Friday May 17, 2013 from 7:30 AM to 5:00 PM EDT
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Milstein East (2nd floor) 
1585 Massachusetts Ave
Harvard Law School
Cambridge, MA 02138


Nearby parking options 

Hyatt Regency Cambridge has a limited number of rooms available in the "MRCT/PFC Conference" block. Contact them directly for reservations: 617-492-1234 or by clicking here.

The Inn at Harvard has a special rate for attendees who mention the "MRCT PFC Conference" or group code 430063 when making reservations at 617-491-2222 or 

Additional nearby hotel accomodations

Please note: May is extremely busy for Boston and Cambridge hotels due to college graduation. Please book early.


MRCT Center at Harvard 
Multi-Regional Clinical Trial Center 

Issues and Case Studies in Clinical Trial Data Sharing: Lessons and Solutions

Wasserstein Lights
  • To convene key global stakeholders on a neutral platform to review evidence from recent case studies in clinical trial data disclosure
  • To discuss key areas of learning and potential solutions for clinical trial data sharing that may inform policy in this important area moving forward
  • To discuss implications of data sharing initiatives for pharmaceutical, medical device and biotechnology regulation in the U.S. and other countries



7:30 – 8:00
Participants arrive, Breakfast and Registration

8:00 - 8:15
Welcome Remarks, Barbara Bierer and Mark Barnes

8:15 - 8:35
Access to Patient-Level Data from Clinical Trials: What Data? For Whom? For What Reason? When?
Jeff Drazen, NEJM
8:35 - 8:55
 Perspectives on Patient-level clinical data sharing from a patient advocate, bioethicist and industry physician
 AJ Allen, Lilly

8:55 - 9:10 

Session I: Rationale for Increased Clinical Trial Data Sharing
Moderator: Michelle Mello, HSPH

9:10 – 9:25 am

Case Study: Model of data sharing among multiple stakeholders

Martha Brumfield, Critical Path Institute and Coalition Against Major Diseases

9:25 – 9:40 am


Case Study: A Review of Project Data Sphere

Leonardo Nicacio, Sanofi

9:40 – 9:55 am

  • What rationales exist for increased public sharing of clinical trial data?
  • What types of data and how much data should be shared (e.g., pre-registration, post-registration, etc.)?
  • Who stands to benefit from sharing more clinical trial data?
  • For what parties will greater sharing of clinical trials data represent a significant burden?
  • Must increased public sharing of clinical trial data be mandatory in order to achieve these benefits?


Pat Teden, Teden Consulting

9:55 – 10:35 am


Discussion Panel / Q & A

AJ Allen, Lilly

John Orloff, Novartis

Martha Brumfield, CPI

Jim Ware, NEJM

Pat Teden, Teden Consulting

Peter Doshi, JHU

Sally Okun, PatientsLikeMe

Leonardo Nicacio, Sanofi

10:35 – 10:45 am

10 Minute Break

Session II: Safeguarding patient privacy, consent principles, and the integrity of data analyses
Moderator: Mark Barnes, MRCT/Ropes and Gray

10:45 – 10:55 am

Introduction of potential data sharing models

Michelle Mello, HSPH

10:55– 11:10am

Case Study: GSK Data Sharing Initiative as one model for increasing data transparency and a first step toward a broader solution

Jessica Scott, GSK

11:10 – 11:25 am

Case Study: How anonymous is genetic research data?

Yaniv Erlich, Whitehead Institute

11:25 – 11:40 am

  • What are the risks of clinical trial data sharing in regard to privacy protection, and how can they be balanced against the potential social benefits of data sharing?
  • Would privacy concerns related to clinical trials data sharing constitute a barrier to participation to clinical trials?
  • Does deidentification of data solve the problem of risks to patient privacy and confidentiality?
  • Should research participant consent be a precondition for sharing of clinical trials data?
  • What could be the consequences (e.g., liability) if/when privacy is compromised as the result of increased clinical trial data sharing?

Mark Barnes, Ropes & Gray / MRCT

11:40 – 12:20 am

Discussion Panel / Q & A

Judith Beach, Quintiles

Yaniv Erlich, Whitehead

Jessica Scott, GSK

Mark Lim, Faster Cures

Mark Barnes, Ropes&Gray / MRCT


12:20 – 12:40 pm

Lunch Served

12:40 – 1:00 pm

Lessons Learned from the implementation of FDAAA and the Results Database

Deborah Zarin, NIH

1:00 – 1:10 pm

Q & A


Session III: Balancing companies’ intellectual property interests with public access to data
Moderator: Justin McCarthy, Pfizer

1:10 – 1:40 pm

Case Study: Legal issues posed by the EMA proposed initiative (including 10 min Q&A)

Richard Kingham, Covington

1:40 – 1:55 pm

  • What intellectual property rights, proprietary interests, and competitive concerns do pharmaceutical companies have that might be adversely affected by data sharing?
  • Would the impingement on these interests that could accompany data sharing likely affect public and private investments in R&D and, ultimately, innovation?
  • How should these concerns be balanced against the potential benefits of data sharing? 
  • What strategies might effectively address companies’ legitimate concerns while maximizing the public benefit of data sharing?
  • Is imposing a “learned intermediary” between those who seek access to data and the data sources a possible approach to ease competitive concerns while still allowing reasonable access for independent researchers?


Jeff Francer, PhRMA

1:55 – 2:35 pm


Discussion Panel / Q & A

Susan Forda, Lilly

Ben Roin, HLS

Richard Kingham, Covington

Jeff Francer, PhRMA

Ira Shoulson, Georgetown

Aaron Kesselheim, HMS

Sandra Morris, J&J


2:35 – 2:50 pm

Afternoon Break

Session IV: Assuming patient-level data is shared in the public domain, what are the ramifications?
Moderator: Marc Wilenzick, MRCT

2:50 – 3:15 pm

EMA Update

Sabine Haubenreisser, EMA

3:15 – 3:40 pm

Anticipated Impact of BMJ’s Data Sharing Policy on the Publications and Scientific Process

Elizabeth Loder, BMJ

3:40 – 3:55 pm

  • What are the implications of public sharing of clinical trial data for regulatory processes?
  • Do the potential benefits of data sharing for regulatory processes outweigh the risks (e.g., second-guessing regulatory agencies, premature or incorrect conclusions on risk/benefit profile of medicines)?
  • Can a move toward increased public data sharing jeopardize ongoing efforts toward improved regulatory harmonization?


Jules Mitchel, Target Health Inc.

3:55 – 4:40 pm

Discussion Panel / Q & A

Bob O’Neill, FDA

Sabine Haubenreisser, EMA

Toshi Tominaga, PMDA

Agnes Klein, Health Canada

Deb Zarin, NIH

Elizabeth Loder, BMJ

Jules Mitchel, Target Health Inc. 

Evgeny Rogoff, Russia


4:40 – 5:00 pm

Wrap Up Discussion


Mark Barnes

Barbara Bierer

Rebecca Li

Holly Lynch


Limited Space Available!

Register Now! Please note - after May 13, we can no longer accommodate any dietary restrictions.