Breakthrough Business Models Drug Development for Rare and Neglected Diseases and Individualized Therapies: Workshop Summary (2009) / Chapter Skim
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5 Strategies for Facilitating Sharing of Research Materials and Data
5 Strategies for Facilitating Sharing of Research Materials and Data
Pages 42-54
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From page 42... ...
This section is based on the presentation of Michael Mowatt, Ph.D., Director, Office of Technology Development, National Institute of Allergy and Infectious Diseases, National Institutes of Health.
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From page 43... ...
The National Institutes of Health (NIH) has supported a number of successful repositories, such as the NIH AIDS Research and Reference Reagent Program, the Malaria Research and Reference Reagent Resource Center (MR4)
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From page 44... ...
The bargaining process could be facilitated through the use of standardized agreements, which would theoretically eliminate the need to conduct de novo legal reviews of MTAs and transfer agreements. An example is the Uniform Biological Material Transfer Agreement (UBMTA)
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From page 45... ...
As a follow-up to the launch of the UBMTA, in 1999 NIH published guidelines for disseminating research resources developed with NIH funding. These guidelines articulate the expectation that recipients of NIH funding will use a Simple Letter Agreement for exchanges of unpatented research tools.
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From page 46... ...
• Biological sample sharing is facilitated by a resource allocation review commit ADNI is a longitudinal, multisite observational study. Its primary goal is to collect data and biological samples to establish a brain imaging, biomarker, and clinical database that will enable identification of the best markers for following disease progression and monitoring treatment response.
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From page 47... ...
The deci sion to allocate biological samples rests with the National Institute on Aging. http://www.adni-info.org, http://www.loni.ucla.edu/ADNI/ Genetic Alliance BioBank Launched in 2004 by seven genetic disease advocacy organizations, the Genetic Alliance Biobank is modeled after the PXE International Blood and Tissue Bank, which was established in 1995.
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From page 48... ...
in the Laboratory of Neuroimaging (LONI) ; a biomarker core; a neuropathology core; a statistics core; and an industry scientific advisory board (ISAB)
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From page 49... ...
ADNI hopes to establish the optimum methods for multisite Alzheimer's clinical trials and to identify imaging and biomarker techniques that have high rates of change, small standard deviations, high power, and correlation with the clinical measures. These imaging and biomarker techniques will be used in Phase II and III studies and validated in treatment settings.
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50 FIGURE 5-1 Worldwide use of ADNI data. More than 270,000 image downloads by 265 investigators occurred in the 22 months following the database's inception, and clinical data were downloaded by 203 investigators.
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From page 51... ...
The Alliance brings together diverse stakeholders to establish novel partnerships in advocacy, integrating individual, family, and community perspectives to improve health systems. By revolutionizing access to genetic information, the Alliance hopes to enable the translation of biomedical research into health services and to facilitate better individual decision making.
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From page 52... ...
, which is part of the NIH system for genotype/phenotype correlations; and • compliance with good manufacturing practices. The Genetic Alliance BioBank is a cooperative model that provides infrastructure for clinical records and images; research questionnaires; and biological materials such as DNA, tissue samples, and cell lines.
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From page 53... ...
The Genetic Alliance BioBank, modeled after the PXE International model, creates a firewall between researchers and many of the costly and time-consuming administrative tasks associated with working with patients. NOTE: IRB = institutional review board.
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From page 54... ...
Constituents are willing to assume additional safety risks if a treatment is effective -- an approach to drug development that reflects the unique needs of people living with a rare disease. Ultimately, a new, flexible paradigm is needed that: • is forward looking and takes into account the rapid changes in research and industry; • is well coordinated across federal agencies and companies; • has safe harbors for high risk, encourages publishing of negative results, and allows companies to take risks without fear of being penalized as they might be under the current regulatory regime; • is transparent and open; and • is characterized by more common registries and more shared data.
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