2020 Interactive Breakout Discussions

We are currently building the agendas for SCOPE 2020 and the early topics and co-moderators for the breakout discussion groups are listed below. This is a preliminary list that will be updated soon. New breakout discussion topic suggestions are welcome.

Wednesday, February 19

BREAKOUT DISCUSSION GROUPS

4:20 Find Your Table and Meet Your Moderator

4:25 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.

5:10 Welcome Reception in the Exhibit Hall

6:45 Close of Day


Patient Experience and Patient-Centric Trial Design

TABLE: How Can We Improve the Patient Experience in Clinical Trials?

Moderators:
Kelly McKee, Head, Patient Recruitment, Vertex Pharmaceuticals Incorporated
Jane Myles, Former Head, Operational Intelligence and Innovation, Roche
Bernadette Tosti, Quest Diagnostics

  • How can we learn from other industries?
  • Advocating for both high tech and high touch solutions
  • The role of storytelling and patient communities

TABLE: Including Patients in Clinical Trial Design

Moderators:
Christina Román, Senior Community Engagement Manager, Community Partnerships, Cystic Fibrosis Foundation

  • What do you currently do at your organization?
  • What are the perceived risks and benefits?
  • How do you overcome these risks?

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

Moderators:
Daniela Shikova, General Manager, FindMeCure Foundation
Moderator to be Announced, ERT

  • 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?

Patient Engagement and Recruitment

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

Moderators:
Robert Loll, Senior Vice President, Business Development & Strategic Planning, Praxis Communications, LLC
Mary Jo Lamberti, PhD, Associate Director and Research Assistant Professor, Tufts Center for the Study of Drug Development (CSDD)
To be Announced, IQVIA

  • 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: eCOa, ePRO, BYOD: Strategies for Improving Study Convenience and Compliance

Moderators:
Kyle Hogan, Director, Outcome Solutions, Clinical Ink

  • Discuss how eCOA supports accurate and timely clinician and patient data collection and improves data quality and accessibility
  • Talk about how ePRO enables patient data to be collected and validated electronically by patients as a part of their daily life — anytime, anywhere
  • Examine how a sound BYOD approach impacts the patient experience and encourages patient engagement and compliance

TABLE: Diving into TransCelerate’s New and Free Patient Engagement Toolkits

Moderators:
Lani Hashimoto, Clinical Program Benchmark Manager, Patient Engagement & Recruitment, Novartis

  • How the Patient Protocol Engagement Toolkit (P-PET) toolkit helps prospective advisory board hosts and discussion on implementation considerations
  • Common questions from early users of the Study Participant Feedback Questionnaire (SPFQ) toolkit

Access and feedback for the toolkits


TABLE: What are the Risks of and Risk Reduction Strategies for Using Social Media in Clinical Trials?

Moderators:
Michael McLaughlin, MS, MSEd, RAC, Associate Director, Clinical Operations, Dermavant Sciences, Inc

  • What are the potential risks and how to reduce risk when using social media?
  • What can we learn from recent FDA Guidance on Recruiting Study Subjects using Media Advertising and recent FDA Warning Letters from monitoring Social Media?
  • What are some valuable risk reduction strategies?

Health Literacy, Cultural Sensitivity, Diversity

TABLE: Integrating Health Literacy and Cultural Sensitivity into Clinical Trials

Moderators:
Laurie Myers, MBA, Global Health Literacy Director, Global Population Health, Merck & Co., Inc.
Alicia Staley, MBA, Senior Director, Patient Engagement, Medidata; Trial Volunteer
Charissa Barger, MS, Recruitment Specialist, Alzheimer’s Therapeutic Research Institute, University of Southern California

  • Gain sponsorship from senior management and legal
  • Move from concept to action: Identify pilots and coordinate across internal groups
  • Include the perspectives of patients across a range of health literacy levels and from different cultural backgrounds
  • Train investigators in teach back and cultural sensitivity

TABLE: Operationalizing Diversity and Inclusion into Your Clinical Trials

Moderators:
Cassandra Smith, MBA, Associate Director, Diversity and Inclusion in Clinical Trials Lead, Janssen R&D

  • What are the barriers to operationalizing diversity and inclusion?
  • How do you improve enrollment of underserved and underrepresented populations in clinical trials to ensure that all patients have access to innovative and high-quality care regardless of race or ethnicity?
  • Key strategies to ensure the patient population in a trial is representative of the actual incidence of the disease itself

Protocol Optimization and Trial Design

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

Moderators:
To be Announced, IBM Watson Health

  • 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?

Feasibility and Site Selection

TABLE: Building and Implementing a Data-Driven Site Selection Approach

Moderators:
Sandra Smyth, Global Feasibility & Site Intelligence Director, AstraZeneca
Gabriela Feldberg, Practice Leader, Applied Analytics & Artificial Intelligence, AstraZeneca

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

Moderators:
Maya Zlatanova, Co-founder, FindMeCure Foundation
Daljit Cheema, Managing Director, PHARMASEAL

  • 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

Study Start Up and Operations, |Site-Sponsor-CRO Perspectives

TABLE: Ask a Site – Tips, Tricks and Trends in Site Operations, Compliance and Siteponsor Relationships

Moderators:
Tamara O’Black, JD, Senior Director, Compliance, Quality & Regulatory, Minneapolis Heart Institute Foundation (MHIF)
Lisa Tindell, RN, Senior Director, Clinical Research Operations, Minneapolis Heart Institute Foundation (MHIF)

  • Study feasibility and start-up – getting to a 90-day launch
  • Working with IRBs – myths of central IRB review
  • Site-Sponsor relationships – the good, the bad & the ugly: how sites and sponsors can work more effectively together
  • Auditing & monitoring – whether it’s sponsor monitors or the FDA, how sites and sponsors can partner for quality

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

Moderators:
Raj Pallapothu, mHealth Global Business Lead, Bayer Pharmaceuticals; mHealth Global Advocate

  • 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?
  • What opportunities exist to streamline and integrate technology in clinical trials?

TABLE: Improving Both Time and Quality in Site Activation and Study Start-Up (Sponsor, CRO and Site Perspectives)

Moderators:
Linda Glaser, MD, PhD, Medical Director, Coastal Biomedical Research

  • 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 startup?

Risk-Based Monitoring and Quality Management

TABLE: Obstacles to Implementing RBM on Medical Device Studies & How to Overcome Them

Moderators:
Stephanie Clark, Director, Risk Management-Central Monitoring, Janssen R&D (J&J)
Erin Creedon, Associate Director, Clinical Operations, Ethicon (J&J)

  • Leadership support
  • Change Management concerns
  • Regulatory support
  • Lack of technology
  • Lack of resources

TABLE: Using eSource, eConsent and Other Technologies in Trials

Moderators:
Laura Whitmore, Head, Clinical Operations, Oversight, Cerevel Therapeutics
Hilde Vanaken, Senior Industry Advisor, TCS Life Sciences and Healthcare, Tata Consultancy Services

  • Barriers to eTrials
  • Best practices
  • Future of eTrials

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

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

  • 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: Quality Monitoring and Quality Tolerance Limits

Moderators:
Andy Lawton, Director & Consultant, Risk Based Approach Ltd.
Ruma Bhagat, MPH, MBBS, Senior GCP Strategy Lead, Site Innovation Group Lead, Genentech, Inc.
Janis LIttle, Vice President, Global R&D Quality, Allergan

  • How many QTLs do we need?
  • What areas should we apply QTLs for?
  • Should the QTLs be set at failure points or reasonable expectations of the quality?
  • What other benefits could QTLs give us?
  • Are your QTLs linked to your QbD initiative?

