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Details

Autor(en) / Beteiligte
Titel
Coalition Against Major Diseases: Precompetitive Collaborations and Regulatory Paths to Accelerating Drug Development for Neurodegenerative Diseases
Ist Teil von
  • Therapeutic innovation & regulatory science, 2013-11, Vol.47 (6), p.632-638
Ort / Verlag
Los Angeles, CA: SAGE Publications
Erscheinungsjahr
2013
Link zum Volltext
Quelle
SpringerLink (Online service)
Beschreibungen/Notizen
  • Precompetitive collaborations have been successful in several disease areas and industries. Such collaborations are critical to address the gaps and challenges in therapeutic development for chronic neurodegenerative diseases. On November 5, 2012, members of the scientific community, advocates, regulators, industry, and government officials met at the US Food and Drug Administration to develop tools to expedite drug development and maximize the potential for success in future drug trials for Alzheimer disease and Parkinson disease. The meeting established that multiple collaborative approaches are essential for accelerating drug development. Such approaches include precompetitive data sharing, regulatory qualification of biomarkers and clinical outcome assessments, implementation of data standards, and development of quantitative drug disease trial models. While challenges to collaboration among industry partners are formidable, they are not insurmountable. The Coalition Against Major Diseases (CAMD) has several positive examples to highlight. This review represents proceedings from CAMD’s annual conference and discusses the key themes that are being advanced by the Critical Path Institute.
Sprache
Englisch
Identifikatoren
ISSN: 2168-4790
eISSN: 2168-4804
DOI: 10.1177/2168479013498386
Titel-ID: cdi_proquest_miscellaneous_2111151960

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