n 6 MAY 2015 | PHARMACEUTICAL PROCESSING
nCOVER STORY ■ PHARMPRO.COM
While much of the atten- tion and development of pharmaceuticals is focused on oral solid
dosage forms, the market for topical
treatments of dermatological indications is growing. In fact, according to
recent reports the dermatology market is expected to grow to more than
$13 billion by 2017.
As the market for dermatology products increase, so does the need for
expert contract formulation and product
development services. With this in mind,
Debra Dow is working to assemble a
team best suited to assist in the development of high-quality topical medicine,
with knowledge and understanding of
FDA dermatology division regulations
and a track record for success.
Dow is a co-founder of Symbio,
HISTORY AND BACKGROUND
LLC, a specialty clinical research or-
ganization with extensive expertise
conducting clinical studies in derma-
tology, and has recently opened Dow
Development Laboratories, (DDL) in
Petaluma, Calif. The new laboratory
facility is set-up to provide full scope
topical product development services.
The team has experience and re-
sources to take dermatology product
from concept through the product
development process, concluding
with submission of the regulatory
application. In collaboration with
Symbio, DDL is a CRO that can bring
API through product approval, in
manner that offers unique efficien-
cies in dermatology development.
Symbio opened in 2002 and has
become a leader in the management
of pivotal clinical dermatology studies
in the U.S. According to Jared Holley,
a project manager at Symbio, this
success can be attributed to strong
relationships with U.S. dermatologists
and clinical research sites, consistent,
high-quality service, and the partner-
ships they form with their sponsors.
Symbio was working out of a small
laboratory in Colorado, but to bet-
ter serve their clients and expand
the services they offer, the company
decided to re-locate to a larger facil-
ity in Petaluma, about two years ago.
Holley, who was involved in initial
planning, says very few organizations
bring together CMC with clinical de-
velopment in the contract dermatol-
ogy industry. In addition to providing
complete topical product develop-
ment services, DDL ensures compli-
ance with FDA and/or EU regulations.
Construction on the new facility
began in December 2013, and it was
completed in May 2014, with a grand
opening on July 15, 2014.
On Top Of Their Game
Dow Development Laboratories, LLC positions itself as the go-to
company for topical product development services.
n By Mike Auerbach