Breakout Discussions - Scope Summit Europe 2019

2019 Archived Content

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.

This year due to positive feedback we will be running two breakout discussion sessions, one on Tuesday afternoon and a second on Wednesday afternoon. Attendees will thus have a chance to join two topic discussions.

Tuesday Afternoon | 17 September 2019

16:10 - 16:15 Find Your Table and Meet Your Moderators

16:15 - 17:00 Interactive Breakout Discussion Groups

TABLE: What Is Holding Back the Adoption of eConsent?

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

Co-Moderators: Thorsten Ruppert, MD, Senior Manager, Research, Development and Innovation, Association of Research-Based Pharmaceutical Companies (vfa)

Begonya Nafra, Clinical Research Unit, Sant Joan de Deu Barcelona Children's Hospital, Research Foundation Barcelona Children's Hospital

Ana Herradon, Associate Director, Site Monitoring Manager and Regional Clinical Operations, Iberia, Bristol-Myers Squibb

Hilde Vanaken, Senior Indsutry Advisor, Life Sciences and Healthcare, Tata Consultancy Services

TABLE: Leverage RWD to Optimize Protocol Design, Reduce Protocol Amendments, Accelerate Recruitment and Increase Patient Centricity – A European Perspective

What are the updated metrics on the prevalence and causes of protocol amendments and trial/recruitment delays and what does this mean for us?
How can we as an industry leverage RWD to improve the process of protocol design and recruitment?
What are some community initiatives and individual company approaches to finding success?
What’s in it for the sponsor, the investigator and ultimately the patient (in protocol design, reduction of amendments, accelerating recruitment, increasing patient centricity)?

Co-Moderators: Marcy Kravet, Head, Operational Design Center (ODC), Global Clinical Operations, Merck KGaA

Gareth Powell, Business Operations, Research Delivery, National Institute for Health Research (NIHR) Clinical Research Network Coordinating Centre

Camilla Ramdeen PhD, Director, Strategic Feasibility, Integrated Solutions, PAREXEL International

Marija Todorovic, Bridges Associate, Hospital Engagement Lead/Data Sciences, Janssen R&D, Clinical Innovation

TABLE: Strategies for Accelerating Recruitment in Complex Clinical Trials in a Resource Constrained Environment

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 (caregivers, Medical Science Liaisons, Clinical Trial Educators)

Co-Moderators: Keir Hodge, Global Studies Leader, Global Clinical Operations, Hoffman La Roche

Mark Summers, President, Patient Engagement, WCG

Jessica Cordes, Head, Clinical Operations, Medigene AG

TABLE: Optimizing Country and Site Selection: Strategies for Positioning Trials for Success Using a Global Footprint

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

Co-Moderators: Sophie Evett, PhD, Director, Feasibility Lead, Clinical Development & Operations, Global Product Development, Pfizer

Daoying Hu, MBA, PhD, Associate Director, Strategic Feasibility, UCB BioSciences

Claire Sears, Director, Product Communications, IQVIA Technologies

Jill Johnston, President, Site Activation Solutions, WCG

TABLE: Improving Both Time and Quality in Site Activation and Study Start-Up (Sponsor, CRO and Site Perspectives)

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?

Co-Moderators: Marina Malikova, PhD, Executive Director, Surgical Translational Research: Operations and Compliance, Boston University School of Medicine

Chibby Ebhogiaye, Head, Feasibility Services, Solution Adoption Center, IQVIA

TABLE: Implications of Sourcing Model on Financial and Resource Budgeting

Choosing a sourcing model to complement your portfolio strategy, and its implication on internal and external sourcing
Approaches for accurately forecasting financial and resource demands
Quantitative and qualitative considerations for adapting resources and budgets for a particular sourcing model

Co-Moderators: Bella Sessoms, MPH, Director, Portfolio Sourcing Management, Portfolio Sourcing and Relationship Management, Astellas Pharma Global Development

Anja Pietsch-Ottinger, Resource Manager, Clinical Operations - Resource Management, Bayer AG

TABLE: Advanced Analytics and Artificial Intelligence in Clinical Trials

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?

Co-Moderators: Jonathan Crowther, PhD, Site Intelligence Lead, Study Optimization, Global Product Development, Pfizer Inc.

Marc Philipp, MBA, Partner, Managing Director, Pharma & Life Sciences, Accenture GmbH

TABLE: Wearable Devices in Clinical Trials

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

Co-Moderators: Raj Pallapothu, mHealth Global Business Lead, Bayer Pharmaceuticals; mHealth Global Advocate

Maya Zlatanova, FindMeCure Foundation

Valentin Hamy, PhD, Data Analytics Leader, Digital Biomarkers, GSK Associate Fellow, Biostatistics, R&D, GlaxoSmithKline

Narayan R, Chief Architect, Head of Connected Clinical Trials Platform, TCS Life Sciences and Healthcare, Tata Consultancy Services

TABLE: Quality Monitoring and Quality Tolerance Limits

How many QTLs do we need?
What areas should we apply QTLs for?
Should the QTLs be set at failure points or reasonable expectations of the quality?
What other benefits could QTLs give us?
Are your QTLs linked to your QbD initiative?

Moderator: Andy Lawton, Director & Consultant, Risk Based Approach Ltd.

17:00 Networking Reception in the Exhibit Hall

Wednesday Afternoon | 18 September 2019

13:35 - 13:40 Find Your Table and Meet Your Moderators

13:40 - 14:10 Interactive Breakout Discussion Groups

TABLE: Impact of the Delays Regarding the Application of the New EU-CTR (EU-Regulation 536/2014)

What is the current implementation status of the EU-CTR (EU-Regulation 536/2014)?
What are the consequences of these delays for Europe as a clinical trial location?
How should organizations prepare for various outcomes/timelines?

