BioSpace.com

Biotech and Pharmaceutical
News & Jobs
Search the Site
 
   
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Browse Biotech Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  US Device
Europe
Asia

DIVERSITY

INVESTOR
Market Summary
News
IPOs

PROFILES
Company Profiles

START UPS
Companies
Events

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Biotech Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
eNewsletter Signup
Miles
Km80.5

   

Ground Zero Pharmaceuticals Announces Enhanced Biosimilars and Personalized Medicine Initiatives for its Clients


11/14/2012 8:18:12 AM

IRVINE, Calif., Nov. 14, 2012 /PRNewswire/ -- GZP is announcing expansion of its longstanding capabilities in helping its clients develop biosimilars and drug or biologic/diagnostic device personalized medicine programs for FDA and EMA review.  New legislative initiatives in the US and subsequent regulations and guidelines have provided a number of pathways for development of biosimilars, with the associated requirements for intensive planning and execution of nonclinical and clinical programs.  GZP's CMC, pharmacology/ toxicology, clinical and regulatory experts are available to assist firms in navigating the complexities of such programs.   

GZP has been working with firms in Australasia, the US and Europe to develop and test prognostic/diagnostic devices and test methodologies, including genetic testing and identification of biomarkers, for use during clinical trials and postapproval therapy.  The selection of appropriate candidates for clinical trials, as well as for specific commercial treatments are important in the personalized medicine and reimbursement arenas.  Regulatory success can be enhanced by assuring that new clinical trial initiatives are carried through to the review and approval process and GZP works with clients to achieve this goal.

Dr. Evan B. Siegel, GZP's CEO, will be in Kuala Lumpur (November 17-22), and will be pleased to meet with interested parties by individual arrangement in Malaysia.

In 2012, GZP increased its global client base across therapeutic areas such as oncology, ophthalmology, and endocrine disease.  The firm created and submitted several INDs and facilitated many meetings and other communications with the FDA, leading to rapid movement of client programs.  GZP believes that early, frequent, targeted, and creative FDA communication leads to successful product development and attracts investors in today's financial climate.

According to Evan Siegel, "We are pleased that firms are still generating promising diagnostic and therapeutic products in the biotechnology and pharmaceutical spaces.  Our clients believe that data speak strongly to regulators and we provide sophisticated and intensive help towards that end.  The continued success of our business is attributable to our long-term clients, repeat business, and referrals, as well as the stability of our team.  This provides an integrated and client-specific approach to delivering the highest quality regulatory and product development services."

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 Brisbane and Melbourne, 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.



Read at BioSpace.com

   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES