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2017 ; 4
(2
): ä Nephropedia Template TP
gab.com Text
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So, You Think You Have an Idea: A Practical Risk Reduction-Conceptual Model for
Academic Translational Research
#MMPMID28952508
Schwartz J
; Macomber C
Bioengineering (Basel)
2017[Apr]; 4
(2
): ä PMID28952508
show ga
Translational research for new drugs, medical devices, and diagnostics
encompasses aspects of both basic science and clinical research, requiring
multidisciplinary skills and resources that are not all readily available in
either a basic laboratory or clinical setting alone. We propose that, to be
successful, "translational" research ought to be understood as a defined process
from basic science through manufacturing, regulatory, clinical testing all the
way to market. The authors outline a process which has worked well for them to
identify and commercialize academic innovation. The academic environment places a
high value on novelty and less value on whether, among other things, data are
reproducible, scalable, reimbursable, or have commercial freedom to operate. In
other words, when investors, strategic companies, or other later stage
stakeholders evaluate academic efforts at translational research the relative
lack of attention to clinical, regulatory, reimbursement, and manufacturing and
intellectual property freedom to operate almost universally results in more
questions and doubts about the potential of the proposed product, thereby
inhibiting further interest. This contrasts with industry-based R&D, which often
emphasizes manufacturing, regulatory and commercial factors. Academics do not so
much choose to ignore those necessary and standard elements of translation
development, but rather, they are not built into the culture or incentive
structure of the university environment. Acknowledging and addressing this
mismatch of approach and lack of common language in a systematic way facilitates
a more effective "translation" handoffs of academic project concepts into
meaningful clinical solutions help translational researchers more efficiently
develop and progress new and better medical products which address validated
needs. The authors provide an overview and framework for academic researchers to
use which will help them define the elements of a market-driven translational
program (1) problem identification and validation; (2) defining the conceptual
model of disease; and (3) risk evaluation and mitigation strategies.
free
free
free
