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International Clinical Trials

ict
Winter 2015

   
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Keynote
Comment from the Editor

Graham Hughes
sees in the New Year by highlighting a selection of articles from this edition, emphasising the need for speed in developing vaccines and other much needed therapies, and the crucial role of different types of data in ultimate trial success.
 
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TRIAL MANAGEMENT
Biomarker Strategies

For Good Measure


How can you develop biomarker-based tests efficiently without extra trials that add to development time and cost? The answer lies in appropriate selection, avoiding the pitfalls and looking to biobanks, argue Simon Goldman and Mike Fisher at Abcodia Ltd.

 
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Site Engagement

Face Value?

When it comes to investigator meetings to set out trial deliverables and get buy-in from site staff, is it best to stick to tried and trusted face-to-face meetings or to go virtual? Marny Bruce and Chuck Johnston of AXON Clinical Trial Services offer some advice.
 
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Clinical Trial Outsourcing
Outsourcing Models

Risky Business


Strategic alliances pose something of a catch-22: CROs need multiple partners to avoid risk, but this can lead sponsors to question the strategic nature of the agreement. With the market in flux, Chris Hamilton of CROS NT calls for a better long-term model that leaves the industry less vulnerable.
 
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eCLINICAL
eSource

Proof Positive


Across therapy areas – from vaccines to Alzheimer's to dermatology – electronic source data is having an impact. Case studies outlined by Ann Neuer at Medical deScriptions show how it goes beyond just cost savings and condensed timelines, with eSource now helping to drive clinical innovation and decision-making.
 
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Trial Master Files

Support System


Even though CROs are under pressure to provide higher levels of collaboration and efficiency, more than 80% use outdated methods to exchange critical trial documents. But a new survey, outlined by Rik Van Mol at Veeva Systems, suggests that a shift to cloud-based eTMF technology is coming.
 
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Regional trials
Biosimilars

Like Minded


Europe has led the charge in bringing biosimilars to market and, despite the difficulties in developing these therapeutic proteins, pharma companies are not put off. Casting a regional eye at Central and Eastern Europe, Magdalena Matusiak and Anna Baran from KCR explain the development route.
 
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Market Analysis: Russia

Federal Factors


Russia has been a rising star of clinical R&D for 20 years, but the slowdown in market growth and emerging competition might block further progress. Maria Bomer at Bomer Pharma Consultancy assesses the country's trial landscape and the mixed success of new regulation.
 
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Central Laboratories

Local Impact


Trials in Russia may have doubled in the last decade, but the costs and delays stemming from its import/export procedures can curb sponsor enthusiasm. Tomasz Anyszek and Michal Dysko of Synevo Central Labs suggest that locally-based central lab networks can help the country get back on track.
 
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Central and Eastern Europe

Uncharted Territory


Given that it is not 'on the map' for most study planners, Belarus is an undiscovered gem for trials beyond Phase 1. Pavle Vukojevic, Alexey Zarubov and Amira Al-Sendi at Pharm-Olam International consider how the clinical infrastructure and strong patient pool make it an attractive new frontier.
 
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DRUG DISCOVERY & DELIVERY
Vaccine Development

Added Impetus


Adjuvants are key to ensuring the efficacy of modern-day vaccines – and a fertile area of research. Robert Lins of SGS Life Science Services examines the novel alternatives being tested, and calls for early comparative trials to further improve immunogenicity.
 
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THERAPEUTICS
Antibiotic Resistance

Up the Anti


Amid repeated warnings that we are heading for a post-antibiotic era, in which common infections and minor injuries once again become lethal, Susie Lunt reviews the efforts of the pharma and science communities to address the crisis.
 
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data management & statistical analysis
Data Integration

Multiple Choice

Pharma companies and CROs have to mine multiple data sources for information on investigative sites – a big task that often leads to poor decisions and inefficiencies in planning and feasibility. No wonder they are now turning to bespoke platforms and data sharing, say Claire Sears and Elisa Cascade from DrugDev.
 
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Statistical Analysis

Data Driven


When it comes to statistical programming, pharma companies are leaning towards an offshoring strategy to help realise cost advantages and more accurate analysis of trial data. Chitra Lele from Sciformix gives some tips on how to optimise and sustain a globally distributed model.
 
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Risk-Based Monitoring

Watch and Wait


With pharma eyeing risk-based monitoring as a more proactive, centralised alternative to 100% source data verification, Wipro Ltd's Hans Poulsen stresses the need to be fully prepared by putting in place a quality cycle of plan, do, check, act.
 
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Supply Chain & Manufacturing
Comparator Drug Supply

Trading Standards


Despite a new industry initiative on comparator drug supply, the trading and pricing concerns in this area remain a conundrum that pharma is yet to crack. David Allen from ADAllen Pharma contemplates where we are now – and the uncertain future.
 
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Trial Design
Feasibility Assessment

Probable Cause


Graham Wylie at the Medical Research Network takes aim at the flawed model of feasibility assessments, arguing for a more patient-centric approach that looks beyond inclusion and exclusion criteria, and harnesses the wealth of digital data to drive trial recruitment.
 
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Interview
Industry Interview

Thinking Allowed


The ever-changing needs of trials mean that integrated response technology must stay one step ahead through customisation and true functionality, says endpoint's Jonathan Dole.
 
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Edited by
Dr Graham Hughes
Consultant in
Pharmaceutical
Development

Published quarterly in
February, May,
August and November

News and Press Releases

Breast Cancer: Targeted Therapies Offer Novel Treatment Modalities

LONDON – 17 March 2015 – Despite the availability of approximately 25 drugs for the treatment of breast cancer, the unmet need in the global market is vast. To address this drawback, pharmaceutical companies have established a robust pipeline that currently has about 52 drugs in development. While chemotherapy remains the most important class of drugs for breast cancer treatment, the trend toward targeted drugs is on the rise.
More info >>

White Papers

pAVEway™ expression system for the efficient expression of therapeutic proteins

Fujifilm Diosynth Biotechnologies

One of the major bottlenecks in the production of biopharmaceuticals is the efficient expression of therapeutic proteins in microbial or mammalian cells. The Escherichia coli pAVEway™ expression system described here has been developed to ensure high product titres and efficient scale up to GMP manufacture, whilst minimising many common issues seen in other expression systems, such as ‘leaky’ expression (expression of recombinant protein in the absence of inducer).
More info >>

Industry Events

Clinical Trial Supply West Coast

2-3 June 2015, San Francisco, USA

This year’s Clinical Trial Supply West Coast conference will be taking place on the 2nd and 3rd of June 2015 in San Francisco, USA. The 8th annual event will bring together more than 150 industry representatives, providing a unique opportunity for attendees to network with their peers and develop the best strategies to overcome their own clinical supply chain challenges.
More info >>

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