News
IXICO’s CEO, Derek Hill to Participate in the Coalition Against Major Diseases (CAMD) Consortium
London, England – January 28th, 2010
IXICO, Ltd. announced today that Derek Hill, PhD, its CEO, has been invited to participate in the Coalition Against Major Diseases (CAMD) Consortium, founded by the Critical Path Institute (C-Path), in collaboration with the Engelberg Center for Health Care Reform at the Brookings Institution. As a participant, Prof. Hill will help the Consortium achieve its goals in better understanding and defining the devastating effects of neurodegenerative diseases.
The initial goal of CAMD is to define clinical data standards and establish a pooled database of the control groups of pharmaceutical clinical trials in order to develop quantitative disease progression models for both Alzheimer's and Parkinson's diseases.
The CAMD brings together major pharmaceutical companies, the US Food and Drug Administration (FDA), the European Medicine Agency (EMEA), the National Institute on Aging (NIA), the National Institute of Neurological Disorders and Stroke (NINDS), and patient groups in a collaboration to develop new knowledge that will enhance the medical product industry’s ability to develop innovative new therapies. The objective is to establish CAMD as a neutral ground where the regulatory agencies (FDA, EMEA), pharmaceutical industry (16 members so far), patient advocacy groups, and government agencies (NINDS and NIA) can come together to discuss the science with the aim of packaging it in a form that is actionable by the regulatory agencies. The members are the stakeholders in the therapeutics enterprise and the output from CAMD is reflective of both the science and the needs of the industry.
The Consortium has the specific aims of:
- Developing an integrated database of aggregated control group trial data in standardized format;
- To submit biomarkers to the FDA for possible qualification;
- To submit quantitative models of disease progression to the FDA for possible qualification.
CAMD members will collaborate to gather and submit the evidence necessary for the FDA and EMEA to officially designate such tools as "qualified for use" in drug development. These newly qualified tools will be made publicly available for use by scientists and commercial developers alike.
The CAMD Consortium is split into four Workgroups: Alzheimer’s Disease (AD) Biomarkers Evaluation, Data, Disease Progression Modeling, and Health Authorities Submissions.
Prof. Hill will take part in the AD Biomarkers Evaluation Workgroup, which aims to establish a process and execute a plan for compiling and evaluating the scientific merit of reported biomarkers (including imaging data) that are potentially useful in drug or diagnostic test development. Specific objectives are to:
- Establish a process for collating a comprehensive list of potential biomarkers using publicly available data and CAMD members’ proprietary data;
- Establish an evidence-based process incorporating current methods to assess scientific strength of candidate biomarkers;
- Determine which biomarkers should have priority for further development efforts, as well as specific use contacts;
- Determine when biomarkers have sufficient evidence to be submitted to the biomarker qualification process with FDA and EMEA;
- Integrate biomarker data into quantitative disease-progression models and use evolving disease models to help with the evaluation of biomarkers.
CAMD participants include the following:
- Abbott
- Alliance for Aging Research
- Alzheimer's Association
- Alzheimer's Foundation of America
- AstraZeneca Pharmaceuticals LP
- Bristol-Myers Squibb Company
- Daiichi Sankyo
- Eli Lilly and Company
- Forest Research Institute
- Genentech Inc.
- GlaxoSmithKline
- Johnson & Johnson
- National Health Council
- Novartis Pharmaceutical Corporation
- Parkinson's Action Network
- Parkinson's Disease Foundation
- Pfizer, Inc.
- Roche
- Sanofi-Aventis, US, Inc.
- Schering-Plough
- Wyeth Pharmaceuticals, Inc.
About Critical Path Institute
C-Path is an independent, non-profit organization uniquely dedicated to implementing the FDA's Critical Path Initiative by creating collaborations among regulators (scientists from the FDA) and the regulated (medical product industry) that result in accelerated development of safe, new medical products.
About IXICO
IXICO offers a full range of Imaging CRO services including comprehensive, technology-based solutions for the pharmaceutical, biotech and medical device industries across all therapeutic areas and clinical trial phases. IXICO recently released Trial Wire, its free, web-based image management tool. IXICO works within an ISO9001:2000 certified Quality Management System.
