2022 Interactive Breakout Discussions

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, FEBRUARY 8

BREAKOUT DISCUSSION GROUPS

4:35 PM                Find Your Table and Meet Your Moderators
4:40 PM                Interactive Discussions
5:25 PM                Welcome Reception in the Exhibit Hall
6:40 PM                Close of Day

TABLE 1: Reducing CO2 Footprint and Waste for Sustainable Clinical Trials: Challenges and Opportunities

• What are current trial factors contributing to CO2 footprint and waste?
• Strategies and areas of opportunity to optimize our trials?
• Engaging our site partners

Co-Moderators:
Kiran Kodali, MBA, Global Data Strategy & Governance Lead, R&D, Sanofi
Donna Libretti Cooke, JD, Director, Contracting & Budgeting, Bayer HealthCare

TABLE 2: Implementing a Data-Driven Site Selection Capability with RWD, Modelling and Analytics

• Opportunities and challenges of utilizing different types of data sources (internal, external public and commercial, etc.) for site selection
• Challenges in shifting an organization towards a more data-driven culture when the data is imperfect
• Discussion on how to best leverage internally built tools on outsourced studies

Co-Moderators:
Sarah McClure, Global Data Engagement Lead, Feasibility Management, R&D, Sanofi
Jon Hill, Clinical Operations Associate Director, Digital Strategy, Innovation, Analytics, IQVIA
Zabir Macci, Director, Digital Trial Management Suite, IQVIA Clinical Technologies

TABLE 3: Building Diversity, Equity, and Inclusion (DE&I) into Trial Design and Ops

• Gaining sponsorship from senior management and legal to integrate health literacy and cultural sensitivity into clinical trials
• Move from concept to action: Identify pilots and coordinate across internal groups to operationalize diversity and inclusion into your clinical trials
• Include the perspectives of patients across a range of health literacy levels and from different cultural backgrounds and train investigators in teach back and cultural sensitivity

Co-Moderators:
Jen Horonjeff, PhD, Founder & CEO, Savvy Cooperative
Michelle Shogren, Senior Director Innovation, Pharma R&D Clinical Operations, Bayer HealthCare

TABLE 4: #NOGOINGBACK: Novel, Hybrid and Decentralized Trials; Study Start-Up and Beyond

• Pandemic-proof trials: case studies and lessons learned
• Optimizing site, patient, CRO, and sponsor interactions to improve study start-up and performance: Innovative approaches to ensure compliance and improve quality in multi-center, hybrid and DCTs
• Driving innovation in study start-up: Optimizing processes, training leaders, and leveraging technology
• Operationalizing Hybrid Trials; Creating the infrastructure: clinical supply, biomarker, etc
• Regulatory support for decentralized and hybrid trials
• How do we ensure sustainable innovation?

Co-Moderators:
Kimberly Richardson, Research Advocate, Founder, Black Cancer Collaborative
Ivor Clarke, CEO, SubjectWell
Gerald Finken, Founder & CEO, RxE2
Nagaraja Srivatsan, SVP & Chief Digital Officer, Clinical Technologies IQVIA
Valerie Reynaert, Executive Director & Head, Global Clinical Operations, CSL Behring
Anthony Davidson, Associate Consultant, Design Hub Medical Writing, Eli Lilly & Company
Melissa Easy, Vice President - R&D Technology Solutions, IQVIA
Laura Galuchie, Senior Director, TransCelerate Program Lead, Oversight Committee, Merck

TABLE 5: Engaging and Understanding Patient Behavior and Behavioral Economics to Improve Accessibility, Retention and Outcomes

• Prioritizing the patient perspective through social/behavioral sciences
• Patient-Centricity in Real-World Research: incorporate and contextualize the patient perspective (linkage across data types, social, behavioral, and spatial contexts of RWD) coupled with behavioral science
• The “behavioral economics” of patient engagement in clinical trials: understanding patient need and behavior to make informed decisions in enrollment planning

Co-Moderators:
Ratan Ratnesh, Senior Director, Outsourcing & Vendor Management, Taiho Oncology Inc.

TABLE 6: Outsourcing Models in the COVID Era and Beyond: FSP vs. Hybrid vs. Strategic Partnerships

• Strategies for choosing an appropriate outsourcing model for individual trials vs. the entire portfolio in the COVID era and beyond
• 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
• Impact of the pandemic on retaining resources, how those resources operate, and how they will operate moving forward
• Impact of the increase of remote monitoring on resource management and effective oversight

Co-Moderators:
Carrie Lewis, Senior Director, Strategy, Oversight, and Training, Endo Pharmaceuticals
Chris Cain, Vice President, Clinical & Regulatory Affairs, DeVoro Medical
Thorsten Ruppert, PhD, Senior Manager, R&D & Innovation, Verband Forschender Arzneimittelhersteller eV
Rene Stephens, Independent Consultant
Christine Burhoe, Associate Director, Global Clinical Operations, KPS Life
Leslie Williams, Associate Director, Vendor Strategy & Relationships, Clinical Development Operations, Abbvie
David Rudnick, CRA Manager, Global Drug Development, Novartis
Scott Sawicki, MA, Senior Director, Strategic Sourcing & Vendor Management, ADC Therapeutics

TABLE 7: Data Management for the “New Normal”

• Data and analytics for “Light Speed” studies
• Frictionless data flow
• Risk-Based Clinical Data Review
• AI applications in clinical data management
• RWD-enhanced trials
• RWE to link healthcare and clinical trial research

Co-Moderators:
Michelle Crouthamel, PhD, Head, Digital Sciences, AbbVie, Inc.
Marcin Makowski, PhD, Head, Centralized Monitoring & Data Analytics, GlaxoSmithKline
Norbert Clemens, Director, Clinical Trial Management EMEA, HOYA Surgical Optics
Amy Neubauer, Director, Data Quality Oversight, Alkermes

TABLE 8: Validating Digital Biomarkers and Endpoints

• Fit-for-purpose validation of digital biomarkers
• Technology validation and selection of candidate endpoints
• Pilot validation studies for clinical endpoints

Co-Moderators:
Ariel Dowling, PhD, Director of Digital Strategy, Data Sciences Institute, Research and Development, Takeda Pharmaceuticals

TABLE 9: The Evolution of Medical Device Clinical Trial Design and Operations

• Planning for remote Trial Participant visits, tests/procedures and data collection
• Pros and cons of remote monitoring, onsite monitoring or hybrid approaches
• Diversity and patient-centric study design in device trials

Co-Moderators:
Glenda Guest, Vice President, NCRA; President, Assured of Quality Consulting & Training
Kelly Van Schouwen, CEO and Director of Research, Research Source

TABLE 10: Adopting Supply Chain Predictive Analytics to Shift from Reactive to Proactive Decision-Making

• How you consider to be Reactive X Predictive? What are the stages to safely jump into Predictive Analytics?
• Which tool are the most recommended tools to support the PA function?
• What do we need to change in order to have it implemented? Mindset? Process?

Co-Moderators:
Luiz Barberini, Head, External Manufacturing Operations, Bayer SA
Bryan O'Neill, Senior Director, Clinical Supply Operations, Daiichi Sankyo, Inc.