Pharmaceutical Executive Europe - March 2008 - (Page 29) Pharmaceutical Executive Europe March 2008 The Mix 29 Medical Imaging: Calling in the Experts Edward Hogan discusses how medical imaging advisors can help trial sponsors make the right technology decisions cientific advances across a broad range of therapeutic areas are increasing the potential for medical imaging to help establish the safety and efficacy of novel therapies during clinical trials. Many study sponsors now rely on advanced imaging modalities such as computed tomography (CT), ultrasound, magnetic resonance imaging (MRI), and positron emission tomography (PET) to validate drug candidates and support regulatory submissions. While these technologies provide substantial benefits for the development of new drugs and biologics, they also present trial sponsors with new challenges, including selecting the best imaging modality for a particular indication or therapy; developing suitable imaging protocols and disease assessment criteria for a trial; collecting the appropriate type and volume of data for a robust regulatory submission, while controlling costs; and maintaining imaging quality across multiple trial sites that have different equipment and varying levels of technical expertise. Making the right imaging technology decisions could spell the difference between a successful product development programme and one that ends in failure or regulatory delay — outcomes that no biopharmaceutical company can afford in this era of rapidly increasing development costs and intense global competition. To help trials sponsors meet those challenges and successfully leverage advanced imaging technologies for their clinical studies, one technology services provider, Perceptive Informatics, has enlisted a distinguished group of medical imaging experts to serve as scientific advisors for its clients. Leaders representing cardiovascular, musculoskeletal, oncological and central nervous system imaging were selected from major universities and hospitals in both the US and Europe. When the specialised therapeutic area expertise of these advisors is combined with the drug development and regulatory experience of an in-house global medical imaging team, S Making the right imaging technology decisions could spell the difference between a successful product development programme and one that ends in failure. Edward Hogan companies can offer clients access to unmatched scientific, medical, and clinical resources in medical imaging. Using that unique level of support, biopharmaceutical companies can make better-informed decisions about the application of medical imaging in their drug development programmes, from the early stages of preclinical development through to post-marketing studies. One of the most valuable areas where sponsors can effectively utilise the expertise of medical imaging advisors is the application of imaging technologies in early-phase drug development. At this stage, when sponsors are trying to determine which investigational products they should move forward into larger clinical trials, imaging technologies are effective tools to speed up the comparative analysis of potential therapies in a product portfolio. For example, biodistribution and clearance imaging using radio-labelled compounds can be used to document the localisation, passage, and clearance of the substance in the human body — enabling sponsors to identify drug candidates that have the fastest or longest-lasting impact at the target sites, with the safest clearance rates and the least impact on other organs. Advisors with sub-specialised imaging expertise in multiple therapeutic areas can prove invaluable in helping sponsors to select the appropriate technologies, evaluate the resulting images, and identify promising drug candidates. With that information, sponsors can make earlier and better informed “go/no-go” decisions — accelerating the development process and reducing the risk of costly late-stage failures. Another important area where the medical imaging advisors can assist clients is the development of imaging protocols, image acquisition guidelines and disease assessment criteria. It is essential that trial sites gather the right data — and the right amount of data — for the specific indication and therapeutic target. Collecting insufficient images, or using the wrong technology, can cause regulatory questions and delays. On the other hand, collecting too much imaging data — given the cost of operating these complex systems — could increase trial times and costs unnecessarily. Perceptive and its advisors work with clients on the vital issue of maintaining data quality and consistency — key considerations for global trials where image acquisition takes place at multiple sites with differing equipment, technical capabilities and medical practices. With the growing importance of medical imaging for early-stage drug development and pivotal clinical trials, combining world-class scientific advisors with in-house technology and development experts can give your clients a clear advantage in leveraging image technology to speed up product development. About the Author Edward Hogan is vice president, operations, Medical Imaging, at Perceptive Informatics, a PAREXEL company.
Table of Contents Feed for the Digital Edition of Pharmaceutical Executive Europe - March 2008 Pharmaceutical Executive Europe - March 2008 Contents From the Editor News and Analysis Brussels Report Calendar The Next Wave of Pharma Talent The New World Order Share of Voice to Share of Care Notes on a Meeting The Malta Story Motivation Across Borders The Mix No GUTs, No Global Green is Good Last Word Pharmaceutical Executive Europe - March 2008 Pharmaceutical Executive Europe - March 2008 - Pharmaceutical Executive Europe - March 2008 (Page 1) Pharmaceutical Executive Europe - March 2008 - Pharmaceutical Executive Europe - March 2008 (Page 2) Pharmaceutical Executive Europe - March 2008 - Contents (Page 3) Pharmaceutical Executive Europe - March 2008 - From the Editor (Page 4) Pharmaceutical Executive Europe - March 2008 - From the Editor (Page 5) Pharmaceutical Executive Europe - March 2008 - News and Analysis (Page 6) Pharmaceutical Executive Europe - March 2008 - News and Analysis (Page 7) Pharmaceutical Executive Europe - March 2008 - Brussels Report (Page 8) Pharmaceutical Executive Europe - March 2008 - Brussels Report (Page 9) Pharmaceutical Executive Europe - March 2008 - Calendar (Page 10) Pharmaceutical Executive Europe - March 2008 - Calendar (Page 11) Pharmaceutical Executive Europe - March 2008 - The Next Wave of Pharma Talent (Page 12) Pharmaceutical Executive Europe - March 2008 - The Next Wave of Pharma Talent (Page 13) Pharmaceutical Executive Europe - March 2008 - The Next Wave of Pharma Talent (Page 14) Pharmaceutical Executive Europe - March 2008 - The New World Order (Page 15) Pharmaceutical Executive Europe - March 2008 - The New World Order (Page 16) Pharmaceutical Executive Europe - March 2008 - The New World Order (Page 17) Pharmaceutical Executive Europe - March 2008 - Share of Voice to Share of Care (Page 18) Pharmaceutical Executive Europe - March 2008 - Share of Voice to Share of Care (Page 19) Pharmaceutical Executive Europe - March 2008 - Share of Voice to Share of Care (Page 20) Pharmaceutical Executive Europe - March 2008 - Notes on a Meeting (Page 21) Pharmaceutical Executive Europe - March 2008 - Notes on a Meeting (Page 22) Pharmaceutical Executive Europe - March 2008 - Notes on a Meeting (Page 23) Pharmaceutical Executive Europe - March 2008 - The Malta Story (Page 24) Pharmaceutical Executive Europe - March 2008 - The Malta Story (Page 25) Pharmaceutical Executive Europe - March 2008 - The Mix (Page 26) Pharmaceutical Executive Europe - March 2008 - No GUTs, No Global (Page 27) Pharmaceutical Executive Europe - March 2008 - No GUTs, No Global (Page 28) Pharmaceutical Executive Europe - March 2008 - No GUTs, No Global (Page 29) Pharmaceutical Executive Europe - March 2008 - Last Word (Page 30)
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