Interactive Roundtable Breakout Discussions
Tuesday, November 10, 2020 at 3:45 pm, followed by the Afternoon Plenary Keynote
3:45 pm Find Your Table and Meet Your Moderator
3:50 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 - View Details
4:25 Afternoon Plenary Keynote
TABLE: Strategies for Patient-Centric Trial Design and Digital Patient Engagement
Helen Kellar-Wood, PhD, Associate Director, Oncology and Immunoscience Lead, Diversity & Patient Engagement, Bristol-Myers Squibb
Kristin Cummings, Director, Implementation-Clinical Operations, Spencer Health Solutions, Inc.
Mike Wenger, Vice President, Patient Engagement, TrialScope
- 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 re-align our processes and our research organizations around the patient-centric model?
TABLE: Building and Implementing an IT Ecosystem for Master Trials
Len Rosenberg, PhD, RPh, Head, Clinical Operations, Beat AML/LLS
Moderator to be Announced, Complion, Inc.
- What would happen if pharma routinely participated in Master Trials managed by non-profits as an alternative to traditional clinical trials?
- Should it be a core element of their pipeline strategies? A centralized resource to quickly and efficiently examine drug candidates.
- Could we save time, money, and other resources if our go/no-go decisions were made in months instead of years through collaborative efforts?
TABLE: FSP vs. Hybrid vs. Strategic Partnership Outsourcing – Choosing an Appropriate Model
Cameron McClure, PMP, PMI-ACP, CSM, CCRP, Senior Manager, Clinical Business Operations, BeiGene
Bella Sessoms, MPH, Director, Portfolio Sourcing Management, Portfolio Sourcing and Relationship Management, Astellas Pharma Global Development
Chuck Bradley, Vice President, Clinical Development, FibroGen, Inc.
Debora Araujo, Founder & CEO, ClinBiz
Karen McCarthy Schau, Director, Global Clinical Operations, Vertex Pharmaceutical
- 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: Identifying the Right Patient Advocacy Organizations to Advance Your Study
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
Michael Keens, COO, Firma Clinical
Hollie Schmidt, Vice President, Scientific Operations, Accelerated Cure Project for MS
- What ware 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?
TABLE: Vendor Performance Metrics and KPIs
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?
TABLE: What Are the Pros and Cons of Using eSource and eConsent for Clinical Trials?
Amy Klawitter, Senior Manager, Clinical Management, Otsuka Pharmaceutical Development & Commercialization, Inc.
Lucien Agnant, Associate Program Manager, Otsuka Pharmaceutical Development & Commercialization, Inc.
- 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?
TABLE: New Approaches to Improving Site Selection
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
Hayden, Senior Director, Global Clinical Services, Clinical Operations, Alkermes
- 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
TABLE: Best Practices in Protocol Design to Reduce Protocol Amendments and Improve Trials
Jane Myles, Founder and Director, JemTech; Former Head, Operational Intelligence and Innovation, Roche
Sandra Smyth, Head, Global Feasibility & Site Intelligence, AstraZeneca
- Leveraging RWD/EHR data for I/E criteria assessment and protocol optimization
- Incorporating patient voice to inform design and conduct
- KPIs used to measure reduction in avoidable amendments and improved study execution
TABLE: Digital Technologies in Clinical Trials: How to Choose, Implement and Work with Vendors
Moderators:Robert G. Wilson III, Consultant, Wilson Digital Health Consulting
Kelly Willenberg, DBA, BSN, Consultant, Kelly Willenberg, LLC
Moderator to be Announced, Agatha
- Scaling technology partners for digital clinical trials
- Coming up with strategy and developing common language
- Medical vs. commercial grade devices
- Dos and don’ts of technology partnerships
TABLE: Implementation of Clinical Development Risk Management
Linda Sullivan, Co-Founder & President, Metrics Champion Consortium LLC
Jonathan Rowe, PhD, Associate Principal, ZS Associates
Morten Thorup Pedersen, M.Sc. (Pharm), GDBA, Principal Risk Based Monitoring Specialist, Centralised Monitoring Unit, Novo Nordisk A/S
- Is RBM delivering?
- What is the role of proactively establishing QTLs
- Any good predictive models?