2023 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 7

BREAKOUT DISCUSSION GROUPS

4:15 PM Find Your Table and Meet Your Moderators
4:20 PM Interactive Discussions
5:00 PM Welcome Reception in the Exhibit Hall

Interactive Breakout Discussion Group Topics for SCOPE 2023

TABLE 1: Integrating Early Patient and Site Insights in Protocol Development and Site Selection
Moderators:
Christina Greene, PhD, Director Global Site Agreements, Global Site Agreements, Merck
Daniel Beal, RN, BSN, CCRP, Associate Director, Site Engagement, Dyne Therapeutics
Tina Karunaratne, Vice President & Head, Global Clinical Operations, Orum Therapeutics
Mike Wenger, Founder and CEO, VersaTrial
Jimmy Bechtel, MBA, Vice President, Site Engagement, Society for Clinical Research Sites

Key learnings and opportunities for different approaches to site selection
How can we as an industry improve our process of protocol development?
What are some community initiatives and individual company approaches to finding success?

TABLE 2: Decentralized and Hybrid Trials: The New Ecosystem
Moderators:
Isaac Rodriguez-Chavez, PhD, Senior Vice President, Scientific & Clinical Affairs & Head, Strategy Center for Decentralized Clinical Trials & Digital Medicine, ICON plc
Joanne Dourado, Senior Director, Medicines Quality Organization
Hassan Kadhim, Director & Head, Clinical Trial Business Capabilities, Bristol Myers Squibb Co.
Christie Fry, Director, Strategic Technology Innovation, Clinical Development Solutions, AbbVie
Fan Gao, Principal, ZS
Derk Arts, MD, PhD, Founder & CEO, Castor

Decentralized and hybrid trials as a mainstream approach
Global regulatory updates on DCTs
Stories of recent successes and failures

TABLE 3: DCTs: Expanding the Zip Code Coverage and Advancing DE&I
Moderators:
Michael Cohen, MSc, MBA, Senior Director, Consultancy, Innovation and Strategy (CIS) Digital and Decentralized Solutions, Clinical Research PPD, part of Thermo Fisher Scientific
Kendal Whitlock, Head, Digital Optimization, RWE Clinical Trials, Walgreens Boots Alliance
Conor Kane, Head, Process Data Integration EBIS, Janssen Pharmaceuticals, Inc.Tina Schlecht, Chief Pharmacy Officer at RxE2Darious T. Davis, Business Development, DataCubed
Tara Palermo, Director of Strategic Partnerships, Clinical Leader, Life Science Connect

Location landscape for new generation trials (retail clinics, pharmacies, telemedicine)
Partnership between pharma and new stakeholders: challenges and solutions
Case studies and next steps

TABLE 4: Implementing a Data-Driven Site Selection Capability with RWD, Modelling and Analytics
Moderators:
Bardia Akbari, Vice President, Development Operations, Oncology, Abbvie, Inc.
Adrienne Walstrum, Program Director, Merck & Co
Corey Jones, Senior Manager, Data Visualization and Design, Janssen R&D Data Science, Johnson & Johnson
Valerie Reynaert, Head of Global Clinical Operations, CSL Behring
Joshua Ransom, Head, Experience and Product, BEKHealth & Associate Director GBEMTI, NAMCP

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

TABLE 5: Operationalizing DE&I in Patient Recruitment, Engagement & Retention
Moderators:
Hala Borno, MD, CEO, Founder, Trial Library
Melanie Goodwin, Director, Patient Recruitment Programs, Clinical Development & Operations,
Global Product Development, Pfizer
Cory Potts, Senior Manager, Site Engagement, Diversity Lead, Bayer
Alicia Staley, VP, Patient Engagement, Medidata, A Dassault Systemes Company

Strategies to improve community engagement and collaboration
Overcoming barriers to participation for underserved populations
Tools and technologies drive DE&I: Identifying sites and patients, improving patient centricity, enabling DCTs

TABLE 6: Strategies for Patient-Centric Trial Design and Patient Engagement
Moderators:
Deborah Howe, Director, Global Patient Recruitment and Engagement, Alexion, AZ Rare Disease
Amy Froment, Head, Global Trial Optimization, Regeneron
Melanie Anderson, Principal Scientist, Translational Medicine, Merck
Joan Chambers, Senior Director, Marketing, Communication & Education, Center for Information & Study on Clinical Research Participation (CISCRP)

