spacer
home > ict > autumn 2009 > solutions central
PUBLICATIONS
International Clinical Trials

Solutions Central

 

TODAY’S CHALLENGE

Over the past 20 years or so, the pharmaceutical service industry has witnessed dramatic changes in the complexity of the compounds being developed and investigated. Along with this complexity came the rationalisation of resources and core competencies in the large and not-solarge pharmas and biotechs, increasing the need for outsourcing the development of speciality assays and biomarkers. With the rapid evolution of molecular biology, immunology and genetic science, finding a competent laboratory with the qualifications and experience to meet the R&D objectives for preclinical and clinical development is a challenge for most drug developers. During the current period of intense change, demand is also increasing due to mergers and acquisitions and the subsequent rationalisation of staffing to meet the economic objectives of the M&A. Conservation of cash by others is resulting in staff reductions and more and more outsourcing to speciality houses that provide the required expertise.

Once the decision to outsource has been taken, a number of additional steps must be considered. A general process would be to identify the types of assays needed (safety assessments, biomarkers, esoteric assays), build a relationship with an appropriate central laboratory that has the capacity to manage your R&D project, negotiate the project parameters so that communication and expectations are clear, and maintain clear communication channels throughout the project to help ensure success in its development.

TODAY’S ENVIRONMENT

Biomarkers and speciality or esoteric assays are today playing an increasingly important role across the clinical development spectrum. From large molecule pharmacokinetic assays and immunogenicity assays, to mutational analysis for subject selection to primary, secondary and exploratory endpoints, biomarker and speciality assays have become critical components in every phase of development.


Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

 You must be a member of the site to make a comment.
spacer
Fraser R Day is a Canadian pharmacist with more than 40 years’ experience in the pharmaceutical, preclinical and clinical trial industries. He has held various strategic sales, marketing and business development positions in all three sectors, including senior management responsibilities on an international scale. Currently Fraser holds the position of Vice- President, Business Development, at CIRION Clinical Trial Services, a Contract R&D and central laboratory in Canada.
spacer
Fraser R Day
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Lynparza recommended for approval in EU by CHMP for BRCA-mutated metastatic pancreatic cancer

AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada) today announced that Lynparza (olaparib) has been recommended for marketing authorisation in the European Union (EU) for the 1st-line maintenance treatment of patients with germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the Phase III POLO trial, which were published in The New England Journal of Medicine.
More info >>

White Papers
 
Industry Events

Outsourcing in Clinical Trials Europe

26-27 October 2020, Paris, France

Arena International are delighted to announce the return of Outsourcing in Clinical Trials Europe. Part of our global series of events, this flagship show will attract the leading clinical professionals from across Europe. The 10th Annual event will be hosted in Paris.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement