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
Room: Regency Ballroom U
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
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?
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
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
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
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
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
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?
Room: Regency Ballroom T
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
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?
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?
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?
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
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?
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
Room: Regency Ballroom R
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
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
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
Room: Regency Ballroom R Mastering an Outsourcing Strategy
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?
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?
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
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
Room: Regency Ballroom R
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
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?
Room: Regency Ballroom R
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
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?
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?
Room: Regency Ballroom R
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?
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
Room: Regency Ballroom R
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
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
Room: Regency Ballroom V
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
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
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?
Room: Regency Ballroom V
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
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?
Room: Regency Ballroom V
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
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