Ground Zero Pharmaceuticals Announces Expansion Of Global Consulting In Somatic Cell Therapies

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6th October 2010, 11:31am - Views: 431






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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,

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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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