Molecular Imaging & Clinical Trials Consultants
WHAT IS A MOLECULAR IMAGING AND CLINICAL TRIAL CONSULTANT?
Provides expert advice on anatomic & molecular imaging from entire organ systems to small molecules, peptides & antibodies for use in early clinical and clinical settings, trial design, data analysis, image reading as well as with all FDA liaisons, CROs and academic imaging sites.
We reached out to BioMolecular Imaging and Dr. Frost in the process of taking a new imaging agent from preclinical to clinical imaging. Dr. Frost identified several academic imaging institutions for the work and he did the initial vetting from the standpoint of capabilities and timing.
The business case
New imaging center planning
Imaging trial execution
Identification of project sub-specialists
WE HAVE THE ANSWERS
What is the potential value of imaging to my company’s development programs?
What imaging technologies are best suited to my needs?
How do I develop my imaging technology or probe internally or through outsourcing?
How do I identify the best qualified academic sites or CROs for my projects?
When is the best time to introduce imaging into my development plans?
Do I need to develop a new imaging technology or are there established ones I can adopt?
How do I optimize quality, accuracy, timeliness and standardization in my trial design and its execution?
How can I maximally increase my company’s valuation by using imaging in order to leverage existing assets?
AREAS OF FOCUS
Imaging in cancer is an increasing component of BioMolecular Imaging consultancy activities, including the use of small molecule, antibody and peptide imaging technologies. We can help your company in all aspects of cancer imaging, including probe molecule choice, isotope selection, GMP manufacturing, protocol preparation, site selection, and image analysis, including tracer kinetic modeling. Anatomic imaging with, for example, CT and MR imaging is also an area of deep knowledge, whether conducted alone or in conjunction with molecular imaging
CNS imaging is a core area of expertise and experience, going back to the early beginning of molecular imaging when Jim and his group developed some of the very first molecular brain imaging technologies. BioMolecular Imaging can advise and assist your company on small molecule imaging projects across diverse areas, including dementia, movement disorders, mental illness, addiction, cancer, and inflammation.
A very active area of current investigation and commercialization is molecular and functional biomarker development. These biomarkers can serve as surrogate endpoints for therapeutic efficacy and are increasingly viewed by the FDA as highly desirable. Attractive features are reduced trial size, shortened completion time, and reduced cost. Biomarkers can also be extended to use as diagnostic agents, either as stand-alone probes or in combination with therapeutic drugs in order to stratify patients for treatment and outcome monitoring.
Molecular, functional, and anatomic cardiovascular imaging continues to be a topic of increasing interest in diagnostics and drug development, especially as related to obesity and metabolic disease. BioMolecular Imaging possesses knowledge and experience across the conventional radiologic and nuclear medicine imaging technologies and has had direct involvement in cardiovascular molecular imaging, for example in receptor and in membrane potential imaging. We can assist your company in all aspects of early and late phase cardiovascular imaging.
CENTRAL IMAGE INTERPRETATIONS
Jim has extensive experience in central image reads for clinical trials. He is board certified in radiology and in nuclear medicine, and therefore is able to cover most all imaging technologies and disease settings. Due to the structure of BioMolecular Imaging, Jim has the latitude and flexibility to commit to and schedule study reads lasting for a year or longer. Importantly, in past reads Jim has been able to always meet read timelines or complete assigned reads ahead of time, thus providing a major advantage to sponsors in timely trial completion and analysis.