|
 |
European Pharmaceutical Contractor
|
| 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 >>
|
|
 |
|
| Rate this article |
You must be a member of the site to make a vote. |
|
Average rating: |
0 |
| | | | | |
|
|
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. |
|
|
|
|
|
 |
Industry Events |
 |
Clinical Trials in Latin America
9-10 September 2010, Lima, Peru
CBI’s Conference on Clinical Trials in Latin America, being held 9–10th September 2010 in Lima, Peru brings together key stakeholders involved with clinical trials in Latin America. Latin America is an increasingly desirable location for running clinical trials, and it is important for those involved to collaborate with colleagues and industry counterparts regarding the challenges of developing, executing and completing clinical trials in Latin America. This is a unique opportunity for pharmaceutical executives in Latin America to hear from key regulatory officials, pharmaceutical leaders, CROs and sites on how all stakeholders in the clinical process can ultimately achieve desired results.
More info >> |
|
 |
News and Press Releases |
 |
ClinTec International
ClinTec International, a global Clinical Research Organisation (“CRO”) announces a financial and strategic partnership with Elephant Capital Plc., an AIM market listed private equity firm. With an investment of £8 Million GBP, Elephant has acquired a significant minority stake in ClinTec. Through this investment, Elephant has entered the attractive clinical research base, where ClinTec operates as a global provider of outsourcing solutions addressing the drug development lifecycle. Managing Partner of Elephant Capital LLP, Gaurav Burman, and Non-Executive Director of Elephant Capital Plc, James Hauslein, have also made personal co-investments in this transaction.
More info >> |
|
 |
