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| home > ict > Spring 2018 |
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 PUBLICATIONS |
International Clinical Trials |
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Editor’s Comment
ICT's Editor Dr Graham Hughes introduces the key focus topics in these editions of ICT and EPC, highlighting a number of articles.
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Clinical Trial Oversight Management
Perfecting Performance
When dealing with new revisions in the ICH E6 (R2) guidelines, Gabriele Faist and Heike Schön at LUMIS International discuss how the implementation of keyperformance indicators could be beneficial.
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Regulation Changes
Clinical Navigation
With new developments in pharmacovigilance being continually implemented, Nick Barker and Katharine Colbert at Medpace express that sponsors andmarketing authorisation holders worldwide must ensure they are prepared
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Obstacles in Cancer Research
Essential Steps
Through a Q&A, Peter Langecker, Brian Travers, and Barb Geiger at Clinipace explain to ICT the intricacies that must be considered within oncological studies.
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Alzheimer’s Research
Improving Success Rates
Significant progress within clinical trials for Alzheimer’s is being made. Dr Michael F Murphy at Worldwide Clinical Trials says new trial designsare now addressing previous research challenges.
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Spotlight
York Health Economics Consortium
York Health Economics Consortium is a health economics consulting company owned by the University of York. It provides a range of services,including economic modelling, literature searching, systematic reviews,
network meta-analyses, outcomes research, and applied research and training to the NHS and the pharmaceutical and healthcare industries |
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Oncology Trial Validity
Imaging Innovations
Working alongside effective site training, today's imaging analysis technology could bring improvements to the quality, timeline, and cost of oncology trials. Sophie Winandy at ERT explores how.
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eClinical Improvements
A New Pathway
Jeff Lee at Bracket details the ways in which technological approaches alongside unified thinking can enhance patient engagement, becominga key asset within clinical research.
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EMA First-in-Human Guidance
Exponential Developments
As regulations for first-in-human trials progress, Bradley Joblin at Q-Pharm examines the new considerationsthat must be made within early phase development.
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The Sponsor/Vendor Relationship
Key Relations
Shanelle Mehta at The Clinigen Group explores how outsourcing is becoming common practice within the pharmaceutical and biotechnology industries, thereby creating a good sponsor/vendor relationship and a reliable process.
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End Point
Public Perception
ICT Editor Dr Graham Hughes considers the role of clinical trials and how they are
publicly perceived
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Oncology Clinical Trials
Optimising Outcomes
Routine cancer care can be enhanced by integrating electronic patient-reported outcomes and clinical outcome assessments. Katie Garner at CRF Health examines how.
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The Patient Experience
The Engagement Equation
Modern clinical trials rely on patient engagement. Aaron Fleishman and Sarah Mandracchia at BBK Worldwide analyse the new tools and techniques that must be utilised to ensure all trial stages are successful.
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Digital and Cloud Developments
Revolution or Evolution?
As the industry begins to embrace new clinical methods, David Goldston at Veracity Logic considers how it disrupts conventional, long-standing trial management.
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News and Press Releases |
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MedPharm Expands Relationship With Novan On Formulation Science
MedPharm Ltd, a leader in topical and transdermal drug delivery, has
expanded its relationship with the NASDAQ listed biopharmaceutical
company Novan Inc.
MedPharm has previously supported Novan by testing the company’s unique
formulations using its proprietary in vitro models to optimise Novan’s
formulations and de-risk product development.
More info >> |
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White Papers |
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Orthogonal Approaches for the Analysis of Protein Sequence and Post Translational Modifications of a Monoclonal Antibody
RSSL
Monoclonal antibodies are an important class of biopharmaceuticals. They are expressed from living cells and therefore, are subject to complex biochemical pathways. Not all of these pathways are fully understood and many are known to be sensitive to subtle environmental changes during production. These changes may affect the final biopharmaceutical sequence, structure and post-translational modifications. This is in addition to any changes that may occur during subsequent purification. This means that the final product from one batch may be subtly different from another batch. Furthermore, each batch is a heterogeneous mix of similar molecules. Analysis of the degree of batch-tobatch variation, and batch heterogeneity, is therefore, very important to establish in order to be confident that the drug is safe and effective for medicinal use.
More info >> |
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Industry Events |
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ESMO Targeted Anticancer Therapies Congress 2020
2-4 March 2020, Paris, France
A unique and international mix of experts, researchers and decision
makers both from academia and industry across the globe, will convene
in Paris for a three-day Congress aiming at exchanging knowledge,
experience and research innovations in cancer.
TAT
2020 will focus, among others, on novel strategies in immuno-oncology,
personalised medicine and molecular tumour boards, preclinical studies
to identify effective combination therapies, use of microbiome, tumour
agnostic trials, ADC technology, oncolytics, multispecific biological
constructs and targeting cytokines.
Participating in TAT 2020 will offer you the possibility to take part in
interdisciplinary discussions inspiring new ideas and new
collaborations.
More info >> |
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