2014 Archived Content

Interactive Breakout Discussions

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.

Breakout Discussions: February 4 | 4:05 pm – 5:15 pm

TABLE 1: Clinical Trial Billing Compliance Programs: Are you ready to manage coverage analysis and compliance with Medicare billing requirements at US sites?

Moderator: Michael Jones, MBA, Senior Director, Global Site Development, Clinical Operations, Eli Lilly & Co.

  • What do sponsors see as trends about reimbursement within clinical trials?
  • How do sponsors manage issues of clinical trial reimbursement compliance?
  • How do you manage variations in reimbursement?

TABLE 2: The Back of a Baseball Card: A discussion of key metrics that help define great investigators

Moderator: Joe Kim, MBA, Director, Clinical Operations, Shire Pharmaceuticals

  • How best to quantify, speed, efficiency and quality
  • Platforms for curating this data
  • Figuring out if THE metric of interest is "most clean data per dollar"

TABLE 3: TransCelerate Investigator Portal Project

Moderator: Jackie Kent, Director, Clinical Development Information & Optimization (CDIO), Eli Lilly & Co.

  • Overview of TransCelerate and 5 workstreams
  • What is the Investigator portal
  • Roadmap and timelines
  • Q & A/open discussion about the change management associated with this project

TABLE 4: A Tour of the Latest Technological Innovations

Moderator: Nancy Mulligan, Senior Director, Operations, Patient & Physician Services, UBC

  • Hands-on demonstrations of the latest mHealth and remote monitoring devices
  • Guided discussion on how and when to use such devices in research and post-marketing programs
  • Learn from others’ experience implementing these tools on past initiatives

TABLE 5: Best Practices for Advocacy Outreach and Engagement

Moderator: Aaron Fleishman, Social Innovation and Advocacy Engagement, BBK Worldwide

  • Building long-term relationships
  • Branching out beyond condition-specific groups
  • Raising awareness of clinical research

TABLE 6: SPF 6002: Avoiding the Burn of the Sunshine Act for Research-Related Payments

Moderator: Abraham Gitterman, Associate, Arnold & Porter, LLP

  • How will manufacturers reconcile transparency and reporting requirements for payments regarding clinical trials across FDA, NIH and CMS, as well as their own institutions?
  • How will manufacturers avoid raising red flags that may be raised by payments related to research, such as payments for new indications or unapproved new use research?
  • How should manufacturers work with clinical researchers to ensure that all payments related to research are included in the total research payment included in the delayed reporting template? How will clinical researchers know when such payments will not be eligible for delayed publication?
  • How should manufacturers and clinical researchers educate patients and other stakeholders about the new transparency requirements, particularly with respect to research and related categories such as consulting?

TABLE 7: Setting Expectations for Transparency Reporting from Third Party Vendor

Moderator: Toby Ann Holetz, Global Head, Global Aggregate Spend Reporting Team, Quintiles

  • What are your company’s expectations for data collection and data validations from your third party vendors?
  • How are you holding your third party vendors accountable for accurate and timely report production?
  • How do you anticipate your company will respond to the expansion of transparency reporting into rest of world? How are you looking to your third party vendors to make this transition to the collection of non-US data successful?

TABLE 8: Optimizing Patient and Investigator Payments for International Trials

Moderator: Simon Venhuizen, Business Development Manager, Chexx Inc.

  • How payment choices can optimize patient recruitment and retention
  • What specific payment types are appropriate, practical and preferred in various countries
  • How to create and implement a workable payment strategy in both major and developing markets

TABLE 9: EHRs to Inform Subject Selection for Clinical Trial Designs

Moderator: Chunhua Weng, Ph.D., Florence Irving Assistant Professor of Biomedical Informatics, Columbia University

  • Existing methods for defining clinical trial eligibility criteria in industry or academia
  • Investigators' information needs for technological support for eligibility criteria design
  • Methods for population modeling using EHRs

TABLE 10: Data Networks to Integrate Experimental Outcomes and More

Moderator: Paul Konstant, Manager, Translational Informatics, Janssen Pharmaceutical Co.

