Nutrition
- Understand budgeting needs for remote and digital trials and how they are different from traditional site-driven trials
- Review differences in contracting: needs, models, and language
- Discuss how to improve and implement a plan to streamline budgets and negotiations
TABLE: Balancing Budgets and Performance in Resource Management and Capacity Planning
Piet Theisohn, Director, Resource Management, R&D - Portfolio & Operations, Bayer Pharma
- What are key factors that should be considered when developing a resource plan?
- What situations warrant a bigger focus on cost savings, and which on using other resources?
- How do training and retention programs fit into capacity planning and overall resource management?
TABLE: Developing Resource Management Tools for Complex Trials and Diverse Portfolios
Gisele Paule, Contract Coordinator, Clinical Planning & Resource Management, Abbott Nutrition
Vladimir Shnaydman, PhD, President, ORBee Consulting
- Understand the important factors that need to be tracked to successfully capacity plan and how to integrate them into a tool
- Discuss how to get buy-in from key stakeholders by demonstrating value, cost savings, and efficiency
- Discuss change management and how to roll out a new tool or process
TABLE: Addressing Current and Future Workforce Challenges
JoAnn Pfeiffer, DrSC., Director, Clinical Research Management, Arizona State University
- What competencies are most lacking in the workforce today?
- How are you addressing these challenges?
- What more can and should the industry be doing to create a more skilled and sustainable workforce?
Clinical Supply and Logistics
TABLE: Clinical Supply in Virtual Trials
- How does clinical supply fit in with the industry trend towards virtual/site-less trials?
- What does clinical ops need to know about direct-to-patient distribution before embarking on a virtual trial?
- What are the logistical, cost and regulatory considerations of direct-to-patient distribution?
Biospecimen and Central Lab Management
TABLE: Biospecimen, Central Lab and Technology
Brenda Yanak, Former Global Head, Specimen Strategy and Innovation, Q2 Solutions, a Quintiles Quest Joint Venture
Caoimhe Vallely-Gilroy, Director, Global Head, Clinical Trials Biosample Management, Global Clinical Operations, Merck KGaA
Karina Bienfait, PhD, Principal Scientist & Head, Global Genomics Policy, Process & Compliance, Merck
- Biorepositories: in house vs. outsourcing
- Advanced informatics for biospecimen management
- Central and reference labs: building the relationship
- Informed consent and data sharing
TABLE: Integrating Sample Management into Clinical Trial Cycle
Michael Tanen, MBA, Director, Clinical Biomarker Specimen Management, Merck Research Laboratories
Matt Harlin, Associate Director, Clinical Pharmacology, Otsuka Pharmaceutical Companies
Sharin Roth, Director, Clinical Pharmacology, Bioanalysis, Otsuka
- Regulatory Compliance
- Site Selection Considerations
- RBM Considerations
TABLE: RWE to Support Regulatory Decisions and the Medicine Lifecycle
Cathy Critchlow, PhD, Vice President, Center for Observational Research, Amgen
William Spalding, MS, Director, Outcomes Research-Epidemiology, Shire
David Vulcano, MBA, Vice President Research Compliance & Development, HCA
- Leverage the power of RWD to enable evidence-based trial feasibility assessment and patient recruitment
- How can RWD support Clinical Operations and the Medical organization overall?
- What opportunities exist to collaborate between Medical and Commercial on RWD assets and insights?
- Which functions can help bridge and facilitate the ingestion of RWD for actionable insights?
- RWE needs to go beyond analysis and clinical trial is calling new clinical-health service to link healthcare and clinical trial research
TABLE: RWD To Accelerate Design and Execution of Clinical Trials
Andrew Roddam, DPhil, Vice President, Head, Epidemiology, RWE & Digital Clinical Platforms, GSK
Xia Wang, PhD, Director, Health Informatics & Global Medicines Development, AstraZeneca
Gregory Daniel, PhD, Deputy Center Director, Duke-Margolis Center for Health Policy, Duke University
Tine Lewi, PhD, MBA, Scientific Director, Janssen R&D, Clinical Innovation
- RWD to improve the efficiency of clinical trials
- RWD to accelerate site selection and patient recruitment
- RWD sources and analytics
- RWD to supplement clinical trials