For more information please contact: Erin Coberth, Contracts & Proposals Manager at erin.coberth@ixico.com or by phone +44 207 691 2064
Company address: The London Bioscience Innovation Centre, 2 Royal College Street, London NW1 0NH England - www.ixico.com
© 2010 IXICO LTD. All rights reserved
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IXICO Appoints Andy Richards as Chairman to initiate next phase of growth
London, England. For immediate release – September 22nd, 2009
IXICO is delighted to announce that on 2nd September, Dr. Andy Richards joined the board as Chairman. Dr Richards is an established bio-science entrepreneur who has been instrumental in the founding or growth of several successful and innovative Healthcare companies including Chiroscience, Arakis, Cambridge Biotechnology, Altacor and Vectura. He has a track record in transforming companies from science based start ups to commercial ventures that raise funds and achieve successful exits. He has wide experience of commercialisation partnerships, M&A transactions and of private and public market financings.
Dr Richards will be joining the Board of IXICO to help steer it through its next phase of growth as it expands its Imaging CRO services business and prepares to launch a new series of technology products that will transform the way that medical images are managed throughout the healthcare sector. IXICO’s technology products include Trial WireTM-free, which was launched in April as a tool for sharing de-identifying and organization of medical image data for research purposes, and Trial TrackerTM, being launched this month, our next-generation image management solution that enables trial sponsors to track and control their data. Both products will be demonstrated at MICCAI, London and WMIC, Montreal in September.
In addition to his role on IXICO’s board, Dr Richards holds other non-executive director positions including Vectura group plc, Summit Corp plc, Altacor, Biowisdom, Babraham Bioscience Technology and Cancer Research Technology (the commercial arm of CR-UK). He is a director of the UK Bio-industry Association and was recently voted both Cambridge Evening News Businessman of the Year and one of the Top100 Living Contributors to Biotechnology.
Derek Hill, IXICO’s CEO said “We are very excited that Andy has joined our board. His enthusiasm, energy and experience will be invaluable as we take our business forward and explore the many opportunities available to us to enhance the way imaging is used in clinical trials, and explore new avenues for our technology.”
Andy Richards commented “IXICO is an exciting and entrepreneurial healthcare information technology (HCIT) business. The solid commercial platform it has built in CRO services along with its transformational new technologies provide real opportunities for growth. I have been impressed with what Derek and his team have achieved to date and I look forward to help make IXICO an international commercial success”
About IXICO
IXICO is dedicated to improving the field of medical imaging through superior service and enabling technologies that support basic imaging research, routine clinical imaging, and imaging-based clinical trials. In its capacity as a full-service Imaging CRO, the company's Trial Service Division provides comprehensive, technology-based solutions and novel imaging biomarkers for the pharmaceutical and biotech industries across all therapeutic areas and clinical trials phases; from expert acquisition design and imaging site management to image QC and proven analysis techniques, IXICO’s workflow technology and imaging know-how is driven by highly qualified and experienced experts and is underpinned by our robust quality management system. The company's New Product Division provides software solutions for image data management: improved regulatory-compliant image workflows, more efficient project management, data re-use; aggregation of data from multiple studies, and easier sharing and communication of images. To learn more about IXICO's service and product offerings, please visit www.ixico.com
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IXICO, Ltd. Announces Formation of US Operation in Chicago, Illinois
London, England. For immediate release – May 11th, 2009
IXICO, Ltd., a global imaging technology and service company, announced today that it has opened its US operations in Chicago, Illinois. The new entity, formally known as IXICO US LLC, is owned in entirety by IXICO, Ltd., of London, England.
IXICO’s US office will provide business development and project management support to its expanding US customer base. The US office will also help facilitate IXICO’s planned expansion of its imaging center network and partnership alliance.
“We are very excited to extend our functional capabilities across the Atlantic, and Chicago provides a perfect central location to support our customers on both coasts,” said Derek Hill, Ph.D., IXICO’s founding CEO. “Chicago also provides a rich environment of imaging expertise at its local universities, as well as a pool of highly educated, well trained professionals in clinical trials project management.”
IXICO US will be managed by Ciaran Mark Cooper, Vice President US Business Development. “Our extended operational footprint is the perfect complement to our expanding business core,” said Cooper. “In addition to our full-service ICRO capabilities, we have recently released several new web-based image management tools that offer terrific value to our customers, both large and small. These tools can help optimize the communication and image management in the execution of imaging trials while providing significant time and cost savings to our clients. Our US expansion is a further indication of our growing business and continuing success.”
