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April 11, 2009:
FDA Approves Treatment of Head Lice - Target Health Was THE CRO
Target Health is pleased to announce that it
was the CRO for the
entire program for the development, and now NDA
approval, of a
novel product for the treatment of head lice.
Our congratulations to Mike
Precopio, President of Summers Laboratories, for
his vision, and for the
dedication and commitment of the excellent staff
at Target Health Inc.
Target Health joined the program at the pre-IND
stage and took the product
from IND to NDA with a true partnership with
Summers Laboratories. Target
Health managed the toxicology program with our
good friend and colleague,
Colleen Johnson of Reno and Associates. Dr. Glen
Park, Sr. Director of
Clinical and Regulatory Affairs ran the clinical
operations and all
interactions with the FDA, including the NDA
preparation and submission
with a terrific team. Yong Joong Kim, Sr.
Director of Data Management and
Application Development directed his excellent
data management team, and
Joonhyuk, Choi Director of Application
Development, together with his
dedicated and extraordinary programming team,
implemented Target e*CRF(r)
for the EDC trials. Leigh Ren, Associate
Director of Biostatistics did the
SAP and all of the analyses, and Daisy Sun,
Clinical Manager wrote all of
the Clinical Study reports. Dr. Mitchel,
President of Target Health did
the original negotiations with FDA, submitted
the IND and "gave advice
from time to time."
The approval of the Summers Laboratories' NDA
comes on the heels of the
approval of Ferring's Degarelix in December 2008
and
SyntheMed 's PMA earlier this year. All three
programs used Target
e*CRF(r) for the Phase 2 and Phase 3 clinical
trials. There are now 16 FDA
approvals that used Targete*CRF for EDC (4 NDAs,
1 BLA, 10 PMAs and 1
510(k). Two additional NDA submissions will
occur this year and we expect
1 MAA (Europe) approval this year.
DNA Bridges is an strategic alliance partner to
Target Health.
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