A European Marie Sklodowska-Curie Actions (MSCA) Innovative Training Network (ITN)
- What and where is the disease?
- Is the disease accurately targeted by the therapy?
- Is the treatment effective?
By answering these questions, PET imaging has the capacity to render much more effectively the transition from pre-clinical to clinical phase, and to strongly facilitate the development of better drugs at an earlier stage and in a much more sustainable manner.
The main obstacle to this change of paradigm in drug design and development is the lack of suitably trained translational scientists directly involved in PET imaging and imaging scientists with high-profile training in chemistry and PET-radiochemistry, which is particularly dramatic in Europe. This consortium is ideally suited to provide top-quality training to the next generation of translational PET imaging scientists who will play a key role in shaping the future of drug design and development.
The PET3D ETN will focus on 15 cutting-edge research projects in the 3 main therapeutic areas oncology, cardiovascular, central nervous system.
(i) To provide cutting edge training to the next generation of translational PET imaging scientists.
PET3D will provide a unique training opportunity that will transfer key multidisciplinary and industry-relevant skills to 15 ESRs for using PET imaging as a key tool in drug design and development. The available research projects will span all of the main therapeutic areas in which PET imaging plays a key role, namely oncology, cardiovascular and neuroscience, and will make use of the whole portfolio of molecular formats available in modern PET imaging, such as small molecules, peptides, nanoparticles and antibody formats using different PET radioisotopes. All of the recruited ESRs will be enrolled in a PhD course, and will develop the research projects in a vibrant cross-sector academic/non-academic training environment. Each ESR will also obtain transferrable and generic skills training – communications, presentation, writing, management, dissemination, intellectual property rights protection, dissemination and exploitation, ethical issues, entrepreneurial initiatives, CV writing and interview training.
(ii) To validate PET imaging as a key technology for drug development
How PET imaging can potentially reduce cost and speed up drug development:
PET imaging can facilitate pre-clinical to clinical phase transition by means of a “Phase 0” study on a small number (10-15) of subjects to (1) validate extending preclinical studies (pharmacokinetics and distribution) to humans and (2) obtain proper dose range for Phase I and II from target occupancy analysis.
PET imaging can be used in Phase I for designing a better Phase II, namely by stratifying patients based on the potential for treatment efficacy and understanding the relationship of target occupancy with toxicity.
In phase II, PET imaging can support the selection of therapy responders and non-responders, and validate blood-concentration as a surrogate for occupancy studies for Phase III. Importantly, using PET imaging in Phase II can help a ‘no go’ decision be made earlier in the drug development process, thus killing the drug candidate before reaching Phase III and saving ca. 3 years and massive economic investments.
Finally, in Phase III PET imaging can be used advantageously to pharmacologically differentiate the new drug (in trial) from marketed drugs or competitor compounds.