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5 Potential Models for Building a Regulatory Science Infrastructure
Pages 31-38

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From page 31...
... FitzGerald suggested that FDA devise new ways to encourage and reward innovation, enhance risk detection to conserve value, and leverage the resources of the academic sector to refine its decision making as drug development grows more disaggregated and globalized. During a panel discussion led by Peter Honig, Head, Global Regulatory Affairs, AstraZeneca, and former Director of the Office of Drug Safety at the Center for Drug Evaluation and Research (CDER)
From page 32...
... This partnership led to a more sensitive and noninvasive strategy for detecting kidney toxicity in animal models, enabling regulatory bodies to perform assessments early in drug development to help prevent investments in scientific dead-ends. Judith Kramer, Executive Director, Clinical Trials Transformative
From page 33...
... Mark McClellan, Director of the Engelberg Center for Healthcare Reform at Brookings Institution, cited BC as an example of a successful public-private partnership, which was first undertaken by FDA, NIH, and the industry trade group -- Pharmaceutical Research and Manufacturers of America (PhRMA) -- in late 2006 to boost the science behind identification of high-impact biological markers for use in drug development, translational research, preventive and predictive medicine, and clinical practice guidelines.
From page 34...
... . BC's research, including FDA's unique access to and analysis of Phase II data from pharmaceutical companies, has since identified adiponectin, a hormone in fat cells, as a predictive biomarker for type 2 diabetes and superior to the existing standard biomarker, hemoglobin A1C (Wagner et al., 2009)
From page 35...
... A COE model at its most basic level consists of a network comprising one intramural center, with connections to extramural centers that can then be linked to other networks and/or centers. Dale Nordenberg, Director, Novasano Health and Science, and former Associate Director, CDC, identified the COE model as a mechanism that could simultaneously support FDA's regulatory activities, encourage partnerships for research in innovation, and help educate outside groups on regulatory processes.
From page 36...
... -- whose hub is FDA IIRIS, as discussed in Chapter 4. • elp FDA educate about regulatory processes -- A useful result H of relationships formed in the COE model is mutual education and understanding.
From page 37...
... The current environment includes particular scrutiny of relationships with industry and suspicion of potential bias arising from collaboration. To implement a collaboration model, it will be necessary to merge differing approaches to confidentiality of information, as academic culture tends toward open sharing of scientific discoveries, while the economics of successful drug development mandate that scientific discoveries be treated as proprietary and confidential, said Ellenberg.


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