2019 Interactive Breakout Discussions

Tuesday, February 19

Regency R

BREAKOUT DISCUSSION GROUPS

4:10 Find Your Table and Meet Your Moderator

4:15 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.

5:00 Welcome Reception in the Exhibit Hall

6:30 Close of Day

TABLE 1: What Is Holding Back the Adoption of eConsent?

Moderators:
Thorsten Ruppert, MD, Senior Manager, Research, Development and Innovation, Association of Research-Based Pharmaceutical Companies (vfa)

Alexa Richie, DHSc, Research Operations Manager, Research Administration, Mayo Clinic

Jeff Lee, President, eCOA & Patient Engagement, Bracket

Jill Collins, Executive Director, Global Operations Management, Syneos Health

Is eConsent for every trial? Discuss when eConsent is or isn’t appropriate
Understand IRB and regulatory feedback on the eConsent process
Discuss how eConsent technology integrates with other systems
Review a typical implementation timeline and how it impacts all stakeholders

TABLE 2: Strategies for Aligning and Accelerating Recruitment in Complex Clinical Trials in a Resource Constrained Environment
Moderators:
Kelly McKee , Head, Patient Recruitment, Vertex
Lynne Becker, Senior Data Analyst, Enterprise Intelligence & Data Solutions (EIDS), Program Management Office (PMO), Deputy Asst Director Information Operations, Defense Health Agency (DHA)
Kevin Hudziak, Consultant, Innovation Lead, Patient Experience and Design Innovation, Eli Lilly & Co.

Dealing with the Acute Patient where timing is critical
Do traditional/past tactics still work in current environment? What tactics (new and old) work best today?
Ensuring success for procedure driven protocols (Non-conventional administration, device and/or diagnostic intense)
Utilization of supportive field resources to accelerate recruitment (Medical Science Liaisons & Clinical Trial Educators)

TABLE 3: Strategies for Patient-Centric Trial Design and Digital Patient Engagement

Moderators:

Carolyn Brehm, Associate Director, BMS Study Connect Business Lead, Bristol-Myers Squibb

Antonieta Sosa, Director, Clinical Innovation, Janssen

David Fuehrer, CEO, GRYT Health

Thérèse Johnsen, Associate Director, Patient Engagement Management, Novartis

Christie Fry, Therapeutic Area Lead Oncology, Patient & Investigator Relations, AbbVie

T. Hephner, Vice President, Patient Engagement, CRF Bracket

Jason LaRoche, Clinical Innovation Leader, Janssen Research & Development

Anthony Costello, Vice President, mHealth, Medidata

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 4: Shiny New Objects: Can Traditional Recruitment Mediums Merge With Technology Driven Solutions for Better Engagement?

Moderators:

David Sall, President & CEO, Patient Enrollment Advisors

Angela Radcliffe, R&D Practice Lead, Life Science, Capgemini Invent

What is at the intersection of conversational ai/chatbots and “old school” techniques such as call centers in last mile recruitment strategies?
What can traditional media (TV, Print and Radio) teach digital about storytelling?
Who is succeeding in marrying technology solutions to identify patients with traditional outreach tactics?

TABLE 5: Embracing Best Practices in Protocol Design to Reduce Protocol Amendments and Improve Trials

Moderators:

Kimberly Cristall, Senior Director, Feasibility Group Lead, Study Optimization, Clinical Development & Operations, Pfizer

Chuck Bradley, Vice President, Clinical Development, FibroGen, Inc.

Michelle Everill, Senior Director, Head of Global Feasibility, Janssen

Michael Fites, Senior Feasibility Strategist, Global Clinical Trial Services, Bayer

What are the updated metrics on the prevalence and causes of protocol amendments and what does this mean for us?
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 6: How to Start from Scratch to Get Patient Input into Clinical Trial Design

Moderators:

Beth Zaharoff, Senior Director, Patient Focused Engagement and Partnerships, TESARO

Stephen Yates, Clinical Program Director, UCB

Michele Teufel, Patient Engagement Lead, Clinical Operations, AstraZeneca

Speaking to objections from senior leadership
Discuss how to partner with advocacy organizations in order to obtain patient input
How to work within timelines to get input from patients

TABLE 7: Optimizing Country and Site Selection: Strategies for Positioning Trials for Success Using a Global Footprint

Moderators:

Matt Cooper, PhD, Director, Business Development & Marketing, Research Delivery, National Institute for Health Research (NIHR) Clinical Research Network Coordinating Centre

Christine Crandall, Head of Strategic Clinical Planning, Study Start Up, R&D Projects Clinical Platforms & Sciences, GSK

Sandra Smyth, Director, Central Feasibility and Recruitment Group, AstraZeneca

Tara Warren, Strategic Feasibility Manager, UCB Biosciences, Inc.