  • Where are the needs for integration?
  • Integration patterns: How do we learn from experience?
  • Beyond outcomes:  What are the needs to integrate chronological observations and/or disease registries?  What are the needs to integrate knowledge-bases? 

TABLE 11:Risk-Based Monitoring

Moderator: Mary Flack, M.D., Vice President, Clinical Research, Nanobio


TABLE 12: Innovative Approach to Improve Internal Development Efficiency: Shifting the Paradigm

Moderator: Kathy Miller, Executive Director, RPS Strategic Solutions

  • Reassessing "Core and Non-Core" elements of large biopharma's business strategy
  • Prioritizing portfolio to best leverage development solutions: Role of Internal vs. Outsourced development options
  • Facilitating paradigm shift: Overcoming Internal Resistance to Change

TABLE 13: Developing a Pharmacoepidemiology Study

Moderator: Fei Xue, M.D., Observational Research Director, Center for Observational Research (CfOR), Amgen, Inc.

  • Pharmacovigilance  studies in support of product launching as well as long-term drug safety evaluation: potential data sources, collaborators and study designs
  • Comparative effective studies to evaluate treatment effect in real-world practice settings: pragmatic trials, databases, meta-analysis or other?
  • Special methodological considerations and implications for the data interpretation

TABLE 14: Designing Successful Patient Registries

Moderator: Alicia Gilsenan, Ph.D., Senior Director, Epidemiology, RTI Health Solutions

  • What questions do stakeholders need to answer before the protocol is written?
  • How will registry participation impact providers and patients?
  • How to minimize  loss to follow-up over time? 

TABLE 15: Observational Research: Working with External Partners

Moderator: Adam Wilcox, Ph.D., Director, Medical Informatics, Intermountain Healthcare

  • Creating governance relationships for observational research using data in Electronic Health Records
  • Creating cohorts for observational studies: Creating models for consent to survey
  • How to sustain use of cohort registries with external partners

TABLE 16: Benefits (or not) in Using Community Outreach Strategies

Moderator: Melynda Geurts, MS, Vice President Operations, DAC Patient Recruitment Services

  • Is there still a place for community outreach in the ever growing technology era
  • Global utilization of community outreach
  • Evaluate and discuss benefits (or not) of service utilization
  • Best practices for measuring ROI

TABLE 17: Biomarkers and Precision Medicine in Clinical Trials

Moderator: Terry Robins, Ph.D., Consultant, former Global Director, Scientific Affairs, Quest Diagnostics

  • Precision medicine relies on the successful transition from biomakers assays used in clinical trials to FDA cleared companion diagnostic assays
  • Laboratory Developed Tests (LDTs) can provide a useful bridging strategy to demonstrate the utility of a specific biomarker to identify the patient population that will respond to therapy
  • Companion Diagnostic assays continue to be refined, even after the drug/diagnostic is approved

TABLE 18: Next Generation Social Media for Patient Recruitment

Moderators: Laura Mulhall, Social Media & Online Marketing, BBK Worldwide &

Elizabeth Mascherino, Associate Director, Clinical Operations, Shire Pharmaceuticals

  • New tactics available
  • What works, what doesn’t
  • Finding the right time to use social media for patient recruitment

TABLE 19: Engaging Primary Care Physicians

Moderator: Janet Jones, Vice President, Access to Patients, Synexus Ltd.

  • How to get engagement
  • What are the costs and benefits to patient’s recruitment and retention
  • Review of regional differences

TABLE 20: Future Use Permissions and Restrictions

Moderator: Katheryn E. Shea, Vice President, BioServices Operations, Precision Bioservices, Inc.

  • ELSI regulatory elements affecting future use
  • Common permission/restriction parameters
  • Annotation of potential uses of specimens and data

TABLE 21: Sponsor and CRO Collaboration: A Marketplace Ripe for Change

Moderator: Kristin Carroll, Prinicipal Solution Consultant, Oracle Health Sciences

  • Why the marketplace is ready to embrace an integrated, collaborative program
  • Building an approach to establish clear, thoughtful, and thorough expectations in exchange of data/information during clinical trial planning, execution, and closeout
  • Challenges, best practices, and key benefits in collaboration

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