transparency solutions ema disclosure for slide share

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The views expressed herein are purely those of Stephen A. Weitzman, J.D. LL.M. Executive Director of MedDATA Foundation.

A reminder from Dr. Martin Kohn , IBM Research

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MAY 28, 2013

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The Proposed Disclosure will include all Market applications – Approved, Disapproved, & Withdrawn – EMA

The European Transparency Rule Mandates Disclosure Is this a Public Trust Issue? Is Public Health the Issue? Is there a Health and Safety Issue? Then why are they doing it?

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FOIA Data has been release where there is a health and safety issue –

Citations FDA has taken a position on “greater transparency.”

Is there a labeling issue? ADEQUATE DIRECTIONS FOR USE

In the age of personalized medicine is a summary sufficient to inform a physician of what is best for his patient based upon omics: Phenomics, Genomics, Proteomics, Metabolism, Nutrition, pharmacology, toxicology, other

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If Europe does this then will other countries follow?

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Loss of Intellectual Property Rights to Competitors of the data in Sections 4 and 5 (Safety and Clinical)

Can One take the EU MA application parts and submit it in China or India and get an Approval?

Can they do it in the U.S. ?

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NEXT STOP MOMBAI

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I2B2 Sites10

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You didn't build that!

Public Funds Contribution to Research Consumer Expectations When Enrolling in a

Study It benefits me and everyone else

Its good science !13

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Survey Results by MRCT, Clinical Data Sharing Evaluation, Harvard, May 17, 2013, Presented by Patricia Teden

http://mrct.globalhealth.harvard.edu/files/mrct/files/mrct_pfc_data_sharing_slides_final_5.17.2013.pdf

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Survey Results by MRCT ,Clinical Data Sharing Evaluation, Harvard, May 17, 2013, Presented by Patricia Teden

Cont.

http://mrct.globalhealth.harvard.edu/files/mrct/files/mrct_pfc_data_sharing_slides_final_5.17.2013.pdf

GSK clinicalstudydata.gsk.com Site sets for the rules for asking; GSK independent body

review; and procedure

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http://www.skepticalscience.com/SkS-Weekly-Digest_20.html

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We (GSK) shall be free to use any ideas, concepts, know-how or techniques contained in such information for any purpose whatsoever including but not limited to developing, manufacturing and marketing products incorporating such information.

SEE TERMS OF USE

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Poor clinical outcomes Unsustainable costs 7.6 million deaths every year worldwide

Massive quantities of clinical trial data No systematic sharing of these data

1: National Cancer Act of 1971

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Engages 3rd parties as “Safe Harbors”

www.ceo-lsc.org

“Life Sciences Consortium” working team

Address issues in cancer research

Accomplish together what no single company might consider alone

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REVISIT HATCH WAXMAN Change the Patent Issue Date to the Date of NDA or

MA approval Give turndown or withdrawal applicants one year (or

other fair term) to re-file or voluntarily disclose (and have fair license terms for the use of their data)

Ban importation of drugs from countries that allow unfair use of data from NDAs, MAs or other nations approval processes See “IT IS TIME: WHY THE FDA SHOULD START

DISCLOSING DRUG TRIAL DATA “by Mustafa Ünlü*

UNLU ITP 8_C.DOC - 5/26/2010

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Are the data sharing terms too restrictive so that researchers will not apply?

Just as we need to incentivize companies to share data we need to “share” the rewards from new discoveries that the applicants for data use may uncover. We can all benefit when we make the PIE Bigger!

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VTY, Steve W.