Tuesday, February 13



3:50 Find Your Table and Meet Your Moderator

4:00 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. 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

6:15 Close of Day

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


Eric Delente, President, Patient Solutions, DrugDev

Jennifer Lentz, Consultant, Global Informed Consent Business Lead, Global Clinical Operations, Eli Lilly and Company; member of TransCelerate

Cassandra Smith, Associate Director, Investigator and Patient Engagement Projects, Global Clinical Development Operations, Janssen R&D

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


Stella Stergiopoulos, Senior Project Manager, Center for the Study of Drug Development, Tufts University

Bina Rathod, Associate Director & Business Lead, MRL IT Global Clinical Development, Merck & Co.

Mitzi Allred, Director, Clinical Research, Clinical Content Standards, Merck & Co.

Julie Dietrich, Director, Development Design Center, Amgen, Inc.

  • 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: Coordinating Contracting and Payments to Enhance Efficiencies


Holly Leslie, Vice President, Payments, DrugDev

Debora Araujo, Associate Director, Clinical Contracting Services, Boehringer Ingelheim Pharmaceuticals

JoAnn Pfeiffer, DrSC., Director, Clinical Research Management, Arizona State University

  • 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 4: Barriers and Opportunities in Site Adoption of Clinical Trial Technology


Claire Sears, Director, DrugDev Data Solutions

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

David Vulcano, Assistant Vice President & Responsible Executive for Clinical Research, Hospital Corporation of America (HCA)

Sean Walsh, MBA, Chief Development Officer, Raleigh Neurology Associates

  • 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 5: Strategies for Accelerating Recruitment in Complex Clinical Trials in a Resource Constrained Environment


Kevin Hudziak, Innovation Lead, Clinical Innovation, Eli Lilly & Company

Jerome Chiaro, Vice President, Clinical Site Operations, StudyKIK

Angela Radcliffe, Managing Director, Executive Vice President, FCBVIO

Matt Miller, Vice President, Global Patient Recruitment & Feasibility, StudyKIK

  • 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 6: Precision Feasibility in Precision Medicine-Driven Trials


Jill Loftiss, Head, Clinical Operations, Oncology, MedImmune/AstraZeneca

Karina Bienfait, Ph.D., Head, Global Genomics Policy, Process and Compliance, Principal Scientist, Clinical Pharmacogenomics and Operations, Genetics and Pharmacogenomics (GpGx), Translational Medicine, Merck Research Laboratories

  • The impact of precision medicine on today's clinical trial feasibility assessment and trial planning
  • The impact of competition, breakthrough FDA approval and change of standard of care
  • Leverage the power of real world data and trial intelligence data to enable evidence-based trial feasibility assessment

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


Christopher Conklin, Director, Feasibility Center of Excellence, Pfizer

Mark Springer, Project Lead, Clinical Innovation, Eli Lilly & Company

Shawn Tedman, MBA, Head of Product Offerings, Clinical Trial Optimization Solutions (CTOS), QuintilesIMS

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


Valerie Reynaert, Head, In-Country Clinical Operations for the Americas, R&D Projects Clinical Platform & Sciences, GlaxoSmithKline

Christina Brennan, M.D., Vice President, Clinical Research, Executive Research Administration, Northwell Health

Marina Malikova, Ph.D., Executive Director, Surgery, Boston University Medical Center

  • 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 9: Strategies for Patient-Centric Trial Design and Digital Patient Engagement


Lynn Hagger, Ph.D., Patient Engagement Director, Respiratory, INA & CVMD, Global Medical Affairs, Astra Zeneca

Gilles Frydman, Patient Advocate; Co-Founder Smart Patients and ACOR (Association of Cancer Online Resources)

Terrie Livingston, Pharm.D., Senior Director, Real World Outcomes, Innovative Partnerships & Insights (RI2), Biogen

Amir Lahav, Digital Innovation, Rare Disease Research Unit, Pfizer

Mari Maurer, Pharma Clinical Solutions Consulting; former Vice President, Clin Ops, REGENXBIO

  • 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 10: Balancing Budgets and Performance in Resource Management and Capacity Planning


Chris Chan, Executive Director, R&D Finance, Finance, FibroGen, Inc.

Heather Baldwin, MPH, Principal Consultant, Frogbottom Consulting, LLC

Rajyalakshmi Nimmagadda, Global Trial Forecast Development Unit Head, Trial Forecasting and Resource Management, Novartis

  • 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 11: RBM in a Finance and Resource Limited Environment


Yiwen Sun, Senior Clinical Research Associate, Samumed, LLC

Andy Lawton, Director & Consultant, Risk Based Approach Ltd.

  • How can we adopt TransCelerate's RACT model for a resource limited company/org?
  • In terms of technology, what are nice to haves vs. need to haves for implementing RBM?
  • Who is involved in putting RBM in action at smaller companies?

TABLE 12: Vendor Performance Metrics and KPIs


Rick Morrison, Co-Founder and CEO, Comprehend Systems

Diane Miller, Director, Vendor Management, AbbVie

Aaron Fleishman, Head of Emerging Markets, BBK Worldwide

  • 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 13: Understanding and Implementing the New Reality of Diversity in Clinical Trials


David Sall, President & CEO, Patient Enrollment Advisors; Co-Creator of the SCOPE Participant Engagement Award

Jeri Burtchell, Director, Patient Initiatives, HealthiVibe, LLC

Marisa Rackley, Director, Clinical Research Operations, Vertex Pharmaceuticals, Inc.

