Design and Development of Theranostic Nanomedicines - Nanotechnology for Biomedical Imaging and Diagnostics - page 420

(a) (b)

250

224

Medicine
Biochemistry, genetics,
and molecular biology
Materials science
Pharmacology, toxicology,
and pharmaceutics
Engineering
Chemistry
Chemical engineering
Physics and astronomy
Health professions

200

143

150

92

100

50 40

22

10

6

1 2 2

0

2001 2002 2005 2006 2007 2008 2009 2010 2011 2012

figure 15.1 Theranostic nanotechnology publication frequency (a) and distribution of
reports by field of study (b). Data obtained from scopus (www.scopus.com) for years
2000-2012.

treatment became a very strong drive for basic and translational research around the
world. ideally, a physician would prescribe theranostic nanosystems to simulta-
neously deliver the drug of choice specifically to the diseased tissue or organ and
monitor both the drug delivery and drug response in real time. This in turn would
allow to further adjustments of drug dose based on feedback from the individual
patient undergoing treatment. Theranostics as a concept promise to be that “smart.”
This ideal has not been reached yet, but much progress has been made to visualize
drug delivery, image drug effects, and use nanosystems for biomarker detection
in vivo . as theranostics continue to be further explored in a variety of disease models
preclinically, some concerns emerged regarding their full translation to the clinic.
one of the problems is the complexity of the system and its effects on future
large-scale manufacturing. The second problem is how to evaluate the entire system
considering its multiple components in respect to efficacy and safety. specifically,
some questions include: are theranostic nanosystems too complicated to be pro-
duced on sufficient scale to be commercially viable? Do we need to revise our tox-
icity testing when both drug and imaging agents are codelivered as one formulation?
how do we account for the unique effects of the diagnostic alone and drug alone and
compare these to the whole system? it is easy to recognize that the toxicity profile of
a nanosystem may present unique features and that it is not a simple sum of its parts.
Choices of imaging agents, excipients, and drugs are critical contributing factors to
theranostic nanosystem complexity and future manufacturing. Can we consider these
issues early in the nanosystem design? Can existing examples in the literature cur-
rently in preclinical development provide enough input to explore the design space
of theranostics and allow us to build predictable models for future manufacturing
friendly formulations? if theranostic nanomedicines are to become future personal-
ized medicines, these questions must be answered.
Theranostic nanosystem design seems to meet similar issues found in classical
small-molecule drug discovery program: targeting, toxicity, efficacy, manufacturing,