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 virtual 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.

SESSION #1 ON DAY 1 | TUESDAY 10 NOVEMBER 2020
AT 16:30 CET (10:30 AM EST, 7:30 AM PST)

BREAKOUT 1: Optimizing Country and Site Selection: Strategies for Positioning Trials for Success Using a Global Footprint

Moderators:
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

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)?

BREAKOUT 2: 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 
Rosamund Round, Vice President, Patient Innovation Center, Medical and Scientific Services, Parexel 

• 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?

BREAKOUT 3: Centralized Monitoring
Moderator:
Mieke Degeyter, Associate Director, PV Supplier Risk Management, Janssen Pharmaceutics
Lukasz Bojarski, Head of Centralized Monitoring, AstraZeneca Pharmaceuticals, Inc.

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

BREAKOUT 4: COVID-19 Impact: What is Temporary and What is Here to Stay
Moderators:
Munther Baara, Vice President, Product Strategy and Innovation, EDETEK, Inc.
Craig Lipset, Independent Adviser, Former Head of Clinical Innovation, Pfizer
Mary Jo Lamberti, PhD, Associate Director and Research Assistant Professor, Tufts Center for the Study of Drug Development (CSDD)

• Decentralized Trials
• Rapid Enrollment
• Technology to the Rescue

BREAKOUT 5: 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

• 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

SESSION #2 ON DAY 1 | TUESDAY 10 NOVEMBER 2020
AT 20:10 CET (2:10 PM EST, 11:10 AM PST)

BREAKOUT 6: 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 
Victor Lobanov, PhD, Vice President, Informatics, Covance

• 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?

BREAKOUT 7: Implementation of Clinical Development Risk Management
Moderators:
Linda Sullivan, Co-Founder & President, Metrics Champion Consortium LLC
Jonathan Rowe, PhD, Associate Principal, ZS Associates
Keith Dorricott, Ambassador, Metrics Champion Consortium
Dagmar Goertz, Director, External Engagement & Business Insights, BioResearch Quality & Compliance, Janssen
Rohit Nambisan, President, Lokavant, Inc.

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

BREAKOUT 8: Identifying the Right Patient Advocacy Organizations to Advance Your Study
Moderators:
Rose Gerber, Director, Patient Advocacy and Education, Community Oncology Alliance (COA); 3x Clinical Trial Participant
Katie Goodman, RN, Director, Clinical Research, Florida Cancer Specialists & Research Institute
Hollie Schmidt, Vice President, Scientific Operations, Accelerated Cure Project for MS

• What are the reasons to partner with patient advocates and advocacy organizations?
• How do you choose the right organizations?
• What are the next steps to onboard their insights and allow them to help advance the research?

BREAKOUT 9: Digital Biomarkers and Endpoints
Moderator:
Robert Wilson III, Consultant, Wilson Digital Health Consulting
Identifying criteria to use digital biomarkers

• Validation studies
• What is the impact of COVID-19 pandemic?

BREAKOUT 10: FSP vs. Hybrid vs. Strategic Partnership Outsourcing – Choosing an Appropriate Model
Moderators:
Chuck Bradley, Vice President, Clinical Development, FibroGen, Inc.
Debora Araujo, Founder & CEO, ClinBiz
Mieke Degeyter, Associate Director, PV Supplier Risk Management, Janssen PharmaceuticsScott Sawicki, MA, Senior Director, Strategic Sourcing & Vendor Management, ADC Therapeutics

• 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

SESSION #3 ON DAY 2 | WEDNESDAY 11 NOVEMBER 2020
AT 15:05 CET (9:05 AM EST, 6:05 AM PST)

Interactive Breakout Discussion Groups #2, then Shared Closing Plenary Keynote & Live Q&A

BREAKOUT 11: What Are the Pros and Cons of Using eSource and eConsent for Clinical Trials?
Moderators:
Amy Klawitter, Senior Manager, Clinical Management, Otsuka Pharmaceutical Development & Commercialization, Inc.
Lucien Agnant, Associate Program Manager, Otsuka Pharmaceutical Development & Commercialization, Inc.
Kyle Hogan, Vice President, Outcome Solutions, Clinical Ink

• What are the potential challenges of using eSource and eConsent?
• What is the value to sites and sponsors of using eSource and eConsent?
• What types of sites would be more interested and successful in using these tools?

BREAKOUT 12: AI in Digital Clinical Trials
Moderators:
Ronald Dorenbos, Principle, BioFrontline
Ijah Mondesire-CrumpIjah Mondesire-Crump, MD, Research Director, nQ Medical Inc

• COVID-19 related challenges and solutions
• Let’s name three most recent novel applications
• AI plus digital: a powerful combination

BREAKOUT 13: Vendor Performance Metrics and KPIs
Moderator:
Andy Lawton, Director & Consultant, Risk Based Approach Ltd.

• How effective are your KPIs for measuring vendor performance and quality?
• What is your strategy for establishing KPIs and metrics?
• What are the key areas that should be evaluated for vendor performance and quality?

BREAKOUT 14: 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

• 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

BREAKOUT 15: New Approaches to Improving Site Selection
Moderators:
Marcy Kravet, BS, MBA, Head, Operational Design Center (ODC), Global Clinical Operations, EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany
Sylvia Marecki, PhD, Design Analyst, Operational Design Center (ODC), Global Clinical Operations, EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany
Joel Selzer, Co-Founder and CEO, ArcheMedX, Inc.

• Data: Novel data types and overcoming challenges to maximally leverage them
• Relationships: Collaborations with internal and external groups, success stories, new opportunities to build valuable relationships
• Wisdom: Challenges with bringing prior learnings to bear on future site selection planning and success stories in overcoming them