Incorporating patient voice into trial design
Leveraging data and technology to improve patient centricity and engagement
Developing internal capabilities to drive patient centricity and patient engagement

TABLE 7: Budgeting for and Contracting with New Technology Companies: Strategies and Challenges
Moderators:
Elizabeth Myers, Senior Clinical Research Planner, Abbott Nutrition
Sonali Bhatnagar, Associate Director, Clinical Innovation & Digital Health, R&D Sourcing & Procurement, Merck
Carrie Lewis, Executive Director, Clinical Program Optimization, Endo Pharmaceuticals
Jeff Kozloff, Executive Chairman, VersaTrial
Jamie Orlando, Vice President Market Development, Clinical Leader, Life Science Connect

Considerations for evaluating new technology providers
Contracting strategies, including cross-departmental conversations and considerations
How to set and evolve a budget when working with a new technology

TABLE 8: Establishing Metrics and Optimizing Governance for CROs and Third-Party Providers
Moderators:
Scott Sawicki, Senior Director, Strategic Sourcing & Vendor Management, ADC Therapeutics
Rosalie Filling, Vice President, Clinical Operations, Endo Pharmaceuticals
Chuck Bradley, Senior Vice President, Global Development Operations, Annexon Biosciences
Randy Krauss, Executive Director, Metrics, Analytics, & Performance, Merck
Richard Scaife, Vice President, Strategic Outsourcing & Vendor Management, VectivBio AG, PCMG Committee Member
Piet Theisohn, Vice President, Resource Management, Clinical Development & Operations, R&D Clinical Operations, Bayer AG – Pharma

Effective KPIs for measuring vendor performance and quality
Strategies for establishing KPIs and metrics
Key areas that should be evaluated for vendor performance and quality

TABLE 9: Developing Tools for Speeding Study Start-Up: Contracting, Budgeting, Capacity Planning
Moderators:
Karen Lodigiani, Senior Director, Head, Site Contracts & Budget Management, Daiichi Sankyo
Erin O'Boyle, Vice President, Clinical Operations, Rezolute, Inc.
Katie Thrush, Section Manager, Clinical Operations & Clinical Planning, Abbott Laboratories
Richard O'Hara, Director, Clinical Business Operations, Endo Pharmaceuticals
Lindsey Synder, Director of Strategic Partnerships, Clinical Leader

Understand the important factors that need to be tracked to successfully forecast needs and how to integrate them into a tool
Getting buy-in from key stakeholders by demonstrating value, cost savings, and efficiency
Change management and how to roll out a new tool or process

TABLE 10: RWD To Accelerate Design and Execution of Clinical Trials
Moderators:
Ankit Lodha, Director, Data Science Portfolio Management, Johnson & Johnson
Aaron Kamauu, MD, Managing Director, Ikaika Health LLC
Lauren Sutton, Senior Director, Product Management, Clinical Research, Flatiron Health
Xia Wang, PhD, Head of RWE Early Solution, Global Real World Evidence and Digital Sciences, UCB
Akiko Shimamura, VP, Medidata LInk Solutions, Medidata, a Dassault Systèmes companyGlynis Daniel-Archibald, MD, MBA, PMP, DPsych, Executive Director, Peri- & Post-Approval Services, UBC

Recent FDA and EMA guidelines and their impact on RWE community
Integrating observational and randomized trials data
Pragmatic trials: are we there yet?

TABLE 11: NextGen Data Management for NextGen Trials: Including AI
Moderators:
Victoria Gamerman, PhD, Global Head of Data Governance, Boehringer Ingelheim Pharmaceuticals, Inc.
Len Rosenberg, PhD, RPh, Head, Clinical Operations, Beat AML/LLS
Ward Lemaire, Lead, Integrated Data Analytics & Reporting Oncology, Janssen Pharmaceuticals, Inc.
Stacy Carbaugh, Director of Strategic Partnerships, Clinical Leader, Life Science Connect
Wendy Morahan, Senior Director, Clinical Data Analytics, IQVIA Technologies

Next generation E-clinical technologies
Clinical data management for DCts and digital trials
AI and ML approaches to transform clinical operations

