IRVINE, Calif., Oct. 15 /PRNewswire/ -- The increased emphasis on
safety by regulatory agencies worldwide has led to more costly medical
product development programs and requires rapid, cost-effective and
resource intensive actions by Sponsors to respond appropriately. Expertise
to effect constructive change can be found in consulting organizations. GZP
has already emplaced systems to protect our clients from compliance errors
that can lead to adverse regulatory action by the FDA. Throughout the
product lifecycle, better use of resources by small and medium sized firms
and wise allocation of funding can lead to more success with the FDA review
process.
In 2008 GZP dramatically increased the number of US, Australian, and
Asian clients (including its first Japanese and Hong Kong firms). Programs
that it represents to the FDA range from mid-discovery through full-scale
clinical, marketing application submission, and post-approval. This
includes bioterrorism and nuclear warfare-related initiatives through the
US government's Project Bioshield/BARDA programs.
Several INDs that GZP created and submitted in 2007/2008 received a
first-cycle clearance to proceed with clinical trials. Throughout its
almost ten year history GZP has had a first-cycle success rate of more than
90%. A number of pre-pre-IND, pre-IND, end of Phase 1 and end of Phase 2
meetings with the FDA led to successful acceleration of drug and biologic
development programs for our clients. The firm expects additional programs
to be initiated in the fourth quarter of 2008 and throughout 2009.
According to Evan Siegel, "The addition of high quality technical Team
Members, with an average of more than 20 years' experience, combined with
zero turnover of our people, allow us to continue the excellent service we
have always provided our clients. We continue to benefit from their
loyalty, referrals, and expansion into new therapeutic areas by maintaining
the continuity of trust that is so central to our industry. We believe that
using sophisticated strategic, tactical regulatory experience and
intelligence to medical product development from the very beginning will
always benefit the generation and integration of technical data into
efficient, viable development programs."
In related developments, GZP has augmented its staff in the Regulatory
and scientific areas to further improve its efficiency in handling the
increased workload attendant to the growth of both its client base and new
programs from existing clients. This includes the addition of Anthony Shaw
and Greg Coulter with expertise in Chemistry, Manufacturing and Controls,
both of whom began working with GZP clients in 2007/2008. In addition, Dr.
Terrence Chew, board certified in internal medicine and an oncologist, has
begun strategic medical consulting to GZP clients, including providing
Medical Monitoring services for Clinical Studies. Evan Siegel, Ph.D.,
President and Chief Executive Officer, lectures as an Adjunct Professor at
the University of Queensland in Brisbane, Australia. GZP, at its Irvine,
California offices, hosted its first regulatory interns from the School of
Pharmacy and Biotechnology programs from the University of Queensland.
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, auditing and review of clinical, nonclinical and CMO
sites, medical writing, chemistry, manufacturing and controls consulting,
clinical assessment, data management, biostatics, and project management.
GZP uses strategically identified resources, throughout the US, Canada,
Australia and Europe, and has a wholly owned subsidiary in Melbourne,
Australia.
For further information please contact Ms. Tisha Templeton, Vice
President of Finance and Operations, Ground Zero Pharmaceuticals, Inc.,
+1-949-419-6136, fax, +1-949-861-9797, ttempleton@groundzerous.com.
Web Site: http://www.groundzerous.com
SOURCE Ground Zero Pharmaceuticals, Inc.
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Related links:
http://www.groundzerous.com
CONTACT:
Tisha Templeton, Vice President of Finance
and Operations of Ground Zero Pharmaceuticals, Inc.,
+1-949-419-6136, fax, +1-949-861-9797,
ttempleton@groundzerous.com
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