IRVINE, Calif., Oct. 9 /PRNewswire/ -- The advent of biosimilar drugs, new combinations of old ingredients and clinical trial failures in Phase 3 have required new emphasis on “doing it right, the first time.” Better use of resources, carefully selected outsource partners and wise allocation of funding lead to fewer failed products in late stages and more success with the FDA review process.
In 2007 GZP added its first South African clients while dramatically increasing the number of Australian and US firms and programs that it represents to the FDA, for mid-discovery through full-scale clinical development and approval.
Several INDs that GZP created and submitted in 2006 received a first-cycle clearance to proceed with clinical trials. A number of pre-IND and end of Phase 2 meetings with the FDA led to successful acceleration of drug and biologic development programs for our clients. Special Protocol Assessments (SPAs) for Phase 3 programs have been submitted and successfully negotiated with the Agency, as well as Orphan Drug and Fast Track status requests. The firm is under contract for two electronic (eCTD) BLAs and three eCTD NDAs and expects 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 us to preserve continuity with our long-term clients and to offer the same level of expertise, commitment and rapid turnaround to our new clients. We continue to enjoy the privilege of working with new additions to drug and biologic pipelines while bringing our more than 400 aggregate years’ experience in medical product development to bear on the programs of firms new to our partnership. We believe more than ever that bringing regulatory excellence to the table at the beginning of a program, combined with efficient and knowledgeable project management and technical expertise in all disciplines, can launch or re-launch a product into the FDA arena in a highly effective manner.”
With GZP’s wholly owned Australian subsidiary, Ground Zero Pharmaceuticals Pty Ltd. reaching its first anniversary, Dr. Sandra Webb, Executive Director, is optimistic about the growth in Australia stating, “More and more small biotech companies with early stage development products are realizing the value of collecting only necessary and sufficient data from the outset for timely discussions with the FDA at the key strategic points in their development plans.”
In related developments, GZP has augmented its staff in the Regulatory, Project Management, 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. Evan Siegel, Ph.D., President and Chief Executive Officer has been regularly lecturing as an Adjunct Professor at the University of Queensland in Brisbane, Australia and will be delivering several lectures at the University of Pretoria in South Africa this month. We expect that this will create new opportunities for client training in the coming years.
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, erythema and herpes, anti-inflammatory/analgesics for rheumatoid arthritis, osteoarthritis and SLE, vaccines, coagulation disorders, wound healing, cardiovascular conditions, 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 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. Some of its service portfolio includes regulatory representation and submissions (paper and electronic), preclinical planning, clinical consulting, biostatistics, chemistry, manufacturing and controls consulting, and medical writing. The GZP core team is located internationally, throughout the US, Canada, Australia and Europe.
For further information please contact Ms. Tisha Templeton, Vice President of Finance and Operations, Ground Zero Pharmaceuticals, Inc., +1-949-419-6136, fax, +1-949-852-3655, ttempleton@groundzerous.com.
CONTACT: Ms. Tisha Templeton, Vice President of Finance and Operations of
Ground Zero Pharmaceuticals, Inc., +1-949-419-6136, fax, +1-949-852-3655,
ttempleton@groundzerous.com
Web site: http://www.groundzerous.com/