Budgeting, Contracting, and Resource Management

TABLE: Coordinating Contracting and Payments to Enhance Efficiencies

Moderators:
Debora Araujo, Founder & CEO, ClinBiz
Chris Chan, Executive Director, R&D Finance, Fibrogen
Kelly Willenberg, President, Kelly Willenberg, LLC

  • 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: Contracting Strategies and Tools for Speedy Study Start-Up

Moderators:
Christina Greene, Esq., Associate Director, Global Site Agreements, Merck Sharp & Dohme Corp.
Ly Kawaguchi, Senior Director, Head, Outsourcing and Procurement, MyoKardia

  • Discuss barriers to speedy study start-up
  • Review contracting strategies: standard templates, language, culture
  • Share tools and processes that speed time-to-contract and study start-up

TABLE: Navigating New Laws and Regulations in Clinical Trial Contracts

Moderators:
John Conley, JD, PhD, Professor, Law, University of North Carolina School of Law

  • Strategies for navigating the revised Common Rule, the US-EU Privacy Shield, and California privacy laws
  • Exploring EU-based regulations, including GDPR
  • How these laws and regulations affect clinical trial design, operations, and execution

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

Moderators:
Piet Theisohn, Director, Head, Resource Management in Clinical Operations, R&D-ClinOps - Business Excellence & Innovation, Bayer AG Pharma Division
Laila Mork, Senior Manager, Systems, Analytics & Reporting, Business Operations, Allergan

  • 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

Outsourcing, Strategic Partnerships, and KPIs

TABLE: Vendor Performance Metrics and KPIs

Moderators:
Keith Dorricott, Ambassador, Metrics Champion Consortium; Director, DMPI 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: Strategies for Becoming a Partner of Choice

Moderators:
Rosalie Filling, Vice President, Clinical Operations, Research and Development, Endo Pharmaceuticals
Wes Bonner, Vice President, Strategic Development, Meridian Clinical Research
Kenneth Olovich, Director, Sourcing and Finance, Chorus Division, Eli Lilly and Company
Justin Bandura, JD, Contract Manager, Clinical Operations, Boehringer Ingelheim

  • What initiatives can different departments take on to enhance the experience of working with partners?
  • How do small vs. large sponsors, CROs, and sites compete?
  • What strategies exist to stand out in a dense market?

TABLE: FSP vs. Hybrid vs. Strategic Partnership Outsourcing – Choosing an Appropriate Model

Moderators:
Todd Reul, Associate Director, Global Strategic Sourcing, BioMarin Pharmaceutical Inc
Erin O’Boyle, Senior Director, Clinical Operations, Rezolute, Inc..
Minji Bae, Associate Director, Vendor Management, AbbVie

  • 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

Digital Tech, Wearables, and Digital Biomarkers

TABLE: Building a Personalized Logistics Network with Tech to Enable Patient-Centered Trials

Moderator:
Laura Davis, Business Technology Leader, Biotherapeutic Development, Information Technology, The Janssen Pharmaceutical Companies of Johnson & Johnson

  • How can we build a personalized logistics network?
  • What technologies will reduce vein-to-vein time?
  • What are the main barriers to new technology adoption in CAR-T trials?

TABLE: Digital Biomarkers and Endpoints

Moderators:
Luis Garcia-Gancedo, PhD, Fellow & Director, Digital Biomarkers, GlaxoSmithKline
Michael Benecky, PhD, Senior Director, Global Regulatory Affairs, Precision and Digital Medicine, R&D Chief Regulatory Office, GlaxoSmithKline
Michelle Crouthamel, Digital Platform Leader, Abbvie

  • Appropriate application of wearables
  • Identifying criteria to use digital biomarkers
  • Challenges presented in digital biomarker exploration. 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?

TABLE: Digital Technologies in Clinical Trials: How to Choose, Implement and Work with Vendors

Moderators:
Jaquie Finn, Global Head, Digital Health, Cambridge Consultants
Krista Emmons, Associate Director, Portfolio Relationship Management, Portfolio Relationship & Sourcing Management
Narayanan R., Chief Architect (Life Sciences and Healthcare) and Head of TCS Connect Clinical Trial platform, TCS Life Sciences and Healthcare, Tata Consultancy Services Ltd.
Robert G. Wilson III, Consultant, Wilson Digital Health Consulting

  • 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: Master Trials – Pragmatic Operations for Complex Oncology Precision Medicine

Moderator:

Len Rosenberg, PhD, RPh, Head, Clinical Operations, Beat AML / LLS

  • Key considerations in program set-up and execution
  • Benchmarks/Performance – Toss conventional oversight metrics?
  • NextGen clinical trial technology solutions – Do they work?

