Ground Zero Pharmaceuticals Announces Expansion Of Regulatory Consulting Services To International Clinical Trial Auditing And Opens An Office In Melbourne, Australia

Published: Nov 01, 2006

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,

Ground Zero Pharmaceuticals, Inc.

CONTACT: Evan B. Siegel, Ph.D. of Ground Zero Pharmaceuticals, Inc.,+1-949-852-3666, or fax, +1-949-852-3655,

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