About IXICO
IXICO offers a full range of Imaging CRO services including comprehensive, technology-based solutions for the pharmaceutical, biotech and medical device industries across all therapeutic areas and clinical trial phases. IXICO recently released Trial Wire, its free, web-based image management tool. IXICO works within an ISO9001:2000 certified Quality Management System.
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For more information please contact: Kranti Parekh, Marketing Manager at Kranti.parekh@ixico.com or by phone 0044 207 6913564
Company address: The London Bioscience Innovation Centre, 2 Royal College Street,
London NW1 0NH England - www.ixico.com
© 2009 IXICO LTD. All rights reserved
IXICO launches Trial Wire, a free, web-based tool for de-identifying, organizing, and moving medical image data. London, England.
Today, at the ISMRM conference in Hawaii, IXICO has released a free medical image management tool, Trial Wire. Trial Wire is a web-based tool for de-identifying, organizing, and electronically transferring medical images in the global standard DICOM format. Developed by IXICO's team of in-house medical imaging experts to maximize speed and efficiency of image data management, Trial Wire's unique technology is already being used for handling image data collected at many dozens of sites around the world. IXICO is now making Trial Wire available to anyone interested in medical image data management, whether they are involved in imaging-based clinical trials, research, or simply need a tool for efficient image data management.
Trial Wire 2.0 beta allows users to easily de-identify image data to help maintain compliance with global patient privacy regulations, including HIPPA and the EU Directive on the Protection of Personal Data. The tool also allows users to organize image data into DICOM hierarchical structures and then transfer the data securely over the internet. As a bonus feature, Trial Wire provides a complete audit trail (a record of everything done to the data and by whom it was done), which can be saved electronically or printed and filed. Whether users need to sort through and organize archived image data or securely transfer de-identified data to a CRO or clinical trial sponsor (or simply from a hospital to an adjacent research lab), Trial Wire can be accessed from any web-enabled computer.
"Medical imaging is very widely used for clinical trials and research", said Derek Hill, CEO of IXICO. "However, it is currently a huge amount of effort to handle this data in a way that preserves patient privacy and organizes the data in a way that is easy to use. We wanted to offer a product that addresses the most basic issues of image data management, and make it freely available", said Derek Hill, CEO of IXICO. "By providing de-identification, organization, and transfer in an easy-to-use web-based tool, we believe we can help the entire imaging research community improve its efficiency while ensuring that patient privacy is protected. We believe that the best way to make a positive impact on these issues is to foster the widespread adoption of a single, easy-to-use, web-based tool. No one should have to pay for image data transfer any more than they should have to pay to send an email or other file over the internet. In addition to the secure transfer function, we felt that it was important for users to also be able to organize and de-identify the data through the same tool. Our hope is that with the adoption of Trial Wire throughout the medical imaging world, we'll help our colleagues around the globe solve the most basic set of problems facing us today while also leading the way to greater innovation in other, more complex areas."
The easy-to-use interface is based on a series of pull-down menus and user prompts, which can be customized to user-specific, or trial-specific requirements. Trial Wire is now available online with the following features enabled:
1. Quick and simple setup - Using a simple web-based Java applet, Trial Wire requires no installation or hardware set-up and no dedicated computer. Simply register online for free, and within minutes you can begin to enjoy the benefits.
2 Easy de-identification - Set up the parameters for your trial and save your settings. De-identify standard tags and additionally ask Trial Wire to search for other potentially identifiable tags to alert you to.
3. Logical sort and structure - Read DICOM files from any directory and sort into Subject, Study, Series hierarchy. Output this new structure locally or transfer elsewhere.
4. Secure DICOM transfer with audit trail - Configure Trial Wire to transfer data to your secure FTP server after de-identification and organization. Print off the audit trail report for inclusion in the study folder.
The IXICO team will be demonstrating Trial Wire at ISMRM in Honolulu. Visit them at booth 322 to register for Trial Wire and receive a free gift. Or register for your free Trial Wire account today! To find out more, visit www.mytrialwire.com.