Jameson Luks, Software Account Manager, Business Development, Cytel

Optimizing the site feasibility process: Improving global site feasibility assessment to identify sites that will recruit on time and within budget
Objective country feasibility and selection: Where are the patients?
Data-driven site selection: Understand the number of sites, their probability of success, and the impact of site non-performance

TABLE 8: Barriers and Opportunities in Site Adoption of Clinical Trial Technology

Moderators:

Jim Kremidas, Executive Director, Association of Clinical Research Professionals (ACRP)

Laura Galuchie, Director, Global Clinical Trial Operations, Merck & Co., Inc. & TransCelerate Program Lead

Jason Methia, Vice President, Site Strategy, Veeva Systems

What site facing technology is critical to improving clinical trials?
What is holding sites back from adopting this technology?
What can be done to minimize the burden of technology for sites?
What opportunities exist to streamline and integrate technology in clinical trials?

TABLE 9: Identifying and Alleviating Burdens Inherent in Clinical Trials (for Patients, Sites, Caregivers, Investigators and Trial Managers)

Moderators:

John Makowski, Head, Clinical Operations, Audentes Therapeutics

Alyssa Lanzi, MS, University of South Florida, Ambassador & Researcher, Patient-Centered Outcomes Research Institute (PCORI)

Trent Farmer, Contract Manager, Attorney, CSL Behring

Identifying study requirements that may be burdensome
Transportation to and from study visits – how can sponsors help
Helping research sites to alleviate their internal burdens

TABLE 10: Partnering with Qualified Investigators and Study Teams for Improved Site Performance, Efficiency, and Execution of Clinical Trials

Moderators:

Kathy Goldstein, PharmD, Senior Director, Head, Quality Management Lead, Regeneron Pharmaceuticals

Joseph Kim, MBA, Senior Advisor, Patient Experience and Design Innovation, Eli Lilly

Jennifer Byrne, Founder and President, Greater Gift, former CEO, PMG Site Network

Dan Milam, Vice President, Global Engagement, SCRS

Idendentify inefficiencies in current approaches to investigator training and lean how these impact the conduct and timelines of clinical trials
Discuss strategies for developing a culture of collaboration between sponsors/CROs and site teams in preparing investigators and their delegates for the quality conduct of clinical trials
Describe approaches to combining “qualification” and “preparation” activities for site teams.

TABLE 11: Improving Both Time and Quality in Site Activation and Study Start-Up

Moderators:

Kelly Loughner, Senior Associate Director, Site Enablement, Boehringer Ingelheim

Lorena Gomez, Director, Global Study Start Up & Essential Documents, Global Site Management Operations, Allergan
Mano Das, IT Business Partner, Clinical Patient and Site Operations, Bristol-Myers Squibb

Julie VanOrsdel Daves, MSHS, Director, Clinical Contracts & Outsourcing, miRagen Therapeutics, Inc.

Identifying and consolidating site start up activities that are redundant, inefficient and needlessly complex
What are key learnings and opportunities for different approaches, including a centralized approach of study activation and site performance?
How can sponsors, CROs and site streamline site activation and study start-up?

TABLE 12: Wearable Devices in Clinical Trials

Moderators:

Pravin Jadhav, PhD, Senior Director, Innovation and Business Transformation, Corporate Projects, Otsuka Pharmaceutical Dev & Commercialization Inc.

Emmanuel Fombu, MD, MBA, Global Commercial Strategy and Digital Innovation, Johnson & Johnson

What is the value, beyond scientific interest?
Where do we want to be in 5 years (and why we are not there already!)?
Key challenges for industry uptake?
Opportunities for industry-wide collaborations

TABLE 13: Digital Data Transfer and Virtual Trials

Moderators:

Mary Hall Gregg, PhD, Vice President, Business Technology, Research & Development, Pfizer

Rob DiCicco, Deputy Chief Health Officer, IBM Watson Health

The Digital Health eco-system and its impact on clinical trials
EHR2EDC: how to implement and advance
Mastering collaborations between pharma companies and academic medical centers

TABLE 14: Artificial Intelligence and Machine Learning: Extreme Case of Data Analytics?

Moderators:

Balazs Flink, MD, Head, Clinical Trial Analytics, Bristol-Myers Squibb

Francis Kendall, Director, Biostatistics & Programming, Cytel, Inc.

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?

TABLE 15: Technologies to Enable Patient-Centered Trials

Moderators:

Munther Baara, Ms, Head, New Clinical Paradigm, Pfizer
Aman Thukral, Assistant Director, DSS, AbbVie

Laurie Myers, Global Health Literacy Director, Merck (MSD)

Rob Nichols, Vice President, Customer Experience, uMotif

Innovative digital technologies
Technologies to capture patient experience
Framework for converging patient-facing technologies
Health literacy considerations in digital transformation

TABLE 16: Clinical Analytics Strategy

Moderators:

Nareen Katta, Director, Operations Analytics, Data Sciences, Data and Statistical Sciences, AbbVie
Faye O’Brien, Director, Metrics and Performance, GMD, AstraZeneca

Kenneth Massey, Chief Life Sciences Officer, Saama

Angelique Hopkins, Director, Clinical Trial Analytics, Business Insights and Analytics, Bristol-Myers Squibb Company

Implementing analytics on top of existing operating model
Study Start Up Methodology to Adopt a Clinical Analytics Strategy
Data analytics in outsourced trials

TABLE 17: RBM in a Finance and Resource Limited Environment

Moderators:

Sarah Bednarski, Associate Director, Strategic Monitoring, Sunovion

Sheri Kuss, Director, Clinical Quality Management, Pfizer

How are you assessing risk and developing an appropriate quality and risk plan?
In terms of technology, what are nice to haves vs. need to haves for implementing RBM?
Who are the stakeholders involved in putting RBM in action at smaller companies?

TABLE 18: RBM and Critical Reasoning Skills

Moderators:

Nechama Katan, Associate Director, Data Monitoring and Management, Clinical Sciences and Operations, Global Product Development, Pfizer

Mary Arnould, Director, Clinical Science Operations and RBM Lead, Astellas

How are central monitoring activities different than traditional monitoring?
How do you train people to do critical problem solving around data?
How do you uncover root causes of data issues instead of just fixing data afterwards?

TABLE 19: Vendor Performance Metrics and KPIs

Moderators:

Rosalie Filling, Vice President, Clinical Operations, Endo Pharmaceuticals

Ann Hegarty, Executive Director, GSMO, Head PLs, CRO Oversight & Ph I Site Management, Allergan

Linda Sullivan, Co-Founder & President, Metrics Champion Consortium LLC

David Nickerson, Head, Clinical Quality Management, Global Clinical Operations, EMD Serono

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

TABLE 20: Building a Clinical Quality Management System (CQMS) from the Ground Up

Moderators:

Jonathan Rowe, PhD, Executive Director, Head of Clinical Development, Quality Performance and Risk Management, Pfizer

Brian Nugent, Senior Director, Clinical Compliance, GRAIL, Inc.

Angie Maurer, MBA, Clinical Quality & Risk Management Consultant, GRAIL, Inc.

Amy Neubauer, Associate Director, Data Management, Alkermes, Inc.

What are the minimum requirements for a CQMS?
What do you need to build a CQMS?
How to build a CQMS with limited resources and budget
Learn from each other’s current experiences with building a CQMS

TABLE 21: Coordinating Contracting and Payments to Enhance Efficiencies

Moderators:

David Posselt, Director, Global Contract Management - Drug Development Operations, Allergan

Ly Kawaguchi, Senior Director, DBO-Outsourcing, Site Budgets, and Business Analytics, MyoKardia, Inc.

