2020 Interactive Breakout Discussions

WEDNESDAY 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.

4:20 Find Your Table and Meet Your Moderator

4:25 Interactive Breakout Discussion Groups

5:10 Welcome Reception in the Exhibit Hall Sponsored by

6:45 Close of Day

STUDY PLANNING & ACTIVATION

Room: Regency Ballroom U

PROTOCOL Development, Global Site Selection, FEASIBILITY AND SITE Management

Improving STUDY START UP, Site Activation and Trial Performance

TABLE 1: 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, a Dassault Systèmes company; Trial Volunteer

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

Lauren Gadsby, MBA, Program Manager, Investigator and Patient

Engagement, Janssen R&D

• 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
• Operationalizing diversity and inclusion into your clinical trials

TABLE 2: Embracing Best Practices in Protocol Design to Reduce Protocol Amendments and Improve Trials

Moderators:

Rob DiCicco, Deputy Chief Health Officer, IBM Watson Health

Sunny Reed, Offering Manager, IBM Watson Health

Faye O’Brien, Director, Performance & Metrics, AstraZeneca

Dan Manak, Executive Director, Business Development, Phesi

• 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 3: 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 4: Optimizing Country and Site Selection: Strategies for Positioning Trials for Success Using a Global Footprint

Moderators:

Maya Zlatanova, Co-founder, FindMeCure Foundation

Ricky Lakhani, Director, Product Management, 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

TABLE 5: Ask a Site – Tips, Tricks and Trends in Site Operations, Compliance and Site-Sponsor 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)

Jessica Schell, Vice President, Clinical Solutions & Partnerships, Business Development, LINEA System

• 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 6: Transforming Clinical Operations with a Data-Driven Approach

Moderators:

Tom Doyle Vice President, Data Science, Medidata, a Dassault Systèmes company

Marie Eckerd, Feasibility and Recruitment Partner, Director, AstraZeneca

• 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 7: 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

Raj Pallapothu, Professor, University of Texas-Dallas & Digital Health Industry Expert

Lindsey Riley, MPH, Senior Associate Director, Research Partnerships, The Michael J. Fox Foundation for Parkinson’s Research

Kathleen Colatrella, President & CEO, LINEA System

• 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?
• Barriers and opportunities in site adoption of clinical trial technology

TABLE 8: 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?

RECRUITMENT & ENGAGEMENT

Room: Regency Ballroom T

Enrolment Planning and Patient Recruitment

Patient Engagement, Enrollment and Retention through Communities and Technology

TABLE 9: How Can We Improve the Patient Experience in Clinical Trials?

Moderators:

Kelly McKee, Head, Patient Recruitment and Patient-Centric Innovations, Vertex Pharmaceuticals

Jane Myles, Former Head, Operational Intelligence and Innovation, Roche

Bernadette Tosti, Executive Director, Information Ventures, Quest Diagnostics

Judith Reece, PhD, Vice President, Digital Development, GSK

Gail Adinamis, CEO, Founder, GlobalCare Clinical Trials

Kate Wilson, Associate Director, Feasibility, Enrollment & Retention Optimization (FERO), Global Clinical Operations, Biogen

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

TABLE 10: Strategies for Patient-Centric Trial Design and Digital Patient Engagement

Moderators:

Daniela Shikova, General Manager, FindMeCure Foundation

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

John Linnell, Clinical Trial Participant and Member of AZ’s Patient Partnership Program

Valeria Nicoli-Carr, Global Director, Patient Services, Patient Services, Mdgroup

Eric Hajjar, Associate Director, Innovation, Global Development Operation, Novartis

Leily Saadat-Lajevardi, Team Leader, Clinical Insights & Experience Group, Janssen R&D

Chris Watson, PhD, Director, Product Strategy, Product Management, 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?
• 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?

TABLE 11: 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)

Jonas Spott, Chief Product Officer, Patiro · Patient Recruitment

Mike Wenger, Vice President, Engagement, TrialScope

• 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?
• Why are more than 80% of patients not aware that clinical trial is a care option? And what do we do?

TABLE 12: eCOa, ePRO, BYOD: Strategies for Improving Study Convenience and Compliance

Moderators:

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

Kyle Hogan, Vice President, Outcome Solutions, Clinical Ink

Matt Noble, Vice President, Product Management, Medidata, a Dassault Systèmes company

• 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
• 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?