Moderator: Thorsten Ruppert, MD, Senior Manager, Research, Development and Innovation, Association of Research-Based Pharmaceutical Companies (vfa)

TABLE: Leverage RWD to Optimize Protocol Design, Reduce Protocol Amendments, Accelerate Recruitment and Increase Patient Centricity – A European Perspective

What are the updated metrics on the prevalence and causes of protocol amendments and trial/recruitment delays and what does this mean for us?
How can we as an industry leverage RWD to improve the process of protocol design and recruitment?
What are some community initiatives and individual company approaches to finding success?
What’s in it for the sponsor, the investigator and ultimately the patient (in protocol design, reduction of amendments, accelerating recruitment, increasing patient centricity)?

Co-Moderators: Sophie Evett, PhD, Director, Feasibility Lead, Clinical Development & Operations, Global Product Development, Pfizer

Marc Philipp, MBA, Partner, Managing Director, Pharma & Life Sciences, Accenture GmbH Maya Zlatanova, FindMeCure Foundation

Daoying Hu, MBA, PhD, Associate Director, Strategic Feasibility, UCB BioSciences

TABLE: Strategies for Patient-Centric Trial Design and Digital Patient Engagement

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 realign our processes and our research organizations around the patient-centric model?

Co-Moderators: Jessica Cordes, Head, Clinical Operations, Medigene AG

Matt Cooper, PhD, Director, Business Development & Marketing, Research Delivery, National Institute for Health Research (NIHR) Clinical Research Network Coordinating Centre

Keir Hodge, Global Studies Leader, Global Clinical Operations, Hoffman La Roche

Raj Pallapothu, mHealth Global Business Lead, Bayer Pharmaceuticals; mHealth Global Advocate

Bert Hartog, PhD, Senior Director, Clinical Innovation, Janssen Pharmaceutica N.V.

TABLE: Optimizing Country and Site Selection: Strategies for Positioning Trials for Success Using a Global Footprint

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

Co-Moderators: Bettina Ryll, MD, PhD, Founder, Melanoma Patient Network Europe

Jonathan Crowther, PhD, Site Intelligence Lead, Study Optimization, Global Product Development, Pfizer Inc.

Gareth Powell, Business Operations, Research Delivery, National Institute for Health Research (NIHR) Clinical Research Network Coordinating Centre

Chibby Ebhogiaye, Head, Feasibility Services, Solution Adoption Center, IQVIA

Camilla Ramdeen PhD, Director, Strategic Feasibility, Integrated Solutions, PAREXEL International

TABLE: Improving Both Time and Quality in Site Activation and Study Start-Up (Sponsor, CRO and Site Perspectives)

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?

Co-Moderators: Bella Sessoms, MPH, Director, Portfolio Sourcing Management, Portfolio Sourcing and Relationship Management, Astellas Pharma Global Development

Marcy Kravet, Head, Operational Design Center (ODC), Global Clinical Operations, Merck KGaA

Claire Sears, Director, Product Communications, IQVIA Technologies

TABLE: RBM in a Finance and Resource Limited Environment

How can we adopt TransCelerate’s RACT model for a resource limited company/organization?
In terms of technology, what are nice to haves vs. need to haves for implementing RBM?
Who is involved in putting RBM in action at smaller companies?

Moderator: Andy Lawton, Director & Consultant, Risk Based Approach Ltd.

TABLE: The Impact of Final ICH GCP E6 Guideline and R2 Addendum in Globalization Environment: Changes Affecting Sponsors, CROs, Clinical Investigators, Sites

Describe the E6 R2 terms that are new/updated
Identify the changes impacting investigators, sites, Sponsors, and CROs for budgeting and contract development and execution
Explain the impact of the revisions on clinical trials conduct and organizational practices
Evaluate solutions for applicability/modification of organizational processes, procedures for forecasting, budgeting and costs estimation
Apply lessons learned for effective implementation of the new ICH GCP E6 R2 guideline

Co-Moderators: Marina Malikova, PhD, Executive Director, Surgical Translational Research: Operations and Compliance, Boston University School of Medicine

Ana Herradon, Associate Director, Site Monitoring Manager and Regional Clinical Operations, Iberia, Bristol-Myers Squibb

TABLE: Implications of Sourcing Model on Financial and Resource Budgeting

Choosing a sourcing model to complement your portfolio strategy, and its implication on internal and external sourcing
Approaches for accurately forecasting financial and resource demands
Quantitative and qualitative considerations for adapting resources and budgets for a particular sourcing model

Moderators: Rikke Winther, CEO and Business Owner, WIN Outsourcing Consult

Klaus Peter Kammerer, MD, Global Head, Vendor Management & Vendor Oversight, Quality Management, Learning & Knowledge Management, Global Clinical Operation, Medicine, Human Pharma Business Unit, Boehringer Ingelheim Pharma GmbH & Co. KG

TABLE: Data Science and AI to Advance Clinical Trials

How do you see digitization making clinical trials more efficient?
Enrollment
Decision making
Adherence
What do you see as major obstacles in implementing advanced analytics, ML and AI in Clinical Trials?
Do you have case studies from your own industry/company (Successes/Failures)?
How do you see the future developing (low-hanging fruit/beyond the horizon)?

Co-Moderators: Ronald Dorenbos, PhD, Head Innovation Management & Scouting, Innovation & Technology Science, Takeda

Mishal Patel, PhD, Head, Health Informatics, AstraZeneca

TABLE: Applying Blockchain for Clinical Trials