Richard O’Hara, Associate Director, Clinical Outsourcing, Endo Pharmaceuticals

Understand how contracting and Investigator payments are connected
Review standard terms to use on both ends of the contracting process
Discuss how to improve and implement a plan to streamline operations

TABLE 22: Budgeting and Contracting for Remote and Digital Trials

Moderators:

Jamie Cash, Section Manager, Clinical Planning & Resource Management, Abbott Nutrition

Debora Araujo, Founder & CEO, ClinBiz

Understand budgeting needs for remote and digital trials and how they are different from traditional site-driven trials
Review differences in contracting: needs, models, and language
Discuss how to improve and implement a plan to streamline budgets and negotiations

TABLE 23: Balancing Budgets and Performance in Resource Management and Capacity Planning

Moderators:

Piet Theisohn, Director, Resource Management, R&D - Portfolio & Operations, Bayer Pharma

Chris Chan, Executive Director, R&D Finance, Fibrogen

What are key factors that should be considered when developing a resource plan?
What situations warrant a bigger focus on cost savings, and which on using other resources?
How do training and retention programs fit into capacity planning and overall resource management?

TABLE 24: Developing Resource Management Tools for Complex Trials and Diverse Portfolios

Moderators:

Gisele Paule, Contract Coordinator, Clinical Planning & Resource Management, Abbott Nutrition

Vladimir Shnaydman, PhD, President, ORBee Consulting

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

TABLE 25: Addressing Current and Future Workforce Challenges

Moderators:

Beth Harper, Workforce Innovation Officer, Association of Clinical Research Professionals (ACRP)

What competencies are most lacking in the workforce today?
How are you addressing these challenges?
What more can and should the industry be doing to create a more skilled and sustainable workforce?

TABLE 26: Clinical Supply in Virtual Trials

Moderators:

How does clinical supply fit in with the industry trend towards virtual/site-less trials?
What does clinical ops need to know about direct-to-patient distribution before embarking on a virtual trial?
What are the logistical, cost and regulatory considerations of direct-to-patient distribution?

TABLE 27: Biospecimen, Central Lab and Technology

Moderators:

Brenda Yanak, Former Global Head, Specimen Strategy and Innovation, Q2 Solutions, a Quintiles Quest Joint Venture

Caoimhe Vallely-Gilroy, Director, Global Head, Clinical Trials Biosample Management, Global Clinical Operations, Merck KGaA

Karina Bienfait, PhD, Principal Scientist & Head, Global Genomics Policy, Process & Compliance, Merck

Eric Delente, Head, Patient Consent, IQVIA Technologies

Biorepositories: in house vs. outsourcing
Advanced informatics for biospecimen management
Central and reference labs: building the relationship
Informed consent and data sharing

TABLE 28: Integrating Sample Management into Clinical Trial Cycle

Moderators:

Michael Tanen, MBA, Director, Clinical Biomarker Specimen Management, Merck Research Laboratories
Matt Harlin, Associate Director, Clinical Pharmacology, Otsuka Pharmaceutical Companies

Sharin Roth, Director, Clinical Pharmacology, Bioanalysis, Otsuka

Regulatory Compliance
Site Selection Considerations
RBM Considerations

TABLE 29: RWE to Support Regulatory Decisions and the Medicine Lifecycle

Moderators:

Cathy Critchlow, PhD, Vice President, Center for Observational Research, Amgen

William Spalding, MS, Director, Outcomes Research-Epidemiology, Shire

David Vulcano, MBA, Vice President Research Compliance & Development, HCA

Leverage the power of RWD to enable evidence-based trial feasibility assessment and patient recruitment
How can RWD support Clinical Operations and the Medical organization overall?
What opportunities exist to collaborate between Medical and Commercial on RWD assets and insights?
Which functions can help bridge and facilitate the ingestion of RWD for actionable insights?
RWE needs to go beyond analysis and clinical trial is calling new clinical-health service to link healthcare and clinical trial research

TABLE 30: RWD To Accelerate Design and Execution of Clinical Trials

Moderators:

Xia Wang, PhD, Director, Health Informatics & Global Medicines Development, AstraZeneca

Gregory Daniel, PhD, Deputy Center Director, Duke-Margolis Center for Health Policy, Duke University

Tine Lewi, PhD, MBA, Scientific Director, Janssen R&D, Clinical Innovation