The Challenges

Establishing and Maintaining a Sustainable PET Research Centre

To appreciate how The PRA Company could advise organizations it is appropriate to define what are the scientific and logistical challenges it can help address.

The Scientific Challenges

These rest foremost on defining the clinical research questions that could be answered with PET based molecular imaging to provide relevant new information that could not be derived in any other way. To answer these questions, experimental paradigms have to be designed to provide statistically significant results. These paradigms which will rest heavily on accessing specific validated imaging biomarkers, suitably radio labeled for human administration, need to produce quantitative values for molecular binding sites or pathways.

The road map to scientific evolution within an organization will rest on a multi-disciplinary approach with iteration between clinical research questions and methodology development and support. There will be a need to foster productive intra and inter institute collaborations along with an evolution to answering more advanced research questions through methodological developments which bring about improved specificity and sensitivity.

The Logistical Challenges

Working with imaging biomarkers with a shelf life of minutes and hours is hugely demanding. It includes the on-line cyclotron production of short lived radioisotopes and their rapid incorporation into tracer molecules using remote automated technology under GMP conditions. Coordination is key between these productions and patients being identified and prepared for imaging and undertaking the PET studies which often involve collecting and processing large volumes of kinetically recorded image data.

These operations have to be addressed within the overriding regulatory demands of:

• Production, storage and disposal of radioactivity,
• Manufacturing radio labeled tracers for human administration under GMP
• Experimental human ethics approval
• Permissions to administer radioactivity to humans
• Clinical Research Governance
• The standards of industrial commissioned studies.

Implications

In meeting these challenges, their totality needs to be addressed with experience and vision, without perceived strengths unbalancing strategy as well as overcoming weaknesses in business plans and funding applications.

The implications of these challenges will impact on both research organizations and funding agencies that may be prejudiced against supporting this costly, complex and perceived to be under achieving area.