TABLE 12: Validating Digital Biomarkers and Endpoints
Moderators:
Ju Ji, PhD, Senior Research Scientist, Eli Lilly & Co.
Michelle Crouthamel, PhD, Head Digital Science, AbbVie, Inc.
Rinol Alaj, Director, Head of COA and Patient Innovation, Regeneron

Digital biomarkers, digital measurements and digital endpoints: terminology check
Examples of digital endpoints used in registration studies
Data integration for digital devices
Digital measurements in decentralized trials

TABLE 13: Risk-based Approaches to Monitoring Hybrid/Decentralized Trials
Moderators:
Laura Galuchie, Senior Director, TransCelerate Program Lead, Oversight Committee, Merck
Marion Wolfs, Head, Senior Director, Risk Management & Central Monitoring, Janssen Pharmaceutical Companies of Johnson & Johnson
Marcin Makowski, PhD, Head, Centralized Monitoring & Data Analytics, GlaxoSmithKline
Olgica Klindworth, Senior Director, R&D, RBQM, Medidata, a Dassault Systèmes company
Esther Huffman O’Keefe, Director Adaptive Monitoring Excellence, Takeda
Gayle Hamilton Director of RBQM, IQVIA Technologies

Considerations for maintaining quality and oversight
Implementing risk-based approaches into new trial designs
Regulatory guidelines and considerations

TABLE 14: Strategies for Working successfully with Central Labs and other Vendors Partners
Moderators:
Michael Tanen, Director, Head of Laboratory Operations and Logistics, Merck
Brenda Yanak, Founder, Clinical Transformation Partners
Rose Redfield, Head of Biospecimen Operations, Daiichi-Sankyo

Operational models, processes and technology
Building relationships and aligning expectations with vendors
Considerations for novel therapeutics and rapidly evolving trial designs

TABLE 15: Medical Device Clinical Trial Design, Operations and Data Strategy
Moderators:
Glenda Guest, President, Assured of Quality Consulting & Training
Anne Swearingen, Head, Medical Operations & Effectiveness, ConvaTec
Ardy Arianpour,CEO & Co-Founder, SEQSTER
Christina Villar, Head Global Clinical Operations, Global Clinical Operations, Philips Healthcare

Clinical data strategy
Diversity and patient-centric study design in device trials
Recent trends, digital tools, and impacts on study design and implementation

TABLE 16: Adopting Supply Chain Predictive Analytics to Shift from Reactive to Proactive Decision-Making
Moderators:
Brian Dunton, Head, Client Services, Atreo.io
Maria Napoliello Humagain, Director, Clinical Supply Technologies, Arcus Biosciences
Alminaz Noorani, Senior Manager Clinical Systems, Global Development Operations, Ultragenyx Pharmaceutical, Inc.
Chris Driver, Director RBQM, Iqvia Technologies

What’s next in IRT system development?
What are the stages to safely jump into predictive analytics?
What do we need to support change in order to have it implemented? mindset? Process?
What tools do you use to support decision making?

TABLE 17: Aligning Training Plans with Organizational Goals and Requirements
Moderators:
Amanda Gutierrez, LMHC-QS, PMP, Director of Learning & Development, Learning and
Development, Quality, Biorasi
Shawn Milheim, EdD, Director Learning & Development, Research & Development,
Organon & Co.
Dara Moore, CPLP/CPTD, MEd, Associate Director, Training and Knowledge Management, Clinical Development and Operations Quality, AstraZeneca, Alexion Rare Disease Unit

Strategies for training and development goals alignment
Aligning compliance training and tracking systems
Team and personnel development

TABLE 18: It’s a Small, Small World: Environmental, Social, and Corporate Governance (ESG) and Sustainability in Clinical Research
Moderators:
Jason LaRoche, Director and Focus Area Leader, Janssen Clinical Innovation
Donna Libretti Cooke, JD, Director, Contracting & Budgeting & Sustainability Champion, Bayer

Explore the climate footprint of clinical research, including areas with potential to have the biggest impact on both emission and cost reduction
Discuss ideas on reducing the climate footprint and how this can co-inform trial design
Share ideas on how pharma and biotech companies, CROs, and service providers can work together towards sustainable clinical research