2018 Interactive Breakout Discussions


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.

TUESDAY, DAY 1 | 16 October 2018

16:10 Find Your Table and Meet Your Moderators

16:15 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.

TABLE 1: What Is Holding Back the Adoption of eConsent?

Moderators:

Scott Askin, Digital Solutions Director, Digital Development, Novartis

Susan Griffing, Vice President, Global Head Country Clinical Operations, Roche

Ashley Polhemus, Innovation Specialist, Global Innovation Center, Merck and Company

Anne Tinggaard, E-Trials System Specialist, Novo Nordisk

David Cocker, CSO, Ta-scan Business Intelligence Systems, MDC Partners

Eric Delente, President, Patient Solutions Business Unit, DrugDev

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

Moderators:

Martine Lewi, PhD, MBA, Scientific Director, Global R&D, Clinical Innovation, Janssen

Tess Gilbert, MS, Senior Manager, Consultative Services, Clinical Trial Optimization Solutions (CTOS), IQVIA

Kyle Holen, MD, Head, Development Design Center, AbbVie

Mats Sundgren, PhD, Director, Health Informatics, AstraZeneca

Nadir Ammour, MDS, MBA, Head, Clinical Digital Innovation, Sanofi

  • 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)?

TABLE 3: Strategies for Accelerating Recruitment in Complex Clinical Trials in a Resource Constrained Environment

Moderators:

Brendan O’Neill, Senior Director, Patient Recruitment Programs, Clinical Development & Operations, Global Product Development, Pfizer

Matt Miller, Vice President, Global Patient Recruitment & Feasibility, StudyKIK

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

Ben Aldridge, Director, Clinical Operations, Highpoint

  • 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)

TABLE 4: Optimizing Country and Site Selection: Strategies for Positioning Trials for Success Using a Global Footprint

Moderators:

Stephen Lock, Head of Business Intelligence, NIHR (National Institute for Health Research)

Silke Strommenger, MD, Head, Feasibility Analytics & Planning, Bayer

Nils Drews, MD, CMO, Clariness

Divya Chadha Manek, PhD, Head, Business Development, National Institute for Health Research (NIHR) Clinical Research Network

Susan Griffing, Vice President, Global Head Country Clinical Operations, Roche

Shawn Tedman, Head, Trial Optimization Offerings, CTOS, IQVIA

Sophie Evett, PhD, Feasibility Lead, Feasibility Center of Excellence, Study Optimization, Pfizer

  • 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

TABLE 5: Improving Both Time and Quality in Site Activation and Study Start-Up (Sponsor, CRO and Site Perspectives)

Moderators:

April Lewis, Head, Global Offerings and Marketing, Clinical Trial Optimization Solutions (CTOS), IQVIA

Miguel Angel Mayer, MD, PhD, Research Programme on Biomedical Informatics (GRIB), Hospital del Mar Medical Research Institute (IMIM), Universitat Pompeu Fabra (UPF)

Joana Claverol, Clinical Research Unit Manager, Sant Joan de Deu Barcelona Children’s Hospital, Research Foundation Barcelona Children’s Hospital

Lorraine Rusch, PhD, President, High Point Clinical Trials Center

  • 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?

TABLE 6: Strategies for Patient-Centric Trial Design and Digital Patient Engagement

Moderators:

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

Robert Kroes, Project Manager, Clinical Dermatology and Pain Global Medical Affairs, Eli Lilly and Company

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

Terrie Livingston, PharmD, Senior Director, Real World Outcomes, Innovative Partnerships & Insights (RI2), Biogen

Maya Zlatanova, FindMeCure Foundation

Narinder Chopra, Director, Feasibility, Enrollment & Retention Optimisation, Global Clinical Operations, Biogen

Kai Langel, Director, Clinical Innovation, Janssen

  • 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?

TABLE 7: RBM in a Finance and Resource Limited Environment

Moderator:

Andy Lawton, Director and Consultant, Risk Based Approach Ltd.

  • 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?

TABLE 8: Centralized Monitoring

Moderator:

Nurcan Coskun, PhD, Global Risk Based Monitoring Program and Technology Solutions Manager, Medtronic

  • Common misconceptions about centralized monitoring
  • What are the tech needs to implementing centralized monitoring?
  • Best practices and lessons learned from those using centralized monitoring

Table 9: The Impact of Final ICH GCP E6 Guideline and R2 Addendum in Globalization Environment: Changes Affecting Sponsors, CROs, Clinical Investigators, Sites

Moderator:

Marina Malikova, PhD, MA, Executive Director, Surgical Translational Research Operations and Compliance, Boston University

  • 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

17:00 - 18:00 Networking Reception with Exhibit Viewing