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 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)


Opening Plenary Keynotes And Panel:
Keeping The Patient In Mind
 

8:05 Chairperson’s Opening Remarks

Kenneth Getz, Director, Sponsored Programs, Tufts CSDD; Chairman, CISCRP

8:15 Plenary Keynote Introduction

Nancy Mulligan, Senior Director, Operations, 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

 

Keynote Details 

9:45 Grand Opening Coffee Break in the Exhibit Hall

 

Impact of Reporting Requirements on Clinical Research & Investigator Relationships 

10:45 Chairperson’s Remarks

KathleenGreenoughKathleen Greenough, Senior Manager, Clinical Systems & Technology, Biogen Idec

 

10:55 Clinical Trials in Light of Global Transparency Trends

TomSullivanThomas 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

KatherineNorrisKatherine 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

ColinScottColin 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 Aggregate Spend Call Center Support Services: Helping Your Customers Understand and Navigate the Data and Systems

Hoover_JackieJackie S. Hoover, Vice President, Account Management, C3i, Inc.

Pharmaceutical companies have been collecting data and are now submitting it for publication to CMS (Centers for Medicaid & Medicare Services). What does this mean for your customers? What if they have questions? Who do they call? What if patients don't understand? Are you prepared to handle an influx of inquiries and possible disputes about the data you submitted? C3i, Inc. has created specialized call center support services to assist you and your customers with this data and related systems.

12:35 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

1:15 End of Morning Session


Building Better Relationships to Tackle State, Federal and Global Reporting Requirements 

1:25 Chairperson’s Remarks
Dolfi_JessicaJessica Dolfi, Senior Business Consultant, Medidata Solutions 

 

1:35 A Case Study for Managing Clinical Data Collection and Reporting

Andrew SmithAndrew Smith, Global Transparency Reporting Associate Consultant, Eli Lilly and Co.

It takes significant effort to both identify an organization's sources of reportable payment data and to work with those sources to ensure complete and accurate reporting of the data. The purpose of this case study is to share learnings from one company's experience, with particular focus on coordinating data collection efforts with clinical research organizations (CROs).

 

2:00 PANEL: Clinical Operations Building Better Relationships to Tackle State, Federal and Global Reporting Requirements

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

 

 

 

 

 

 

Andrew SmithAndrew Smith, Global Transparency Reporting Associate Consultant, Eli Lilly and Co.

 

KevinWilliamsKevin Williams, Vice President, Corporate Development & Marketing, CFS Clinical (CFS)

 

TobyAnnHoletzToby Ann Holetz, Global Head, Global Aggregate Spend Reporting Team, Quintiles

 

Heidi Shea, Director, Vendor & Outsourcing Management, Vertex

 

BrendaMedinaBrenda Medina, former Director, Global Head, Clinical Business Operations, Eisai, Inc.

 

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 Practical Solutions: Ensuring Consistency Across State, Federal and Global Reporting Requirements

Abraham GittermanAbraham Gitterman, Associate, Arnold & Porter, LLP

With overlapping and sometimes inconsistent reporting requirements, stakeholders will need practical solutions to ensure consistency in reporting to various government agencies, as well as ways to reduce redundancies. This talk will offer practical solutions and a “checklist” for parties to consider when tracking payments related to research, such as who must payments be reported for; what kind of payments are prohibited or permissible based on geographic region; and what is necessary to ensure delayed publication. This talk will also offer brief guidance on overlapping NIH and FDA requirements and how to handle disputes regarding “total amount of research payments” and payments that may not be eligible for delay.

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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