Corporate Banner
Satellite Banner
Technology
Networks
Scientific Communities
 
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
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 2,500+ scientific posters on ePosters
  • More Than 3,800+ 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
NIH Study Finds Calorie Restriction Lowers Some Risk Factors for Age-Related Diseases
Two-year trial did not produce expected metabolic changes, but influenced other life span markers.
Immunotherapy Agent Benefits Patients with Drug-Resistant Multiple Myeloma in First Human Trial
Daratumumab proved generally safe in patients, even at the highest doses.
Low-level Arsenic Exposure Before Birth Associated with Early Puberty in Female Mice
Study examine whether low-dose arsenic exposure could have similar health outcomes in humans.
Inciting an Immune Attack On Cancer Cells
A new minimally invasive vaccine that combines cancer cells and immune-enhancing factors could be used clinically to launch a destructive attack on tumors.
‘Mutation-Tracking’ Blood Test for Breast Cancer
Scientists have developed a blood test for breast cancer able to identify which patients will suffer a relapse after treatment, months before tumours are visible on hospital scans.
Cellular Contamination Pathway for Heavy Elements Identified
Berkeley Lab scientists find that an iron-binding protein can transport actinides into cells.
Intensity of Desert Storms May Affect Ocean Phytoplankton
MIT study finds phytoplankton are extremely sensitive to changing levels of desert dust.
Common ‘Heart Attack’ Blood Test May Predict Future Hypertension
Small rises in troponin levels may have value as markers for subclinical heart damage and high blood pressure.
LaVision BioTec Reports on the Neuro Research on the Human Brain After Trauma
Company reports on the work of Dr Ali Ertürk from the Institute for Stroke and Dementia Research at LMU Munich.
NIH Study Shows No Benefit of Omega-3 Supplements for Cognitive Decline
Research was published in the Journal of the American Medical Association.
Scroll Up
Scroll Down
Skyscraper Banner

Skyscraper Banner
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
2,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,800+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!