Cambridge Healthtech Institute's Inaugural
Aggregate Spend and Transparency Reporting in Clinical Trials
Sunshine Act Compliance from a Clinical Ops Perspective
February 4-5, 2014 | Hyatt Regency Miami | Miami, FL
Physician payment disclosures such as the Sunshine Act impact all stakeholders involved in clinical research, including sponsors, investigators, sites and third parties (CROs, SMOs). Pharmaceutical, biotechnology, and medical device companies are now held accountable for tracking and reporting clinical trial research payments made to physicians. CHI's Inaugural Aggregate Spend and Transparency Reporting in Clinical Trials: Sunshine Act Compliance from a Clinical Ops Perspective helps navigate these new reporting requirements by outlining the impact of the Sunshine Act and other global laws on clinical research, how to build successful working relationships with key stakeholders responsible for reporting, best practices in spend reporting from a clinical ops perspective, and how to analyze aggregate spend data to improve business and clinical trial management.
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Mon February 3 See all 7 Short Courses
TUESDAY, FEBRUARY 4
7:00 am Registration and Morning Coffee
8:00 Organizer’s Welcome
Micah Lieberman, Executive Director, Conferences, Cambridge Healthtech Institute (CHI)
8:05 Chairperson’s Opening Remarks
Kenneth Getz, Director, Sponsored Programs, Tufts CSDD; Chairman, CISCRP
8:15 Plenary Keynote Introduction
Abbe Steel, Vice President, Patient & Physician Services, United BioSource Corporation
8:20 Plenary Keynotes and Panel
What Does a Trial Mean in the Era of Real-Time Measurement?
Jamie Heywood, Co-Founder and Chairman, PatientsLikeMe
The Silent Partners and Their Role in Clinical Research: Improving Trial Design and Management by Understanding the Real “Customer”
Christine Pierre, President, The Society for Clinical Research Sites (SCRS)
PANEL: Perspectives from a Cast of Characters Needed for Any Successful Study Execution
9:45 Grand Opening Coffee Break in the Exhibit Hall
10:45 Chairperson’s Remarks
10:55 Clinical Trials in Light of Global Transparency Trends
Thomas Sullivan, President, Rockpointe Corporation
Transparency of payments from manufacturers to healthcare providers is becoming more and more common place. With the rise of global multicenter clinical trials, manufacturers and CROs will have to understand how these laws and codes apply to the investigators they hire. During this session we will discuss 1. International Sunshine Laws, 2. Industry and country specific codes of conduct that include payment and clinical trial disclosure, 3. FCPA and UK Bribery Act’s impact on clinical trials in emerging markets, 4. Strategies for keeping up with national and international laws, and 5. Tactics to educate your employees on applicable disclosure rules and laws.
11:20 Physician Payment Disclosures: Assessing Requirements and the Impact on Clinical Trials and Physician Interactions
Katherine Cartwright Norris, Director, Compliance & Integrity Programs, Becker & Associates Consulting; former Director, Corporate Compliance, The Spectranetics Corporation
Physician payment disclosures are imminent, and the requirements impact everything from operations to interactions with customers and researchers. With so many uncertainties surrounding reportable payments and adequate data collection, many companies are looking both inward and outward to determine whether their payment recording and reporting strategies are sufficient. This session includes an overview of the Open Payments reporting requirements with specific focus on clinical trial activities, key operational aspects for implementing and managing an aggregate spend program, improving current processes, payment management for clinical trials, and working with CROs/SMOs to support transparency strategies. Additional perspectives on education and communication initiatives as well as the potential impact reporting requirements may have on physician interactions will also be addressed.
11:45 Shedding Light on Sunshine
Colin Scott, M.D., Senior Director, Respiratory Development, Clinical Development, Forest Research Institute, Inc.
In the scramble to get data collection and reporting procedures into compliance for the Sunshine Act scant attention has been paid to mitigation of the negative impact that this piece of legislation will have on investigator/sponsor relations. This presentation will focus on this aspect and explore avenues for sponsors to explore to minimize the risk of disaffecting investigators. Issues addressed will include: 1. The need for investigator information packs, 2. Methods of reducing the perception of erroneous reporting of transfers of value, 3. The development of processes and procedures to avoid the need for conflict resolution, and 4. Ways to counter negative public opinion. The spin-off benefit of minimizing the negative impact of the Sunshine Act will be to close the widening communication gap between sponsors and investigators. It will be advanced that there is ‘Sunshine’ at the end of the tunnel.
12:10 pm Sponsored Presentation (Opportunity Available)
12:35 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own
1:15 End of Morning Session
1:25 Chairperson’s Remarks
1:35 A Case Study of the Impact of US State and Federal Payment Reporting Requirements on Clinical Trial Operations
Lisa Ingellis, Global Transparency Reporting Consultant, Eli Lilly and Co.
For clinical trial operations, translating payment reporting requirements into “on-the-job” actions can often be challenging. It is essential, however, for clinical trial operations to fully understand the “What do I do differently?” as new requirements are introduced. The purpose of this case study is to share the approach that one company has developed to communicate with clinical trial operations the interpretations and changes for on-the-job compliance.
2:00 PANEL: Clinical Operations Building Better Relationships to Tackle State, Federal and Global Reporting Requirements
Moderator: Lisa Ingellis, Global Transparency Reporting Consultant, Eli Lilly and Co.
Kevin Williams, Vice President, Corporate Development & Marketing, CFS Clinical (CFS)
Toby Ann Holetz, Global Head, Global Aggregate Spend Reporting Team, Quintiles
Additional Panelists to be Announced
Physician payment disclosures impact all of the stakeholders involved in clinical research, including sponsors, investigators, sites and third parties (CROs, SMOs). Implementing accurate and timely reporting requires the clinical operations executive to strengthen her relationship with each of these players. The panel will discuss the following topics:
- Clinical research involvement in managing and monitoring aggregate spend
- Educating and training clinical trial investigators and sites on reporting requirements and data collection
- Working with third parties (CROs, SMOs, sites) on collecting accurate spend data and supporting transparency strategies: impact on sponsor-CRO-site relationships
2:50 Sponsored Presentation (Opportunity Available)
3:05 Refreshment Break in the Exhibit Hall
4:05 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.
CLICK HERE to view the current topics and moderators
5:15 Welcome Reception in the Exhibit Hall
6:15 End of Day
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