THE FOX FOCUS...
COULD SMART DEVICES HELP US TEST
NEW DRUGS?
BY MAGGIE KUHL
T
But a new Phase III trial is testing an approach that could bring significant change.
The Michael J. Fox Foundation (MJFF) has
united two of its research partners, Cynapsus Therapeutics and Intel Corporation,
for a pilot study testing the potential of
wearable computing devices (smartwatches
and smartphones) and “big data” analytics in
clinical trials of Parkinson’s medications.
“Clinical studies are the most expensive and
time-consuming stages of drug development. Data science approaches may help
accelerate the pace of progress,” said MJFF
CEO Todd Sherer, PhD. “We are optimistic that these technologies will allow drug
developers to objectively gather and analyze
much greater volumes of data and more
quickly reveal critical insights into potential
new treatments.”
Uniting Two MJFF Partners
Cynapsus, a Toronto-based biotech, is testing a new formulation of a drug that helps
patients return to an “on” state (when symptoms are well managed) from an “off” state
(when medications stop working before it is
time for the next dose). The drug, apomorphine, is already approved for this use,
but is available only in an injectable form.
Cynapsus has developed a thin-strip, underthe-tongue formulation (called APL-130277
2 THE FOX FOCUS
SAM OGDEN
oday in most clinical trials testing a
therapy to treat Parkinson’s motor
symptoms, researchers assess the
drug or intervention’s impact by
using a rating scale and patient diaries. Researchers observe patients at periodic clinic
visits, or participants take the drug and each
day record any effects on their symptoms.
These methods are not unreliable, but they
are subjective, burdensome to patients and
time-consuming.
in testing) that’s much easier to use. MJFF
funded Phases I and II of this work, which
successfully teed up the Phase III trial — the
final stage before applying for FDA approval.
In parallel with supporting the development of
new therapies, MJFF is committed to developing new technologies that could increase both
the effectiveness and the efficiency of Parkinson’s research. In August 2014 the Foundation
launched an ongoing data science partnership
with computing giant Intel. The goal of the
partnership is to develop platforms to store
large volumes of patient-generated data from
online and wearables studies (“big data”), and
to develop sophisticated algorithms allowing
researchers to glean insights from that data.
The Cynapsus pilot study unites these
partners to investigate how clinical trials can
use “big data” to learn more about PD and
measure the impact of therapies.
Albert Agro, PhD, chief medical officer of
Cynapsus, hopes that “the data analytics capabilities enabled by Intel and The Michael J.
Fox Foundation will allow us to better evaluate how APL-130277 is helping patients.”
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