MEDIA RELEASE PR41620
Ground Zero Pharmaceuticals Announces Expansion of Global Consulting in Somatic Cell Therapies
IRVINE, Calif., Oct. 6 /PRNewswire-AsiaNet/ --
GZP is pleased to announce that it has expanded its capabilities for
strategic regulatory and product development support of gene therapy and
somatic cell therapies, including treatment vaccines for cancer and other
serious or life-threatening diseases. New senior associates with expertise in
manufacturing and clinical development in these expanding areas allow GZP to
provide its clients with hands-on guidance through the FDA regulatory review
process. Firms in the US and Australia have already taken advantage of this
expertise and are preparing to launch programs in Phase 1, 2 and 3 clinical
trials for their "new concept" products. Two of our staff, Dr. Chaline Brown
and Ms. Tisha Templeton, will be attending and presenting this month at the
TRX10 and AusBiotech conferences in Brisbane and Melbourne Australia,
respectively, and will be available to discuss these added capabilities. They
will be available for partnering meetings as well.
Specifics of these Australian speaking engagements are:
12 October 2010 - Brisbane - TRX10 - "Regulations Pertinent to
Pharmacogenomics and Biomarkers in Europe and USA"
20 October 2010 - Melbourne - AusBiotech 2010 - "Dealing with the FDA -
What's Hot?"
GZP continues to believe that early, frequent, and creative communication
with the FDA (including informal targeted review of specific issues that can
slow down development programs at both early and mid-stages) can lead to more
successful medical product development, attracting more funding in today's
difficult financial climate.
In 2010, GZP increased its global client base at all phases of
development across therapeutic areas such as oncology and neurological
disease, and created and submitted several INDs.
Pre-pre-IND, pre-IND and mid-phase meetings with the FDA led to
acceleration of drug and biologic development programs for our clients. Our
medical device practice also expanded and included consultation with
California's Food and Drug Branch as well as the FDA.
According to Evan Siegel, "We are pleased to see that the need for
continued review and approval of key medical products and the determination
of our clients to be successful has contributed to the recovery from the
global financial crisis across industry. Our client's dedication, loyalty,
their referrals, and the excellence of our staff and associates in
maintaining an integrated, cohesive and client-specific approach furthers the
commitment of GZP to provide the highest quality ethical and knowledgeable
consulting."
Based in Irvine, a major biotechnology center in Southern California,
Ground Zero Pharmaceuticals, Inc. is a regulatory affairs and product
development consulting firm providing strategic and tactical services to the
pharmaceutical, biotechnology and medical device industries. These include
regulatory representation and submissions (paper and electronic), strategic
medical consulting, preclinical/nonclinical planning, auditing and review of
clinical, nonclinical and CMO sites, medical writing, chemistry,
manufacturing and controls consulting, clinical assessment, data management,
biostatistics, and project management. GZP has resources throughout the US,
Canada, Australia and Europe, and a wholly owned subsidiary in Brisbane and
Melbourne, Australia.
For further information please contact Ms. Tisha Templeton, Senior Vice
President of Finance and Operations, Ground Zero Pharmaceuticals, Inc.,
+1-949-852-3666, fax, +1-949-852-3655, ttempleton@groundzerous.com.
SOURCE: Ground Zero Pharmaceuticals
CONTACT: Tisha Templeton,
Senior Vice President of Finance and Operations of Ground Zero
Pharmaceuticals, Inc.,
+1-949-852-3666,
fax, +1-949-852-3655,
ttempleton@groundzerous.com
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