TABLE 13: Diving into TransCelerate’s New and Free Patient Engagement Toolkits

Moderators:

T.J. Sharpe, Survivor, Patient Advisor and Advocate

Michele Teufel, Patient and Site Engagement Lead, Development Operations, AstraZeneca

Mike Keens, COO, Firma Clinical Research

David Kiger, Chief Commercial Officer, Datacubed Health

Jasmine Benger, Senior Project Manager, Research Services, Center for Information and Study on Clinical Research Participation (CISCRP)

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

Moderator:

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?

TABLE 15: 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

Amanda Wright, Vice President, Partnership Development, Javara, Inc.

• 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

BUDGETING & Resources

Room: Regency Ballroom R

Clinical Trial Forecasting, Budgeting and Contracting

Resource Management and Capacity Planning for Clinical Trials

TABLE 16: 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

Bill Karich, Senior Manager, Site Business Relations, CSL Behring

• 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 17: Navigating New Laws, Regulations, and Strategies for Clinical Trial Contracts and Speedy Study Start-Up

Moderators:

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

Christina Greene, Esq., Associate Director, Global Site Agreements, Merck Sharp & Dohme Corp.

Ly Kawaguchi, Senior Director, Head, Outsourcing and Procurement, MyoKardia

• Barriers to speedy study start-up and efficient contracting
• Review contracting strategies: standard templates, language, culture
• Strategies for navigating the revised Common Rule, the US-EU Privacy Shield, and California privacy laws, as well as EU-based regulations, including GDPR
• How these laws and regulations affect clinical trial design, operations, and execution

TABLE 18: 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

Anca Copaescu, CEO and Founder, Clinical Maestro by Strategikon Pharma

• 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

Room: Regency Ballroom R Mastering an Outsourcing Strategy

Managing Outsourced Clinical Trials

TABLE 19: Vendor Performance Metrics and KPIs

Moderators:

Keith Dorricott, Ambassador, Metrics Champion Consortium; Director, DMPI Ltd.

Caro Unger, Senior Clinical Operations Standards and Innovation Manager,Clovis Oncology

Kate Hermans, Chief Business Officer, Pharma, 83bar

• 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 20: Strategies for Becoming a Partner of Choice

Moderators:

Rosalie Filling, Vice President, Clinical Operations, Research and Development, Endo Pharmaceuticals

Geri Masessa, Senior Resource Manager, Clinical Operations, Bayer Healthcare

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

Moderators:

Amanda Hovda, MBA, Associate Director, Business Strategy & Operations, Analytics and Data Sciences, Biogen

Erin O’Boyle, Senior Director, Clinical Operations, Rezolute, Inc.

Minji Bae, Associate Director, Vendor Management, AbbVie

Rick O’Hara, Director, Clinical Business Operations, Clinical Operations, Endo Pharmaceuticals, Inc.

• 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

TABLE 22: Bringing New Therapies to Market in the West and in China: Clinical Development Partnering

Moderators:

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

Wendy Wang, PhD, MD, Managing Director, Linical Accelovance China

• 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

CLINICAL SUPPLY

Room: Regency Ballroom R

Clincal Supply Management

TABLE 23: Clinical Supply in Hybrid Virtual Trials

Moderators:

Adama Ibrahim, EMBA, Associate Director, Global Clinical Operations, Biogen

Abby Stephens, Project Manager II, Group Lead Services, 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

TABLE 24: Building a Personalized Logistics Network with Tech to Enable Patient-Centered Trials

Moderators:

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

Alan K. Smith, PhD, Executive Vice President, Technical Operations, Bellicum Pharmaceuticals, Inc.

Gerald Finken, CEO, RXE2

Megan McBride, MPH, Associate Director, Janssen Clinical Innovation, GCDO, R&D, Janssen, The 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?

DATA

Room: Regency Ballroom R

Clinical Data Strategy and Analytics

Artificial Intelligence in Clinical Research

TABLE 25: Advances in Clinical Data Management and Analytics

Moderators:

Craig Serra, Global Head, Strategy and Innovation, Data Operations, Novartis

Ozgur Ozkan, IT Director, Clinical Decision Support, The Janssen Pharmaceutical Companies of Johnson & Johnson

Charles Romano, Vice President, Global Clinical Research, Peachtree Bioresearch Solutions

Andy Maloy, Vice President, Connected Health, Global IoT, Business Development, Integron, a KORE Company

Jeff Evernham, Vice President, Customer Solutions, Consulting, Sinequa

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

TABLE 26: 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.