Clinical Data Management, Analytics, and AI/ML

TABLE: Advances in Clinical Data Management and Analytics

Moderators:
Dermot Kenny, Global Head, Data Operations, Novartis
Nareen Katta, Head, Clinical Analytics, AbbVie
Ozgur Ozkan, IT Director, Clinical Decision Support, The Janssen Pharmaceutical Companies of Johnson & Johnson
Charles Romano, Vice President, Global Clinical Research, Peachtree Bioresearch Solutions

  • Data Operations
  • Process Automation
  • Innovation in Clinical Trials
  • Machine Learning/Artificial Intelligence

TABLE: Transforming Clinical Operations with a Data-Driven Approach

Moderator:
Tom Doyle Vice President, Data Science Medidata

  • Using analytics from a unified platform to inform better decision making
  • Using data to Identify potential problems before they become bigger issues ensuring better outcomes
  • Data that drives effectiveness in clinical trial operations, not just efficiencies

TABLE: Artificial Intelligence and Machine Learning: Reporting Progress

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?

Virtual Trials, Remote Trials, and De-Centralized Trials

TABLE: Virtual Trials: The New Ecosystem

Moderators:
Pam Duffy, Senior Director & Digital Strategic Planning and Demand Lead, Pfizer
Kevin Bateman, Distinguished Scientist & Scientific Associate Vice President, Merck & Co., Inc.

  • Let’s discuss terminology: Site-less, de-centralized, virtual? Does it have to be one model, or can we mix (e.g. traditional and remote)?
  • Where do retrospective/eTrials fit in? virtual control arms? Does digital technology inevitably lead to virtual trials?
  • What are some specific challenges in retaining patients and investigators? What are the data science considerations in de-centralized/virtual trial?

TABLE: Remote Trials, Digital Technology Adoption in Clinical Trials, and Patient Centricity

Moderators:
Hassan Kadhim, Director, Clinical Trial Business Capabilities, GCO, Bristol-Myers Squibb

  • Which strategies shall we use to further proliferate and scale Remote Trials?
  • How to enable culture change in pharma for further innovation in clinical trials?

Clinical Supply and Logistics

TABLE: Clinical Supply in Hybrid Virtual Trials

Moderator:
Adama Ibrahim, EMBA, Associate Director, Global Clinical Operations, Biogen
Moderator to be Announced, Suvoda

  • What is the value to stakeholders?
  • What are the main barriers to adoption? How can they be addressed?
  • Defining success metrics and sharing case studies

Ops and Data Ownership in Sample, Biomarker, Biospecimen Management

TABLE: Data Ownership and Returning Results to Patients

Moderators:
Karina Bienfait, PhD, Principal Scientist & Head, Global Genomics Policy, Process & Compliance, Merck
David Leventhal, Senior Director, Clinical Innovation, Global Product Development, Pfizer Inc.

  • Who owns the patient data in clinical research?
  • Do the patients get longitudinal choice and control of ongoing use of their data?
  • Returning biomarker data to patients

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

Moderators:
Brenda Yanak, Principal, Clinical Transformation Partners
Michael Tanen, MBA, Director, Clinical Biomarker Specimen Management, Merck Research Laboratories

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

Early Phase Trial Planning and Ops, a Focus on Phase 1

TABLE: Sponsor and Site Interactions in Phase 1 Site Selection, Recruitment and Contract Negotiations

Moderators:
Kristi Womack, Director, Clinical Pharmacology Operations, Allergan
Mark Scheetz, Associate Director, Program Lead for Phase I Studies, Allergan
Carol Miller, Senior Director, Business Development, Spaulding Clinical Research

  • Sponsor representatives and site representatives sharing “what works” in Phase 1 trials
  • Early phase Site Selection process from the Sponsor point of view
  • Meeting recruitment and retention goals: How Phase 1 centers distinguish themselves to retain a healthy volunteer database and how do we find the special patient populations?
  • Maintaining strong Sponsor and site relations: How does contracting play a role?

