Extension of molecular or animal preclinical imaging results to human clinical trials for new therapeutics or diagnostics can be a major challenge.
BioMolecular Imaging can guide your company through the initial considerations and decision making to approval for the first human subject to final approval. Identifying the best molecular probe, the radioactive isotope, the most efficient clinical design and the experiences sites are some of the key decisions.
Within the broad decisions, with which a company is faced, addressing the fine detail is paramount. Accurate estimates of radiation absorbed dose is a requirement for new clinical imaging probes; Dr. J. James Frost has the needed experience in this area and with the companies who can execute the animal studies and perform the calculations for human subjects. As a member of the Johns Hopkins IRB for over 20 years, we can also guide your company in the intricacies of human research and approval.
The go/no-go decision is a most critical decision along the several nodes of the pathway to approval – both go and no-go decisions have profound financial implications. BioMolecular Imaging has been key in helping companies across this divide for numerous new therapeutic and diagnostic imaging agents.
The chances of scientific and clinical success are the key and require a detailed analysis of the results to date; time factors; site, approval, and other uncertainties; data analysis; and market opportunity. Integration of therapeutics and diagnostics into companion diagnostics or theronositics represent an added challenge where we have the requisite experience and insight.
Companies and academic institutions often determine that a new molecular imaging center is required within their enterprise. Dr. J. James Frost has been involved in several new imaging centers, including the strategic plan for molecular or disease focus; the design, including cyclotron, radiochemistry modules; PET/SPECT scanners; and needed scientific and clinical personnel.
Center funding and year-to-year budgeting is a key aspect. Center start-up to the first clinical subjects to trial or scientific results is important for followthrough.
About BioMolecular Imaging
BioMolecular Imaging (BMI Consultants) is a molecular imaging and clinical trial consultancy owned and operated by Dr. J. James Frost M.D./Ph.D out of Baltimore Maryland. BMI has been involved with clinical, therapeutic & diagnostic imaging focused on Oncology, Brain, Biomarkers, Cardiology and Central Image Interpretations for over 20 years.
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