IRVINE, Calif., March 25 /PRNewswire/ -- In the race to bring safe and
effective pharmaceuticals, biologics and medical devices for serious and
life-threatening diseases to an increasingly needy world population, new
medical products must be brought to approval and entry into the market as
efficiently as possible. Key to this is the proper application of regulatory
knowledge toward working closely with government agencies, such as the FDA, to
accelerate the process in a more efficient and cost-effective manner. New
areas of monoclonal antibody therapy and vaccine technology are critical in
the development of novel therapeutic interventions and it is the integration
of multiple disciplines throughout the research and testing phases that will
lead to faster approvals.
Ground Zero Pharmaceuticals, Inc. (GZP), a regulatory affairs and product
development consulting company, has tapped the opportunity to bring on
additional expertise in the clinical, pharmacology, manufacturing, medical
writing and regulatory areas. The firm can now provide sophisticated medical
strategy, pharmacokinetic/pharmacodynamic study planning and assessment,
toxicological analysis, review of chemistry, manufacturing and controls data.
This improves the workflow of client programs through the application of a
broad body of knowledge and experience to the submission of information that
is critical to serious and rapid FDA review of new medical products. GZP has
also augmented its capabilities in providing review and advice of medical
device Quality Systems.
Over the last year GZP has dramatically increased the number of European
and US firms that it represents to the FDA, and has expanded into Australia,
acting as a bridge between early discovery and development work and full-scale
clinical development of products under regulatory review. Therapeutic areas
covered include cancers of both hard and soft tissues, AIDS,
anti-inflammatory/analgesics for diseases such as rheumatoid arthritis,
vaccines (both preventive and treatment, subunit and recombinant), and serious
neurological disorders such as Parkinson's disease, Alzheimer's disease, and
Epilepsy.
According to Evan Siegel, Ph.D., President and Chief Executive Officer,
"The continued expansion of our client base in the biotech areas related to
cancer, AIDS and other serious and life-threatening disease reflects the
growing importance of the pharmaceutical, biologics, medical device and
biotechnology revolution in those areas and the recognition that an integrated
approach to the basic sciences, medical strategy, clinical development and
realistic needs of the regulatory agencies are critical for the early
penetration of important and advanced products into the American marketplace.
Planning for, identifying and addressing regulatory issues as early in the
product development process as possible is the most certain way to save
valuable resources, time and funding. Key to the success of this facilitated,
orderly and aggressive approach is the pre-IND consultation. The regulatory
interactions that lead the development process can be more productive and
successful when conducted in a forthright manner through an experienced
development partner and consultant such as Ground Zero Pharmaceuticals."
In a related development, Tisha A. Holle has been promoted to the position
of Director of Finance and Operations, responsible for all financial
transactions of the firm and day-to-day operations, including Corporate
Project Management. This centralizes interrelated functions in one place,
improving the efficiency of the management of the firm. Ms. Holle has been
with GZP since shortly after its founding in 1999.
In additional company news, Dr. Andreas Konar has been elected to the
Board of Directors. Dr. Konar brings to GZP a broad knowledge of business
development, clinical research and formulations development in the
pharmaceutical industry. As his physical location is in Sweden, his
experience with and knowledge of European pharmaceutical companies greatly
enhances our ability to work effectively in that region.
Based in its newly expanded space in Irvine, a major center of
pharmaceutical and 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, and medical device industries. Its service
portfolio includes regulatory representation and submissions, strategic
medical strategy, preclinical planning and data assessment, medical writing,
manufacturing controls analysis, clinical assessment, and project management.
In addition to the above, GZP has added portfolio management to its service
portfolio in order to meet the needs of those firms that have multiple
compounds and indications in their pipelines. The GZP network has
participants in San Francisco, Sacramento and San Diego, California; the
Research Triangle Park, North Carolina; Houston, Texas, Washington, DC;
Phoenix, Arizona; Birmingham, Alabama; British Columbia, Canada; Brisbane,
Australia; and Malmo, Sweden.
For further information please contact Evan B. Siegel. Ph.D. of Ground
Zero Pharmaceuticals, Inc., +1-949-852-3666, fax, +1-949-852-3655,
ebs@groundzerous.com
SOURCE Ground Zero Pharmaceuticals, Inc.
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Related links:
http://www.groundzerous.com
CONTACT:
Evan B. Siegel. Ph.D. of Ground Zero
Pharmaceuticals, Inc., +1-949-852-3666, fax, +1-949-852-3655,
ebs@groundzerous.com
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