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.

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

Mr Turhan Ozen Chief Cargo Officer at Turkish Airlines elected to the International Air Cargo Association (TIACA) Committee

Turhan Ozen, serving as Chief Cargo Officer at the global brand Turkish Airlines, was elected to the International Air Cargo Association (TIACA) Committee, the joint voice of the industry that aims to enhance the air cargo profile with intensive efforts towards the global standards.
More info >>

White Papers

CRSF Label - Child-Resistant Blister Packs With Booklet Label

Faubel & Co. Nachfolger GmbH

This case study explains how Faubel was commissioned by a leading global pharmaceutical company to develop a label for an aluminum blister pack with 14 cavities, which was used as part of a multinational clinical trial. This label was intended to both protect infants from erroneous ingestion and facilitate use by seniors.
More info >>

 
Industry Events

CPhI & P-MEC China

18-20 June 2019, SNIEC, Shanghai, China

CPhI & P-MEC China 2019 is your gateway to successfully grow your business at the 2nd largest pharma market in the world. Whether you are looking for sourcing new business or getting the latest market insight, this is your one-stop shop pharmaceutical platform in Asia.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement