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Posted on 2014-06-10, 17:32 by KOL Project 0 comments Leave a comment Permalink Novel Compound, Novel Mechanism and a Novel Journey As a physician and a clinical trialist, I was excited when I recently had the opportunity to collaborate in a tripartite early phase research program on an agent that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), that in the near future may profoundly change the treatment landscape for the millions of patients around the world with Familial Hypercholesterolemia (FH) Posted on 2014-05-06, 11:09 by Deirdre Murphy 0 comments Leave a comment Permalink Late Phase Centralised Site Management; An Integrated Approach Toward Risk-Based Monitoring By: Hady Khoury. I have the pleasure of speaking at the DIA China Conference in Shanghai (May 11-14, 2014) on Late Phase Centralised Site Management; An Integrated Approach Toward Risk-Based Monitoring. Posted on 2014-05-02, 14:16 by Deirdre Murphy 0 comments Leave a comment Permalink The Clinical Trial of the Future Dr. Nicholas Alp, Vice President, Drug Development Services at ICON gives his thoughts on what we should expect of the Clinical Trial of the Future. Posted on 2014-04-08, 15:46 by Deirdre Murphy 4 comments Leave a comment Permalink Optimising Operations to Deliver Longitudinal Research in the Peri/Post Approval Space Top 4 Considerations for Optimising Operations to Deliver Longitudinal Research in the Peri/Post Approval Space – the latest blog post by Lee King, MEd - VP Operations and Strategic Programs, ICON Commercialisation and Outcomes Posted on 2014-03-21, 10:05 by Deirdre Murphy 0 comments Leave a comment Permalink Clinical Outsourcing Models: “Drive a Hybrid” Colin Stanley, President of DOCS, looks at an emerging trend in clinical outsourcing that seeks to take the best of both full- service outsourcing and functional service provision to build custom, end-to-end hybrid outsourcing solutions on a sponsor- specific basis Posted on 2014-02-17, 09:43 by Deirdre Murphy 1 comments Leave a comment Permalink 5 Things you need to know about Adaptive Clinical Research 5 things you need to know about Adaptive Clinical Research Posted on 2014-02-06, 11:01 by Deirdre Murphy 3 comments Leave a comment Permalink Strategic Resourcing Watch this short video overview by Paula Mumby, Vice President of Operations Asia Pacific DOCS, of strategic resourcing - what it looks like, trends and key considerations. Posted on 2014-01-13, 11:38 by Deirdre Murphy 0 comments Leave a comment Permalink 2013 ICON Views Blog Posts Proof of Concept and Proof of Value In this video, ICON’s VP of Translational Medicine, Dr. Cyril Clark, shares his perspective on the integration of “proof of concept and proof of value”-- influencing early phase development today. Posted on 2013-11-25, 15:35 by Deirdre Murphy 0 comments Leave a comment Permalink 3 Things you need to know about ICONIK 3 things you need to know about ICONIK, ICON's integrated informatics platform that provides transparency and visibility of all clinical and operational data in near real time. Posted on 2013-11-14, 14:04 by Deirdre Murphy 0 comments Leave a comment Permalink Final Rule on Safety Reporting Hear from Marcin Wlodarczyk, Vice President of Medical Affairs at ICON, on what the FDA is expecting of Pharmaceutical Companies following the “Final Rule on Safety Reporting” for drugs and biological projects. Posted on 2013-09-24, 18:45 by Deirdre Murphy 0 comments Leave a comment Permalink The Development Safety Update Report 2 Years On – What Have We Learned? The DSUR has been used for almost 2 years now, and during that time various lessons have emerged with the legislation, DSUR submission, health authority expectations and more. In this article, we weigh up the worldwide requirements for submission with our own experience of writing DSURs Posted on 2013-08-15, 16:10 by Deirdre Murphy 0 comments Leave a comment Permalink Novel Imaging Methods Watch this short video from Dr.Greg Goldmacher of ICON on novel imaging methods being used today. Posted on 2013-08-07, 15:13 by Deirdre Murphy 0 comments Leave a comment Permalink Oncology Biomarker: Circulating Tumour Cells Circulating tumour cell (CTC) is increasingly seen as a strong prognostic factor for overall survival in patients with metastatic breast. Dr. Chengsen Xue discourses CTC’s as a biomarker for clinical trials, as well as presenting an exciting overview of the present and future of CTC technology Posted on 2013-07-23, 14:31 by Deirdre Murphy 0 comments Leave a comment Permalink Biomarker Strategies for More Efficient Early-Phase Drug Development in Alzheimer's Disease In June of this year ICON hosted a webinar titled “Biomarker Strategies for More Efficient Early-Phase Drug Development in Alzheimer's Disease” through DIA’s Solution Provider Webinar platform: ICON’s Prof. Dr. Klaudius Siegfried and three distinguished speakers summarised the progress that researchers are making in using biomarkers to diagnose AD, stage the disease and select trial participants. Read Prof. Dr. Siegfried’s synopsis of the event. Posted on 2013-07-16, 11:17 by Deirdre Murphy 0 comments Leave a comment Permalink Risk Based Monitoring The ability to access real time data in relation to clinical trials is revolutionising the drug development process – hear from Malcolm Burgess, ICON’s Executive Vice President of ICONIK on Risk Based Monitoring. Posted on 2013-06-26, 16:32 by Deirdre Murphy 1 comments Leave a comment Permalink Proof of Concept and Proof of Value –Inexorably Interlinked or Destined to Meet Too Late? As part of ICON’s partnership with Oxford Biotech Network (OBN), Cyril Clarke recently attended Biotrinity; a partnering and investment conference that brings together more R&D companies with big pharma and investors than any other European partnering conference. Over 890 global delegates from 28 countries gathered at a rain sodden Newbury Race course –May 14-16, 2013 Posted on 2013-06-12, 16:11 by Deirdre Murphy 1 comments Leave a comment Permalink Document templates and dot files: medical writing improvements for study-related documents One characteristic shared by most medical writers is their ability to adapt to different sponsor requirements. Unfortunately, that adaptability is sometimes stretched to the limit and things can turn rather ugly when document formatting falls apart. Posted on 2013-05-22, 11:06 by Deirdre Murphy 2 comments Leave a comment Permalink Combating Cancer Amidst the Cherry Blossoms This year’s American Association for Cancer Research annual meeting presented three clear trends: 1. Immunotherapy in the active treatment of cancer and curable metastatic diseases. 2. More widely deploying molecular biomarkers from an understanding of genomics. 3. More focused research on the treatment of tumor cell invasion and metastasis -- a core problem of cancer. Detection of CTC is at the forefront of the focus on invasion on metastasis in cancer research. Because of the progression in the field of CTC detection, knowledge and insight regarding these critical tumor cells is rapidly accumulating. A number of top pharmaceutical companies and research organisations utilise CTC technology. A Veridex instrument is utilised in the R&D department at ICON Central Laboratories Farmingdale, New York facility. Posted on 2013-05-13, 15:21 by Deirdre Murphy 2 comments Leave a comment Permalink Flow Cytometry Society Meets in NYC Tom McCloskey discusses the latest from the Flow Cytometry Society of NY. Lectures covered designing panels consisting of fluorochrome conjugated monoclonal antibodies or dyes to identify discrete subpopulations of cells in a homogenous sample, and optimising flow cytometer performance for polychromatic flow cytometric measurements. Posted on 2013-03-28, 09:10 by Deirdre Murphy 1 comments Leave a comment Permalink Oncology Clinical Trial Endpoints – Keys to Maximising Success in Your Development Posted on 2013-03-15, 18:53 by Deirdre Murphy 1 comments Leave a comment Permalink Managing Central Laboratories Logistics Budgets with ever Evolving Study Demands I recently had the pleasure in presenting at a workshop in London hosted by the PCMG (Pharmaceutical Contracts Management Group), a dedicated and unique association of outsourcing professionals working in research and development functions within the pharmaceutical industry. Posted on 2013-03-12, 10:05 by Deirdre Murphy 1 comments Leave a comment Permalink Changes to the Periodic Safety Update Report (PSUR) July 2012 As a result of changes to the PSUR guidelines in July 2012, the way we write all PSURs will be affected. These changes put more emphasis on risk-benefit, and introduce measures that should help streamline the writing of safety documents. The good pharmacovigilance practice (GVP) guidelines came into effect in July 2012. The guidelines bring together a set of measures drawn up to facilitate the performance of Pharmacovigilance (PV) in the European Union (EU). The GVP guidelines are divided into 16 modules, each covering a major process in PV. Module VII discusses changes to the format and content of the PSUR. Posted on 2013-01-22, 14:47 by Vanessa Byrne 5 comments Leave a comment Permalink 2012 Icon Views Blog Posts A change of scope in early phase trials is on the horizon. The combination of increased R&D efforts in targeted therapies and the high failure rates in late stage trials will soon change the endpoints of early phase trials. The major change will be to focus more on proof-of-mechanism and proof-of-concept studies, in addition to safety and dose finding analysis. The ability to confirm that a drug has a viable chance of reducing symptoms or modifying disease ensures that only the most promising drugs will proceed through the development cycle. Furthermore, the removal of poorly performing compounds early on will potentially reduce R&D costs. Posted on 2012-10-24, 18:46 by Deirdre Murphy 2 comments Leave a comment Permalink Paediatric Psychopharmacology – Challenges, Unmet Needs and Consequences for Clinical Development Over the last 10 to 15 years, several regulatory measures have been taken by the FDA and the European authorities to stimulate clinical development and the systematic collection of evidence in paediatric pharmacology. Posted on 2012-09-12, 08:43 by Deirdre Murphy 1 comments Leave a comment Permalink No Pain, No Development Gain Over the last twenty years there has been a significant change in the approach taken to the early stages of clinical development. Early studies with a new compound are no longer focused purely on safety, tolerability and PK but are layering in techniques to better understand and characterise a molecule in terms of putative efficacy, wanted and undesired side effects, time course of pharmacodynamic effects and competitive performance to existing therapies. Posted on 2012-09-03, 10:39 by Development 1 comments Leave a comment Permalink Personalised medicine in oncology and the implication for clinical development The incremental progress in tumor biology, genomics and imaging technology, has amplified the promise to individualise oncology care. Personalised medicine in oncology offers the hope of delivering the right treatment, to the right patients, to improve quality of life and clinical benefit to the patient, while reducing exposure to ineffective therapies and the cost of cancer care. Posted on 2012-07-30, 10:55 by Deirdre Murphy 2 comments Leave a comment Permalink The Value of Strategic Epidemiology to Inform Product Development and Commercialisation The following article was Contributed by: Adrian Levy PhD, Senior Scientific Advisor, Oxford Outcomes (an ICON plc Company) and Nigel Gregson, Partner, PriceSpective (an ICON plc Company) to the June edition of PharmaVoice Posted on 2012-06-01, 16:47 by Deirdre Murphy 2 comments Leave a comment Permalink Cardiovascular Outcomes Studies Since the publication of the ISIS-1 Trial in the mid 1980s, clinical outcomes studies have provided a broad and robust evidence base for cardiovascular medical practice. Posted on 2012-04-26, 10:39 by Deirdre Murphy 1 comments Leave a comment Permalink FDA Issues Draft Guidance’s on Biosimilars FDA Issues Draft Guidance’s on Biosimilars Commentary/insight by Tim Clark, VP Scientific Affairs, ICON Clinical Research Posted on 2012-02-23, 12:34 by Deirdre Murphy 1 comments Leave a comment Permalink Phase I Study Evaluating the Safety and Pharmacokinetics of MDX-1303, a Fully Human Monoclonal Antibody against Bacillus anthracis Protective Antigen, in Healthy Volunteers Article published in December 2011, co-authored by Melany Adamcio, IDS Medical Monitor Assoc, featuring a Phase I study of a fully human monoclonal antibody (MDX-1303 ) to characterize the safety, tolerability, immunogenicity, and PK/PD in healthy human subjects. Posted on 2012-01-17, 10:45 by Deirdre Murphy 1 comments Leave a comment Permalink Concomitant blockade of 5-HT1A receptor and 5-HT transporter: Use of the Hunter Serotonin Toxicity Criteria in a clinical pharmacology study John Connell, Vice President Pharmacodynamics, ICON Development Solutions, had the article entitled “Concomitant blockade of 5-HT1A receptor and 5-HT transporter: Use of the Hunter Serotonin Toxicity Criteria in a clinical pharmacology study” recently published in European Neuropsychopharmacology. Posted on 2012-01-10, 14:44 by Deirdre Murphy 2 comments Leave a comment Permalink 2011 ICON Views Blog Posts Clamping Down Clay Dehn, Director of Metabolic Research, ICON Development Solutions, had the article entitled “Clamping Down” recently published in International Clinical Trials (ICT). Posted on 2011-10-18, 14:51 by Deirdre Murphy 2 comments Leave a comment Permalink To Maximise Market Access: Start Early and Update Often Andrew Briggs, Ph. D. Senior Scientific Advisor @ Oxford Outcomes (an ICON plc Company). Writes on Why to maximize market access you need to start early and update often. Posted on 2011-09-21, 10:27 by Deirdre Murphy 1 comments Leave a comment Permalink Print page Email to a friend Twitter Facebook Linkedin Disclaimer Privacy Policy Sitemap Cookies