Medical Device Clinical Trial Operations and Regulations

TABLE: Navigating the EU MDR

Moderators:
To be Announced

  • Strategies for getting products already on the market approved under the EU MDR
  • Tips for updating internal processes
  • Long-term changes for new clinical trials

TABLE: Pre- Vs. Post-Market Studies: Different Challenges and Strategies

Moderators:
Jane Jacob, PhD, CCRP, Vice President, Research and Clinical Affairs, Orthofix, Inc
Jennifer Bolton, Senior Fellow, Regulatory Affairs, Boston Scientific Corporation

  • Strategies for pre- vs. post-market studies: site identification, study start-up, etc.
  • Comparing study types and their unique requirements
  • Using national registries for post-market studies

TABLE: Obstacles to Implementing RBM on Medical Device Studies & How to Overcome Them

Moderators:
Stephanie Clark, Director, Risk Management-Central Monitoring, Janssen R&D (J&J)
Erin Creedon, Associate Director, Clinical Operations, Ethicon (J&J)

  • Leadership and regulatory support
  • Change Management concerns
  • The impact of the lack of technology and resources

Clinical Research as a Care Option (CRAACO)

TABLE: Clinical Research as a Care Option (CRAACO): Changing Large Health Organizations from Bureaucratic Behemoths to Operationally Efficient Research Centers

Moderators:
Jim Kremidas, Executive Director, ACRP

  • Defining roles and responsibilities of academic and health system-based site staff
  • Driving change to ensure operational efficiency and quality via standardized performance metrics and processes
  • Ensuring career paths for site staff to drive employee engagement

Real-World Data (RWD/RWE)

TABLE: Global Regulatory Atmosphere Surrounding Real World Data: FDA and Beyond

Moderators:
Steven Draikiwicz, MD, Global Medical Bioinformatics Lead, Sanofi
Cathy Critchlow, PhD, Vice President, Center for Observational Research, Amgen
Gracie Lieberman, Senior Director, Regulatory Policy, Genentech

  • Regulatory standards for use of real-world data (R+D and Medical Affairs)
  • Challenges of international data application
  • High level review and commentary of latest FDA guidelines – commentary on expanding international real-world data usage

TABLE: Innovative RWD-Based Studies

Moderators:
Charles Makin, Global Head, Real World Evidence Strategy, Biogen
David Van Brunt, PhD, Senior Research Fellow and Head, HEOR Division of Evidence and Analytics AbbVie, Inc.

  • Types of studies (pragmatic, hybrid, learning healthcare, etc.)
  • How to gain internal support for novel studies
  • How to integrate novel studies into existing programs

TABLE: RWD To Accelerate Design and Execution of Clinical Trials

Moderators:
Xia Wang, PhD, Director, Health Informatics & Global Medicines Development, AstraZeneca
Michael Kelsh, PhD, Director, Center for Observational Research, Amgen
Jyotsna Mehta, Senior Director & Head, HEOR, Karyopharm Therapeutics

  • 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

Clinical Development Partnering in China

TABLE: Bringing New Therapies to Market in the West and in China: Clinical Development Partnering

Moderators:
Chuck Bradley, Vice President, Clinical Development, FibroGen, Inc.
Jane Fang, MD, MS, Director, Leader of Digital Clinical Innovations, RWD/RWE for Clinical Trials, AstraZeneca
Sean Zhou, PhD, Head, US Patient Safety, AstraZeneca

  • Best practices for developing and bringing new therapies to market here in the West and in China
  • Conducting clinical development programs in China and partnering with up-and-coming Chinese biotech companies and CROs
  • Chinese innovators and CROs working with US-based CROs or licensing partners to expand their market and reach to collaborate