IRVINE, Calif., Nov. 1 /PRNewswire/ -- The landscape of new drugs,
biologicals and combinations with medical devices has been dramatically
changed by increased costs and safety concerns raised by physicians and
regulatory agencies. More organized, effective and proactive medical
product programs lead to fewer failed products while expediting FDA
approval.
Ground Zero Pharmaceuticals, Inc. (GZP), a regulatory affairs and
product development consulting company, has added additional expertise in
clinical protocol development, study auditing and pharmacogenomics. Working
seamlessly with clinicians and data management partners, the firm provides
sophisticated regulatory and medical strategy, preclinical study planning
and review, biostatistical analysis, medical writing, manufacturing
compliance, and clinical trials conduct for programs in the US,
Australasia, and Europe.
In 2006 GZP dramatically increased the number of Australian and US
firms and programs that it represents to the FDA, for early discovery
through full-scale clinical development and approval. An office has been
opened in Melbourne, Australia to accommodate a wholly owned subsidiary,
Ground Zero Pharmaceuticals Pty Ltd., established in October 2006 to better
service its clients in that region. In addition, Evan Siegel, Ph.D.,
President and Chief Executive Officer has been appointed an Adjunct
Professor at the University of Queensland School of Pharmacy and its Centre
for Integrated Preclinical Drug Development.
An NDA that GZP created and submitted in 2005 received a first-cycle
approval in May 2006. The firm is under contract for two electronic (eCTD)
BLAs and an electronic (eCTD) NDA and expects additional such programs to
be initiated in 2007.
According to Evan Siegel, "The in-depth expertise that we have always
had at GZP, enhanced by our new resources, enables us to expand into more
of our clients' late-stage development programs, with the potential for
creating the marketing submissions which lead to FDA approval. This brings
us additional satisfaction as we see the end result of these programs, some
of which we have helped develop from their earliest stages. We have worked
with several of our clients for many years and believe that the most
effective outsourcing relationships are those based on quality and trust,
with the inevitable facilitative working relationships and cost savings
fostered by long-term commitment on both sides."
In related developments, GZP has augmented its Doctoral level staff in
both the Medical and scientific areas to increase its emphasis on drug and
biologics safety during development. Dr. Chaline Brown has been promoted to
the position of Director of Clinical Affairs, responsible for our clinical
pharmacology and clinical operations. Dr. Brown has been with GZP since
shortly after its founding in 1999. In addition we are pleased to announce
that Anne Sexton, MD has joined us and will enhance our clinical protocol
development and review, auditing, and medical monitoring capabilities. Dr.
Sexton has experience in the large Pharma (GlaxoSmithKline), CRO
(Quintiles), and biotechnology (Archos) industries.
Therapeutic areas covered by GZP's services include cancers of both
hard and soft tissues, AIDS, antiinfectives and antivirals, medical
imaging, dermatological disorders such as psoriasis, acne, rosacea and
herpes, anti-inflammatory/analgesics for rheumatoid arthritis,
osteoarthritis and SLE, vaccines, coagulation disorders, wound healing,
cardiovascular conditions, emergency plasma volume expansion, and serious
neurological disorders such as Stroke, Peripheral Arterial Occlusion,
Parkinson's disease, and Alzheimer's disease.
Based in Irvine, a major center of biotechnology innovation in Southern
California, Ground Zero Pharmaceuticals, Inc. is a regulatory affairs and
product development consulting firm providing strategic and tactical
support to the pharmaceutical, biologics, biotechnology and medical device
industries. Its service portfolio includes regulatory representation and
submissions (paper and electronic), strategic medical consulting,
preclinical planning, monitoring and data assessment, medical writing,
chemistry, manufacturing and controls consulting, clinical assessment, data
management, clinical monitoring and auditing, biostatics, and project
management. The GZP core team is located internationally, throughout the
US, Canada, Australia and Europe.
For further information please contact Evan B. Siegel, Ph.D., Ground
Zero Pharmaceuticals, Inc., +1-949-852-3666, fax, +1-949-852-3655,
esiegel@groundzerous.com.
SOURCE Ground Zero Pharmaceuticals, Inc.
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Related links:
http://www.groundzerous.com
CONTACT:
Evan B. Siegel, Ph.D. of Ground Zero
Pharmaceuticals, Inc., +1-949-852-3666, or fax, +1-949-852-3655,
esiegel@groundzerous.com
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