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Issue 19

You could argue that anything done in a new way, however small, can be counted as an innovation. Introducing innovation at a game-changing level, however, is not so simple, and it's only going to get harder for the pharmaceutical industry.

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Spencer Green
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Sales and the 'Talent Magnet'

A lot is written about being a ‘Talent Magnet’, either as a company, or as President. It’s all good practice – listen, mentor, reward, provide clear goals and career maps. Good practice for the employer, but what about the employee?
26 May 2011

The right PET

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Affiliated with the American College of Radiology (ACR), ACR Image Metrix is an imaging contract research organization (CRO) that improves the efficiency of drug and medical device development programs through the inclusion of appropriate imaging modalities.


Working with Avid Radiopharmaceuticals, a clinical-stage, product-oriented company, ACR Image Metrix is concentrated on protocol requirements, including site qualification, procedures for image acquisition and reconstruction, quality assurance, quality control and centralized interpretation. Critical to streamlining Avid’s clinical trials was the integration of the most appropriate functional imaging modality available − positron emission tomography (PET) − to evaluate target molecular compounds. This article will discuss how ACR Image Metrix implemented PET imaging into a late-stage clinical trial involving one of Avid’s molecular compounds.

PET is an excellent imaging modality to showcase the benefits of molecular biomarkers. The presence of amyloid plaques in the brain is one of the pathologic hallmarks of Alzheimer’s diseases (AD). Because PET scanning effectively highlights amyloid plaques, ACR Image Metrix integrated PET imaging into a late-stage clinical trial utilizing one of Avid’s target agents to detect indicators of AD. Implementation began with ensuring study design regarded PET imaging results as a reliable endpoint. ACR Image Metrix’s expertise was applied in other preliminary aspects of the trial, including site qualification and training. In addition to the subspecialty imaging expertise offered in its imaging core laboratories, ACR Image Metrix provided comprehensive data management, from image acquisition to archival to analysis.

Many of the typical challenges encountered in the implementation of PET imaging in a late-phase clinical trial were averted. Historically, it has been difficult to integrate PET imaging in multicenter trials due to inconsistent site preparation and a lack of standardized operating procedures. Yet in this case, all participating sites were well prepared and qualified due to standardized site training and uniformity in operational protocol. ACR Image Metrix requires standardized imaging protocols across study sites to ensure consistent acquisition techniques, accurate quantitation, reliable interpretation and uniform reporting. This standardized approach promotes the normalization of quantitative data across vendors and platforms in a multicenter trial. 

Avid Radiopharmaceuticals has benefited tremendously from its relationship with ACR Image Metrix. Providing comprehensive imaging services and data management, ACR Image Metrix seamlessly incorporated PET imaging into a late-stage clinical trial involving one of Avid’s molecular compounds. This allowed researchers to assess the efficacy of Avid’s proprietary target agent in the detection of amyloid plaques in AD. PET imaging produced functional imaging data that could either stand alone as an exploratory endpoint or be integrated with anatomic imaging results. Thus, PET technology in this late-stage clinical trial provided valuable information to guide decision-making about the molecular agent’s future.

As imaging technology advances, ACR Image Metrix will strive to remain at the forefront with state-of-the-art molecular imaging modalities capable of monitoring the action of therapeutic candidates in the human body. An industry leader in trial design, imaging techniques and data analysis, ACR Image Metrix has proven experience using cutting-edge technology to provide comprehensive imaging services that streamline clinical trials. The successful implementation of PET imaging in this late-stage clinical trial for Avid Radiopharmaceuticals is yet another success story for ACR Image Metrix.



About

Mehdi Adineh is the Scientific Director of the core laboratory of the American College of Radiology (ACR). He has more than 15 years of experience in the applications of multi-modality image acquisition and processing for various stages of clinical trials. He is a PhD level imaging physicist who has contributed significantly in developing novel imaging techniques for biomarker investigations, as well as verification of imaging instrument performance and standardization of image acquisition protocols across sites.

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