title: Nanomedicines: From Bench to Bedside and Beyond.
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.
authors.affiliation: Phytoption LLC, West Lafayette, Indiana, USA. havelh@gmail.com.
authors.forename: Henry
authors.identifier: 0000-0001-7106-8203
authors.initials: H
authors.lastname: Havel
authors.affiliation: Pfizer, Inc., Groton, Connecticut, USA.
authors.forename: Gregory
authors.initials: G
authors.lastname: Finch
authors.affiliation: Cerulean Pharma, Waltham, Massachusetts, USA.
authors.forename: Pamela
authors.initials: P
authors.lastname: Strode
authors.affiliation: Cerulean Pharma, Waltham, Massachusetts, USA.
authors.forename: Marc
authors.initials: M
authors.lastname: Wolfgang
authors.affiliation: BIND Therapeutics, Cambridge, Massachusetts, USA.
authors.forename: Stephen
authors.initials: S
authors.lastname: Zale
authors.affiliation: NanoCarrier Co. Ltd., Kashiwa, Japan.
authors.forename: Iulian
authors.initials: I
authors.lastname: Bobe
authors.affiliation: BIND Therapeutics, Cambridge, Massachusetts, USA.
authors.forename: Hagop
authors.initials: H
authors.lastname: Youssoufian
authors.affiliation: Amgen, Inc., Cambridge, Massachusetts, USA.
authors.forename: Matthew
authors.initials: M
authors.lastname: Peterson
authors.affiliation: Drinker Biddle & Reath, Washington, District of Columbia, USA.
authors.forename: Maggie
authors.initials: M
authors.lastname: Liu
mesh_terms: D000818:Animals; D001688:Biological Products / Q000627:therapeutic use; D017277:Drug Approval; D016503:Drug Delivery Systems / Q000639:trends; D004345:Drug Industry / Q000331:legislation & jurisprudence / Q000639:trends; D006801:Humans; D050997:Nanomedicine / Q000331:legislation & jurisprudence / Q000639:trends*; D053758:Nanoparticles / Q000008:administration & dosage
chemical_list: D001688:Biological Products
keywords: ADME; CMC; PK/PD; academic-industrial collaboration; biodistribution; oncology; preclinical; quality by design; targeted delivery; toxicology