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Nanomedicines: From Bench to Bedside and Beyond

The AAPS Journal volume 18, pages 1373–1378 (2016)Cite this article

Abstract

Advancing nanomedicines from concept to clinic requires integration of new science with traditional pharmaceutical development. The medical and commercial success of nanomedicines is greatly facilitated when those charged with developing nanomedicines are cognizant of the unique opportunities and technical challenges that these products present. These individuals must also be knowledgeable about the processes of clinical and product development, including regulatory considerations, to maximize the odds for successful product registration. This article outlines these topics with a goal to accelerate the combination of academic innovation with collaborative industrial scientists who understand pharmaceutical development and regulatory approval requirements—only together can they realize the full potential of nanomedicines for patients.

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Author information

Authors and Affiliations

  1. Phytoption LLC, West Lafayette, Indiana, USA

    Henry Havel

  2. Pfizer, Inc., Groton, Connecticut, USA

    Gregory Finch

  3. Cerulean Pharma, Waltham, Massachusetts, USA

    Pamela Strode & Marc Wolfgang

  4. BIND Therapeutics, Cambridge, Massachusetts, USA

    Stephen Zale & Hagop Youssoufian

  5. NanoCarrier Co. Ltd., Kashiwa, Japan

    Iulian Bobe

  6. Amgen, Inc., Cambridge, Massachusetts, USA

    Matthew Peterson

  7. Drinker Biddle & Reath, Washington, District of Columbia, USA

    Maggie Liu

Authors
  1. Henry Havel
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  2. Gregory Finch
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  3. Pamela Strode
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  4. Marc Wolfgang
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  5. Stephen Zale
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  6. Iulian Bobe
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  7. Hagop Youssoufian
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  8. Matthew Peterson
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  9. Maggie Liu
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Corresponding author

Correspondence to Henry Havel.

Additional information

Guest Editors: Katherine Tyner, Sau (Larry) Lee, and Marc Wolfgang

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Havel, H., Finch, G., Strode, P. et al. Nanomedicines: From Bench to Bedside and Beyond. AAPS J 18, 1373–1378 (2016). https://doi.org/10.1208/s12248-016-9961-7

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  • DOI: https://doi.org/10.1208/s12248-016-9961-7

Key words

  • academic-industrial collaboration
  • ADME
  • biodistribution
  • CMC
  • oncology
  • PK/PD
  • preclinical
  • quality by design
  • targeted delivery
  • toxicology