Interactive Breakout Discussion Groups

Interactive Breakout Discussion Groups are concurrent, interactive, informal, and 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.

SESSION #1 ON DAY 1 | WEDNESDAY 14 OCTOBER 2020

Interactive Breakout Discussion Groups #1, then Networking Reception in the Exhibit Hall

SESSION #2 ON DAY 2 | THURSDAY 15 OCTOBER 2020

Interactive Breakout Discussion Groups #2, then Shared Closing Plenary Keynote & European Innovation Awards

TABLE 1: Understanding Challenges in Global eConsent Implementations
Moderators:
Ana Herradón, Associate Director, Clinical Operations, Clinical Trial Manager Spain and Portugal, Bristol-Myers Squibb; TransCelerate Program Lead
Victoria Dwyer DiBiaso, Vice President, Region Head Clinical Study Units AP-Eurasia, Middle-East & Africa; Global Head Strategy & Collaboration, Sanofi
Marta Garcia Manrique, PharmD, MBA, Director Patient Involvement in R&D, Clinical Development, Servier International
Gareth Powell, Business Operations, Research Delivery, National Institute for Health Research (NIHR), Clinical Research Network Coordinating Centre
Thorsten Ruppert, PhD, Senior Manager, R&D & Innovation, Verband Forschender Arzneimittelhersteller, eV
Additional Moderators to be Announced

  • What are complexities behind challenges in global eConsent Implementations and how to address them?
  • Using data from the eConsent landscape survey on pilot programs, where and how is eConsent utilized around the globe?
  • How can eConsent improve patient understanding of clinical trials, enable better informed decision-making and increase patient participation?

TABLE 2: Leverage RWD to Optimize Protocol Design, Reduce Protocol Amendments, Accelerate Recruitment and Increase Patient Centricity – A European Perspective
Moderators:
Victoria Dwyer DiBiaso, Vice President, Region Head Clinical Study Units AP-Eurasia, Middle-East & Africa; Global Head Strategy & Collaboration, Sanofi
Kieran Whelton, Associate Director, Feasibility Analytics for Clinical Trials (FACT), Allergan
Sophie Evett, Feasibility Lead, Study Optimization, Global Product Development, Pfizer
Additional Moderators to be Announced

  • 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:
Mark Summers, President of Patient Engagement, WCG
Jeffrey Siracuse, MD, Associate Professor, Surgery, Boston University
Moderator to be Announced, Studykik
Additional Moderators to be Announced

  • 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:
Jill Johnston, President of Site Activation, WCG
Speaker to be Determined, IQVIA
Kieran Whelton, Associate Director, Feasibility Analytics for Clinical Trials (FACT), Allergan
Megan Heath, Vice President, Region Head Clinical Studies Unit Europe, Sanofi
Sophie Evett, Feasibility Lead, Study Optimization, Global Product Development, Pfizer
Additional Moderators to be Announced

  • 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:
Megan Heath, Vice President, Region Head Clinical Studies Unit Europe, Sanofi
Speaker to be Determined, IQVIA
Additional Moderators to be Announced

  • 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:
Tamás Bereczky, PhD, Patient Representative, Courses and Content, European Patient’s Academy on Therapeutic Innovation (EUPATI)
Maria Dutarte, The European Patients’ Academy on Therapeutic Innovation (EUPATI)
Marta Garcia Manrique, PharmD, MBA, Director Patient Involvement in R&D, Clinical Development, Servier International
Additional Moderators to be Announced

  • 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: Centralized Monitoring
Moderators:
Speaker to be Determined, TRI
Speaker to be Determined, IQVIA
Keith Dorricott, Ambassador, Metrics Champion Consortium
Morten Thorup Pedersen, Principal Risk Based Monitoring Specialist, Centralized Monitoring, Novo Nordisk AS

  • 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 8: Implementation of Clinical Development Risk Management
Moderators:
Andy Lawton, Director & Consultant, Risk Based Approach Ltd.
Linda Sullivan,Co-Founder & Executive Director, Metrics Champion Consortium (MCC)
Keith Dorricott, Ambassador, Metrics Champion Consortium
Dagmar Goertz, Director, External Engagement & Business Insights, BioResearch Quality & Compliance, Janssen
Morten Thorup Pedersen, Principal Risk Based Monitoring Specialist, Centralized Monitoring, Novo Nordisk AS

  • Is RBM delivering?
  • What is the role of proactively establishing QTLs?
  • Are there any good predictive models?

