Strategic Initiatives
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Advancing science and best practices in nanomedicines research and development. The Nanomedicines Alliance conducted a blinded survey of its member companies on the topic of particle size analysis. The survey was followed by an expert panel discussion. A presentation summarizing the survey and panel outcomes is available here. Member of the Alliance are currently collaborating with experts from the Nanotechnology Characterization Laboratory and other organizations to assess and summarize findings on particle size analysis technologies.
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Regulatory surveillance of developments related to nanomedicines and nanotechnology. The Alliance facilitates sharing of concise and practical information on key regulatory, legislative, and policy developments, and provide perspectives and insights for regulatory strategies that can be discussed in various forums.
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Participating in standard-setting and benchmarking activities for nanotechnology. The Nanomedicines Alliance is actively participating in the ASTM E56 Committee on Nanotechnology.
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Organizing/Co-organizing conferences and workshops. Click here for more information on Nanomedicines Alliance events.
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2016: Participated in Global Summit on Regulatory Science: Nanotechnology Standards and Applications
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2015: Co-organized “Current Challenges in the Characterization of Complex Drug Formulations Containing Nanomaterials” session with FDA at the FDA/PQRI conference on Advancing Product Quality
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2014: Presented on risk assessment and management at the PQRI workshop on nanomaterial drug products
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2013: Organized roundtable discussion at National Nanotechnology Initiative Workshop on the Perception, Assessment, and Management of the Potential Risks of Nanotechnology
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2013: Organized Symposium “Charting a Roadmap to Commercialization”. A white paper based on the conference was published in the AAPS Journal
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Publishing the NanoMed Digest, a free newsletter monitoring regulatory and legislative developments in nanomedicines and publications and events of interest. Our list of subscribers includes regulatory agencies, pharmaceutical companies, biotechs, research and contract research organizations, trade associations, and academia.
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The Nanomedicines Alliance monitors draft regulations and legislation in the United States and European Union for information on rules that might impact the development or commercialization of nanomedicines. The Alliance has submitted several comments on these guidances to communicate with government and other stakeholders on the potentials for use of nanomaterials and nanotechnology in medical applications: