How can early and effective decision making be made easier with novel imaging of biomarkers and high-quality quantitative imaging trials? Pharma and medical device companies have been answering this question with the support of GE Healthcare’s Imanet, an imaging solutions business, for the past ten years.
Since 2001, one of Imanet’s core efforts has been conducting exploratory phase Positron Emission Tomography (PET) imaging studies to aid in drug development for the pharmaceuticals industry since 2001. From PET micro-dosing to dose-occupancy profiles, PET imaging assists decision makers to select the best drug candidate, monitor treatment response and make informed portfolio management decisions. To be really successful, the company also believes that imaging in support of pharma and device trials needs to address a number of specific issues about quality, choice of imaging sites, novel imaging and analysis methods.
Imanet combines PET imaging with their second area of emphasis: broad clinical R&D imaging capabilities. This covers everything from imaging protocol development to analysis of the image data using dedicated methodology and software tools. The in-house team can deliver blinded read hosting and operates out of centres of expertise in six countries worldwide.
Imanet’s PET imaging services for drug development have emerged as both tactical and strategic methods to evaluate drug candidates in specific trials and drug programs. Radiotracers for PET have been used extensively for product and dosage selection in micro-dosing to Phase II studies. The in vivo monitoring of treatment response at a molecular level using PET is also well suited for molecularly targeted therapeutic drugs in development. De novo tracer development or radiolabelling of therapeutic candidates allows for subsequent down-selection of molecules in a drug portfolio via in vitro, ex vivo, and in vivo preclinical methods. The success of our clients’ use of PET imaging solutions is critically dependent on the most effective study design.
As an imaging solutions business, Imanet provides a comprehensive imaging trial management service, which encompasses the initial design through to reporting endpoints.
Our comprehensive imaging trial services include the following:
- Protocol development and integrated electronic Case Report Form (CRF) production
- Imaging site set-up including safety evaluations, imaging procedures and hands-on training of personnel, and alignment to local practices, ensuring the right combination of clinical expertise, patient population and imaging equipment
- Submissions to regulatory authorities and ethics boards, including documentation that ensures regulatory compliance with the Imaging Manual, Image Quality Control Manual and Image Transfer Manual.
- Image transfer, automated anonymisation, effective real-time quality control checks and site feedback to reduce the number of non-evaluable image datasets
- Qualitative and quantitative analysis of results (safety, dosimetry and efficacy)
- Blinded reads, statistical analysis and endpoint reporting.
Imanet has insight into the challenges of PET in drug trials and experience of providing solutions using PET imaging in clinical trials worldwide.