TABLE 9: The Impact of Final ICH GCP E6 Guideline and R2 Addendum in Globalization Environment: Changes Affecting Sponsors, CROs, Clinical Investigators, Sites
Moderators:
Dagmar Goertz, Director, External Engagement & Business Insights, BioResearch Quality & Compliance, Janssen
Marina Malikova, PhD, Executive Director, Surgical Translational Research: Operations and Compliance, Boston University School of Medicine
Thorsten Ruppert, PhD, Senior Manager, R&D & Innovation, Verband Forschender Arzneimittelhersteller eV
Additional Moderators to be Announced

  • 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

TABLE 10: Budgeting and Contracting Strategies to Speed Study Start-Up
Moderators:
Marina Malikova, PhD, Executive Director, Surgical Translational Research: Operations and Compliance, Boston University School of Medicine
Chibby Ebhogiaye, Business Optimisation, R&D Clinical Technologies, GSK
Additional Moderators to be Announced

  • Barriers to speedy study start-up and efficient contracting with CROs, vendors, and sites
  • Review contracting strategies: standard templates, language, culture
  • Strategies for navigating the revised Common Rule, the US-EU Privacy Shield, and EU-based regulations, including GDPR
  • How these laws and regulations affect clinical trial design, operations, and execution

TABLE 11: FSP vs. Hybrid vs. Strategic Partnership Outsourcing – Choosing an Appropriate Model
Moderators:
Andy Lawton, Director & Consultant, Risk Based Approach Ltd.
Additional Moderators to be Announced

  • Strategies for choosing an appropriate outsourcing model for individual trials vs. the entire portfolio
  • Determining pros and cons of each model – cost, resources, performance, study start-up
  • Determining sourcing needs vs. budget vs. relationships with previous and new partners

TABLE 12: Advanced Analytics and Artificial Intelligence in Clinical Trials
Moderators:
Jonathan Crowther, Director, Site Intelligence Lead |Study Optimization, Global Site & Study Operations, Global Product Development, Pfizer
Erbin Lin, Site Intelligence Director, Pfizer
Additional Moderators to be Announced

  • 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 13: Wearable Devices in Clinical Trials
Moderators:
Mohanad Fors, Head, Global Commercial Digital Innovation, Almirall LLC
Additional Moderators to be Announced

  • 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
  • What is the role of the regulator in acceptance of wearables in clinical trial and how can industry participate in the discussion?

TABLE 14: Decentralized, Virtual and Remote Trials...the New Ecosystem
Moderators:
Mohanad Fors, Head, Global Commercial Digital Innovation, Almirall LLC
Tamás Bereczky, PhD, Patient Representative, Courses and Content, European Patient’s Academy on Therapeutic Innovation (EUPATI)
Maria Dutarte, The European Patients’ Academy on Therapeutic Innovation (EUPATI)
Gareth Powell, Business Operations, Research Delivery, National Institute for Health Research (NIHR) , Clinical Research Network Coordinating Centre
Moderator to be Announced, Studykik
Additional Moderators to be Announced

  • Let’s discuss terminology: Site-less, de-centralized, virtual? Does it have to be one model, or can we mix (e.g. central and remote)?
  • Where do retrospective/eTrials fit in? virtual control arms? Does digital technology inevitably lead to virtual trials?
  • What are some specific challenges in retaining patients and investigators? What are the data science considerations in de-centralized/virtual trial?
  • As we move to decentralised clinical trial what does that mean in terms of definition of ‘site’ and ‘investigator’? Is changing the mindset of the PI a key to broader industry adoption?