Milstein East (2nd floor)
1585 Massachusetts Ave
Harvard Law School
Cambridge, MA 02138
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 reservations@theinnatharvard.com
Additional nearby hotel accomodations
Please note: May is extremely busy for Boston and Cambridge hotels due to college graduation. Please book early.
Schedule:
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
Q&A
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 |
|
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 |
|
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 ClinicalTrials.gov 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 |
|
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 |
|
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!