  • What are the regulatory changes from FDA and updated requirements for ethnicity/race inclusion in trial populations?
  • How do you formalize into a clinical development plan at a company level to make it part of corporate culture by educating and training teams so that they can embrace the ethnicity value?
  • How do you then implement at project team level and operationalize the activities to support diversity in clinical trials?

TABLE 14: Selecting, Developing and Incorporating Novel Endpoints, Generated from Data Captured by Mobile Technologies, for Use in Clinical Trials


Jennifer Goldsack Senior Project Manager, Clinical Trials Transformation Initiative (CTTI)

Rob DiCicco, Ph.D., Vice President, Clinical Innovation and Digital Platforms, GSK

Michelle Crouthamel, Digital Platform Leader, GSK

Amy Calvin, BS, MT (ASCP), MBA, Digital Strategy and Implementation, Advisor, Eli Lilly and Company

Christian Gossens, Ph.D., Global Head Early Development Workflows, pRED Informatics, Roche Pharmaceutical Research and Early Development

  • Describe approaches to identifying mobile technology-derived outcome measures that are most valuable and warrant development
  • Review approaches for optimizing the efficiency of technology-derived novel endpoint development
  • Discuss how to include and position technology-derived novel endpoints to be most impactful

TABLE 15: RWE in Clinical Trial Research and Patient Recruitment


Jane Fang, M.D., Head, Research & Development Information for Clinical Biologics, MedImmune Biologics Science Unit, AstraZeneca

Jyotsna Mehta, Director, Economics Value Evidence and Outcomes, Alkermes, Inc.

Hui Cao, M.D., Ph.D., Executive Director, Real-World Evidence, COE for RWE, Global Medical Affairs, Novartis Pharmaceuticals Corporation

  • The impact of precision medicine on today's clinical trial feasibility assessment and trial planning
  • Leverage the power of real world data to enable evidence-based trial feasibility assessment
  • RWE needs to go beyond analysis and clinical trial is calling new clinical-health service to link healthcare and clinical trial research

TABLE 16: Visual Analytics in Clinical Research


Charlie Romano, Senior Director, Clinical Trial Management, Clearside Biomedical

Steven Sweeney, Vice President, Surgery & Perioperative Care, The Medicines Company

  • Data visualizations for clinical operations
  • Focus on decision making and value
  • Using the data properly

TABLE 17: Addressing Chronic Site and CRA Turnover Issues through a Competency-Based Approach to Workforce Development


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

Divya Chadha Manek, Head, Business Development (Commercial), Clinical Research Network, National Institute of Health Research

Jeff Kingsley, CEO, IACT Health

Lisa Hegg, Ph.D., Vice President, Head Project Planning and Management, Project Management and Business Performance, GSK

  • Discuss common sources and reasons for CRA turnover and why those issues arise
  • Examine the role of workforce development and how a competency-based system can address turnover issues
  • Discuss strategies for implementing a competency-based approach

TABLE 18: Biospecimen, Central Lab and Technology


Michael Tanen, Director, Clinical Biomarker Specimen Management, Merck

Brenda Yanak, Global Head, Specimen Strategy & Innovation, End-to-End Specimen Management, Q² Solutions

Jonathan Reuter, Associate Director, Global Procurement R&D, Clinical Labs, Bristol-Myers Squibb

  • Biorepositories: in house vs. outsourcing
  • Advanced informatics for biospecimen management
  • Central and reference labs: building the relationship
  • Biospecimen and central lab considerations for risk-based monitoring

TABLE 19: Artificial Intelligence and Machine Learning: Extreme Case of Data Analytics?


Balazs Flink, M.D., Clinical Trial Analytics Lead, R&D Business Insights and Analytics, Bristol-Myers Squibb

Francis Kendall, Technology Evaluation and Implementation Leader, Product Development, Roche

  • 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?
  • Will clinicians use and have confidence in ML using clinical decision support tools
  • Will a ML algorithm be part of the molecule package?

TABLE 20: Blurring the Division between Clinical and Observational Studies


Cathy Critchlow, Ph.D., Vice President, Center for Observational Research, Amgen

Christopher Chinn, Head, Real World Investigations, Sanofi

Mark Price, Senior Director, Surveys and Observational Studies, RTI Health Solutions

  • Similarities and differences in operationalizing observational studies vs. clinical trials
  • Building a continuous program that includes post-approval studies
  • Integration of real world data into decision-making across the drug development cycle

TABLE 21: Driving Fully eSource Clinical Trial


Michelle Crouthamel, Digital Platform Leader, GSK

Jaydev Thakkar, IS Director, R&D Informatics, Amgen

Aman Thukral, Assistant Director, Data and Statistical Sciences, AbbVie

  • What is the current state?
  • High and low of eSource adoption, what are the drivers and barriers
  • How to get to 100% eSource?



* 不測の事態により、事前の予告なしにプログラムが変更される場合があります。

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In Memory of Gerald "Jerry" Matczak
Matczak Jerry

Gerald "Jerry" Matczak, lead consultant in clinical innovation at Eli Lilly & Co., was a rare breed in the pharmaceutical world, someone who not only embraced social media, but also listened to activist patients. He has been a part of the SCOPE conference since its inception and won the Patient Engagement Award on Wednesday, the day before his passing. Matczak died suddenly on Feb. 2 at age 54. We will all miss him.

- Cambridge Healthtech Institute (CHI)