spacer
home > epc > autumn 2008 > hit the mark
PUBLICATIONS
European Pharmaceutical Contractor

Hit the Mark

Increasing pressure is being placed on the pharmaceutical industry to limit the costs and time associated with delivering a drug to the market. First-in-human and other early phase studies are a critical step in the complex process. Normally limited to objectives based around pharmacokinetics, safety and tolerability, early phase studies provide an underutilised opportunity to obtain valuable pharmacodynamic data regarding a drug’s mechanism of action, pharmacological activity and potential dosing regimens. Carefully chosen biomarkers are able to be easily incorporated into early phase drug studies and provide guidance for important decisions concerning a drug’s future.

Analyses show that the largest part of the development costs are spent on failures, particularly in the latter part of the process because of the high costs of large-scale clinical trials (1,2). Consequently, there is much pressure on the drug development process to ‘kill failures early’ by showing that the compound does not have the characteristics of a proper drug – or vice versa – and preferably to show that it does (3). Thus, drug development has become a much more continuous process than is suggested by the ‘classic’ separation into distinct phases. In fact, modern ICH guidelines, as implemented by the regulatory authorities, stipulate the intelligent use of pharmacodynamic drug effect measurements during all stages of development (4-6).


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
Professor Joop van Gerven is Director of CNS Studies at CHDR. Joop studied English and Medicine at Utrecht University. After obtaining his MD in 1984, he worked in the Department of Internal Medicine of Leiden University Medical Center (LUMC). In 1990 he completed a PhD thesis on aldose reductase inhibitor treatment in diabetes mellitus. He was trained as a Neurologist in Dijkzigt University Hospital in Rotterdam from 1988 to 1994. During that period, he was also a consultant for Wyeth on diabetic complications. Since 1994 he has been responsible for CNS research at CHDR in Leiden, and is responsible for consultancy and research on central nervous system drugs and methods. He is also active clinically as a Consultant Neurologist at LUMC. In 2004 he was appointed Professor of Clinical Psychoneuropharmacology at Leiden University.

Justin Hay is Senior Clinical Scientist, CNS Studies at CHDR. Justin completed his BSc (Biomed Science) with majors in Pharmacology, Microbiology & Immunology (2001) and graduated with First Class Honours (2002). In 2007 he was conferred his PhD in Pharmacology from the University of Adelaide, Australia. His thesis investigated the pain sensitivity of chronic opioid users. Since March 2007, Justin has held his current position, where he is investigating how pain tests can be used as a screening tool in early drug development.

spacer
Professor Joop van Gerven
spacer
spacer
spacer
Justin Hay
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Introducing Signant Health [Formerly CRF Bracket] and the Industry’s Most Comprehensive Patient-Centric Suite for Clinical Research

Philadelphia and London – June 10, 2019: CRF Bracket, formed by the 2018 merger of CRF Health and Bracket, today launched as Signant Health (signanthealth.com). Uniting eCOA, eConsent, Patient Engagement, IRT, Clinical Supplies and Endpoint Quality into the industry’s most comprehensive patient-centric suite, Signant makes it easier to participate in – and sites and study teams to run – clinical trials. This intense focus on the patient experience, deep therapeutic area expertise and global operational scale enable sponsors and CROs to extend the reach of drug development, expand patient opportunities and improve data quality.
More info >>

White Papers

Is Your Biobank Ready for the Challenge of Biomarker-based Research?

BioFortis

Targeted and personalized studies with well-defined patient segmentation biomarkers are becoming the norm in clinical trials. This increased interest in molecular biomarker studies necessitates a rigor and sophistication in sample management within the clinical trial context that is often not supported either by traditional clinical trial management software (CTMS), or biobanking systems.  Download our Next Generation Biobanking whitepaper and learn about how to overcome the key challenges in clinical trial sample management from working in a distributed network of partners and stakeholder to managing consents and generating scientific insights.
More info >>

 
Industry Events

PDA Europe Annual Meeting 2019

24 June 2019, Hilton Amsterdam

Featuring updates from international regulatory agencies as well as industry, this promises to become another highlight in the 2019 event calendar and is a meeting not to be missed!
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement