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.



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

Sandra Smyth, Senior Director, Global Feasibility and Site Intelligence, Development Operations, AstraZeneca
Marion Wolfs, Head, Senior Director, Risk Management & Central Monitoring, Janssen Pharmaceutical Companies of Johnson & Johnson
Kiran Kodali, MBA, Global Data Strategy & Governance Lead, R&D, Sanofi
Leslie Williams, Associate Director, Vendor Strategy & Relationships, Clinical Development Operations, Abbvie
Donna Libretti Cooke, JD, Director, Contracting & Budgeting, Bayer HealthCare

TABLE 2: Integrating Early Patient and Site Insights in Protocol Development and Feasibility

  • How best to leverage data, technology, patient insights and innovative solutions to optimize study designs and increase operational delivery
  • Actual process and organization change needed to better integrate the patient perspective into protocol design
  • Conducting patient research, feasibility assessments, and other qualitative and quantitative research to understand the motivations and challenges related to your respective indication, protocol design and patient population

Michele Teufel, Patient & Site Engagement Lead, Development Operations, AstraZeneca Pharmaceuticals, Inc.
Jade Dennis, Advisor, Design Hub, Eli Lilly and Company
Adam Halbridge, Principal, Medical Informatics & Digital Health, ICON
Lorena Kuri, Head, Diversity Strategy, Bristol-Myers Squibb Co.

TABLE 3: 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

Olga Bershevits, PhD, Advisor, Design Hub Data Insights, Eli Lilly & Co
Mary Murray, Vice President, Collaborative Action Networks, National Minority Quality Forum
Jennifer Weaver, Director, Study Delivery Shared Services and Analytics, CSL Behring
Megan Heath, Vice President, Region Head, Clinical Studies Unit Europe, Sanofi
Sarah McClure, Global Data Engagement Lead, Feasibility Management, R&D, Sanofi
Jon Hill, Clinical Operations Associate Director, Digital Strategy, Innovation, Analytics, IQVIA

TABLE 4: 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

Kelly McKee, Vice President, Patient Recruitment and Registries, Medidata
Jen Horonjeff, PhD, Founder & CEO, Savvy Cooperative
Julien Kroll, Clinical Trial Technology Strategist, Bayer HealthCare

TABLE 5: Strategies for Patient-Centric Trial Design and Digital Patient Engagement

  • 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? How do you include patients in clinical trial design?
  • 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?

Craig Lipset, Founder & Advisor, Clinical Innovation Partners; Co-Chair, Decentralized Trials & Research Alliance (DTRA)
Antonios Clapsis, Vice President, Clinical Trial Services, CVS Health
Jane Hiatt, Executive Director, Site Management and Monitoring, Early-Stage Development, Merck

TABLE 6: Future State of Trials Due To COVID-19: Planning for and Enabling Smooth Start Up in Multi-Center, Hybrid and Decentralized Trials

  • 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
  • Improving clinical study planning and ops through patient-centric initiatives: How do we meet the patient where they are (planning, process, technology)?
  • Driving innovation in study start-up: Optimizing processes, training leaders, and leveraging technology

Kimberly Richardson, Research Advocate, Founder, Black Cancer Collaborative
Ivor Clarke, CEO, SubjectWell
Patty Donnelly, Vice President, Global Quality - Research and Development
Gerald Finken, Founder & CEO, RxE2

TABLE 7: 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

Ratan Ratnesh, Senior Director, Outsourcing & Vendor Management, Taiho Oncology Inc.
Karen Horgan, CEO & Co-Founder, VAL Health LLC
Meghan McKenzie, Principal Inclusion, Patient Insights and Health Equity, Chief Diversity Office, Genentech

TABLE 8: Budgeting for and Contracting with New Technology Companies: Strategies and Challenges

  • New types of technologies and vendors entering the clinical space, from virtual reality to wellness products
  • Challenges around contracting with non-clinical trial technology companies
  • Strategies for accurate budgeting

Scott Sawicki, MA, Senior Director, Strategic Sourcing & Vendor Management, ADC Therapeutics
Chuck Bradley, Senior Vice President, Global Development Operations, Annexon Biosciences
Devon Kelly, Associate Director Biorepository, Translational Pharmacology, CRISPR Therapeutics

TABLE 9: Re-Examining 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

Carrie Lewis, Senior Director, Strategy, Oversight, and Training, Endo Pharmaceuticals
Chris Cain, Vice President, Clinical & Regulatory Affairs, DeVoro Medical

TABLE 10: Managing Resources and Proper Oversight for Outsourced Decentralized Clinical Trials

  • Impact of the pandemic on retaining resources, how those resources operate, and how they will operate moving forward
  • Developing proper oversight standards for decentralized trials
  • Impact of the increase of remote monitoring on resource management and effective oversight

Michael McLaughlin, Associate Director, Clinical Operations, Dermavant Sciences, Inc.
David Rudnick, CRA Manager, Global Drug Development, Novartis
Thorsten Ruppert, PhD, Senior Manager, R&D & Innovation, Verband Forschender Arzneimittelhersteller eV
Rene Stephens, Independent Consultant
Sandra Freeman, Director, Global Clinical Operations, Janssen Pharmaceuticals

TABLE 11: Developing Tools for Speeding Study Start-Up: Contracting, Budgeting, Capacity Planning

  • Understanding the important factors that need to be incorporated into a tool to make it successful
  • Getting buy-in from stakeholders by demonstrating value, cost savings, and efficiency
  • Strategies for testing and rolling out new tools to scale

Richard O'Hara, Director, Clinical Business Operations, Endo Pharmaceuticals
Peter Payne, Vice President, Head, Digital Research Network, Optum
Christina Villar, Head, Global Clinical Operations, Philips Healthcare
Li Wang, PhD, Senior Director & Head, Statistical Innovation, AbbVie, Inc.

TABLE 12: RWD To Accelerate Design and Execution of Clinical Trials

  • RWD-enhanced trials
  • RWD for artificial control arms
  • RWE to link healthcare and clinical trial research

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 13: Data Management for the “New Normal”

  • Data and analytics for “Light Speed” studies
  • Frictionless data flow 
  • Risk-Based Clinical Data Review
  • The Future of Statistical Analysis and Data Visualization

Patrick Schwab, PhD, Director, Artificial Intelligence and Machine Learning, GSK
Yixin Wang, Executive Director, Innovative Solutions, Precision Medicine, Bristol-Myers Squibb Co.
Michelle Crouthamel, PhD, Head, Digital Sciences, AbbVie, Inc.

TABLE 14: 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

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

TABLE 15: Decentralized and Hybrid Trials: The New Ecosystem

  • Operationalizing Hybrid Trials; Creating the infrastructure: clinical supply, biomarker, etc
  • Regulatory support for decentralized and hybrid trials
  • Pandemic-proof trials: case studies and lessons learned

Jennifer Aquino, VP Digital Patient Suite, IQVIA Clinical Technologies
Valerie Reynaert, Executive Director & Head, Global Clinical Operations, CSL Behring
Natalie Blake, Director, Global Clinical Trials - Project Management Office, Merck

Michelle Shogren, Senior Director Innovation, Pharma R&D Clinical Operations, Bayer HealthCare
Anthony Davidson, Associate Consultant, Design Hub Medical Writing, Eli Lilly & Company

TABLE 16: #NOGOINGBACK: Thriving for Sustainable Innovation

  • What are the "dinosaurs" of clinical research processes that will become extinct? 
  • What are the innovations that have helped us continue to find new therapies? 
  • What are the obstacles to change? How do we ensure sustainable innovation?   

Melissa Easy, VP & Head of Clinical Technologies, IQVIA
Laura Galuchie, Senior Director, TransCelerate Program Lead, Oversight Committee, Merck

TABLE 17: The Car is Ready, But No Fuel in the Tank: Overcoming Data Challenges of RBQM

  • How do you know when you have enough data to start seeing trends?
  • With multiple data streams, does one have priority over another?
  • How do you set thresholds and determine when action is needed when working in a new indication area or with a new data source?

Zabir Macci, Director, Digital Trial Management Suite, IQVIA Clinical Technologies
Michael Tanen, Director, Clinical Biomarker Specimen Management, Merck
Lynn Wetherwax, R&D Strategy and Operations, Amgen
Lynne Krajkovich, Global Head, Biomarker & Imaging Operations, Novartis Global Development Operations

TABLE 18: Technologies and Partnerships to Streamline Sample/Biomarker Management in Clinical Trials

  • COVID altered biomarker and biospecimen operations: should some of the changes stay beyond the pandemic (#nogoingback)? 
  • Advanced informatics for biospecimen management & Central and reference labs: building the relationship
  • Informed consent and data sharing

Karina Bienfait, PhD, Executive Director, Specimen Infrastructure & Informed Consent, Global Biospecimen & Imaging Management, Bristol-Myers Squibb
Brenda Yanak, Vice President, Global Biospecimen & Imaging Management, Bristol-Myers Squibb Co. Mary Zuniga, Consultant, Translational Science Immunology, Eli Lilly & Co.
Kelly Van Schouwen, CEO and Director of Research, Research Source
Justin Heyl, Director, Enterprise Risk Management, Baxter Healthcare Corporation
Andrew Albright, PhD, Program Manager, Molecular Profiling, Merck & Co., Inc.

TABLE 19: 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 

Jennifer Bolton, Senior Fellow, Regulatory Affairs, Boston Scientific Corporation
Glenda Guest, Vice President, NCRA; President, Assured of Quality Consulting & Training
Jane Jacob, PhD, Vice President, Research & Clinical Affairs, Synergy Disc Replacement, Inc. 

TABLE 20: 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?

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