2023年対話型ブレイクアウトディスカッション

同時進行のブレイクアウトディスカッションは、ファシリテーターまたは共同ファシリテーターが司会を務める対話型のディスカッションで、当日のセッションで提示された重要な問題について話し合います。参加者は、関心のあるテーブルに就き、積極的に議論に参加します。製薬企業、バイオテクノロジー企業、CRO、治験実施施設、病院、患者など、それぞれの立場から、ディスカッションにご参加ください。この対話型セッションと形式を最大限に活用するために、仕事の実例を共有し、仲間とアイデアを出し合う、グループでの質疑応答に参加に向けてご準備ください。

2月7日（火）

グループ別ブレイクアウトディスカッション

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

「SCOPE 2023」グループ別ブレイクアウトディスカッションのトピック

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

• 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?

Decentralized and Hybrid Trials: The New Ecosystem
Moderators:
Tina Caruana, Subject Matter Expert, eClinical Solutions, Digital & Decentralized Trials, Medrio
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

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

DCTs: Expanding the Zip Code Coverage and Advancing DE&I 
Moderators:
Michael Cohen, Clinical Trial Innovation, CVS Health
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 RxE2
Darious T. Davis, Business Development, DataCubed

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

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

• 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

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

• 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

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

• 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

Budgeting for and Contracting with New Technology Companies: Strategies and Challenges
Moderators:
Wanda Shoer, Head, Strategic Business Operations, Global Development, Johnson & Johnson
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

• 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
  

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

• 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

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

• 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

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

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

NextGen Data Management for NextGen Trials: Including AI
Moderators:
Gregory Goldmacher, MD, PhD, MBA, Head of Clinical Imaging, Merck & Co.
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.

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

Validating Digital Biomarkers and Endpoints
Moderators:
Ju Ji, PhD, Senior Research Scientist, Eli Lilly & Co.
Gregory Goldmacher, MD, PhD, MBA, Head of Clinical Imaging, Merck & Co. 

• 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

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

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

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
Prod/Non-Vendor Speaker
Sales/Vendor Speaker
Sales/Vendor Speaker
Sales/Vendor Speaker

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

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
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

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.

• 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? 

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

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
Greg Folz, CCRP, Founder, Kits4Life
Josh Kravitz, Kits4Life Program Coordinator, MedSurplus Alliance

• 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