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In 2007 GZP added its first South African clients while dramaticallyincreasing the number of Australian and US firms and programs that itrepresents to the FDA, for mid-discovery through full-scale clinicaldevelopment and approval.
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Several INDs that GZP created and submitted in 2006 received a first-cycleclearance to proceed with clinical trials. A number of pre-IND and end ofPhase 2 meetings with the FDA led to successful acceleration of drug andbiologic development programs for our clients. Special Protocol Assessments(SPAs) for Phase 3 programs have been submitted and successfully negotiatedwith the Agency, as well as Orphan Drug and Fast Track status requests. Thefirm is under contract for two electronic (eCTD) BLAs and three eCTD NDAs andexpects additional such programs to be initiated in 2008.
According to Evan Siegel, Ph.D., President and Chief Executive Officer,"The additional resources, combined with zero turnover of our people, allow usto preserve continuity with our long-term clients and to offer the same levelof expertise, commitment and rapid turnaround to our new clients. We continueto enjoy the privilege of working with new additions to drug and biologicpipelines while bringing our more than 400 aggregate years' experience inmedical product development to bear on the programs of firms new to ourpartnership. We believe more than ever that bringing regulatory excellence tothe table at the beginning of a program, combined with efficient andknowledgeable project management and technical expertise in all disciplines,can launch or re-launch a product into the FDA arena in a highly effectivemanner."
With GZP's wholly owned Australian subsidiary, Ground Zero PharmaceuticalsPty Ltd. reaching its first anniversary, Dr. Sandra Webb, Executive Director,is optimistic about the growth in Australia stating, "More and more smallbiotech companies with early stage development products are realizing thevalue of collecting only necessary and sufficient data from the outset fortimely discussions with the FDA at the key strategic points in theirdevelopment plans."
In related developments, GZP has augmented its staff in the Regulatory,Project Management, and scientific areas to further improve its efficiency inhandling the increased workload attendant to the growth of both its clientbase and new programs. Evan Siegel, Ph.D., President and Chief ExecutiveOfficer has been regularly lecturing as an Adjunct Professor at the Universityof Queensland in Brisbane, Australia and will be delivering several lecturesat the University of Pretoria in South Africa this month. We expect that thiswill create new opportunities for client training in the coming years.
Therapeutic areas covered by GZP's services include cancers of both hardand soft tissues, AIDS, antiinfectives and antivirals, medical imaging,dermatological disorders such as psoriasis, acne, rosacea, erythema andherpes, anti-inflammatory/analgesics for rheumatoid arthritis, osteoarthritisand SLE, vaccines, coagulation disorders, wound healing, cardiovascularconditions, emergency plasma volume expansion, gastrointestinal disorders,hematological illness, 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 SouthernCalifornia, Ground Zero Pharmaceuticals, Inc. is a regulatory affairs andproduct development consulting firm providing strategic and tactical supportto the phar
