Corporate Banner
Satellite Banner
Genotyping & Gene Expression
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

GZP Announces Enhanced Biosimilars and Personalized Medicine Initiatives for its Clients

Published: Tuesday, November 20, 2012
Last Updated: Monday, November 19, 2012
Bookmark and Share
Company is expanding its capabilities in helping its clients develop biosimilars and drug device personalized medicine programs.

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 post approval 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."


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,200+ scientific posters on ePosters
  • More than 4,700+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.


Scientific News
New Cancer Drug Target in Dual-Function Protein
Scientists at The Scripps Research Institute (TSRI) have identified a protein that launches cancer growth and appears to contribute to higher mortality in breast cancer patients.
Contagious Cancers Are Spreading in Shellfish
Direct transmission of cancer among some marine animals may be more common than once thought, suggests a new study published in Nature by researchers at Columbia University Medical Center (CUMC).
Contagious Cancers Are Spreading in Shellfish
Direct transmission of cancer among some marine animals may be more common than once thought, suggests a new study published in Nature by researchers at Columbia University Medical Center (CUMC).
Fix for 3-Billion-Year-Old Genetic Error
Researchers at The University of Texas at Austin have developed a fix that allows RNA to accurately proofread for the first time.
“Amazing Protein Diversity” Discovered in Maize
The genome of the corn plant – or maize, as it’s called almost everywhere except the US – “is a lot more exciting” than scientists have previously believed. So says the lead scientist in a new effort to analyze and annotate the depth of the plant’s genetic resources.
Higher Frequency of Huntington's Disease Mutations Discovered
University of Aberdeen study shows that the gene change that causes Huntington's disease is much more common than previously thought.
Revealing the Genetic Causes of Bowel Cancer
A landmark study has given the most detailed picture yet of the genetics of bowel cancer — the UK's fourth most common cancer.
Tumor Cells Develop Predictable Characteristics
Scientists have discovered that cancer cells at the edge of a tumor that are close to the surrounding environment are predictably different from the cells within the interior of the tumor.
New Imaging Method Reveals Nanoscale Details about DNA
Enhancement to super-resolution microscopy shows orientation of individual molecules, providing a new window into DNA’s structure and dynamics.
Genetic Research Can Significantly Improve Drug Development
With drug development costs topping $1.2bn (£850 million) to get a single treatment to the point it can be sold and used in the clinic, could genetic analysis save hundreds of millions of dollars?
Skyscraper Banner

SELECTBIO Market Reports
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,200+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!