Demetris Zambas, Vice President and Global Head, Data Monitoring and Management, Pfizer, Inc.

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

• 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 27: Virtual Trials: The New Ecosystem

Moderators:

John Kim, Project Manager, Pfizer

Kevin Bateman, Distinguished Scientist & Scientific Associate Vice President, Merck & Co., Inc.

Katherine Vandebelt, Global Head, Clinical Innovation, Oracle Health Sciences, Global Business Unit, Oracle, Inc.

Jeff Kingsley, DO, MBA, CPI, FACRP, CEO, IACT Health

Jennifer Tontini, Vice President, Global Business Development, Educational Measures

Dawn Anderson, Managing Director, R&D Life Sciences Consulting, Deloitte

• Let’s discuss terminology: Site-less, de-centralized, virtual? Does it have to be one model, or can we mix (e.g. centrall 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?

TECHNOLOGY

Room: Regency Ballroom R

Sensors, Wearables and Digital Biomarkers in Clinical Trials

Clinical Technology and Innovation

TABLE 28: Digital Biomarkers and Endpoints

Moderators:

Michael Benecky, PhD, Senior Director, Global Regulatory Affairs, Precision and Digital Medicine, R&D Chief Regulatory Office, GlaxoSmithKline

Michelle Crouthamel, Digital Platform Leader, Abbvie

Matt Pipke, CTO, physIQ

Vanja Vlajnic, Statistician, Clinical Statistics, Bayer

Christina Silcox, PhD, Managing Associate, Duke-Margolis Center for Health Policy, Duke University

• 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 29: 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 Ramaswamy, 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

REAL WORLD Evidence

Room: Regency Ballroom R

Accessing and Generating RWD

Leveraging Real World Data for Clinical and Observational Research

TABLE 30: Global Regulatory Atmosphere Surrounding Real World Data and Innovative RWD-Based Studies

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

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.

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

TABLE 31: 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

David Tabano, PhD, MA, Associate Director, Center for Observational Research & Data Sciences (CORDS), Business Insights & Analytics, BristolMyers Squibb

Yue Yang, PhD, Director, International Center for Food and Drug Policy and Legal Research, Shenyang Pharmaceutical University

• 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

BIOMARKERS & BIOSPECIMENS

Room: Regency Ballroom V

Clinical Biomarkers Operations and Innovation

Clinical Biospecimens Technology and Outsourcing

TABLE 32: 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.

Emily Castellanos, MD, Associate Medical Director, Research Oncology, Flatiron Health

• 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 33: 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

Deborah Shepard, PhD, Senior Manager, Biomarker Assay Specialist, Global Product Development, Oncology, Pfizer, Inc.

Mary Zuniga, Consultant, Translational Science, Immunology, Eli Lilly and Co.

Jennifer Ribeiro, Informed Consent Process Lead, Global Clinical Documentation & Submissions, Global Clinical Operations, Bristol-Myers Squibb

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

TABLE 34: Master Trials – Pragmatic Operations for Complex Oncology Precision Medicine Trials

Moderators:

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

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

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

QUALITY & MONITORING

Room: Regency Ballroom V

Implementing Risk-Based Monitoring

TABLE 35: Using eSource, eConsent, Etc and Building a Clinical Quality Management System (CQMS) from the Ground Up

Moderators:

Laura Whitmore, Head, Clinical Operations, Oversight, Cerevel Therapeutics

Hilde Vanaken, Senior Industry Advisor, TCS Life Sciences and Healthcare, Tata Consultancy Services

Jonathan Rowe, PhD, Associate Principal, ZS Associates

Gayle Hamilton, Associate Director, Risk Based Monitoring, Project Operations and Business Performance, IQVIA

• Barriers to eTrials and Best Practices
• Future of eTrials
• What are the minimum requirements for a CQMS?
• How to build a CQMS with limited resources and budget
• Learn from each other’s current experiences with building a CQMS

TABLE 36: Quality Monitoring, 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

Erin Reynolds, Manager, Clinical Analytics, Data and Statistical Science, Research & Development, Abbvie

Rachel Lewis, Director, Project Management, Project Management Office, Global Clinical Trial Operations, Merck & Co., Inc.

• 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?

MED Device Trials

Room: Regency Ballroom V

Medical Device Clincal Trial Operations and Regulations

TABLE 37: Pre- Vs. Post-Market Medical Device 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 38: 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