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Ground Zero Pharmaceuticals (GZP) Announces New Accelerated Development Initiatives for Its Clients


10/14/2013 8:59:00 AM

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IRVINE, Calif., Oct. 14, 2013 /PRNewswire/ -- GZP announces its V-Team. An increasing proportion of small firms with innovative drug, biologic and vaccine programs are remaining virtual as long as possible, to conserve funding and apply it directly to the generation of data that will hold the attention of Regulators and bring in additional investors. While employees are "owned" by a firm, the overhead to retain them leads to a high burn rate. An employee may be an expert in his or her field; however he/she is still limited in breadth of experience across product types, i.e., may be expert in clinical development but not in preclinical/nonclinical, or CMC. Regulatory expertise is often lacking in small firms, even considered as an afterthought, rather than a critical program component.

GZP has developed a "V-Team" to augment the most critical resources in early stage firms. This V-Team includes the following:

  • Regulatory Expert
  • Clinical Expert
  • Preclinical/Nonclinical Expert
  • CMC Expert
  • Medical Writer
  • Project Manager
  • Operations and Administrative Manager

GZP team members have an average of more than 20 years' experience in their areas of concentration, and are typically multidisciplinary. Including experienced C-level executives, they have worked in small and large pharma, biotechnology firms, CROs, and regulatory agencies, thus providing a unique perspective to apply to client projects.

Some members have worked together for over 15 years, providing comfort to clients that a GZP team will integrate well into the fabric of a young firm. This true partnership provides access to these 7 high-level experts on a regular basis for all of a firm's strategic preclinical/nonclinical, CMC, clinical and regulatory development needs, including submissions and FDA meetings. This allows the company to better project costs; the ability to use even more specialized resources when necessary; and most importantly, fostering rapid and facilitated progress towards investor accepted milestones.

In 2013, GZP increased its global client base across programs in oncology, dermatology, medical imaging, and endocrine disease. Of note, Consultation was initiated with several organs of the Australian Commonwealth Government. The firm created and submitted several INDs and facilitated many meetings and other communications with the FDA, from pre-pre-IND through End of Phase 2, leading to rapid movement for client programs, including those suitable for Orphan Drug, Fast Track and Breakthrough Designations. GZP believes that early, frequent, targeted, and creative FDA communication leads to successful product development and attracts additional funding.

According to Evan Siegel, "The FDA and other regulatory agencies are responding to the needs of healthcare professionals and patients by improving communication with industry, developing and furthering accelerated programs for medical product development and approvals, and at the same time insisting on higher quality data and regulatory compliance. GZP is perfectly positioned to deal with these challenges and guide clients in a positive and productive direction."

Dr. Siegel will be in Australia speaking at seminars in Brisbane and Adelaide from October 17-31.

Based in Irvine, Ground Zero Pharmaceuticals, Inc. is a regulatory affairs, product development, and clinical consulting firm providing strategic and tactical services to the pharmaceutical, biotechnology and medical device industries. These include regulatory representation and submissions, preclinical and clinical planning, auditing of clinical, nonclinical and manufacturing sites, medical writing, chemistry, manufacturing and controls consulting, and project management. GZP has resources throughout the US, Canada, Australia and Europe, and a wholly owned subsidiary in Australia.

For further information please contact Ms. Tisha Templeton, Senior Vice President, Finance and Operations, Ground Zero Pharmaceuticals, Inc., +1-949-419-6136, fax, +1-949-861-9797, ttempleton@groundzerous.com.

Web Site: http://www.groundzerous.com

SOURCE Ground Zero Pharmaceuticals, Inc.



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